{ "code": "JHI", "deviceName": "Visual, Pregnancy Hcg, Prescription Use", "deviceClass": "II", "regulationNumber": "862.1155", "panel": "Clinical Chemistry", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 375, "last12Months": 0 }, "adverseEvents": { "total": 670, "last12Months": 122 }, "reviewDays": { "median": 55, "sampleSize": 375 }, "recalls": { "total": 43, "recent": [ { "resNumber": "Z-0259-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "Princeton Biomeditech Corp", "firmAsPublished": "Princeton Biomeditech Corp", "reason": "This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in false negative results. An end user reported that the OSOM Ultra hCG Combo Test, lot 563L13, produced false negative test results from 2 patient urine samples as confirmed by quantitative hCG and ultrasound. During further root cause testing and investigation, an additional 6 devices were found to produce false negative test results from hCG positive samples.", "initiated": "2024-08-23" }, { "resNumber": "Z-0048-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Universal Meditech Inc.", "firmAsPublished": "Universal Meditech Inc.", "reason": "Universal Meditech Inc. was violatively distributing PrestiBio\" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast\" Ketone Test Strips and PrestiBio\" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.", "initiated": "2023-05-22" }, { "resNumber": "Z-0050-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Universal Meditech Inc.", "firmAsPublished": "Universal Meditech Inc.", "reason": "Universal Meditech Inc. was violatively distributing PrestiBio\" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast\" Ketone Test Strips and PrestiBio\" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.", "initiated": "2023-05-22" }, { "resNumber": "Z-0061-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Universal Meditech Inc.", "firmAsPublished": "Universal Meditech Inc.", "reason": "Universal Meditech Inc. was violatively distributing PrestiBio\" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast\" Ketone Test Strips and PrestiBio\" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.", "initiated": "2023-05-22" }, { "resNumber": "Z-0063-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Universal Meditech Inc.", "firmAsPublished": "Universal Meditech Inc.", "reason": "Universal Meditech Inc. was violatively distributing PrestiBio\" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast\" Ketone Test Strips and PrestiBio\" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.", "initiated": "2023-05-22" } ] }, "recentClearances": [ { "kNumber": "K241919", "deviceName": "Innovita HCG Pregnancy Rapid Combo Test", "applicant": "Innovita (Tangshan) Biological Technology Co., Ltd.", "company": "Innovita (Tangshan) Biological Technology Co., Ltd.", "decisionDate": "2024-08-02", "dateReceived": "2024-07-01" }, { "kNumber": "K203272", "deviceName": "Alltest Pregnancy Rapid Combo Test Cassette", "applicant": "Hangzhou AllTest Biotech Co., Ltd.", "company": "Hangzhou AllTest Biotech Co., Ltd.", "decisionDate": "2022-01-31", "dateReceived": "2020-11-06" }, { "kNumber": "K172322", "deviceName": "Atellica IM Total hCG (ThCG)", "applicant": "Siemens Healthcare Diagnostics, Inc.", "company": "Siemens Healthcare Diagnostics, Inc.", "decisionDate": "2018-03-29", "dateReceived": "2017-08-01" }, { "kNumber": "K172257", "deviceName": "TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)", "applicant": "True Diagnostics, Inc.", "company": "True Diagnostics, Inc.", "decisionDate": "2017-12-22", "dateReceived": "2017-07-26" }, { "kNumber": "K152768", "deviceName": "Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip", "applicant": "Assure Tech. Co., Ltd.", "company": "Assure Tech. Co., Ltd.", "decisionDate": "2016-02-24", "dateReceived": "2015-09-24" }, { "kNumber": "K130456", "deviceName": "WUNDER PREGNANCY TEST", "applicant": "James Nguyen", "company": "James Nguyen", "decisionDate": "2014-04-08", "dateReceived": "2013-02-22" }, { "kNumber": "K132834", "deviceName": "FASTEP S10 HCG SERUM/URINE COMBO TEST", "applicant": "Polymed Therapeutics, Inc.", "company": "Polymed Therapeutics, Inc.", "decisionDate": "2014-01-09", "dateReceived": "2013-09-10" }, { "kNumber": "K131166", "deviceName": "SOFIA(R) HCG FIA", "applicant": "Quidel Corp.", "company": "Quidel Corporation", "decisionDate": "2013-08-02", "dateReceived": "2013-04-24" }, { "kNumber": "K123844", "deviceName": "CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST", "applicant": "Chemtron Biotech, Inc.", "company": "Chemtron Biotech, Inc.", "decisionDate": "2013-05-30", "dateReceived": "2012-12-13" }, { "kNumber": "K112101", "deviceName": "FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS", "applicant": "Polymed Therapeutics, Inc.", "company": "Polymed Therapeutics, Inc.", "decisionDate": "2012-07-17", "dateReceived": "2011-07-22" } ], "topApplicants": [ { "name": "Quidel Corp.", "count": 19 }, { "name": "Abbott Laboratories", "count": 15 }, { "name": "Hybritech, Inc.", "count": 14 }, { "name": "Pacific Biotech, Inc.", "count": 13 }, { "name": "Leeco Diagnostics, Inc.", "count": 10 } ], "topCompanies": [ { "name": "Quidel Corporation", "count": 20, "spellings": 2 }, { "name": "Abbott Laboratories, Inc.", "count": 15, "spellings": 1 }, { "name": "Hybritech, Inc.", "count": 14, "spellings": 1 }, { "name": "Pacific Biotech, Inc.", "count": 13, "spellings": 1 }, { "name": "Leeco Diagnostics, Inc.", "count": 10, "spellings": 1 } ], "newEntrants": [], "baseline": { "months": [ { "month": "2023-01-01", "observed": 12, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 12, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 12, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 14, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 16, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 10, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 10, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 9, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 8, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 17, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 22, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 12, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 19, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 22, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 24, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 47, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 26, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 23, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 24, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 14, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 40, "expectedLow": 2.5200545709544064, "expectedHigh": 37.34905085519964, "isSufficient": true }, { "month": "2025-02-01", "observed": 18, "expectedLow": 4.633100948800347, "expectedHigh": 40.70463948970701, "isSufficient": true }, { "month": "2025-03-01", "observed": 18, "expectedLow": 3.3948939887086285, "expectedHigh": 43.780823749034184, "isSufficient": true }, { "month": "2025-04-01", "observed": 38, "expectedLow": 4.188081115349845, "expectedHigh": 41.276683477241946, "isSufficient": true }, { "month": "2025-05-01", "observed": 18, "expectedLow": 7.776905807394317, "expectedHigh": 43.6001268361759, "isSufficient": true }, { "month": "2025-06-01", "observed": 29, "expectedLow": 5.896734132712046, "expectedHigh": 42.72865564985281, "isSufficient": true }, { "month": "2025-07-01", "observed": 11, "expectedLow": 11.22998540906347, "expectedHigh": 69.5588953495391, "isSufficient": true }, { "month": "2025-08-01", "observed": 22, "expectedLow": 0, "expectedHigh": 49.400356366935945, "isSufficient": true }, { "month": "2025-09-01", "observed": 18, "expectedLow": 1.367888367349126, "expectedHigh": 47.57459199485544, "isSufficient": true }, { "month": "2025-10-01", "observed": 15, "expectedLow": 0, "expectedHigh": 45.853935593222076, "isSufficient": true }, { "month": "2025-11-01", "observed": 24, "expectedLow": 0, "expectedHigh": 40.193596391500186, "isSufficient": true }, { "month": "2025-12-01", "observed": 8, "expectedLow": 0, "expectedHigh": 46.31083441409952, "isSufficient": true }, { "month": "2026-01-01", "observed": 15, "expectedLow": 0, "expectedHigh": 50.80419857453155, "isSufficient": true }, { "month": "2026-02-01", "observed": 16, "expectedLow": 0, "expectedHigh": 37.288766885684915, "isSufficient": true }, { "month": "2026-03-01", "observed": 15, "expectedLow": 0, "expectedHigh": 41.010396218909534, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "JHI (Visual, Pregnancy Hcg, Prescription Use): nothing changed in the six FDA sources we watch.", "severity": 1, "factors": [], "sourcesChecked": [ "predicate ancestry", "recalls", "adverse events", "new entrants", "review time", "crowding" ] }, "predicatePreview": { "edges": [], "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet." }, "sources": [ { "label": "classification", "url": "https://api.fda.gov/device/classification.json?search=product_code%3AJHI" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJHI" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJHI" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJHI" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJHI" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJHI" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJHI" } ], "provenance": [ { "dataset": "device/510k", "loadedAt": "2026-08-10T19:40:09Z", "ingestRun": 51, "exportDate": "2026-08-08" }, { "dataset": "device/classification", "loadedAt": "2026-08-10T06:54:18Z", "ingestRun": 2, "exportDate": "2026-08-08" }, { "dataset": "device/enforcement", "loadedAt": "2026-08-10T19:40:12Z", "ingestRun": 53, "exportDate": "2026-08-04" }, { "dataset": "device/event", "loadedAt": "2026-08-11T13:49:57Z", "ingestRun": 73, "exportDate": "2026-08-11" }, { "dataset": "device/recall", "loadedAt": "2026-08-10T19:40:11Z", "ingestRun": 52, "exportDate": "2026-08-08" }, { "dataset": "device/registrationlisting", "loadedAt": "2026-08-10T07:06:24Z", "ingestRun": 10, "exportDate": "2026-08-08" } ], "retrievedAt": "2026-08-11T13:51:45.718Z" }