FDA product code · Clinical Chemistry
JHIVisual, Pregnancy Hcg, Prescription Use
Product code JHI covers Visual, Pregnancy Hcg, Prescription Use, a Class II device regulated under 21 CFR 862.1155. FDA has cleared 375 devices in this code. Median review time across the 375 most recent decisions is 55 days. openFDA lists 43 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 862.1155
- Review panel
- Clinical Chemistry
- Clearances
- 375
What is happening in JHI right now?
JHI (Visual, Pregnancy Hcg, Prescription Use): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in JHI?
FDA has cleared 375 devices under product code JHI since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241919 | Innovita HCG Pregnancy Rapid Combo Test | Innovita (Tangshan) Biological Technology Co., Ltd. | |
| K203272 | Alltest Pregnancy Rapid Combo Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | |
| K172322 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | |
| K172257 | 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) | True Diagnostics, Inc. | |
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip | Assure Tech. Co., Ltd. | |
| K130456 | WUNDER PREGNANCY TEST | James Nguyen | |
| K132834 | FASTEP S10 HCG SERUM/URINE COMBO TEST | Polymed Therapeutics, Inc. | |
| K131166 | SOFIA(R) HCG FIA | Quidel Corp. | |
| K123844 | CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST | Chemtron Biotech, Inc. | |
| K112101 | FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS | Polymed Therapeutics, Inc. |
How long does FDA review take for JHI?
The median FDA review time for JHI is 55 days, measured across the 375 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in JHI?
openFDA lists 43 recall records against product code JHI. A recall record covers one firm's corrective action and may span many device lots.
Z-0259-2025Open, ClassifiedPrinceton Biomeditech Corp
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.
Z-0048-2024Open, ClassifiedUniversal Meditech Inc.
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.
Z-0050-2024Open, ClassifiedUniversal Meditech Inc.
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.
Z-0061-2024Open, ClassifiedUniversal Meditech Inc.
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.
Z-0063-2024Open, ClassifiedUniversal Meditech Inc.
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.
Showing the 5 most recently initiated of 43. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for JHI?
MAUDE holds 670 adverse-event reports naming product code JHI, 122 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in JHI unusual?
One month sits above JHI's own expected range: 1 January 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 12 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 22 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 22 | Insufficient history | No expected range — too little history | |
| 24 | Insufficient history | No expected range — too little history | |
| 47 | Insufficient history | No expected range — too little history | |
| 26 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 24 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 40 | 3–37 | Above expected (3–37) | |
| 18 | 5–41 | Within expected (5–41) | |
| 18 | 3–44 | Within expected (3–44) | |
| 38 | 4–41 | Within expected (4–41) | |
| 18 | 8–44 | Within expected (8–44) | |
| 29 | 6–43 | Within expected (6–43) | |
| 11 | 11–70 | Below expected (11–70) | |
| 22 | 0–49 | Within expected (0–49) | |
| 18 | 1–48 | Within expected (1–48) | |
| 15 | 0–46 | Within expected (0–46) | |
| 24 | 0–40 | Within expected (0–40) | |
| 8 | 0–46 | Within expected (0–46) | |
| 15 | 0–51 | Within expected (0–51) | |
| 16 | 0–37 | Within expected (0–37) | |
| 15 | 0–41 | Within expected (0–41) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in JHI.
What are the predicate devices in JHI?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in JHI?
Across the 375 most recent decisions, these applicants filed most often in JHI.
| Applicant | Recent clearances |
|---|---|
| Quidel Corp. | 19 |
| Abbott Laboratories | 15 |
| Hybritech, Inc. | 14 |
| Pacific Biotech, Inc. | 13 |
| Leeco Diagnostics, Inc. | 10 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in JHI files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Quidel Corporation | 20 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch JHI
Get an email the morning anything changes in JHI — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.