FDA product code · Clinical Chemistry
LCXKit, Test, Pregnancy, Hcg, Over The Counter
Product code LCX covers Kit, Test, Pregnancy, Hcg, Over The Counter, a Class II device regulated under 21 CFR 862.1155. FDA has cleared 226 devices in this code, 1 of them in the last 12 months. Median review time across the 226 most recent decisions is 69 days. openFDA lists 25 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 862.1155
- Review panel
- Clinical Chemistry
- Clearances
- 226
What is happening in LCX right now?
LCX (Kit, Test, Pregnancy, Hcg, Over The Counter) has one finding. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1184-2026, Z-0749-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1184-2026, Z-0749-2026 |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in LCX?
FDA has cleared 226 devices under product code LCX since the 510(k) programme began in 1976, 1 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test | Guangzhou Decheng Biotechnology Co., Ltd. | |
| K251053 | Shinetell PlusTM Digital Early Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | Assure Tech., LLC | |
| K242135 | Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream | Nanjing Synthgene Medical Technology Co., Ltd. | |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream | Assure Tech., LLC | |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip | Andon Health Co, Ltd. | |
| K240242 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) | Anhui Deepblue Medical Technology Co., Ltd. | |
| K241978 | Shinetell Digital Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream | Guangzhou Decheng Biotechnology Co., Ltd. | |
| K232715 | Distinct® Digital Pregnancy Test | ACON Laboratories, Inc. |
How long does FDA review take for LCX?
The median FDA review time for LCX is 69 days, measured across the 226 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 LCX?
openFDA lists 25 recall records against product code LCX. A recall record covers one firm's corrective action and may span many device lots.
Z-1184-2026Open, ClassifiedGOLD STAR DISTRIBUTION INC
Potential exposure of rodents and rodent activity in the distribution center.
Z-0749-2026Open, ClassifiedGET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
Z-0261-2024Open, ClassifiedFamily Dollar Stores, Llc.
Products were stored outside of labeled temperature requirements.
Z-0264-2024Open, ClassifiedFamily Dollar Stores, Llc.
Products were stored outside of labeled temperature requirements.
Z-0266-2024Open, ClassifiedFamily Dollar Stores, Llc.
Products were stored outside of labeled temperature requirements.
Showing the 5 most recently initiated of 25. 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 LCX?
MAUDE holds 14 adverse-event reports naming product code LCX.
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 LCX unusual?
LCX does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history |
7 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.
What are the predicate devices in LCX?
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 LCX?
Across the 226 most recent decisions, these applicants filed most often in LCX.
| Applicant | Recent clearances |
|---|---|
| Unipath , Ltd. | 20 |
| ACON Laboratories, Inc. | 10 |
| Armkel, LLC | 10 |
| Quidel Corp. | 9 |
| Syntron Bioresearch, Inc. | 6 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch LCX
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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.