FDA product code LCX: Kit, Test, Pregnancy, Hcg, Over The Counter
LCX is the FDA product code for kit, test, pregnancy, hcg, over the counter. It is a Class II device, regulated under 21 CFR 862.1155 and reviewed by the Clinical Chemistry panel. FDA has cleared 226 510(k) submissions under LCX, 23 in the last five years, from 120 different applicants. The average 510(k) review took 104 days (median 70); 126 days on average over the last three years. FDA has posted 25 recalls for LCX devices, 15 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 862.1155 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LCX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 217 |
| 2018 | 4 | 147 |
| 2019 | 7 | 102 |
| 2020 | 2 | 234 |
| 2021 | 2 | 384 |
| 2022 | 6 | 252 |
| 2023 | 2 | 132 |
| 2024 | 10 | 143 |
| 2025 | 5 | 108 |
Compare with all 510(k) review times · Search every LCX clearance
Top LCX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Unipath , Ltd. | 20 | 2006-07-03 |
| ACON Laboratories, Inc. | 10 | 2024-05-31 |
| Armkel, LLC | 10 | 2004-10-19 |
| Quidel Corp. | 9 | 1998-06-03 |
| Syntron Bioresearch, Inc. | 6 | 1996-12-02 |
115 more applicants have LCX clearances. See the full list in Caduvo.
Most recent LCX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251040 | Guangzhou Decheng Biotechnology Co., Ltd. | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test | 2025-09-09 | 159 |
| K251053 | Hangzhou AllTest Biotech Co., Ltd. | Shinetell PlusTM Digital Early Pregnancy Test | 2025-07-15 | 102 |
| K250117 | Assure Tech., LLC | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | 2025-02-13 | 28 |
| K242135 | Nanjing Synthgene Medical Technology Co., Ltd. | Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream | 2025-01-31 | 193 |
| K243573 | Assure Tech., LLC | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream | 2025-01-15 | 57 |
Recalls for LCX devices
25 product recalls in 13 recall events; 15 initiated in the last five years and 15 still open. Most recent: 2025-12-26.
| Year | Recalls |
|---|---|
| 2022 | 4 |
| 2023 | 9 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code LCX?
LCX is the FDA product code for kit, test, pregnancy, hcg, over the counter. It is a Class II device, regulated under 21 CFR 862.1155 and reviewed by the Clinical Chemistry panel.
What device class is LCX?
Class II, regulation 21 CFR 862.1155. Typical premarket route: 510(k).
How long does a 510(k) take for product code LCX?
Across 226 cleared submissions the average was 104 days from receipt to decision (median 70).
Which companies have the most LCX clearances?
Unipath , Ltd. (20); ACON Laboratories, Inc. (10); Armkel, LLC (10); Quidel Corp. (9); Syntron Bioresearch, Inc. (6).
Have LCX devices been recalled?
Yes: 25 product recalls across 13 recall events; the most recent began 2025-12-26.
Next steps
- Run an FDA pathway report with predicate devices for product code LCX
- Run a recall and safety report across every LCX manufacturer
- Watch product code LCX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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