FDA product code LCP: Assay, Glycosylated Hemoglobin
LCP is the FDA product code for assay, glycosylated hemoglobin. It is a Class II device, regulated under 21 CFR 864.7470 and reviewed by the Hematology panel. FDA has cleared 249 510(k) submissions under LCP, 3 in the last five years, from 118 different applicants. The average 510(k) review took 146 days (median 100); 931 days on average over the last three years. FDA has posted 103 recalls for LCP devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Assay, Glycosylated Hemoglobin |
| Device class | Class II |
| Regulation | 21 CFR 864.7470 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
510(k) clearances per year for LCP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 244 |
| 2018 | 2 | 362 |
| 2019 | 4 | 238 |
| 2020 | 1 | 153 |
| 2023 | 2 | 418 |
| 2024 | 1 | 931 |
Compare with all 510(k) review times · Search every LCP clearance
Top LCP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories | 19 | 1995-07-11 |
| Bio-Rad | 15 | 2000-12-19 |
| Bio-Rad Laboratories, Inc. | 8 | 2014-06-25 |
| Metrika, Inc. | 7 | 2005-06-13 |
| Abbott Laboratories | 7 | 2000-05-25 |
113 more applicants have LCP clearances. See the full list in Caduvo.
Most recent LCP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221326 | Nova Biomedical Corporation | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | 2024-11-22 | 931 |
| K231465 | Qurasense | Q-Pad Test System | 2023-12-06 | 201 |
| K214117 | Abbott Diagnostics Technologies AS | Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer | 2023-09-27 | 636 |
| K192987 | Jana Care, Inc. | Aina HbA1c Monitoring System 2 | 2020-03-26 | 153 |
| K192369 | Ixensor Co, Ltd. | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | 2019-10-29 | 60 |
Recalls for LCP devices
103 product recalls in 48 recall events; 6 initiated in the last five years and 5 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 4 |
| 2020 | 3 |
| 2022 | 1 |
| 2024 | 3 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code LCP?
LCP is the FDA product code for assay, glycosylated hemoglobin. It is a Class II device, regulated under 21 CFR 864.7470 and reviewed by the Hematology panel.
What device class is LCP?
Class II, regulation 21 CFR 864.7470. Typical premarket route: 510(k).
How long does a 510(k) take for product code LCP?
Across 249 cleared submissions the average was 146 days from receipt to decision (median 100).
Which companies have the most LCP clearances?
Helena Laboratories (19); Bio-Rad (15); Bio-Rad Laboratories, Inc. (8); Metrika, Inc. (7); Abbott Laboratories (7).
Have LCP devices been recalled?
Yes: 103 product recalls across 48 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LCP
- Run a recall and safety report across every LCP manufacturer
- Watch product code LCP 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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