Product code LCP: 510(k) clearances and predicates
Product code LCP covers PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit. FDA lists 249 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
249 clearances on file under product code LCP. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest LCP clearances in the FDA index, with applicant and decision date:
- K221326, Nova Allegro HbA1c Assay, Nova Allegro Analyzer, applicant Nova Biomedical Corporation, decided 2024-11-22. FDA record
- K231465, Q-Pad Test System, applicant Qurasense, decided 2023-12-06. FDA record
- K214117, Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer, applicant Abbott Diagnostics Technologies AS, decided 2023-09-27. FDA record
- K192987, Aina HbA1c Monitoring System 2, applicant Jana Care, Inc., decided 2020-03-26. FDA record
- K192369, PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit, applicant Ixensor Co, Ltd., decided 2019-10-29. FDA record
- K183230, OneDraw A1C Test System, applicant Drawbridge Health, Inc., decided 2019-08-15. FDA record
- K181915, PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit, applicant Ixensor Co, Ltd., decided 2019-04-12. FDA record
- K180509, Quo-Test A1c System, applicant Ekf-Diagnostic GmbH, decided 2019-02-16. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Nova Allegro HbA1c Assay, Nova Allegro Analyzer, Q-Pad Test System. Watch new LCP clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code LCP?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent LCP clearances include PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit.
How many 510(k) clearances use product code LCP?
249 at the time this page was generated, from openFDA records.
How do I find a predicate device under LCP?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new LCP clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.