FDA product code GKA: Abnormal Hemoglobin Quantitation
GKA is the FDA product code for abnormal hemoglobin quantitation. It is a Class II device, regulated under 21 CFR 864.7415 and reviewed by the Hematology panel. FDA has cleared 23 510(k) submissions under GKA, 3 in the last five years, from 13 different applicants. The average 510(k) review took 194 days (median 129); 272 days on average over the last three years. FDA has posted 10 recalls for GKA devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Abnormal Hemoglobin Quantitation |
| Device class | Class II |
| Regulation | 21 CFR 864.7415 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GKA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 100 |
| 2018 | 1 | 266 |
| 2022 | 1 | 915 |
| 2023 | 1 | 338 |
| 2024 | 1 | 272 |
Compare with all 510(k) review times · Search every GKA clearance
Top GKA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sebia | 7 | 2024-04-04 |
| Bio-Rad | 3 | 1996-04-26 |
| Bio-Rad Laboratories, Inc. | 2 | 2017-09-13 |
| Helena Laboratories | 2 | 1982-08-05 |
| Trinity Biotech (Primus Corporation, Dba Trinity Biotech) | 1 | 2023-08-04 |
8 more applicants have GKA clearances. See the full list in Caduvo.
Most recent GKA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232027 | Sebia | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | 2024-04-04 | 272 |
| K222635 | Trinity Biotech (Primus Corporation, Dba Trinity Biotech) | Premier Resolution System | 2023-08-04 | 338 |
| K192931 | Helena Laboratories, Corp. | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | 2022-04-19 | 915 |
| K180762 | Sebia | CAPI 3 HEMOGLOBIN(E) | 2018-12-14 | 266 |
| K171664 | Bio-Rad Laboratories, Inc. | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software | 2017-09-13 | 100 |
Recalls for GKA devices
10 product recalls in 6 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-04-07.
| Year | Recalls |
|---|---|
| 2018 | 5 |
| 2020 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code GKA?
GKA is the FDA product code for abnormal hemoglobin quantitation. It is a Class II device, regulated under 21 CFR 864.7415 and reviewed by the Hematology panel.
What device class is GKA?
Class II, regulation 21 CFR 864.7415. Typical premarket route: 510(k).
How long does a 510(k) take for product code GKA?
Across 23 cleared submissions the average was 194 days from receipt to decision (median 129).
Which companies have the most GKA clearances?
Sebia (7); Bio-Rad (3); Bio-Rad Laboratories, Inc. (2); Helena Laboratories (2); Trinity Biotech (Primus Corporation, Dba Trinity Biotech) (1).
Have GKA devices been recalled?
Yes: 10 product recalls across 6 recall events; the most recent began 2022-04-07.
Next steps
- Run an FDA pathway report with predicate devices for product code GKA
- Run a recall and safety report across every GKA manufacturer
- Watch product code GKA 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.
All Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times