FDA product code CKA: Nadh Oxidation/Nad Reduction, Alt/Sgpt
CKA is the FDA product code for nadh oxidation/nad reduction, alt/sgpt. It is a Class I device, regulated under 21 CFR 862.1030 and reviewed by the Clinical Chemistry panel. FDA has cleared 127 510(k) submissions under CKA, from 76 different applicants. The average 510(k) review took 52 days (median 41). FDA has posted 18 recalls for CKA devices.
Classification
| Field | Value |
|---|---|
| Device name | Nadh Oxidation/Nad Reduction, Alt/Sgpt |
| Device class | Class I |
| Regulation | 21 CFR 862.1030 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CKA clearance
Top CKA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 10 | 1994-01-13 |
| Boehringer Mannheim Corp. | 5 | 1988-01-21 |
| Trace Scientific , Ltd. | 4 | 1996-04-25 |
| Beckman Instruments, Inc. | 4 | 1995-09-21 |
| Coulter Electronics, Inc. | 4 | 1991-01-25 |
71 more applicants have CKA clearances. See the full list in Caduvo.
Most recent CKA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K120945 | Hitachi Chemical Diagnostics, Inc. | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST | 2013-06-07 | 435 |
| K113382 | Alfa Wassermann | ACE ALT REAGENT | 2012-07-19 | 246 |
| K061020 | Dade Behring, Inc. | DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE | 2006-05-10 | 27 |
| K020487 | Careside, Inc. | CARESIDE ALT | 2002-06-04 | 111 |
| K980028 | Trace America, Inc. | ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | 1998-02-02 | 28 |
Recalls for CKA devices
18 product recalls in 6 recall events; 0 initiated in the last five years and 4 still open. Most recent: 2021-06-10.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2021 | 4 |
Frequently asked questions
What is FDA product code CKA?
CKA is the FDA product code for nadh oxidation/nad reduction, alt/sgpt. It is a Class I device, regulated under 21 CFR 862.1030 and reviewed by the Clinical Chemistry panel.
What device class is CKA?
Class I, regulation 21 CFR 862.1030. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CKA?
Across 127 cleared submissions the average was 52 days from receipt to decision (median 41).
Which companies have the most CKA clearances?
Em Diagnostic Systems, Inc. (10); Boehringer Mannheim Corp. (5); Trace Scientific , Ltd. (4); Beckman Instruments, Inc. (4); Coulter Electronics, Inc. (4).
Have CKA devices been recalled?
Yes: 18 product recalls across 6 recall events; the most recent began 2021-06-10.
Next steps
- Run an FDA pathway report with predicate devices for product code CKA
- Run a recall and safety report across every CKA manufacturer
- Watch product code CKA 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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