FDA product code CIT: Nadh Oxidation/Nad Reduction, Ast/Sgot
CIT is the FDA product code for nadh oxidation/nad reduction, ast/sgot. It is a Class II device, regulated under 21 CFR 862.1100 and reviewed by the Clinical Chemistry panel. FDA has cleared 139 510(k) submissions under CIT, from 81 different applicants. The average 510(k) review took 61 days (median 46). FDA has posted 13 recalls for CIT devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Nadh Oxidation/Nad Reduction, Ast/Sgot |
| Device class | Class II |
| Regulation | 21 CFR 862.1100 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CIT clearance
Top CIT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 10 | 1994-01-27 |
| Abbott Laboratories | 8 | 2008-03-19 |
| Roche Diagnostic Systems, Inc. | 6 | 1996-01-25 |
| American Monitor Corp. | 5 | 1990-01-11 |
| Sigma Diagnostics, Inc. | 4 | 1999-09-28 |
76 more applicants have CIT clearances. See the full list in Caduvo.
Most recent CIT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093883 | Seppim S.A.S. | AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- | 2010-09-20 | 276 |
| K080485 | Diasys Diagnostics Systems GmbH | ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS | 2008-12-04 | 286 |
| K071525 | Abbott Laboratories | ACTIVATED ASPARTATE AMINOTRANSFERASE | 2008-03-19 | 289 |
| K071580 | Thermofisher Scientific OY | AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL | 2007-10-03 | 117 |
| K071211 | Roche Diagnostics | COBAS C 111 ANALYZER | 2007-07-30 | 90 |
Recalls for CIT devices
13 product recalls in 11 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-09-06.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code CIT?
CIT is the FDA product code for nadh oxidation/nad reduction, ast/sgot. It is a Class II device, regulated under 21 CFR 862.1100 and reviewed by the Clinical Chemistry panel.
What device class is CIT?
Class II, regulation 21 CFR 862.1100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CIT?
Across 139 cleared submissions the average was 61 days from receipt to decision (median 46).
Which companies have the most CIT clearances?
Em Diagnostic Systems, Inc. (10); Abbott Laboratories (8); Roche Diagnostic Systems, Inc. (6); American Monitor Corp. (5); Sigma Diagnostics, Inc. (4).
Have CIT devices been recalled?
Yes: 13 product recalls across 11 recall events; the most recent began 2023-09-06.
Next steps
- Run an FDA pathway report with predicate devices for product code CIT
- Run a recall and safety report across every CIT manufacturer
- Watch product code CIT 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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