FDA product code CGS: Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
CGS is the FDA product code for nad reduction/nadh oxidation, cpk or isoenzymes. It is a Class II device, regulated under 21 CFR 862.1215 and reviewed by the Clinical Chemistry panel. FDA has cleared 123 510(k) submissions under CGS, from 72 different applicants. The average 510(k) review took 65 days (median 42). FDA has posted 10 recalls for CGS devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes |
| Device class | Class II |
| Regulation | 21 CFR 862.1215 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CGS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 202 |
| 2020 | 1 | 455 |
Top CGS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 14 | 1993-07-27 |
| Helena Laboratories | 7 | 1992-12-28 |
| Harleco | 6 | 1981-10-02 |
| Abbott Laboratories | 4 | 1999-02-16 |
| Randox Laboratories, Ltd. | 3 | 2013-11-21 |
67 more applicants have CGS clearances. See the full list in Caduvo.
Most recent CGS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191296 | Medtest DX | Pointe Scientific Creatinine Kinase (CK) Reagent Set | 2020-08-11 | 455 |
| K182702 | Sekisui Diagnostics P.E.I., Inc. | SEKURE Creatine Kinase Assay | 2019-04-17 | 202 |
| K160724 | Siemens Healthcare Diagnostics, Inc. | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator | 2016-09-07 | 175 |
| K123977 | Randox Laboratories, Ltd. | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR | 2013-11-21 | 330 |
| K112416 | Vital Diagnostics (Manufacturing) Ptyltd | CPK REAGENT | 2011-11-09 | 79 |
Recalls for CGS devices
10 product recalls in 7 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 2 |
| 2022 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code CGS?
CGS is the FDA product code for nad reduction/nadh oxidation, cpk or isoenzymes. It is a Class II device, regulated under 21 CFR 862.1215 and reviewed by the Clinical Chemistry panel.
What device class is CGS?
Class II, regulation 21 CFR 862.1215. Typical premarket route: 510(k).
How long does a 510(k) take for product code CGS?
Across 123 cleared submissions the average was 65 days from receipt to decision (median 42).
Which companies have the most CGS clearances?
Em Diagnostic Systems, Inc. (14); Helena Laboratories (7); Harleco (6); Abbott Laboratories (4); Randox Laboratories, Ltd. (3).
Have CGS devices been recalled?
Yes: 10 product recalls across 7 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code CGS
- Run a recall and safety report across every CGS manufacturer
- Watch product code CGS 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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