FDA product code CGL: Electrode, Ion Based, Enzymatic, Creatinine
CGL is the FDA product code for electrode, ion based, enzymatic, creatinine. It is a Class II device, regulated under 21 CFR 862.1225 and reviewed by the Clinical Chemistry panel. FDA has cleared 8 510(k) submissions under CGL, 1 in the last five years, from 7 different applicants. The average 510(k) review took 168 days (median 104); 88 days on average over the last three years. FDA has posted 9 recalls for CGL devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Ion Based, Enzymatic, Creatinine |
| Device class | Class II |
| Regulation | 21 CFR 862.1225 |
| 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 CGL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 46 |
| 2026 | 1 | 88 |
Compare with all 510(k) review times · Search every CGL clearance
Top CGL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nova Biomedical Corp. | 2 | 2007-05-07 |
| Abbott Point of Care, Inc. | 1 | 2026-06-26 |
| Nova Biomedical Corporation | 1 | 2017-05-26 |
| Epocal, Inc. | 1 | 2012-10-05 |
| Radiometer Medical Aps | 1 | 2006-10-16 |
2 more applicants have CGL clearances. See the full list in Caduvo.
Most recent CGL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261039 | Abbott Point of Care, Inc. | i-STAT Crea cartridge with the i-STAT 1 System | 2026-06-26 | 88 |
| K171059 | Nova Biomedical Corporation | Nova StatSensor Creatinine Hospital Meter System | 2017-05-26 | 46 |
| K113726 | Epocal, Inc. | EPOC CHLORIDE TEST AND EPOC CREATININE TEST | 2012-10-05 | 291 |
| K070068 | Nova Biomedical Corp. | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS | 2007-05-07 | 119 |
| K051968 | Radiometer Medical Aps | ABL8X7 FLEX | 2006-10-16 | 453 |
Recalls for CGL devices
9 product recalls in 7 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-04-24.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code CGL?
CGL is the FDA product code for electrode, ion based, enzymatic, creatinine. It is a Class II device, regulated under 21 CFR 862.1225 and reviewed by the Clinical Chemistry panel.
What device class is CGL?
Class II, regulation 21 CFR 862.1225. Typical premarket route: 510(k).
How long does a 510(k) take for product code CGL?
Across 8 cleared submissions the average was 168 days from receipt to decision (median 104).
Which companies have the most CGL clearances?
Nova Biomedical Corp. (2); Abbott Point of Care, Inc. (1); Nova Biomedical Corporation (1); Epocal, Inc. (1); Radiometer Medical Aps (1).
Have CGL devices been recalled?
Yes: 9 product recalls across 7 recall events; the most recent began 2025-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code CGL
- Run a recall and safety report across every CGL manufacturer
- Watch product code CGL 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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