FDA product code CGX: Alkaline Picrate, Colorimetry, Creatinine
CGX is the FDA product code for alkaline picrate, colorimetry, creatinine. It is a Class II device, regulated under 21 CFR 862.1225 and reviewed by the Clinical Chemistry panel. FDA has cleared 159 510(k) submissions under CGX, 5 in the last five years, from 96 different applicants. The average 510(k) review took 72 days (median 47); 300 days on average over the last three years. FDA has posted 15 recalls for CGX devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Alkaline Picrate, Colorimetry, 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 CGX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 399 |
| 2024 | 2 | 485 |
| 2025 | 1 | 236 |
| 2026 | 1 | 179 |
Compare with all 510(k) review times · Search every CGX clearance
Top CGX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 10 | 1993-07-09 |
| Harleco | 8 | 1981-11-10 |
| Abbott Laboratories | 7 | 2009-04-07 |
| Olympus Corp. | 6 | 1993-11-16 |
| Siemens Healthcare Diagnostics, Inc. | 4 | 2024-12-04 |
91 more applicants have CGX clearances. See the full list in Caduvo.
Most recent CGX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252206 | Nova Biomedical Corporation | Nova Allegro UACR Assay, Nova Allegro Analyzer | 2026-01-09 | 179 |
| K251058 | Truvian Health | Tru Kidney Health Test Panel; Tru Analyzer | 2025-11-26 | 236 |
| K242685 | Siemens Healthcare Diagnostics, Inc. | Atellica® CH Creatinine_3 (Crea3) | 2024-12-04 | 89 |
| K221813 | Nova Biomedical Corporation | Nova Allegro UACR Assay, Nova Allegro Analyzer | 2024-11-19 | 881 |
| K210452 | Abbott Ireland Diagnostics Division | Creatinine2 | 2022-03-22 | 399 |
Recalls for CGX devices
15 product recalls in 14 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-03-18.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2022 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code CGX?
CGX is the FDA product code for alkaline picrate, colorimetry, creatinine. It is a Class II device, regulated under 21 CFR 862.1225 and reviewed by the Clinical Chemistry panel.
What device class is CGX?
Class II, regulation 21 CFR 862.1225. Typical premarket route: 510(k).
How long does a 510(k) take for product code CGX?
Across 159 cleared submissions the average was 72 days from receipt to decision (median 47).
Which companies have the most CGX clearances?
Em Diagnostic Systems, Inc. (10); Harleco (8); Abbott Laboratories (7); Olympus Corp. (6); Siemens Healthcare Diagnostics, Inc. (4).
Have CGX devices been recalled?
Yes: 15 product recalls across 14 recall events; the most recent began 2026-03-18.
Next steps
- Run an FDA pathway report with predicate devices for product code CGX
- Run a recall and safety report across every CGX manufacturer
- Watch product code CGX 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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