FDA product code CGA: Glucose Oxidase, Glucose
CGA is the FDA product code for glucose oxidase, glucose. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel. FDA has cleared 401 510(k) submissions under CGA, 8 in the last five years, from 184 different applicants. The average 510(k) review took 129 days (median 92); 679 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 89 recalls for CGA devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Glucose Oxidase, Glucose |
| Device class | Class II |
| Regulation | 21 CFR 862.1345 |
| 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 CGA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 212 |
| 2018 | 2 | 156 |
| 2019 | 2 | 44 |
| 2020 | 2 | 218 |
| 2021 | 1 | 135 |
| 2022 | 1 | 683 |
| 2023 | 4 | 240 |
| 2024 | 2 | 1092 |
| 2026 | 1 | 266 |
Compare with all 510(k) review times · Search every CGA clearance
Top CGA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lifescan, Inc. | 21 | 2005-05-20 |
| Boehringer Mannheim Corp. | 17 | 1996-04-17 |
| Apex BioTechnology Corp. | 14 | 2015-08-06 |
| Miles Laboratories, Inc. | 12 | 1987-12-22 |
| Medisense, Inc. | 11 | 1999-07-09 |
179 more applicants have CGA clearances. See the full list in Caduvo.
Most recent CGA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252488 | Radiometer Medicals Aps | ABL90 FLEX PLUS System | 2026-05-01 | 266 |
| K210933 | Ysi, Inc. | YSI 2900C Biochemistry Analyzer | 2024-09-30 | 1281 |
| K220328 | Medica Corporation | EasyStat 300 | 2024-07-26 | 903 |
| K223179 | Alere San Diego, Inc. | Cholestech LDX System | 2023-09-20 | 344 |
| K223755 | Abbott Point of Care, Inc. | i-STAT G cartridge with the i-STAT 1 System | 2023-09-11 | 270 |
Recalls for CGA devices
89 product recalls in 62 recall events; 8 initiated in the last five years and 7 still open. Most recent: 2025-05-12.
| Year | Recalls |
|---|---|
| 2019 | 3 |
| 2020 | 1 |
| 2022 | 2 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code CGA?
CGA is the FDA product code for glucose oxidase, glucose. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel.
What device class is CGA?
Class II, regulation 21 CFR 862.1345. Typical premarket route: 510(k).
How long does a 510(k) take for product code CGA?
Across 401 cleared submissions the average was 129 days from receipt to decision (median 92).
Which companies have the most CGA clearances?
Lifescan, Inc. (21); Boehringer Mannheim Corp. (17); Apex BioTechnology Corp. (14); Miles Laboratories, Inc. (12); Medisense, Inc. (11).
Have CGA devices been recalled?
Yes: 89 product recalls across 62 recall events; the most recent began 2025-05-12.
Next steps
- Run an FDA pathway report with predicate devices for product code CGA
- Run a recall and safety report across every CGA manufacturer
- Watch product code CGA 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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