FDA product code · Clinical Chemistry
CGAGlucose Oxidase, Glucose
Product code CGA covers Glucose Oxidase, Glucose, a Class II device regulated under 21 CFR 862.1345. FDA has cleared 401 devices in this code, 1 of them in the last 12 months. Median review time across the 401 most recent decisions is 92 days. openFDA lists 89 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 862.1345
- Review panel
- Clinical Chemistry
- Clearances
- 401
What is happening in CGA right now?
CGA (Glucose Oxidase, Glucose) has two findings, most consequential first. 1 first-time filer in the last 12 months, Radiometer Medicals Aps (K252488). The code is crowded, scoring 71 of 100 — 179 companies hold a clearance here and 1 arrived in the last 12 months (CGA:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K252488 |
| Crowding | Context | CGA:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in CGA?
FDA has cleared 401 devices under product code CGA since the 510(k) programme began in 1976, 1 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252488 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | |
| K210933 | YSI 2900C Biochemistry Analyzer | Ysi, Inc. | |
| K220328 | EasyStat 300 | Medica Corporation | |
| K223179 | Cholestech LDX System | Alere San Diego, Inc. | |
| K223755 | i-STAT G cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | |
| K223710 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | |
| K223090 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | |
| K203549 | Nova Primary Glucose Analyzer System | Nova Biomedical Corporation | |
| K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | |
| K200349 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation |
How long does FDA review take for CGA?
The median FDA review time for CGA is 92 days, measured across the 401 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in CGA?
openFDA lists 89 recall records against product code CGA. A recall record covers one firm's corrective action and may span many device lots.
Z-2070-2025Open, ClassifiedHemoCue AB
Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1827-2025Open, ClassifiedMckesson Medical-Surgical Inc. Corporate Office
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1702-2024Open, ClassifiedAlere San Diego, Inc.
There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low current electrical shock to the user.
Z-0198-2024Open, ClassifiedRandox Laboratories, Limited
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
Z-0201-2024Open, ClassifiedRandox Laboratories, Limited
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
Showing the 5 most recently initiated of 89. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for CGA?
MAUDE holds 1,396 adverse-event reports naming product code CGA, 25 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in CGA unusual?
Every month with enough history behind it falls inside CGA's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 845 | Insufficient history | No expected range — too little history | |
| 22 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 21 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 34 | Insufficient history | No expected range — too little history | |
| 39 | Insufficient history | No expected range — too little history | |
| 32 | Insufficient history | No expected range — too little history | |
| 34 | Insufficient history | No expected range — too little history | |
| 28 | Insufficient history | No expected range — too little history | |
| 28 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 27 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 28 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 28 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 7 | 3–31 | Within expected (3–31) | |
| 8 | 0–24 | Within expected (0–24) | |
| 3 | 0–26 | Within expected (0–26) | |
| 3 | 0–24 | Within expected (0–24) | |
| 5 | 0–22 | Within expected (0–22) | |
| 6 | 0–21 | Within expected (0–21) | |
| 6 | 0–34 | Within expected (0–34) | |
| 2 | 0–22 | Within expected (0–22) | |
| 1 | 0–22 | Within expected (0–22) | |
| 5 | 0–20 | Within expected (0–20) | |
| 8 | 0–13 | Within expected (0–13) | |
| 2 | 0–14 | Within expected (0–14) | |
| 3 | 0–12 | Within expected (0–12) | |
| 2 | 0–10 | Within expected (0–10) | |
| 2 | 0–9 | Within expected (0–9) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in CGA.
Who has entered CGA in the last year?
One company filed in CGA for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Radiometer Medicals Aps | K252488 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in CGA?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in CGA?
Across the 401 most recent decisions, these applicants filed most often in CGA.
| Applicant | Recent clearances |
|---|---|
| Lifescan, Inc. | 21 |
| Boehringer Mannheim Corp. | 17 |
| Apex BioTechnology Corp. | 14 |
| Miles Laboratories, Inc. | 12 |
| Medisense, Inc. | 11 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch CGA
Get an email the morning anything changes in CGA — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.