FDA product code CGI: Radioimmunoassay, Estriol
CGI is the FDA product code for radioimmunoassay, estriol. It is a Class I device, regulated under 21 CFR 862.1265 and reviewed by the Clinical Chemistry panel. FDA has cleared 42 510(k) submissions under CGI, from 27 different applicants. The average 510(k) review took 58 days (median 38). FDA has posted 2 recalls for CGI devices.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Estriol |
| Device class | Class I |
| Regulation | 21 CFR 862.1265 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Top CGI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Amersham Corp. | 4 | 1984-12-11 |
| Bio-Rad | 4 | 1982-04-06 |
| Diagnostic Systems Laboratories, Inc. | 3 | 1996-08-23 |
| Diagnostic Products Corp. | 3 | 1994-12-19 |
| Immunotech Corp. | 2 | 1990-08-22 |
22 more applicants have CGI clearances. See the full list in Caduvo.
Most recent CGI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974721 | Bayer Corp. | UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | 1998-03-03 | 75 |
| K962875 | Diagnostic Systems Laboratories, Inc. | ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA | 1996-08-23 | 30 |
| K955356 | Diagnostic Systems Laboratories, Inc. | ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL | 1996-05-15 | 176 |
| K932989 | Diagnostic Products Corp. | COAT-A-COUNT FREE ESTRIOL | 1994-12-19 | 549 |
| K944490 | Wallac OY | AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT | 1994-12-09 | 87 |
Recalls for CGI devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-08-26.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code CGI?
CGI is the FDA product code for radioimmunoassay, estriol. It is a Class I device, regulated under 21 CFR 862.1265 and reviewed by the Clinical Chemistry panel.
What device class is CGI?
Class I, regulation 21 CFR 862.1265. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CGI?
Across 42 cleared submissions the average was 58 days from receipt to decision (median 38).
Which companies have the most CGI clearances?
Amersham Corp. (4); Bio-Rad (4); Diagnostic Systems Laboratories, Inc. (3); Diagnostic Products Corp. (3); Immunotech Corp. (2).
Have CGI devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2020-08-26.
Next steps
- Run an FDA pathway report with predicate devices for product code CGI
- Run a recall and safety report across every CGI manufacturer
- Watch product code CGI 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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