FDA product code GPW: Antigen, Cf, Psittacosis (Chlamydia Group)
GPW is the FDA product code for antigen, cf, psittacosis (chlamydia group). It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under GPW, from 4 different applicants. The average 510(k) review took 139 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cf, Psittacosis (Chlamydia Group) |
| Device class | Class I |
| Regulation | 21 CFR 866.3120 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GPW clearance
Top GPW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sita, Inc. | 1 | 1987-10-15 |
| Institute Virion , Ltd. | 1 | 1985-08-08 |
| Hillcrest Biologicals | 1 | 1985-03-05 |
| Electro-Nucleonics Laboratories, Inc. | 1 | 1981-07-23 |
Most recent GPW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872700 | Sita, Inc. | YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN | 1987-10-15 | 100 |
| K843654 | Institute Virion , Ltd. | CHLAMYDIA | 1985-08-08 | 325 |
| K844868 | Hillcrest Biologicals | CHLAMYDIA GROUP CF ANTIGEN | 1985-03-05 | 81 |
| K811570 | Electro-Nucleonics Laboratories, Inc. | ANTIBODY TO CHLAMYDIA TRACHOMATIS | 1981-07-23 | 49 |
Recalls for GPW devices
openFDA lists no recalls for product code GPW.
Frequently asked questions
What is FDA product code GPW?
GPW is the FDA product code for antigen, cf, psittacosis (chlamydia group). It is a Class I device, regulated under 21 CFR 866.3120 and reviewed by the Microbiology panel.
What device class is GPW?
Class I, regulation 21 CFR 866.3120. Typical premarket route: 510(k).
How long does a 510(k) take for product code GPW?
Across 4 cleared submissions the average was 139 days from receipt to decision (median 90).
Which companies have the most GPW clearances?
Sita, Inc. (1); Institute Virion , Ltd. (1); Hillcrest Biologicals (1); Electro-Nucleonics Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GPW
- Run a recall and safety report across every GPW manufacturer
- Watch product code GPW 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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