FDA product code CHP: Radioimmunoassay, Estradiol
CHP is the FDA product code for radioimmunoassay, estradiol. It is a Class I device, regulated under 21 CFR 862.1260 and reviewed by the Clinical Chemistry panel. FDA has cleared 50 510(k) submissions under CHP, from 34 different applicants. The average 510(k) review took 72 days (median 58). FDA has posted 31 recalls for CHP devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Estradiol |
| Device class | Class I |
| Regulation | 21 CFR 862.1260 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Top CHP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 5 | 1995-02-23 |
| Serono-Baker Diagnostics, Inc. | 4 | 1991-07-25 |
| Diagnostic Systems Laboratories, Inc. | 3 | 1995-10-02 |
| Boehringer Mannheim Corp. | 2 | 1997-02-18 |
| Biomerieux Vitek, Inc. | 2 | 1996-02-06 |
29 more applicants have CHP clearances. See the full list in Caduvo.
Most recent CHP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K041349 | Ibl GmbH | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM | 2004-09-24 | 127 |
| K973901 | Kmi Diagnostics, Inc. | 17 B-ESTRADIOL (ELISA) | 1997-11-24 | 41 |
| K973743 | Beckman Instruments, Inc. | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | 1997-10-31 | 30 |
| K970386 | Chiron Diagnostics Corp. | ACS ESTADIOL-6 II | 1997-06-04 | 121 |
| K970643 | Johnson & Johnson Clinical Diagnostics, Inc. | VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) | 1997-03-18 | 26 |
Recalls for CHP devices
31 product recalls in 19 recall events; 7 initiated in the last five years and 8 still open. Most recent: 2022-11-09.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 4 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 7 |
Frequently asked questions
What is FDA product code CHP?
CHP is the FDA product code for radioimmunoassay, estradiol. It is a Class I device, regulated under 21 CFR 862.1260 and reviewed by the Clinical Chemistry panel.
What device class is CHP?
Class I, regulation 21 CFR 862.1260. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CHP?
Across 50 cleared submissions the average was 72 days from receipt to decision (median 58).
Which companies have the most CHP clearances?
Diagnostic Products Corp. (5); Serono-Baker Diagnostics, Inc. (4); Diagnostic Systems Laboratories, Inc. (3); Boehringer Mannheim Corp. (2); Biomerieux Vitek, Inc. (2).
Have CHP devices been recalled?
Yes: 31 product recalls across 19 recall events; the most recent began 2022-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code CHP
- Run a recall and safety report across every CHP manufacturer
- Watch product code CHP 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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