FDA product code CEP: Radioimmunoassay, Luteinizing Hormone
CEP is the FDA product code for radioimmunoassay, luteinizing hormone. It is a Class I device, regulated under 21 CFR 862.1485 and reviewed by the Clinical Chemistry panel. FDA has cleared 143 510(k) submissions under CEP, from 88 different applicants. The average 510(k) review took 72 days (median 57). FDA has posted 6 recalls for CEP devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Luteinizing Hormone |
| Device class | Class I |
| Regulation | 21 CFR 862.1485 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CEP clearance
Top CEP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 5 | 1995-05-15 |
| Unipath , Ltd. | 4 | 2002-02-19 |
| Nichols Institute Diagnostics | 4 | 1995-04-05 |
| Amersham Corp. | 4 | 1988-07-28 |
| Monoclonal Antibodies, Inc. | 4 | 1987-07-27 |
83 more applicants have CEP clearances. See the full list in Caduvo.
Most recent CEP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K013582 | Maybe?Mom | MAYBE?MOM MINI OVULATION MICROSCOPE | 2003-01-16 | 443 |
| K022829 | Alfa Scientific Designs, Inc. | INSTANT-VIEW LH OVULATION PREDICTING TEST | 2002-11-05 | 71 |
| K021409 | Phamatech, Inc. | AT HOME OVULATION TEST, MODEL 9032 | 2002-05-24 | 21 |
| K013874 | Unipath , Ltd. | CLEARPLANE EASY OVULATION TEST | 2002-02-19 | 90 |
| K013323 | Tci New York | TCI-31 LIFELONG OVULATION TESTER | 2001-12-05 | 61 |
Recalls for CEP devices
6 product recalls in 6 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2022-11-09.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 1 |
| 2022 | 2 |
Frequently asked questions
What is FDA product code CEP?
CEP is the FDA product code for radioimmunoassay, luteinizing hormone. It is a Class I device, regulated under 21 CFR 862.1485 and reviewed by the Clinical Chemistry panel.
What device class is CEP?
Class I, regulation 21 CFR 862.1485. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CEP?
Across 143 cleared submissions the average was 72 days from receipt to decision (median 57).
Which companies have the most CEP clearances?
Diagnostic Products Corp. (5); Unipath , Ltd. (4); Nichols Institute Diagnostics (4); Amersham Corp. (4); Monoclonal Antibodies, Inc. (4).
Have CEP devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2022-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code CEP
- Run a recall and safety report across every CEP manufacturer
- Watch product code CEP 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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