FDA product code CFP: Radioimmunoassay, Immunoreactive Insulin
CFP is the FDA product code for radioimmunoassay, immunoreactive insulin. It is a Class I device, regulated under 21 CFR 862.1405 and reviewed by the Clinical Chemistry panel. FDA has cleared 27 510(k) submissions under CFP, from 24 different applicants. The average 510(k) review took 43 days (median 30). FDA has posted 8 recalls for CFP devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Immunoreactive Insulin |
| Device class | Class I |
| Regulation | 21 CFR 862.1405 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CFP clearance
Top CFP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ventrex Laboratories, Inc. | 2 | 1981-06-09 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 1981-05-15 |
| Micromedic Systems | 2 | 1979-12-06 |
| American Laboratory Products Co., Ltd. | 1 | 1996-11-01 |
| Bio-Rad Laboratories, Inc. | 1 | 1995-09-25 |
19 more applicants have CFP clearances. See the full list in Caduvo.
Most recent CFP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K963911 | American Laboratory Products Co., Ltd. | ALPCO/MERCODIA INSULIN ELISA | 1996-11-01 | 32 |
| K953084 | Bio-Rad Laboratories, Inc. | ACCESS ULTRASENSITIVE INSULIN ASSAY | 1995-09-25 | 84 |
| K920109 | Abbott Laboratories | IMX INSULIN | 1992-05-07 | 118 |
| K914820 | Diagnostic Systems Laboratories, Inc. | DSL INSULIN RIA (DSL 1600) | 1992-01-09 | 76 |
| K903628 | Tosoh Corp. | AIA-PACK IRI | 1990-09-07 | 28 |
Recalls for CFP devices
8 product recalls in 7 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-10-07.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2023 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code CFP?
CFP is the FDA product code for radioimmunoassay, immunoreactive insulin. It is a Class I device, regulated under 21 CFR 862.1405 and reviewed by the Clinical Chemistry panel.
What device class is CFP?
Class I, regulation 21 CFR 862.1405. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CFP?
Across 27 cleared submissions the average was 43 days from receipt to decision (median 30).
Which companies have the most CFP clearances?
Ventrex Laboratories, Inc. (2); Bd Becton Dickinson Vacutainer Systems Preanalytic (2); Micromedic Systems (2); American Laboratory Products Co., Ltd. (1); Bio-Rad Laboratories, Inc. (1).
Have CFP devices been recalled?
Yes: 8 product recalls across 7 recall events; the most recent began 2024-10-07.
Next steps
- Run an FDA pathway report with predicate devices for product code CFP
- Run a recall and safety report across every CFP manufacturer
- Watch product code CFP 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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