FDA product code CFT: Radioimmunoassay, Prolactin (Lactogen)
CFT is the FDA product code for radioimmunoassay, prolactin (lactogen). It is a Class I device, regulated under 21 CFR 862.1625 and reviewed by the Clinical Chemistry panel. FDA has cleared 80 510(k) submissions under CFT, from 52 different applicants. The average 510(k) review took 59 days (median 49). FDA has posted 6 recalls for CFT devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Prolactin (Lactogen) |
| Device class | Class I |
| Regulation | 21 CFR 862.1625 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CFT clearance
Top CFT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 6 | 1993-03-05 |
| Abbott Laboratories | 5 | 1994-06-21 |
| Hybritech, Inc. | 4 | 1986-11-21 |
| Medix Biotech, Inc. | 3 | 1992-03-18 |
| Amersham Corp. | 3 | 1992-02-18 |
47 more applicants have CFT clearances. See the full list in Caduvo.
Most recent CFT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971921 | Monobind | PROLACTIN (PRL) HORMONE MICROPLATE ELISA | 1997-06-24 | 32 |
| K970281 | Johnson & Johnson Clinical Diagnostics, Inc. | VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS | 1997-02-25 | 32 |
| K970188 | Sealite Sciences, Inc. | SEALITE SCIENCES, INC. AQUALITE PROLACTIN | 1997-02-20 | 34 |
| K964748 | Boehringer Mannheim Corp. | ELECSYS PROLACTIN ASSAY | 1997-01-21 | 56 |
| K960561 | Diagnostic Systems Laboratories, Inc. | DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 | 1996-04-26 | 77 |
Recalls for CFT devices
6 product recalls in 6 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2022-03-25.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code CFT?
CFT is the FDA product code for radioimmunoassay, prolactin (lactogen). It is a Class I device, regulated under 21 CFR 862.1625 and reviewed by the Clinical Chemistry panel.
What device class is CFT?
Class I, regulation 21 CFR 862.1625. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CFT?
Across 80 cleared submissions the average was 59 days from receipt to decision (median 49).
Which companies have the most CFT clearances?
Diagnostic Products Corp. (6); Abbott Laboratories (5); Hybritech, Inc. (4); Medix Biotech, Inc. (3); Amersham Corp. (3).
Have CFT devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2022-03-25.
Next steps
- Run an FDA pathway report with predicate devices for product code CFT
- Run a recall and safety report across every CFT manufacturer
- Watch product code CFT 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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