FDA product code CDP: Radioimmunoassay, Total Triiodothyronine
CDP is the FDA product code for radioimmunoassay, total triiodothyronine. It is a Class II device, regulated under 21 CFR 862.1710 and reviewed by the Clinical Chemistry panel. FDA has cleared 144 510(k) submissions under CDP, from 90 different applicants. The average 510(k) review took 62 days (median 50). FDA has posted 20 recalls for CDP devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Total Triiodothyronine |
| Device class | Class II |
| Regulation | 21 CFR 862.1710 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CDP clearance
Top CDP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 13 | 1998-11-20 |
| Amersham Corp. | 7 | 1989-02-08 |
| Diagnostic Products Corp. | 6 | 1998-01-02 |
| Boehringer Mannheim Corp. | 4 | 1996-12-16 |
| Tosoh Medics, Inc. | 3 | 1999-05-11 |
85 more applicants have CDP clearances. See the full list in Caduvo.
Most recent CDP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K001607 | Repromedix Corp. | REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) | 2000-10-05 | 134 |
| K991692 | Chiron Diagnostics Corp. | CHIRON DIAGNOSTICS ACS: 180 FT3 | 1999-06-18 | 31 |
| K991311 | Biocheck, Inc. | TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 | 1999-06-02 | 47 |
| K991252 | Tosoh Medics, Inc. | AIA-PACK FT3 ASSAY | 1999-05-11 | 28 |
| K981824 | Biotecx Laboratories, Inc. | OPTICOAT T3 EIA KIT | 1998-12-22 | 214 |
Recalls for CDP devices
20 product recalls in 16 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-04-09.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 5 |
| 2019 | 2 |
| 2023 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code CDP?
CDP is the FDA product code for radioimmunoassay, total triiodothyronine. It is a Class II device, regulated under 21 CFR 862.1710 and reviewed by the Clinical Chemistry panel.
What device class is CDP?
Class II, regulation 21 CFR 862.1710. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CDP?
Across 144 cleared submissions the average was 62 days from receipt to decision (median 50).
Which companies have the most CDP clearances?
Abbott Laboratories (13); Amersham Corp. (7); Diagnostic Products Corp. (6); Boehringer Mannheim Corp. (4); Tosoh Medics, Inc. (3).
Have CDP devices been recalled?
Yes: 20 product recalls across 16 recall events; the most recent began 2024-04-09.
Next steps
- Run an FDA pathway report with predicate devices for product code CDP
- Run a recall and safety report across every CDP manufacturer
- Watch product code CDP 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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