FDA product code JKC: Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
JKC is the FDA product code for radioimmunoassay, dehydroepiandrosterone (free and sulfate). It is a Class I device, regulated under 21 CFR 862.1245 and reviewed by the Clinical Chemistry panel. FDA has cleared 28 510(k) submissions under JKC, from 17 different applicants. The average 510(k) review took 61 days (median 42). FDA has posted 7 recalls for JKC devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) |
| Device class | Class I |
| Regulation | 21 CFR 862.1245 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Top JKC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Systems Laboratories, Inc. | 7 | 1996-09-10 |
| Diagnostic Products Corp. | 4 | 1994-04-26 |
| Nichols Institute | 2 | 1995-05-15 |
| Wien Laboratories, Inc. | 2 | 1982-11-29 |
| Beckman Coulter, Inc. | 1 | 2004-03-24 |
12 more applicants have JKC clearances. See the full list in Caduvo.
Most recent JKC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040181 | Beckman Coulter, Inc. | ACCESS DHEA-S REAGENT ASSAY | 2004-03-24 | 57 |
| K003174 | Roche Diagnostics Corp. | ELECSYS DHEA-S | 2001-01-17 | 99 |
| K973897 | Kmi Diagnostics, Inc. | DHEA-S | 1997-11-13 | 30 |
| K962895 | Diagnostic Systems Laboratories, Inc. | DSL DHEA-S-7 | 1996-09-10 | 47 |
| K955114 | Diagnostic Systems Laboratories, Inc. | DSL AACTIVE DHEA EIA KIT | 1996-02-23 | 106 |
Recalls for JKC devices
7 product recalls in 6 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2025 | 2 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J2274 — Injection, morphine sulfate, preservative-free for epidural or intrathecal use, 10 mg
Frequently asked questions
What is FDA product code JKC?
JKC is the FDA product code for radioimmunoassay, dehydroepiandrosterone (free and sulfate). It is a Class I device, regulated under 21 CFR 862.1245 and reviewed by the Clinical Chemistry panel.
What device class is JKC?
Class I, regulation 21 CFR 862.1245. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JKC?
Across 28 cleared submissions the average was 61 days from receipt to decision (median 42).
Which companies have the most JKC clearances?
Diagnostic Systems Laboratories, Inc. (7); Diagnostic Products Corp. (4); Nichols Institute (2); Wien Laboratories, Inc. (2); Beckman Coulter, Inc. (1).
Have JKC devices been recalled?
Yes: 7 product recalls across 6 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code JKC
- Run a recall and safety report across every JKC manufacturer
- Watch product code JKC 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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