Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1245](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1245) → JKC — Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) # JKC · Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) _Clinical Chemistry · 21 CFR 862.1245 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC ## Overview - **Product Code:** JKC - **Device Name:** Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) - **Regulation:** [21 CFR 862.1245](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1245) - **Device Class:** 1 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## Identification A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. ## Recent Cleared Devices (20 of 28) Showing 20 most recent of 28 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K040181](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K040181.md) | ACCESS DHEA-S REAGENT ASSAY | Beckman Coulter, Inc. | Mar 24, 2004 | SESE | | [K003174](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K003174.md) | ELECSYS DHEA-S | Roche Diagnostics Corp. | Jan 17, 2001 | SESE | | [K973897](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K973897.md) | DHEA-S | Kmi Diagnostics, Inc. | Nov 13, 1997 | SESE | | [K962895](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K962895.md) | DSL DHEA-S-7 | Diagnostic Systems Laboratories, Inc. | Sep 10, 1996 | SESE | | [K955114](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K955114.md) | DSL AACTIVE DHEA EIA KIT | Diagnostic Systems Laboratories, Inc. | Feb 23, 1996 | SESE | | [K950524](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K950524.md) | NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY | Nichols Institute | May 15, 1995 | SESE | | [K942051](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K942051.md) | SR1 DHEA-S ENZYME IMMUNOASSAY | Serono Diagnostics, Inc. | Jul 13, 1994 | SESE | | [K935014](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K935014.md) | ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) | Diagnostic Systems Laboratories, Inc. | May 9, 1994 | SESE | | [K935806](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K935806.md) | IMMULITE DHEA-S04 | Diagnostic Products Corp. | Apr 26, 1994 | SESE | | [K935469](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K935469.md) | SYNELISA DHEA-SULFATE | Elias U.S.A., Inc. | Mar 22, 1994 | SESE | | [K931601](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K931601.md) | CHEMILUMINESCENCE DHEA-S IMMUNOASSAY | Nichols Institute | Jul 27, 1993 | SESE | | [K903616](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K903616.md) | DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000) | Diagnostic Systems Laboratories, Inc. | Sep 10, 1990 | SESE | | [K891478](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K891478.md) | DSL 7900 ACTIVE DHEA-S (DSL #7900) | Diagnostic Systems Laboratories, Inc. | Apr 26, 1989 | SESE | | [K872879](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K872879.md) | DHEA-S RIA KIT | Endocrine Associates, Inc. | Oct 23, 1987 | SESE | | [K853867](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K853867.md) | PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY | Pantex, Div. Bio-Analysis, Inc. | Oct 4, 1985 | SESE | | [K852847](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K852847.md) | SOPHEIA DHEA-SO4 EIA KIT | Diagnostic Products Corp. | Aug 2, 1985 | SESE | | [K851239](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K851239.md) | ACTIVE DHEA-SULFATE DSL3500 | Diagnostic Systems Laboratories, Inc. | Apr 25, 1985 | SESE | | [K843635](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K843635.md) | MATCHED COMPONENT SET FOR RADIOIMMUNO- | Cambridge Medical Technology | Sep 28, 1984 | SESE | | [K842606](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K842606.md) | COAT-A-COUNT DHEA RIA KIT | Diagnostic Products Corp. | Aug 17, 1984 | SESE | | [K842552](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K842552.md) | COAT-A-COUNT DHEA-SO4 RIA KIT | Diagnostic Products Corp. | Aug 17, 1984 | SESE | ## Top Applicants - Diagnostic Systems Laboratories, Inc. — 7 clearances - Diagnostic Products Corp. — 4 clearances - Nichols Institute — 2 clearances - Wien Laboratories, Inc. — 2 clearances - Beckman Coulter, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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