JKC · Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Clinical Chemistry · 21 CFR 862.1245 · Class 1
Overview
| Product Code | JKC |
|---|---|
| Device Name | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) |
| Regulation | 21 CFR 862.1245 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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 | ACCESS DHEA-S REAGENT ASSAY | Beckman Coulter, Inc. | Mar 24, 2004 | SESE |
| K003174 | ELECSYS DHEA-S | Roche Diagnostics Corp. | Jan 17, 2001 | SESE |
| K973897 | DHEA-S | Kmi Diagnostics, Inc. | Nov 13, 1997 | SESE |
| K962895 | DSL DHEA-S-7 | Diagnostic Systems Laboratories, Inc. | Sep 10, 1996 | SESE |
| K955114 | DSL AACTIVE DHEA EIA KIT | Diagnostic Systems Laboratories, Inc. | Feb 23, 1996 | SESE |
| K950524 | NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY | Nichols Institute | May 15, 1995 | SESE |
| K942051 | SR1 DHEA-S ENZYME IMMUNOASSAY | Serono Diagnostics, Inc. | Jul 13, 1994 | SESE |
| K935014 | ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) | Diagnostic Systems Laboratories, Inc. | May 9, 1994 | SESE |
| K935806 | IMMULITE DHEA-S04 | Diagnostic Products Corp. | Apr 26, 1994 | SESE |
| K935469 | SYNELISA DHEA-SULFATE | Elias U.S.A., Inc. | Mar 22, 1994 | SESE |
| K931601 | CHEMILUMINESCENCE DHEA-S IMMUNOASSAY | Nichols Institute | Jul 27, 1993 | SESE |
| K903616 | DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000) | Diagnostic Systems Laboratories, Inc. | Sep 10, 1990 | SESE |
| K891478 | DSL 7900 ACTIVE DHEA-S (DSL #7900) | Diagnostic Systems Laboratories, Inc. | Apr 26, 1989 | SESE |
| K872879 | DHEA-S RIA KIT | Endocrine Associates, Inc. | Oct 23, 1987 | SESE |
| K853867 | PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY | Pantex, Div. Bio-Analysis, Inc. | Oct 4, 1985 | SESE |
| K852847 | SOPHEIA DHEA-SO4 EIA KIT | Diagnostic Products Corp. | Aug 2, 1985 | SESE |
| K851239 | ACTIVE DHEA-SULFATE DSL3500 | Diagnostic Systems Laboratories, Inc. | Apr 25, 1985 | SESE |
| K843635 | MATCHED COMPONENT SET FOR RADIOIMMUNO- | Cambridge Medical Technology | Sep 28, 1984 | SESE |
| K842606 | COAT-A-COUNT DHEA RIA KIT | Diagnostic Products Corp. | Aug 17, 1984 | SESE |
| K842552 | 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
