JLX · Radioimmunoassay, 17-Hydroxyprogesterone
Clinical Chemistry · 21 CFR 862.1395 · Class 1
Overview
| Product Code | JLX |
|---|---|
| Device Name | Radioimmunoassay, 17-Hydroxyprogesterone |
| Regulation | 21 CFR 862.1395 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A 17-hydroxyprogesterone test system is a device intended to measure 17-hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.
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.
Cleared Devices (19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K100682 | GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U | Wallac OY | Jul 23, 2010 | SESE |
| K081922 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Wallac OY | Apr 16, 2009 | SESE |
| K062534 | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE | Drg Intl., Inc. | Jan 29, 2008 | SESE |
| K060452 | ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH | Neo-Genesis | Mar 13, 2007 | SESE |
| K050960 | MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT | Wallac OY | Jul 11, 2005 | SESE |
| K042425 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Wallac OY | Sep 30, 2004 | SESE |
| K042424 | DELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Wallac OY | Sep 30, 2004 | SESE |
| K973350 | BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST | Bio-Rad | Feb 9, 1998 | SESE |
| K934178 | ACCUSCREEN 17-HYDROXYPROGESTERONE | Neometrics, Inc. | Mar 30, 1995 | SESE |
| K940233 | NEOSCREEN ELISA HYDROXYPROGESTERONE | Pantex | Dec 28, 1994 | SESE |
| K943148 | DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) | Diagnostic Systems Laboratories, Inc. | Nov 10, 1994 | SESE |
| K912026 | DELFIA(R) 17 -OH-PROGESTERON KIT | Pharmacia Diagnostics, Inc. | Jun 25, 1991 | SESE |
| K911839 | NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT | Pantex, Div. Bio-Analysis, Inc. | Jun 18, 1991 | SESE |
| K894265 | DSL 17A-OH PROGERSTERONE (DSL #6800) | Diagnostic Systems Laboratories, Inc. | Sep 7, 1989 | SESE |
| K885198 | 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA | Icn Biomedicals, Inc. | Feb 23, 1989 | SESE |
| K874782 | COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT | Diagnostic Products Corp. | Feb 11, 1988 | SESE |
| K860335 | COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT | Diagnostic Products Corp. | Apr 24, 1986 | SESE |
| K834246 | PROGESTERONE TEST SET 125I 17-OH | Wien Laboratories, Inc. | Feb 4, 1984 | SESE |
| K771729 | 17-HYDROXYPROGESTERONE TEST SET | Wien Laboratories, Inc. | Oct 21, 1977 | SESE |
Top Applicants
- Wallac OY — 5 clearances
- Wien Laboratories, Inc. — 2 clearances
- Diagnostic Systems Laboratories, Inc. — 2 clearances
- Diagnostic Products Corp. — 2 clearances
- Pharmacia Diagnostics, Inc. — 1 clearance
