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 862.1395](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1395) → JLX — Radioimmunoassay, 17-Hydroxyprogesterone # JLX · Radioimmunoassay, 17-Hydroxyprogesterone _Clinical Chemistry · 21 CFR 862.1395 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX ## Overview - **Product Code:** JLX - **Device Name:** Radioimmunoassay, 17-Hydroxyprogesterone - **Regulation:** [21 CFR 862.1395](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1395) - **Device Class:** 1 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## 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. ## Recent Cleared Devices (19 of 19) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K100682](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K100682.md) | GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U | Wallac OY | Jul 23, 2010 | SESE | | [K081922](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K081922.md) | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Wallac OY | Apr 16, 2009 | SESE | | [K062534](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K062534.md) | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE | Drg Intl., Inc. | Jan 29, 2008 | SESE | | [K060452](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K060452.md) | ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH | Neo-Genesis | Mar 13, 2007 | SESE | | [K050960](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K050960.md) | MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT | Wallac OY | Jul 11, 2005 | SESE | | [K042425](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K042425.md) | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Wallac OY | Sep 30, 2004 | SESE | | [K042424](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K042424.md) | DELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Wallac OY | Sep 30, 2004 | SESE | | [K973350](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K973350.md) | BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST | Bio-Rad | Feb 9, 1998 | SESE | | [K934178](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K934178.md) | ACCUSCREEN 17-HYDROXYPROGESTERONE | Neometrics, Inc. | Mar 30, 1995 | SESE | | [K940233](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K940233.md) | NEOSCREEN ELISA HYDROXYPROGESTERONE | Pantex | Dec 28, 1994 | SESE | | [K943148](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K943148.md) | DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) | Diagnostic Systems Laboratories, Inc. | Nov 10, 1994 | SESE | | [K912026](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K912026.md) | DELFIA(R) 17 -OH-PROGESTERON KIT | Pharmacia Diagnostics, Inc. | Jun 25, 1991 | SESE | | [K911839](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K911839.md) | NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT | Pantex, Div. Bio-Analysis, Inc. | Jun 18, 1991 | SESE | | [K894265](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K894265.md) | DSL 17A-OH PROGERSTERONE (DSL #6800) | Diagnostic Systems Laboratories, Inc. | Sep 7, 1989 | SESE | | [K885198](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K885198.md) | 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA | Icn Biomedicals, Inc. | Feb 23, 1989 | SESE | | [K874782](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K874782.md) | COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT | Diagnostic Products Corp. | Feb 11, 1988 | SESE | | [K860335](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K860335.md) | COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT | Diagnostic Products Corp. | Apr 24, 1986 | SESE | | [K834246](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K834246.md) | PROGESTERONE TEST SET 125I 17-OH | Wien Laboratories, Inc. | Feb 4, 1984 | SESE | | [K771729](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX/K771729.md) | 17-HYDROXYPROGESTERONE TEST SET | Wien Laboratories, Inc. | Oct 21, 1977 | SESE | ## Top Applicants - Wallac OY — 5 clearances - Diagnostic Products Corp. — 2 clearances - Diagnostic Systems Laboratories, Inc. — 2 clearances - Wien Laboratories, Inc. — 2 clearances - Bio-Rad — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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