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 862.1485](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1485) → CEP — Radioimmunoassay, Luteinizing Hormone # CEP · Radioimmunoassay, Luteinizing Hormone _Clinical Chemistry · 21 CFR 862.1485 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP ## Overview - **Product Code:** CEP - **Device Name:** Radioimmunoassay, Luteinizing Hormone - **Regulation:** [21 CFR 862.1485](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1485) - **Device Class:** 1 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## Identification A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction. ## 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 143) Showing 20 most recent of 143 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K013582](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K013582.md) | MAYBE?MOM MINI OVULATION MICROSCOPE | Maybe?Mom | Jan 16, 2003 | SESE | | [K022829](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K022829.md) | INSTANT-VIEW LH OVULATION PREDICTING TEST | Alfa Scientific Designs, Inc. | Nov 5, 2002 | SESE | | [K021409](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K021409.md) | AT HOME OVULATION TEST, MODEL 9032 | Phamatech, Inc. | May 24, 2002 | SESE | | [K013874](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K013874.md) | CLEARPLANE EASY OVULATION TEST | Unipath , Ltd. | Feb 19, 2002 | SESE | | [K013323](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K013323.md) | TCI-31 LIFELONG OVULATION TESTER | Tci New York | Dec 5, 2001 | SESE | | [K012252](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K012252.md) | QUIK-CHECK OVULATION PREDICTOR | ACON Laboratories, Inc. | Aug 24, 2001 | SESE | | [K010244](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K010244.md) | SURE CHECK OVULATION PREDICTOR | Chembio Diagnostic Systems, Inc. | May 2, 2001 | SESE | | [K002867](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K002867.md) | INVERNESS MEDICAL OVULATION PREDICTOR TEST | Selfcare, Inc. | Oct 12, 2000 | SESE | | [K991466](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K991466.md) | EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) | Selfcare, Inc. | May 25, 1999 | SESE | | [K991386](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K991386.md) | EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) | Selfcare, Inc. | May 25, 1999 | SESE | | [K990249](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K990249.md) | OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 | Phamatech | Mar 22, 1999 | SESE | | [K983113](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K983113.md) | BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT | Syntron Bioresearch, Inc. | Nov 18, 1998 | SESE | | [K981271](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K981271.md) | CLEARPLAN EASY OVULATION TEST | Unipath , Ltd. | Jun 25, 1998 | SESE | | [K974508](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K974508.md) | DBEST ONE-STEP OVULATION TEST | Ameritek, Inc. | Feb 2, 1998 | SESE | | [K973310](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K973310.md) | TBD* ONE-STEP OVULATION PREDICTOR TEST | Armkel, LLC | Oct 27, 1997 | SESE | | [K970467](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K970467.md) | EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT | Excel Scientific, Inc. | Mar 18, 1997 | SESE | | [K964982](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K964982.md) | VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) | Johnson & Johnson Clinical Diagnostics, Inc. | Feb 20, 1997 | SESE | | [K964694](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K964694.md) | ELECSYS LH ASSAY | Boehringer Mannheim Corp. | Jan 24, 1997 | SESE | | [K964925](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K964925.md) | SEALITE SCIENCES, INC. AQUALITE LH | Sealite Sciences, Inc. | Jan 22, 1997 | SESE | | [K963693](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K963693.md) | OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST | Princeton BioMeditech Corp. | Nov 29, 1996 | SESE | ## Top Applicants - Diagnostic Products Corp. — 5 clearances - Amersham Corp. — 4 clearances - Leeco Diagnostics, Inc. — 4 clearances - Monoclonal Antibodies, Inc. — 4 clearances - Nichols Institute Diagnostics — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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