Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CEP — Predicate Candidate Screening
143 FDA 510(k) clearances under this product code; the 50 most recent screened below.
57 daysmedian FDA review time
141 days90th percentile
143clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013582 | MAYBE?MOM MINI OVULATION MICROSCOPE | Maybe?Mom | 2003-01-16 | 443 | 0 |
| K022829 | INSTANT-VIEW LH OVULATION PREDICTING TEST | Alfa Scientific Designs, Inc. | 2002-11-05 | 71 | 0 |
| K021409 | AT HOME OVULATION TEST, MODEL 9032 | Phamatech, Inc. | 2002-05-24 | 21 | 0 |
| K013874 | CLEARPLANE EASY OVULATION TEST | Unipath , Ltd. | 2002-02-19 | 90 | 0 |
| K013323 | TCI-31 LIFELONG OVULATION TESTER | Tci New York | 2001-12-05 | 61 | 0 |
| K012252 | QUIK-CHECK OVULATION PREDICTOR | ACON Laboratories, Inc. | 2001-08-24 | 37 | 0 |
| K010244 | SURE CHECK OVULATION PREDICTOR | Chembio Diagnostic Systems, Inc. | 2001-05-02 | 97 | 0 |
| K002867 | INVERNESS MEDICAL OVULATION PREDICTOR TEST | Selfcare, Inc. | 2000-10-12 | 29 | 0 |
| K991466 | EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PRE | Selfcare, Inc. | 1999-05-25 | 28 | 0 |
| K991386 | EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDIC | Selfcare, Inc. | 1999-05-25 | 34 | 0 |
| K990249 | OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVUL | Phamatech | 1999-03-22 | 55 | 0 |
| K983113 | BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT | Syntron Bioresearch, Inc. | 1998-11-18 | 75 | 0 |
| K981271 | CLEARPLAN EASY OVULATION TEST | Unipath , Ltd. | 1998-06-25 | 79 | 0 |
| K974508 | DBEST ONE-STEP OVULATION TEST | Ameritek, Inc. | 1998-02-02 | 63 | 0 |
| K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | Armkel, LLC | 1997-10-27 | 54 | 0 |
| K970467 | EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT | Excel Scientific, Inc. | 1997-03-18 | 39 | 0 |
| K964982 | VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-20 | 70 | 0 |
| K964694 | ELECSYS LH ASSAY | Boehringer Mannheim Corp. | 1997-01-24 | 63 | 0 |
| K964925 | SEALITE SCIENCES, INC. AQUALITE LH | Sealite Sciences, Inc. | 1997-01-22 | 44 | 0 |
| K963693 | OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST | Princeton BioMeditech Corp. | 1996-11-29 | 74 | 0 |
| K962866 | OPUS HLH | Behring Diagnostics, Inc. | 1996-08-23 | 31 | 0 |
| K962041 | ACS LH2 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1996-06-21 | 24 | 0 |
| K960233 | MINICLINIC OVULATION PREDICTOR | Vanguard Biomedical Corp. | 1996-04-23 | 97 | 0 |
| K961109 | ACTIVE LH IRMA | Diagnostic Systems Laboratories, Inc. | 1996-04-05 | 16 | 0 |
| K953581 | FIRST RESPONSE OVULATION PREDICTOR TEST | Armkel, LLC | 1995-10-03 | 63 | 0 |
| K953063 | CONCEIVE OVULATION PREDICTOR | Quidel Corp. | 1995-08-23 | 54 | 0 |
| K951538 | BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT | Syntron Bioresearch, Inc. | 1995-07-11 | 99 | 0 |
| K951748 | COAT-A-COUNT LH IRMA | Diagnostic Products Corp. | 1995-05-15 | 28 | 0 |
| K935319 | CHEMILUMINESCENCE LH | Nichols Institute Diagnostics | 1995-04-05 | 532 | 0 |
| K943252 | PRO-STEP LH OVULATION PREDICTION TEST | Disease Detection International, Inc. | 1994-10-25 | 111 | 0 |
| K943188 | SEALITE SCIENCE, INC. AQUALITE(R) LH | Sealite Sciences, Inc. | 1994-10-20 | 107 | 0 |
| K943996 | DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD | Dupont Medical Products | 1994-10-20 | 65 | 0 |
| K942638 | SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-09-07 | 96 | 0 |
| K940549 | ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY | Bio-Rad Laboratories, Inc. | 1994-04-06 | 58 | 1 |
| K935134 | ONE STEP LH TEST | Tcpi, Inc. | 1994-01-11 | 75 | 0 |
| K926394 | VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY | Syva Co. | 1993-05-26 | 156 | 0 |
| K930306 | COBAS CORE LH EIA | Roche Diagnostic Systems, Inc. | 1993-05-26 | 125 | 0 |
| K930185 | OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP | Princeton Biomedix | 1993-03-04 | 49 | 0 |
| K922944 | IMMUCHEM LH-MW ELISA | Icn Biomedicals, Inc. | 1993-02-02 | 229 | 0 |
| K921176 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Vitek Systems, Inc. | 1992-04-08 | 28 | 1 |
| K920920 | ELISA TUBE LH TEST KIT | Bio Clinic Co. | 1992-04-08 | 40 | 0 |
| K920160 | LH GEN III SELF-TEST/CONCEIVE | Quidel Corp. | 1992-03-11 | 57 | 0 |
| K920411 | IMMULITE HLH | Cirrus Diagnostics, Inc. | 1992-03-11 | 40 | 0 |
| K920504 | MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1992-03-02 | 26 | 0 |
| K913938 | OPUS(R) LH TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1991-11-07 | 65 | 0 |
| K911050 | LH IRMA IMMUNOMAG | Pantex, Div. Bio-Analysis, Inc. | 1991-04-12 | 35 | 0 |
| K910351 | MINICLINIC OVULATION PREDICTION TEST | Vanguard Biomedical Corp. | 1991-03-21 | 65 | 0 |
| K910717 | PANTEX IRMA LH 1251 KIT | Pantex, Div. Bio-Analysis, Inc. | 1991-03-19 | 27 | 0 |
| K910198 | CIBA CORNING ACS LH IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-02-04 | 19 | 0 |
| K904387 | BIOCLONES ELEGANCE LH ELISA KIT | Bioclone Australia Pty , Ltd. | 1990-11-06 | 42 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda