Radioimmunoassay, Luteinizing Hormone
FDA product code CEP · Class I (low risk) · 21 CFR 862.1485 · Clinical Chemistry
143510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Diagnostic Products Corp. 5
- Nichols Institute Diagnostics 4
- Pcl-Ria, Inc. 4
- Amersham Corp. 4
- Monoclonal Antibodies, Inc. 4
- Unipath , Ltd. 4
- Leeco Diagnostics, Inc. 4
- Selfcare, Inc. 3
- Syntron Bioresearch, Inc. 3
- Quidel Corp. 3
- Hybritech, Inc. 3
- Medix Biotech, Inc. 3
- Vanguard Biomedical Corp. 3
- Bio-Rad 3
- Serono Diagnostics, Inc. 3
- Ciba Corning Diagnostics Corp. 3
- Armkel, LLC 3
- Syncor Intl. Corp. 2
- Bioclinical Systems, Inc. 2
- Biogenex Laboratories 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013582 | Maybe?Mom Mini Ovulation MicroscopeCEP · Traditional | Maybe?Mom | 01/16/2003SE |
| K022829 | Instant-View LH Ovulation Predicting TestCEP · Abbreviated | Alfa Scientific Designs, Inc. | 11/05/2002SE |
| K021409 | At Home Ovulation Test, Model 9032CEP · Special | Phamatech, Inc. | 05/24/2002SE |
| K013874 | Clearplane Easy Ovulation TestCEP · Traditional | Unipath , Ltd. | 02/19/2002SE |
| K013323 | TCI-31 Lifelong Ovulation TesterCEP · Traditional | Tci New York | 12/05/2001SE |
| K012252 | Quik-Check Ovulation PredictorCEP · Traditional | ACON Laboratories, Inc. | 08/24/2001SE |
| K010244 | Sure Check Ovulation PredictorCEP · Traditional | Chembio Diagnostic Systems, Inc. | 05/02/2001SE |
| K002867 | Inverness Medical Ovulation Predictor TestCEP · Special | Selfcare, Inc. | 10/12/2000SE |
| K991466 | Early Ovulation Predictor (Cassette), One Step Ovulation Predictor (Cassette), Ovulation…CEP · Traditional | Selfcare, Inc. | 05/25/1999SE |
| K991386 | Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation…CEP · Traditional | Selfcare, Inc. | 05/25/1999SE |
| K990249 | Ovustick LH Ovulation Predictor, Model 9030, Ovucard LH Ovulation Predictor, Model 9031CEP · Traditional | Phamatech | 03/22/1999SE |
| K983113 | Besure Plus One-Step Home Ovulation Predictor KitCEP · Traditional | Syntron Bioresearch, Inc. | 11/18/1998SE |
| K981271 | Clearplan Easy Ovulation TestCEP · Traditional | Unipath , Ltd. | 06/25/1998SE |
| K974508 | Dbest One-Step Ovulation TestCEP · Traditional | Ameritek, Inc. | 02/02/1998SE |
| K973310 | Tbd* One-Step Ovulation Predictor TestCEP · Traditional | Armkel, LLC | 10/27/1997SE |
| K970467 | Ez Sure One Step Ovulation Predictor Home Test KitCEP · Traditional | Excel Scientific, Inc. | 03/18/1997SE |
| K964982 | Vitros Immunodiagnostics Products LH Reagent Pack (GEM.1055) and LH Calibrators (GEM.CO55)CEP · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 02/20/1997SE |
| K964694 | Elecsys LH AssayCEP · Traditional | Boehringer Mannheim Corp. | 01/24/1997SE |
| K964925 | Sealite Sciences, Inc. Aqualite LHCEP · Traditional | Sealite Sciences, Inc. | 01/22/1997SE |
| K963693 | Ovusign - One-Step Home Ovulation Predictor TestCEP · Traditional | Princeton BioMeditech Corp. | 11/29/1996SE |
| K962866 | Opus HLHCEP · Traditional | Behring Diagnostics, Inc. | 08/23/1996SE |
| K962041 | Acs LH2 ImmunoassayCEP · Traditional | Ciba Corning Diagnostics Corp. | 06/21/1996SE |
| K960233 | Miniclinic Ovulation PredictorCEP · Traditional | Vanguard Biomedical Corp. | 04/23/1996SE |
| K961109 | Active LH IrmaCEP · Traditional | Diagnostic Systems Laboratories, Inc. | 04/05/1996SE |
| K953581 | First Response Ovulation Predictor TestCEP · Traditional | Armkel, LLC | 10/03/1995SE |
| K953063 | Conceive Ovulation PredictorCEP · Traditional | Quidel Corp. | 08/23/1995SE |
| K951538 | Besure One-=Step Home Ovulation Predictor KitCEP · Traditional | Syntron Bioresearch, Inc. | 07/11/1995SE |
| K951748 | Coat-A-Count LH IrmaCEP · Traditional | Diagnostic Products Corp. | 05/15/1995SE |
| K935319 | Chemiluminescence LHCEP · Traditional | Nichols Institute Diagnostics | 04/05/1995SE |
| K943252 | Pro-Step LH Ovulation Prediction TestCEP · Traditional | Disease Detection International, Inc. | 10/25/1994SE |
| K943996 | Dupont Aca Plus Luteinizing Hormone (LH) MethodCEP · Traditional | Dupont Medical Products | 10/20/1994SE |
| K943188 | Sealite Science, Inc. Aqualite(R) LHCEP · Traditional | Sealite Sciences, Inc. | 10/20/1994SE |
| K942638 | Simultrac Lh/Fsh Radioummunoassay KitCEP · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/07/1994SE |
| K940549 | Access(R) Human Luteinzing Hormone AssayCEP · Traditional | Bio-Rad Laboratories, Inc. | 04/06/1994SE |
| K935134 | One Step LH TestCEP · Traditional | Tcpi, Inc. | 01/11/1994SE |
| K930306 | Cobas Core LH EiaCEP · Traditional | Roche Diagnostic Systems, Inc. | 05/26/1993SE |
| K926394 | Vista(R) Human Luteinizing Hormone(Hlh) AssayCEP · Traditional | Syva Co. | 05/26/1993SE |
| K930185 | Ovusign Lh/Conception Plus/Ovudate LH One-StepCEP · Traditional | Princeton Biomedix | 03/04/1993SE |
| K922944 | Immuchem Lh-Mw ElisaCEP · Traditional | Icn Biomedicals, Inc. | 02/02/1993SE |
| K921176 | Vitek Immunodiagnostic Assay SystemCEP · Traditional | Vitek Systems, Inc. | 04/08/1992SE |
| K920920 | Elisa Tube LH Test KitCEP · Traditional | Bio Clinic Co. | 04/08/1992SE |
| K920411 | Immulite HLHCEP · Traditional | Cirrus Diagnostics, Inc. | 03/11/1992SE |
| K920160 | LH Gen III Self-Test/ConceiveCEP · Traditional | Quidel Corp. | 03/11/1992SE |
| K920504 | Medix Biotech LH Enzyme Immunoassay Test KitCEP · Traditional | Medix Biotech, Inc. | 03/02/1992SE |
| K913938 | Opus(R) LH Test SystemCEP · Traditional | Pb Diagnostic Systems, Inc. | 11/07/1991SE |
| K911050 | LH Irma ImmunomagCEP · Traditional | Pantex, Div. Bio-Analysis, Inc. | 04/12/1991SE |
| K910351 | Miniclinic Ovulation Prediction TestCEP · Traditional | Vanguard Biomedical Corp. | 03/21/1991SE |
| K910717 | Pantex Irma LH 1251 KitCEP · Traditional | Pantex, Div. Bio-Analysis, Inc. | 03/19/1991SE |
| K910198 | Ciba Corning Acs LH ImmunoassayCEP · Traditional | Ciba Corning Diagnostics Corp. | 02/04/1991SE |
| K904387 | Bioclones Elegance LH Elisa KitCEP · Traditional | Bioclone Australia Pty , Ltd. | 11/06/1990SE |
| K902786 | Milenia (TM) LHCEP · Traditional | Diagnostic Products Corp. | 10/12/1990SE |
| K903052 | Immunocorp LH Irma Coated TubeCEP · Traditional | Immunocorp Sciences, Inc. | 08/29/1990SE |
| K902443 | Lumatag(Tm) LH Diagnostic KitCEP · Traditional | London Diagnostics, Inc. | 08/02/1990SE |
| K902208 | Modified OvugenCEP · Traditional | Biogenex Laboratories | 07/17/1990SE |
| K902398 | Ciba Corning Magic Lite LH ImmunoassayCEP · Traditional | Ciba Corning Diagnostics Corp. | 06/28/1990SE |
| K900779 | Enzymun Test(R) LHCEP · Traditional | Boehringer Mannheim Corp. | 04/03/1990SE |
| K900621 | Fiagen(Tm) Hlh.SCEP · Traditional | Cyberfluor, Inc. | 03/01/1990SE |
| K896866 | Luteinizing Hormone-Eia-XtCEP · Traditional | In Vitro Diagnostics, Inc. | 02/13/1990SE |
| K896642 | Modified LH Enzyme Immunoassay Test KitCEP · Traditional | Medix Biotech, Inc. | 01/30/1990SE |
| K895094 | Tandem-E LH Immunoenzymetric Assay KitCEP · Traditional | Hybritech, Inc. | 10/31/1989SE |
| K894579 | Clearplan EasyCEP · Traditional | Unipath , Ltd. | 10/12/1989SE |
| K894279 | Luteinizing Hormone Mab Solid Phase Component SystCEP · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/15/1989SE |
| K891762 | Miniclinic Ovulation Prediction TestCEP · Traditional | Vanguard Biomedical Corp. | 07/20/1989SE |
| K893605 | Sri Luteinizing Hormone Immunoenzymetric AssayCEP · Traditional | Serono-Baker Diagnostics, Inc. | 06/20/1989SE |
| K890510 | Abbott Ovulation Predictor TestCEP · Traditional | Abbott Laboratories | 03/24/1989SE |
| K883814 | Delfia HLH Spec KitCEP · Traditional | Pharmacia, Inc. | 03/08/1989SE |
| K884498 | Cotube LH Irma AssayCEP · Traditional | Bio-Rad | 12/22/1988SE |
| K883530 | First Response 10 Minute Ovulation Predictor TestCEP · Traditional | Tambrands, Inc. | 12/19/1988SE |
| K884138 | Abbott Imx LHCEP · Traditional | Abbott Laboratories | 11/29/1988SE |
| K882340 | LH Serozyme Immunoenzymetric Assay Kit,Mag Sol PhaCEP · Traditional | Serono Diagnostics, Inc. | 08/08/1988SE |
| K882252 | Phase II LH KitCEP · Traditional | Vitek Systems, Inc. | 08/04/1988SE |
| K880933 | Amerlite LH-30 Assay, LAN.0082/2082 240/144 TestCEP · Traditional | Amersham Corp. | 07/28/1988SE |
| K881124 | Allegro(Tm) Luteinizing Hormone ImmunoassayCEP · Traditional | Nichols Institute Diagnostics | 04/18/1988SE |
| K880758 | Sucrosep Specific Immunoradiometric AssayCEP · Traditional | Boots-Celltech Diagnostics, Inc. | 04/18/1988SE |
| K874624 | Fiagen(Tm) HLH Catalogue Number: 102-301CEP · Traditional | Cyberfluor, Inc. | 01/11/1988SE |
| K874032 | Irma-Count LH W/Mono. Antibodies RKLH1,2,5CEP · Traditional | Diagnostic Products Corp. | 12/30/1987SE |
| K870584 | O.P.T.(Tm) Ovulation Prediction TestCEP · Traditional | Warner-Lambert Co. | 11/25/1987SE |
| K873534 | Ovugen SuretestCEP · Traditional | Biogenex Laboratories | 11/23/1987SE |
| K873668 | Medix Biotech LH Enzyme Immunoassay Test KitCEP · Traditional | Medix Biotech, Inc. | 10/07/1987SE |
| K871241 | Answer Ovulation Test KitCEP · Traditional | Armkel, LLC | 10/02/1987SE |
| K873186 | LH Maiaclone Immunoradio. Assay Kit, Mag Solid PhaCEP · Traditional | Serono Diagnostics, Inc. | 09/29/1987SE |
| K873052 | Stratus(R) HLH Fluorometric Enzyme ImmunoassayCEP · Traditional | American Dade | 09/14/1987SE |
| K872131 | Tandemr M-Pak LH Immunoenzymetric AssayCEP · Traditional | Hybritech, Inc. | 08/25/1987SE |
| K872727 | LH Serozyme Immunoenzymetric Assay Kit, Mag. PhaseCEP · Traditional | Serono Diagnostics, Inc. | 08/05/1987SE |
| K871332 | ClearplanCEP · Traditional | Unipath , Ltd. | 08/05/1987SE |
| K871726 | Ovuquick Self-Test (Ovuquick; Ramp LH Assay)CEP · Traditional | Monoclonal Antibodies, Inc. | 07/27/1987SE |
| K871602 | Microcheck LH Ovulation TestCEP · Traditional | Syntron Bioresearch, Inc. | 06/11/1987SE |
| K863934 | DPC Coat-A-Count Irma LH KitCEP · Traditional | Diagnostic Products Corp. | 02/06/1987SE |
| K863442 | Ubi Magiwel(Tm) LH Quantitative & QualitativeCEP · Traditional | United Biotech, Inc. | 02/04/1987SE |
| K862055 | Canwest Ovu-BlueCEP · Traditional | Canwest Medictex, Inc. | 01/06/1987SE |
| K864144 | Luteinizing Hormone (Lh-Irma) Ria KitCEP · Traditional | Immuchem Corp. | 11/24/1986SE |
| K863929 | Terumo Sensibead(Tm) Eia HLH KitCEP · Traditional | Terumo Medical Corp. | 11/13/1986SE |
| K863679 | Allegro Luteinizing Hormone Immunoassay SystemCEP · Traditional | Nichols Institute Diagnostics | 10/16/1986SE |
| K861354 | Right-Day Ovulation Home TestCEP · Traditional | Leeco Diagnostics, Inc. | 09/16/1986SE |
| K860828 | Foretel, Color Ovulation TestCEP · Traditional | Nms Pharmaceuticals, Inc. | 08/04/1986SE |
| K860538 | Right-Day Urinary LH (Eia)CEP · Traditional | Leeco Diagnostics, Inc. | 07/29/1986SE |
| K862180 | Modified Cotropin Radioimmunoassay KitCEP · Traditional | Clinetics Corp. | 07/07/1986SE |
| K860984 | Tandem Icon LH Assay (Urine) Immunoenzymetric KitCEP · Traditional | Hybritech, Inc. | 04/29/1986SE |
| K860334 | Visi-Check HLH Test MonoclonalCEP · Traditional | Bioclinical Systems, Inc. | 04/21/1986SE |
| K860333 | Micro-Elisa HLH Test Kit MonoclonalCEP · Traditional | Bioclinical Systems, Inc. | 04/21/1986SE |
| K860308 | Sucrosep Luteinizing Hormone (LH) IrmaCEP · Traditional | Boots-Celltech Diagnostics, Inc. | 03/17/1986SE |
| K855173 | Delfia TM HLH KitCEP · Traditional | Lkb Instruments, Inc. | 02/28/1986SE |
| K854838 | Lee-Bead Beta LH (Eia)CEP · Traditional | Leeco Diagnostics, Inc. | 01/07/1986SE |
| K853142 | Ovutime Ovulation Predictor TestCEP · Traditional | Advanced Care Products | 12/17/1985SE |
| K853837 | Lh/Fsh Radioimmunoassay KitCEP · Traditional | Bioclinical Group | 10/16/1985SE |
| K852146 | Quidel Quest Ovulation TestCEP · Traditional | Quidel Corp. | 07/29/1985SE |
| K851445 | Color Ovulation TestCEP · Traditional | Nms Pharmaceuticals, Inc. | 07/29/1985SE |
| K852376 | Simultaneous Lh/Fsh System by RiaCEP · Traditional | American Bioclinical, Inc. | 07/09/1985SE |
| K851332 | Blhi Luteinizing HormoneCEP · Traditional | Euro-Diagnostics BV | 07/09/1985SE |
| K851104 | Amerlex-M Luteinizing Hormone Radioimmuno-KitCEP · Traditional | Amersham Corp. | 04/10/1985SE |
| K850480 | Ovu Stick Self-Test -ModificationCEP · Traditional | Monoclonal Antibodies, Inc. | 03/05/1985SE |
| K843284 | Ovustick Self-TestCEP · Traditional | Monoclonal Antibodies, Inc. | 12/11/1984SE |
| K841545 | Enzyme Immunoassay for Detection HormCEP · Traditional | Btc Diagnostics, Inc. | 11/27/1984SE |
| K842445 | LH RiaCEP · Traditional | Syncor Intl. Corp. | 09/04/1984SE |
| K840412 | Ovu Stick Urine HLH KitCEP · Traditional | Monoclonal Antibodies, Inc. | 04/13/1984SE |
| K840188 | Micromedic LH & FSH Ria KitCEP · Traditional | Micromedic Systems | 03/23/1984SE |
| K840174 | LH Quik Ria KitCEP · Traditional | Pacific Biotech, Inc. | 03/19/1984SE |
| K833854 | LH RiaCEP · Traditional | Syncor Intl. Corp. | 01/13/1984SE |
| K833376 | Rianen Luteinizing Hormone Ria KitCEP · Traditional | New England Nuclear | 12/20/1983SE |
| K823476 | Gammadab LH Radio-Kit #CA-1508CEP · Traditional | Clinical Assays, Inc. | 12/28/1982SE |
| K823380 | 125-I LH Radioimmunoassay KitCEP · Traditional | Clinetics Corp. | 12/22/1982SE |
| K822288 | LH (125I) RadioimmunoassayCEP · Traditional | Corning Medical & Scientific | 09/13/1982SE |
| K821346 | Quantimune HLH RiaCEP · Traditional | Bio-Rad | 05/28/1982SE |
| K820760 | LH Radioimmunoassay Test SystemCEP · Traditional | Monobind | 04/16/1982SE |
| K820741 | MR1 Lutropin Ria KitCEP · Traditional | Microanalytic Research, Inc. | 04/14/1982SE |
| K820753 | Amerlex LH Ria Kit (Code IM2081)CEP · Traditional | Amersham Corp. | 04/09/1982SE |
| K820357 | Luteinizing Hormone KitCEP · Traditional | Pcl-Ria, Inc. | 03/25/1982SE |
| K813213 | Sharia-Lh Ria Kit for Quantitation HormoCEP · Traditional | Intl. Immunoassay Laboratories, Inc. | 12/22/1981SE |
| K811994 | Radioimmunoassay Luteinizing HormoneCEP · Traditional | Endocrine-Metabolic Center | 07/27/1981SE |
| K811024 | Luteinizing Hormone Direct Ria Kit 125/ICEP · Traditional | Immunalysis Corporation | 05/08/1981SE |
| K810754 | Lutenizing HormonesCEP · Traditional | Pcl-Ria, Inc. | 03/31/1981SE |
| K810741 | Luteinizing HormoneCEP · Traditional | Pcl-Ria, Inc. | 03/31/1981SE |
| K810662 | Leeco Lh-Quant Diagnostic KitCEP · Traditional | Leeco Diagnostics, Inc. | 03/31/1981SE |
| K810302 | Quantimune HLH Ria Human Lutenizing HormCEP · Traditional | Bio-Rad | 02/25/1981SE |
| K803278 | Luteinizing Hormone Radioimmunoassay KitCEP · Traditional | Immuno Nuclear Corp. | 01/21/1981SE |
| K800106 | Luteinizing Hormone Radioimmunoassay SysCEP · Traditional | Radioimmunoassay, Inc. | 02/13/1980SE |
| K792350 | Centria LH RiaCEP · Traditional | Union Carbide Corp. | 01/16/1980SE |
| K792000 | Luteinizing Hormone (LH) RiaCEP · Traditional | Cis Radiopharmaceuticals, Inc. | 10/30/1979SE |
| K791405 | 125I Leutinizing Hormone Ria KitCEP · Traditional | Diagnostic Products Corp. | 09/17/1979SE |
| K781685 | Ria Kit, LHCEP · Traditional | Amersham Corp. | 10/27/1978SE |
| K780576 | 125-I Labeled Human Luteinizing HormoneCEP · Traditional | Pcl-Ria, Inc. | 05/19/1978SE |
| K780367 | Ria Sys. for Human Luteinizing HormoneCEP · Traditional | Calbiochem-Behring Corp. | 04/28/1978SE |
| K770854 | Luteinizing Hormone Ria Reagent, Lh-RiaCEP · Traditional | Nichols Institute Diagnostics | 05/26/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0865-2023 Class II | VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Biomerieux Inc | 11/09/2022Open, Classified |
| Z-1113-2022 Class II | VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic… | Ortho-Clinical Diagnostics, Inc | 03/25/2022Open, Classified |
| Z-0433-2022 Class II | VIDAS LH, REF 30406-01bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It… | bioMerieux, Inc. | 09/22/2021Open, Classified |
| Z-2090-2018 Class II | ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-0572-2013 Class II | The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the…Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain… | Beckman Coulter Inc. | 11/05/2012Terminated |
| Z-0488-2007 | ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles…The lots of ARCHITECT LH Reagent List 6C25-22, have the potential to generate patient specimen results that… | Abbott Laboratories MPG | 11/22/2006Terminated |