Test, Luteinizing Hormone (Lh), Over The Counter
FDA product code NGE · Class I (low risk) · 21 CFR 862.1485 · Clinical Chemistry
6510(k) clearances
0PMA approvals
10recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020808 | Fertilite OvNGE · Traditional | Pheromone Sciences Corp. | 09/23/2002SE |
| K990223 | Modification of Clearplan Easy Fertility MonitorNGE · Special | Unipath , Ltd. | 02/24/1999SE |
| K981207 | Clearplan Easy Fertility MonitorNGE · Traditional | Unipath , Ltd. | 10/28/1998SE |
| K973860 | Ovulon MonitorNGE · Traditional | Conception Technology, Inc. | 01/07/1998SE |
| K863121 | Peak Ovulation PredictorNGE · Traditional | Micron Technology, Inc. | 10/14/1986SE |
| K850579 | Cue Fertility MonitorNGE · Traditional | Zetek, Inc. | 03/22/1985SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1259-2026 Class II | LH One Step Ovulation Test Device (Urine)Test strips and other tests including for near-patient testing, that require a 510(k) were distributed… | Changchun Wancheng Bio-Electron Co., Ltd. | 11/22/2025Open, Classified |
| Z-0747-2026 Class II | Ovulation Test (5 tests)Distribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0068-2024 Class II | OMTMO One Step Ovulation (LH) Test Strips REF 200-07Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS… | Universal Meditech Inc. | 05/22/2023Open, Classified |
| Z-0067-2024 Class II | DiagnosUS Ovulation Predictor Midstream REF 200-17Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS… | Universal Meditech Inc. | 05/22/2023Open, Classified |
| Z-0062-2024 Class II | Lem Fertility LH Ovulation Test (Strip) REF 200-07Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS… | Universal Meditech Inc. | 05/22/2023Open, Classified |
| Z-0058-2024 Class II | DiagnosUS One Step LH Ovulation Test Strip REF 200-07Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS… | Universal Meditech Inc. | 05/22/2023Open, Classified |
| Z-0053-2024 Class II | PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30…Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS… | Universal Meditech Inc. | 05/22/2023Open, Classified |
| Z-0052-2024 Class II | PrestiBio Ovulation Strips REF 200-4 60 LH Test StripsUniversal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS… | Universal Meditech Inc. | 05/22/2023Open, Classified |
| Z-0043-2024 Class II | One Step Ovulation Test REF 200-01Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS… | Universal Meditech Inc. | 05/22/2023Open, Classified |
| Z-0968-2010 | OvuChek Saliva Ovulation Disposable Test Strips; 5 disposable test strips per pouch…The ovulation test strips were shipped without 510(k) premarket notification clearance from the FDA. | Quest Products Inc. | 11/07/2008Terminated |