OSOM CLASSIC HCG-URINE TEST (115)
Device Facts
| Record ID | K965227 |
|---|---|
| Device Name | OSOM CLASSIC HCG-URINE TEST (115) |
| Applicant | Wyntek Diagnostics, Inc. |
| Product Code | JHI · Clinical Chemistry |
| Decision Date | Feb 4, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1155 |
| Device Class | Class 2 |
Intended Use
The OSOM™ Classic hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
Device Story
Lateral flow immunochromatographic assay; detects hCG in urine samples. Device utilizes membrane coated with anti-hCG antibodies; presence of hCG results in blue test line formation. Used in clinical or point-of-care settings; operated by healthcare professionals. Provides qualitative visual output; assists in pregnancy confirmation. Benefits patient through rapid, early detection.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Immunochromatographic assay; membrane-based; anti-hCG antibody coating; visual colorimetric readout (blue line).
Indications for Use
Indicated for qualitative detection of hCG in urine for early pregnancy diagnosis in patients.
Regulatory Classification
Identification
A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.
Predicate Devices
- Quidel RapidVue hCG Test
- Abbott TestPack Plus hCG Urine Test
Related Devices
- K193132 — CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream · Hangzhou Clongene Biotech Co., Ltd. · Dec 11, 2019
- K032661 — ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE) · ACON Laboratories, Inc. · Oct 14, 2003
- K981722 — QUIDEL HOME PREGNANCY TEST · Quidel Corp. · Jun 3, 1998
- K013702 — VICTORCH HCG TEST STRIP · Victorch Meditek, Inc. · Dec 27, 2001
- K172257 — TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format) · True Diagnostics, Inc. · Dec 22, 2017
