PLATFORM ONESTEP PREGNANCY HOME TEST
Device Facts
| Record ID | K960117 |
|---|---|
| Device Name | PLATFORM ONESTEP PREGNANCY HOME TEST |
| Applicant | Syntron Bioresearch, Inc. |
| Product Code | LCX · Clinical Chemistry |
| Decision Date | Mar 19, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1155 |
| Device Class | Class 2 |
Intended Use
Platform OneStep pregnancy test is Syntron Bioresearch, Inc. name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of human Chorionic Gonadotropin (hCG) in urine.
Device Story
Solid phase immunoassay test kit; detects hCG in urine. Principle: sandwich solid phase dye-conjugate non-enzyme immunoassay. Gold-sol-antibody conjugate binds hCG in specimen; complex binds anti-hCG antibody in positive reaction zone. Output: purple-pink color band indicates hCG concentration >25 mIU/ml; control band indicates reagent/device function. Used by consumers in home setting. Results provide qualitative pregnancy status.
Clinical Evidence
Bench testing only; comparative data provided against Besure OneStep immunoassay.
Technological Characteristics
Solid phase immunoassay; gold-sol-antibody conjugate; lateral flow absorbent device; qualitative visual readout; 25 mIU/ml sensitivity threshold.
Indications for Use
Indicated for qualitative determination of human Chorionic Gonadotropin (hCG) in urine for OTC pregnancy detection.
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
- Besure OneStep immunoassay
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