FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
Device Facts
| Record ID | K250117 |
|---|---|
| Device Name | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette |
| Applicant | Assure Tech., LLC |
| Product Code | LCX · Clinical Chemistry |
| Decision Date | Feb 13, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1155 |
| Device Class | Class 2 |
Indications for Use
FaStep Pregnancy Rapid Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in the early detection of pregnancy. For over-the-counter use. The Fastep HCG Rapid Test Cassette is a rapid visual immunoassay for the qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in the early detection of pregnancy. The test kits are for health care professionals use including professionals at physician's office labs (POLs).
Device Story
Lateral flow immunoassay for qualitative HCG detection in human urine; utilizes mouse monoclonal anti-ßhCG antibody colloidal gold conjugate on sample pad; mouse monoclonal anti-a-hCG antibody on test line; goat anti-mouse IgG on control line. User applies urine sample via pipette; gold-conjugated antibodies rehydrate and bind HCG; complex migrates to test zone; captured antibodies form visible line for positive result. Used in home (OTC) or clinical settings (POLs). Provides visual qualitative output (two lines = positive; one line = negative). Aids in early pregnancy detection; assists clinical decision-making by confirming pregnancy status.
Clinical Evidence
Bench testing and clinical study performed. Analytical performance: sensitivity 20 mIU/mL; no hook effect up to 2,000,000 mIU/mL; no interference from common substances, pH (4-9), or density (1.000-1.035). Method comparison study (n=112) showed 100% agreement with predicate. Lay-user study (n=112) showed 100% agreement with professional results. Specificity study (n=300) across pre-, peri-, and post-menopausal groups showed 0% false-positive rate.
Technological Characteristics
Lateral flow immunochromatographic assay. Materials: nitrocellulose membrane, colloidal gold conjugate. Sensitivity: 20 mIU/mL. Calibration: WHO International Standard 5th edition (NIBSC 07/364). Form factor: test cassette. No electronic components or software algorithms.
Indications for Use
Indicated for qualitative detection of HCG in human urine to aid in early pregnancy detection. Intended for use by lay persons (OTC) or healthcare professionals (prescription).
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.
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