WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream

K190705 · Wholepower Biotech Co., Ltd. · LCX · Apr 15, 2019 · Clinical Chemistry

Device Facts

• Record ID: K190705
• Device Name: WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream
• Applicant: Wholepower Biotech Co., Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Apr 15, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

WHOLEPOWER Pregnancy Rapid Test Cassette is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy. WHOLEPOWER Pregnancy Rapid Test Midstream is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy. WHOLEPOWER Pregnancy Rapid Test Strip is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

Device Story

WHOLEPOWER Pregnancy Rapid Test (Strip, Cassette, Midstream) detects human chorionic gonadotropin (hCG) in urine. Device uses colloidal gold immunochromatography; hCG in urine binds to colloidal gold-labeled rat anti-beta-hCG monoclonal antibody. Complex migrates via capillary action to nitrocellulose membrane; captured by immobilized anti-alpha-hCG antibody, forming visible red line in test zone (T) for positive result. Control zone (C) contains immobilized goat anti-mouse IgG to verify sample flow. Used by lay persons (OTC) or healthcare professionals in clinics. Provides qualitative visual result in 3 minutes. Aids in early pregnancy detection. No electronic components or software.

Clinical Evidence

Clinical performance evaluated via method comparison study with 120 women at OB/GYN offices, comparing subject device to predicate. Results showed >98% agreement. Lay person study (n=300) demonstrated 100% positive and >97% negative conformity between self-testing and professional testing. Analytical performance confirmed 25 mIU/mL sensitivity, no hook effect up to 2,000,000 mIU/mL, and no interference from common exogenous substances, pH (4-9), or specific gravity (1.002-1.032).

Technological Characteristics

Immunochromatographic assay using colloidal gold labeling. Nitrocellulose membrane with immobilized anti-hCG antibodies. Formats: strip, cassette, midstream. Sensitivity: 25 mIU/mL. No energy source, software, or connectivity. Shelf-life: 24 months at 4-30°C.

Indications for Use

Indicated for qualitative detection of hCG in urine for early pregnancy detection in women. Intended for over-the-counter use.

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.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) Number: k190705

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.