CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream

K193132 · Hangzhou Clongene Biotech Co., Ltd. · LCX · Dec 11, 2019 · Clinical Chemistry

Device Facts

• Record ID: K193132
• Device Name: CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream
• Applicant: Hangzhou Clongene Biotech Co., Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Dec 11, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

CLUNGENE HCG Pregnancy Rapid Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy. CLUNGENE HCG Pregnancy Rapid Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy. CLUNGENE HCG Pregnancy Rapid Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.

Device Story

Lateral flow sandwich immunochromatographic assay; detects hCG hormone in urine. Available in strip, cassette, and midstream formats. Used for early pregnancy detection. Operated by lay users (OTC) or healthcare professionals at point-of-care. User applies urine sample to device; results interpreted visually via color change on test line within 3 minutes. Provides qualitative positive/negative result. Benefits patient by enabling rapid, convenient, early pregnancy confirmation.

Clinical Evidence

Bench testing and lay-user study. Analytical performance: 25 mIU/mL sensitivity; no hook effect up to 2,000,000 mIU/mL; no interference from common exogenous substances, pH (4-9), or specific gravity (1.000-1.035). Method comparison: 120 clinical samples tested by professionals showed 100% positive/negative conformity with predicate. Lay-user study: 300 participants across three sites demonstrated 100% positive/negative conformity with professional results; questionnaire confirmed ease of use and interpretation.

Technological Characteristics

Lateral flow sandwich immunochromatographic assay. Formats: strip, cassette, midstream. Sensitivity: 25 mIU/mL. Calibrated against WHO 5th International Standard. Shelf-life: 24 months at 4-30°C. No electronic components; non-networked; standalone diagnostic test.

Indications for Use

Indicated for qualitative detection of human chorionic gonadotropin (HCG) in urine for early pregnancy detection in women. Suitable for over-the-counter (OTC) 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: k193132

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.