HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream

K192123 · Qingdao Hightop Biotech Co., Ltd. · LCX · Sep 5, 2019 · Clinical Chemistry

Device Facts

• Record ID: K192123
• Device Name: HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream
• Applicant: Qingdao Hightop Biotech Co., Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Sep 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

HIGHTOP 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. HIGHTOP 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. HIGHTOP 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

HIGHTOP Pregnancy Rapid Test (Strip, Cassette, Midstream) detects human chorionic gonadotropin (hCG) in urine samples. Device utilizes colloidal gold immunochromatography; hCG in urine binds to colloidal gold-labeled rat anti-beta-hCG monoclonal antibody. Complex migrates along nitrocellulose matrix; 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 output (presence/absence of red lines) within 5 minutes. Assists in early pregnancy confirmation. No electronic components or software.

Clinical Evidence

Bench testing and clinical performance studies conducted. Analytical sensitivity established at 25 mIU/mL. No hook effect observed up to 2,000,000 mIU/mL. Specificity testing showed no interference from common hormones (LH, FSH, TSH) or exogenous substances. Method comparison study (n=120) against predicate showed >96% agreement. Lay-person study (n=300) demonstrated 100% concordance between self-testing and professional testing results.

Technological Characteristics

Immunochromatographic assay using colloidal gold labeling. Nitrocellulose membrane matrix. Immobilized rat anti-beta-hCG monoclonal antibody (detector), anti-alpha-hCG antibody (capture), and goat anti-mouse IgG (control). Form factors: strip, cassette, midstream. Qualitative visual readout. No energy source, software, or connectivity.

Indications for Use

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

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: k192123

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.