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

K192843 · Innovita (Tangshan) Biological Technology Co., Ltd. · LCX · Nov 22, 2019 · Clinical Chemistry

Device Facts

• Record ID: K192843
• Device Name: INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream
• Applicant: Innovita (Tangshan) Biological Technology Co., Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Nov 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

The INNOVITA HCG Pregnancy Rapid Test Strip detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only. The INNOVITA HCG Pregnancy Rapid Test Cassette detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only. The INNOVITA HCG Pregnancy Rapid Test Midstream detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only.

Device Story

Lateral flow chromatographic immunoassay for qualitative detection of hCG in human urine; detects pregnancy. Device formats: strip, cassette, midstream. Input: urine sample applied to sample pad; hCG binds to colloidal gold-labeled mouse monoclonal anti-beta-hCG antibodies in conjugate pad; complex migrates via lateral flow. Detection: T-line contains immobilized anti-alpha-hCG antibodies capturing complex to form visible pink line; C-line contains immobilized goat anti-mouse IgG capturing excess gold-labeled antibodies to confirm test validity. Used in home/OTC setting by lay users. Results interpreted visually by user; positive result indicates presence of hCG. Benefits: provides rapid, accessible, early pregnancy determination.

Clinical Evidence

Bench testing included precision/sensitivity (25mIU/mL), cross-reactivity (LH, FSH, TSH), interference (endogenous/exogenous compounds), pH, specific gravity, and hook effect (up to 2000IU/mL). Method comparison study (n=300) against predicate showed 100% agreement. Lay user study (n=300) across three sites with diverse demographics demonstrated 100% agreement between lay user results and professional interpretation of the predicate device. Questionnaire confirmed ease of use and instruction clarity; Flesch-Kincaid reading level is 7th grade.

Technological Characteristics

Lateral flow chromatographic immunoassay. Components: membrane coated with mouse monoclonal anti-alpha-hCG antibodies; conjugate pad with colloidal gold-labeled mouse monoclonal anti-beta-hCG antibodies; control line with goat anti-mouse IgG. Formats: strip, cassette, midstream. Sensitivity: 25mIU/mL. Storage: 4–30°C. Shelf-life: 3 years. No electronic components or software.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. Intended for Over-the-Counter, in vitro diagnostic use by lay users.

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: k192843

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.