Innovita HCG Pregnancy Rapid Combo Test

K241919 · Innovita (Tangshan) Biological Technology Co., Ltd. · JHI · Aug 2, 2024 · Clinical Chemistry

Device Facts

• Record ID: K241919
• Device Name: Innovita HCG Pregnancy Rapid Combo Test
• Applicant: Innovita (Tangshan) Biological Technology Co., Ltd.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Aug 2, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

The Innovita HCG Pregnancy Rapid Combo Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy. The test is for health care professionals use including professionals at point of care (POC).

Device Story

The Innovita HCG Pregnancy Rapid Combo Test is a lateral flow sandwich immunochromatographic assay used for the qualitative detection of HCG in human urine or serum. The device consists of a single-use cassette. During operation, the specimen is applied to the device; if HCG is present, it binds to colloidal gold-conjugated anti-beta-HCG antibodies on the conjugate pad. This complex migrates to the nitrocellulose membrane where it is captured by immobilized anti-alpha-HCG antibodies, forming a visible red-purple line in the Test Zone. A Control Zone line confirms proper test completion. The test is performed by healthcare professionals in clinical or point-of-care settings. Results are visually interpreted by the provider within 5 minutes. The presence of the test line indicates pregnancy, while its absence indicates a negative result. The device aids in early pregnancy detection by identifying HCG levels at or above 10 mIU/mL for serum and 20 mIU/mL for urine.

Clinical Evidence

Bench testing only. Method comparison study performed on 210 samples (108 urine, 102 serum) from women aged 20-49. Results showed 100% agreement with the predicate device (K203272). Analytical performance verified cut-off values (10 mIU/mL serum, 20 mIU/mL urine), precision, and lack of interference from exogenous compounds, glycoprotein hormones (LH, FSH, TSH), and urine matrix effects (pH, specific gravity). No hook effect observed up to 2,000,000 mIU/mL.

Technological Characteristics

Lateral flow sandwich immunochromatographic assay. Components: nitrocellulose membrane, colloidal gold-conjugated anti-beta-HCG antibodies, immobilized anti-alpha-HCG antibodies. Form factor: single-use cassette. Detection: visual red-purple line. Cut-offs: 10 mIU/mL (serum), 20 mIU/mL (urine). Storage: 4-30°C. No electronic components, software, or connectivity.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (HCG) in urine or serum to aid in the early detection of pregnancy in women. For use by healthcare professionals, including at point-of-care settings.

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: K241919

This 510(k) was reviewed under the OHT7/OHT8 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.