CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST

K131931 · Chemtron Biotech, Inc. · LCX · Jul 26, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131931
• Device Name: CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
• Applicant: Chemtron Biotech, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Jul 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Chemtrue® hCG Pregnancy Urine Midstream Test is a rapid lateral flow qualitative immunoassay for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Midstream. The test is designed to aid early detection of pregnancy by home users. The device is intended for Over-The-Counter (OTC) Use.

Device Story

Chemtrue® hCG Pregnancy Urine Midstream Test is a lateral flow qualitative immunoassay for hCG detection in human urine. Device format is midstream; contains conjugate pad with colloidal gold-conjugated monoclonal anti-hCG antibodies and nitrocellulose membrane with goat anti-hCG (test line) and goat anti-mouse (control line) antibodies. User applies urine to midstream device; capillary action moves specimen across membrane. If hCG concentration ≥20 mIU/mL, red line appears at test region. Control line indicates proper migration and sample volume. Results read visually at 3 minutes. Intended for home use by lay persons to aid early pregnancy detection. Healthcare providers may also use device. Output is qualitative (positive/negative); informs pregnancy status decision-making.

Clinical Evidence

Clinical study included 300 women (100 per site) at three hospitals. Samples tested by both lay users and healthcare professionals (HCPs). Comparison between lay-user midstream testing and HCP dip-method testing showed 100% agreement. Sensitivity/cutoff confirmed at 20 mIU/mL using spiked urine samples across three lots. Reproducibility study across three sites, nine operators, and five days showed consistent performance. No interference observed from common exogenous compounds, pH (2.0-9.0), specific gravity (1.003-1.030), or high-dose hook effect up to 500 IU/mL.

Technological Characteristics

Lateral flow immunoassay; colloidal gold conjugate; nitrocellulose membrane; monoclonal goat anti-hCG antibodies; midstream form factor; visual readout; 20 mIU/mL cutoff; 3-minute read time; storage 4°C-30°C; traceable to WHO 5th International Standard.

Indications for Use

Indicated for early detection of pregnancy in human urine for home users (OTC).

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) #: k131931

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.