ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT

K955707 · Excel Scientific, Inc. · DHA · May 2, 1996 · Clinical Chemistry

Device Facts

• Record ID: K955707
• Device Name: ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT
• Applicant: Excel Scientific, Inc.
• Product Code: DHA · Clinical Chemistry
• Decision Date: May 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

Excel OneStep Urine/Serum hCG Module Pregnancy Test is Excel Scientific, Inc.'s name for the professional use of solid phase chromatographic immunoassay in vitro diagnostic test kit for the qualitative determination of human chorionic gonadotropin in urine or serum.

Device Story

Solid phase chromatographic immunoassay; detects hCG in urine or serum. Specimen flows via capillary action through absorbent device; labeled antibody dye-conjugate binds hCG; complex binds to immobilized anti-hCG antibody in reaction zone. Produces pink-rose color band if hCG concentration ≥ 25 mIU/mL; control zone band confirms device function. Professional use in clinical settings; provides rapid qualitative results to aid pregnancy diagnosis.

Clinical Evidence

Bench testing only. Performance validated against 25 mIU/mL cutoff; comparison of protocol steps and reagent requirements provided.

Technological Characteristics

Solid phase chromatographic immunoassay; lateral flow device; dye-conjugate labeling; no external energy source; manual operation; qualitative visual readout.

Indications for Use

Indicated for professional use for the qualitative determination of human chorionic gonadotropin (hCG) in urine or serum to aid in the early detection of pregnancy.

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.

Predicate Devices

• Syntron Quikpac I enzyme immunoassay

Submission Summary (Full Text)

{0}

Attachment #6
K955707
Summary of Safety and Effectiveness
MAY - 2 1996

Excel OneStep Urine/Serum hCG Module Pregnancy Test

Excel OneStep Urine/Serum hCG Module Pregnancy Test is Excel Scientific, Inc.'s name for the professional use of solid phase chromatographic immunoassay *in vitro* diagnostic test kit for the qualitative determination of human chorionic gonadotropin in urine or serum. The exact differences between the Excel OneStep Urine/Serum hCG Module Pregnancy Test and the Syntron Quikpac I enzyme immunoassay, an assay for human chorionic gonadotropin currently being marketed are as follows:

1. The Syntron Quikpac I EIA protocol is a classical sandwich enzyme immunoassay where endogenous hormone hCG, is first bound by antibody covalently linked to a solid membrane. A second enzyme linked antibody is then reacted to the membrane to form antibody-hCG-antibody-enzyme complexes. The complex is reacted with a suitable substance to produce a visible "+" positive when the hCG concentration is greater than 25 mIU/mL; and "-" negative on the center of the membrane indicates the absence of detectable levels of hCG.

2. The Excel OneStep Urine/Serum hCG Module Pregnancy Test is a sandwich solid phase dye-conjugate non-enzyme chromatographic immunoassay. As the specimen flows through the absorbent device via capillary action, the labeled antibody dye conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody immobilized on the membrane in the positive reaction zone and produces a pink-rose color band when the hCG concentration in the specimen is equal to or greater than 25 mIU/mL. In the absence of hCG, no colored line will appear in the positive reaction zone. The reaction mixture continues to flow through the absorbent device past the positive reaction zone and produce a pink-rose color band in the control zone, demonstrating that the reagent and device are functioning correctly.

The exact reagent addition differences between the above two test protocols are as follows:

| | Syntron Quikpac I EIA | Excel OneStep Urine/Serum hCG Module |
| --- | --- | --- |
| Specimen Volume | 5 drops urine
3 drops serum | 4 drops urine
4 drops serum |
| Reagent | 2 bottles for either urine or serum | No reagent for urine or serum |
| Incubation | 3 minutes with antibody and 3 minutes with substrate | No pre-incubation with urine or serum |
| Steps | three | one |
| Cutoff | 25 mIU/mL | 25 mIU/mL |