EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST

K963231 · Excel Scientific, Inc. · JHI · Dec 4, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963231
• Device Name: EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST
• Applicant: Excel Scientific, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Dec 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

Excel OneStep Urine hCG Pregnancy Module 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.

Device Story

Solid phase chromatographic immunoassay; detects human chorionic gonadotropin (hCG) in urine. Specimen flows via capillary action through absorbent device; labeled antibody dye conjugate binds hCG; complex binds to immobilized anti-hCG antibody on membrane. Produces pink-rose color band at positive reaction zone if hCG concentration ≥ 25 mIU/mL; control zone band confirms reagent/device function. Professional use in clinical settings; provides qualitative visual result to aid pregnancy diagnosis.

Clinical Evidence

No clinical data provided; substantial equivalence based on analytical performance comparison of cutoff sensitivity (25 mIU/mL) and qualitative visual interpretation.

Technological Characteristics

Solid phase chromatographic immunoassay; dye-conjugate technology; lateral flow via capillary action; visual colorimetric readout; no external energy source; manual test format.

Indications for Use

Indicated for professional use for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. Cutoff concentration is 25 mIU/mL.

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)

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EXCEL

"Commitment to Excellence"

Attachment #4

K96323

Summary of Safety and Effectiveness

DEC - 4 1993

# Excel OneStep Urine hCG Pregnancy Module Test

Excel OneStep Urine hCG Pregnancy Module 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. The exact differences between the Excel OneStep Urine hCG Pregnancy Module 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 hCG Pregnancy Module 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 differences between the two protocols :

| | Syntron QuikPac I OneStep hCG Pregnancy Test | Excel OneStep Urine hCG Module Pregnancy Test |
| --- | --- | --- |
| Specimen Volume | 5 drops urine | 4 drops of urine |
| Reagent | 2 bottles | None |
| Pre-incubation | 6 minutes | None |
| Step | one step | three steps |
| Cutoff | 25 mIU/mL | 25 mIU/mL |

3. For questions related to the performance and safety of the Excel OneStep Urine hCG Pregnancy Module Test, please contact :

Min-Lee Cheng, Ph.D.
Regulatory Affairs
Excel Scientific, Inc.
23071 E. La Palma Avenue
Yorba Linda, CA 92887
TEL: [phone]
FAX: [phone]

23071 E. La Palma Ave., Yorba Linda, CA 92887, U.S.A. Tel: [phone] Fax: [phone]