EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST

K971286 · Excel Scientific, Inc. · LCX · May 8, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971286
• Device Name: EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST
• Applicant: Excel Scientific, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: May 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

EZS Sure™ (Excel) Urine Midstream Early Pregnancy Home Test is Excel Scientific, Inc.'s name for OTC use of solid phase migratory chromatography immunoassay in vitro diagnostic test kit for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine.

Device Story

Solid phase migratory chromatography immunoassay for qualitative hCG detection in urine; utilizes sandwich dye-conjugate non-enzyme principle. User applies urine stream directly to absorbent reaction device; labeled antibody dye-conjugate binds hCG forming antibody-antigen complex; complex binds anti-hCG antibody in positive reaction zone producing rose-pink band at ≥25 mIU/mL hCG. Control zone confirms reagent/device function. Intended for home use by consumers. Provides rapid visual results to assist in pregnancy determination.

Clinical Evidence

Bench testing only; >99% agreement with predicate Syntron Quikpac II test. Consumer feedback indicates test is simple to perform and provides fast results.

Technological Characteristics

Solid phase migratory chromatography immunoassay; sandwich dye-conjugate non-enzyme format; midstream urine collection; 25 mIU/mL sensitivity cutoff; 5-minute incubation time.

Indications for Use

Indicated for OTC qualitative detection of human Chorionic Gonadotropin (hCG) in urine for early pregnancy testing.

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 II pregnancy test (BeSure Home Test)

Submission Summary (Full Text)

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K971286

Attachment #5

MAY - 8 1997

# Summary of Safety and Effectiveness

EZS Sure™ (Excel) Urine Midstream Early Pregnancy Home Test is Excel Scientific, Inc.'s name for OTC use of solid phase migratory chromatography immunoassay in vitro diagnostic test kit for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. EZS Sure™ (Excel) Urine Midstream Early Pregnancy Home Test is based on comparative data with Syntron Quikpac II pregnancy test (BeSure Home Test), an assay also for human Chorionic Gonadotropin currently being marketed.

The Principle of EZS Sure™ (Excel) Urine Midstream Early Pregnancy Home Test is as follows:

1. The EZS Sure™ (Excel) Urine Midstream Pregnancy Home Test also is a sandwich solid phase dye-conjugated non-enzyme immunoassay. The stream of urine goes directly into the absorbent windows of the reaction device. 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 in the positive reaction zone and produces a rose-pink color band when hCG concentration is equal to or greater than 25 mIU/mL. In the absence of hCG, there is no line formation in the positive reaction zone. The reaction mixture continues to flow through the device and migrates to the control reaction zone by producing a rose-pink color band, demonstrating that the reagents and device are functioning correctly.

2. The Quikpac II (or BeSure Home Test) also is a solid phase sandwich dye-conjugate non-enzyme immunoassay. As the specimen is added to the reaction device, 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 in the positive reaction zone and produces a rose-pink color band when hCG concentration is equal to or greater than 25 mIU/mL in the specimen. In the absence of hCG, there is no line formation in the positive reaction zone. The reaction mixture continues to flow through the device and migrates into the control reaction zone by producing a rose-pink color band control, demonstrating that the reagents and device are functioning correctly.

3. The exact differences between the EZS Sure™ (Excel) Urine Midstream Early Pregnancy Home Test protocol and the Syntron's Quikpac II pregnancy test (BeSure Home Test) protocol are as follows:

| | Quikpac II pregnancy test (BeSure Home Test) | EZS Sure™ (Excel) Urine Midstream Early Pregnancy Home Test |
| --- | --- | --- |
| Specimen Volume | 6 drops | Urine stream |
| Incubation | 5 minutes | 5 minutes |
| Reagent | No | No |
| Step | one step | one step |
| Cutoff | 25 mIU/mL | 25 mIU/mL |
| Urine Cup | Yes | No |

4. The EZS Sure™ (Excel) Urine Midstream Early Pregnancy Home Tests has been found to be greater than 99% in agreement with another test (the Syntron Quikpac II test) that is currently available commercially. Comments from consumers also support that the test is simple to perform and the results are fast.

5. For questions concerning the safety and effectiveness of the EZS Sure™ Urine Midstream Early Pregnancy Home Test, please contact:

Min-Lee Cheng, Ph.D.
23071 E. La Palma Avenue
Yorba Linda, CA 92887
Tel: [phone]

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