EZ SURE URINE DIPSTICK PREGNANCY HOME TEST

K970425 · Excel Scientific, Inc. · LCX · Mar 6, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970425
• Device Name: EZ SURE URINE DIPSTICK PREGNANCY HOME TEST
• Applicant: Excel Scientific, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Mar 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

EZ%Sure™ Urine DipStick 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; detects hCG in urine. Input: urine specimen in test cup. Principle: capillary action moves urine through gold sol-antibody conjugate pad; hCG-antibody-antigen complex forms; binds to immobilized anti-hCG in reaction zone. Output: rose-pink color band indicates hCG concentration ≥ 25 mIU/mL; control band confirms reagent function. Used in home setting by lay users. Visual interpretation of color bands by user; presence of test band indicates pregnancy; absence indicates non-pregnant state. Benefits: rapid, one-step, qualitative pregnancy determination.

Clinical Evidence

No clinical data provided. Substantial equivalence based on comparative analytical performance data against the predicate device, specifically confirming identical 25 mIU/mL cutoff sensitivity.

Technological Characteristics

Solid phase migratory chromatography immunoassay; non-enzyme; gold sol-antibody conjugate; white membrane with immobilized anti-hCG antibody; absorbent device for capillary flow. Qualitative visual readout.

Indications for Use

Indicated for OTC qualitative detection of hCG in urine for 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 EIA

Reference Devices

• QuikStrip (or E.Z. Strip) Pregnancy Home test

Submission Summary (Full Text)

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EXCEL

"Commitment to Excellence"

Attachment #5

K970425

MAR - 6 1997

# Summary of Safety and Effectiveness

## EZ%Sure™ Urine DipStick Pregnancy Home Test

EZ%Sure™ Urine DipStick 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. EZ%Sure™ Urine DipStick Pregnancy Home Test is based on comparative data with Syntron Quikpac EIA, an assay for human Chorionic Gonadotropin currently being marketed.

The Principle of EZ%Sure™ Urine DipStick Pregnancy Home Test is as follows:

1. Both the EZ%Sure™ Urine DipStick Pregnancy Home Test and the QuikStrip (or E.Z. Strip) Pregnancy Home test are a sandwich solid phase dye-conjugated non-enzyme immunoassay. When the EZ%Sure™ Urine DipStick Pregnancy Home Test is placed in a urine test cup containing the urine specimen, the urine will migrate by capillary action. The gold sol-antibody conjugate in the gold sol pad of the EZ%Sure™ Urine DipStick Pregnancy Home Test binds to the hCG molecules in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody immobilized in the positive reaction zone in the white membrane area and produces a rose-pink color band when the hCG concentration is at or greater than 25 mIU/mL. In the absence of detectable levels of hCG, there is no rose-pink band in the positive reaction zone. The reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a rose-pink color band in the control zone of the white membrane area, demonstrating that the reagents and the device are functioning correctly.

2. The Differences Between the EZ%Sure™ Urine DipStick Pregnancy Home Test and the Syntron's QuikStrip (or E.Z. Strip) Pregnancy Home test are as follows:

| | QuikStrip (or E.Z. Strip) Pregnancy Home test | EZ%Sure™ Urine DipStick Pregnancy Home Test |
| --- | --- | --- |
| Specimen Volume | 6 drops | 6 drops of urine |
| Incubation | 5 minutes | 5 minutes |
| Reagent | No | No |
| Step | one step | one step |
| Cutoff | 25 mIU/mL | 25 mIU/mL |
| Urine Cup | Yes | Yes |

3. The Differences Between the EZ%Sure™ Urine DipStick Pregnancy Home Test and the Syntron Quikpac EIA Pregnancy Test are as follows:

| | Syntron Quikpac EIA Pregnancy Test | EZ%Sure™ Urine DipStick Pregnancy Home Test |
| --- | --- | --- |
| Specimen Volume | 3 drops of urine | 6 drops of urine |
| Incubation | 3 minutes with antibody and 3 minutes with substrate | 5 minutes |
| Reagent | 2 bottles | No |
| Step | 3 steps | one step |
| Cutoff | 25 mIU/mL | 25 mIU/mL |

1119-010

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

{1}

EXCEL

"Commitment to Excellence"

3. For questions concerning the safety and effectiveness of the EZ® Sure™ Urine DipStick Pregnancy Home Test, please contact:

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

7110

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

15