EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST

K970424 · Excel Scientific, Inc. · JHI · Mar 6, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970424
• Device Name: EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST
• Applicant: Excel Scientific, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Mar 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

Excel OneStep Urine hCG Pregnancy DipStick Test is Excel Scientific, Inc.'s name for professional 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

Device is a solid-phase migratory chromatography immunoassay dipstick for qualitative hCG detection in urine. Operated by healthcare professionals in clinical settings. Input is urine specimen; capillary action draws sample through gold sol-antibody conjugate pad. hCG binds to conjugate, forming complex that migrates to immobilized anti-hCG antibody zone, producing rose-pink band if hCG concentration ≥ 25 mIU/mL. Control zone confirms reagent/device function. Output is visual color band indicating presence or absence of hCG. Results assist clinicians in pregnancy diagnosis.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by comparative bench testing against the predicate device, demonstrating identical sensitivity (25 mIU/mL) and functional performance.

Technological Characteristics

Solid-phase migratory chromatography immunoassay. Employs gold sol-antibody conjugate and immobilized anti-hCG antibodies on a membrane. Form factor is a dipstick. No external energy source or software required.

Indications for Use

Indicated for professional use for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the early 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 EIA

Reference Devices

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

Submission Summary (Full Text)

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EXCEL

"Commitment to Excellence"

Attachment #4

K970424

MAR - 6 1997

# Summary of Safety and Effectiveness

Excel OneStep Urine hCG Pregnancy DipStick Test

Excel OneStep Urine hCG Pregnancy DipStick Test is Excel Scientific, Inc.'s name for professional use of solid phase migratory chromatography immunoassay in vitro diagnostic test kit for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. Excel OneStep Urine hCG Pregnancy DipStick Test is based on comparative data with Syntron Quikpac EIA, an assay for human Chorionic Gonadotropin currently being marketed.

The Principle of Excel OneStep Urine hCG Pregnancy DipStick Test is as follows:

1. Both the Excel OneStep Urine hCG Pregnancy DipStick and the QuikStrip (or E.Z. Strip) Pregnancy Home tests are a sandwich solid phase dye-conjugated non-enzyme immunoassay. When the Excel OneStep Urine hCG Pregnancy DipStick 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 Excel OneStep Urine hCG Pregnancy DipStick 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. There is no difference in the testing procedure between the Excel OneStep Urine hCG Pregnancy DipStick Test and the Syntron's QuikStrip (or E.Z. Strip) Pregnancy Home test as shown below:

| | QuikStrip (or E.Z. Strip) Pregnancy Home test | Excel OneStep Urine hCG Pregnancy DipStick 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 Excel OneStep Urine hCG Pregnancy DipStick Test and the Syntron Quikpac EIA Pregnancy Test are as follows:

| | Syntron Quikpac EIA Pregnancy Test | Excel OneStep Urine hCG Pregnancy DipStick 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 |

Rev. C1, 9-96

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

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EXCEL

"Commitment to Excellence"

4. For questions concerning the safety and effectiveness of the Excel OneStep Urine hCG Pregnancy DipStick, please contact:

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

Rev. C1, 9-06

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

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