EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT

K970467 · Excel Scientific, Inc. · CEP · Mar 18, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970467
• Device Name: EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT
• Applicant: Excel Scientific, Inc.
• Product Code: CEP · Clinical Chemistry
• Decision Date: Mar 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1485
• Device Class: Class 1

Intended Use

EZY Sure™ OneStep Ovulation Predictor Home Test Kit is Excel Scientific, Inc.'s name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of Luteinizing Hormone (LH) in urine.

Device Story

Device is a lateral flow, sandwich solid phase dye-conjugate non-enzyme immunoassay for home use. User applies urine sample to device; gold-sol-antibody conjugate binds to LH in specimen; complex migrates to positive reaction zone; rose-pink band forms if LH concentration ≥30 mIU/mL. Control line confirms reagent/device function. Results interpreted visually by user to identify LH surge, aiding in ovulation prediction. No liquid reagents required; 4-drop sample volume; 5-minute incubation.

Clinical Evidence

Clinical study with 103 female volunteers comparing EZY Sure™ results to trained technician results using the predicate (Conceive®) and a quantitative microtiter EIA (Medix) on identical urine specimens. Results demonstrated equivalence. Bench testing confirmed no interference from homologous hormones (hFSH, TSH), common drugs, or other substances (glucose, hemoglobin, antibiotics). Stability testing substantiated an 18-month shelf-life.

Technological Characteristics

Solid phase immunoassay; gold-sol-antibody conjugate; lateral flow format. Qualitative visual readout. No liquid reagents. 5-minute incubation time. 4-drop specimen volume. Cutoff sensitivity ≥30 mIU/mL.

Indications for Use

Indicated for OTC use by women to qualitatively detect Luteinizing Hormone (LH) in urine to predict ovulation by identifying the LH surge (concentration ≥30 mIU/mL).

Regulatory Classification

Identification

A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.

Predicate Devices

• Conceive® OneStep Ovulation Predictor (Quidel Corporation)

Reference Devices

• Medix quantitative microtiter EIA LH assay

Submission Summary (Full Text)

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FROM

FAX NO

MAR 10,1997 12:10 PM P 2

EXCEL

K970467

Attachment #9

MAR 18 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

## EZY Sure™ OneStep Ovulation Predictor Home Test Kit

1. EZY Sure™ OneStep Ovulation Predictor Home Test Kit is Excel Scientific, Inc.'s name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of Luteinizing Hormone (LH) in urine. EZY Sure™ OneStep Ovulation Predictor Home Test Kit is based on comparative data with Conceive® OneStep Ovulation Predictor test, a semi-quantitative test for the determination of LH currently being marketed by Quidel Corporation.

The EZY Sure™ OneStep Ovulation Predictor Home Test Kit is a sandwich solid phase dye-conjugate non-enzyme immunoassay. As the specimen is added to the reaction device, the gold-sol-antibody conjugate binds to the LH in the specimen forming an antibody-antigen complex. This complex binds to the anti-LH antibody in the positive reaction zone and produces a rose pink color band when LH concentration is present in the specimen. In the absence of LH, there is no rose-pink line in the positive reaction zone. The reaction continues to flow through the absorbent device, pass the positive reaction zone, producing a rose-pink color band, demonstrating that the reagents and device are functioning correctly. This working principle can also be applied for the Conceive® OneStep Ovulation Prediction Test.

2. The performance of EZY Sure™ OneStep Ovulation Predictor Home Test Kit is summarized as follows:

a. It is capable to discern an LH concentration between ≥30 mIU/mL and <30 mIU/mL in the urine. When the LH concentration in the urine is ≥30 mIU/mL, it is indicative that LH surge is in progress.

b. It is not interfered by the presence of homologous hormones (such as 1,000 mIU/mL hFSH or 1,000 μIU/mL TSH), common drugs (such as acetaminophen, acetylsalicylic acid, ascorbic, acid, atropine, caffeine or gentisic acid, each at 20 mg/dL), or other substances (such as 2 g/dL glucose, 1 mg/dL hemoglobin, 20 mg/dL ampicillin, or 20 mg/dL tetracycline) in the specimen.

c. Using this test kit, consumers (103 female volunteers) were able to obtain results that were equivalent to those obtained by trained laboratory technicians who employed another commercially available one-step ovulation prediction test (Conceive® by Quidel) and a quantitative microtiter EIA LH assay (Medix) on the same patient urine specimens.

d. No detectable intra- and inter-assay variation between replicates of the same reagent lots and between different reagent lots using spiked urine pool or patient specimens with known LH concentrations have been substantiated.

e. An eighteen-month shelf-life has been substantiated by the real-time and accelerated stability testing of the sample reagent.

3. The exact differences between the EZY Sure™ OneStep Ovulation Predictor Home Test Kit and Conceive® OneStep Ovulation Prediction Test are as follows:

| | Conceive® OneStep Ovulation Prediction Test | EZY Sure™ OneStep Ovulation Predictor Home Test |
| --- | --- | --- |
| SPECIMEN VOLUME | 3 drops | 4 drops |
| REAGENT | No Liquid Reagent | No Liquid Reagent |
| INCUBATION | 3 Minutes | 5 Minutes |
| STEPS | 1 Step | 1 Step |
| SURGE CUTOFF | ≥ 30 mIU/mL | ≥ 30 mIU/mL |

4. For any questions pertaining to this 510(K) application, please contact:

Min-Lee Cheng, Ph.D.

Excel Scientific, Inc.

23071 E. La Palma Avenue

Yorba Linda, CA 92887

Tel. [phone]

FAX [phone]