MINICLINIC OVULATION PREDICTOR

K960233 · Vanguard Biomedical Corp. · CEP · Apr 23, 1996 · Clinical Chemistry

Device Facts

• Record ID: K960233
• Device Name: MINICLINIC OVULATION PREDICTOR
• Applicant: Vanguard Biomedical Corp.
• Product Code: CEP · Clinical Chemistry
• Decision Date: Apr 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1485
• Device Class: Class 1

Intended Use

The MiniClinic Ovulation Predictor is a monoclonal antibody-based immunoassay intended for the visual qualitative detection of human Luteinizing Hormone (hLH) in urine. This test is used to detect the mid-cycle LH surge which occurs approximately 24 hours prior to ovulation. By predicting ovulation, conception can be planned most effectively. Its intended use is identical to that of several over-the-counter (OTC) products currently available for home use.

Device Story

MiniClinic Ovulation Predictor is an OTC home-use immunoassay; detects human Luteinizing Hormone (hLH) in urine. Device utilizes paper reservoir and membrane strip with colloid gold-monoclonal antibody conjugate. Principle: chromatographic migration; hLH binds to immobilized goat anti-hLH antibody forming visible reddish test line. Control line (goat anti-mouse IgG) confirms test validity. User compares test line intensity to control line; darker test line indicates LH surge. Predicts ovulation ~24 hours in advance to assist in conception planning.

Clinical Evidence

No clinical data provided; device relies on established immunochromatographic principles and comparison to predicate devices.

Technological Characteristics

Monoclonal antibody-based lateral flow immunoassay. Components: paper sample reservoir, membrane strip, colloid gold-monoclonal antibody conjugate, immobilized goat anti-hLH (test line), immobilized goat anti-mouse IgG (control line). Visual qualitative readout.

Indications for Use

Indicated for women of childbearing age desiring to plan conception by detecting the mid-cycle LH surge in urine to predict ovulation.

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 @ Ovulation Predictor (Quidel)
• Clearplan Easy One Step Ovulation Predictor (Whitehall Labs, Inc.)

Submission Summary (Full Text)

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K960233

VANGUARD

BIOMEDICAL CORPORATION

10225 BARNES CANYON ROAD, SUITE A108

SAN DIEGO, CALIFORNIA 92121 USA

TEL: [phone] FAX: [phone]

APR 23 1996

# MiniClinic Ovulation Predictor for Consumer Use

510(k) Summary of Product Safety and Effectiveness

Contact: John Chiu, Ph.D.
Director, Research & Development
Prepared: January 8, 1996

The trade name of this device is *MiniClinic Ovulation Predictor*. It is a qualitative visual test system for the detection of human Luteinizing Hormone (hLH) in urine as an indicator of ovulation and would be classified as a Human Luteinizing Hormone Test System.

Vanguard Biomedical Corporation considers the *MiniClinic Ovulation Predictor* to be substantially equivalent to other comparable FDA-approved products in intended use, test procedure, and test principles.

## INTENDED USE

The *MiniClinic Ovulation Predictor* is a monoclonal antibody-based immunoassay intended for the visual qualitative detection of human Luteinizing Hormone (hLH) in urine. This test is used to detect the mid-cycle LH surge which occurs approximately 24 hours prior to ovulation. By predicting ovulation, conception can be planned most effectively. Its intended use is identical to that of several over-the-counter (OTC) products currently available for home use.

These include: **Conceive @ Ovulation Predictor**
Quidel
10165 McKellar Court
San Diego, CA 92121

**Clearplan Easy One Step Ovulation Predictor**
Whitehall Labs, Inc.
New York, N.Y.

## PRINCIPLES AND PROCEDURES

The urine sample is applied to a paper reservoir which is in contact with a pad containing a dried conjugate of colloid gold-monoclonal antibody (reddish in color). The urine sample will then reconstitute the dried conjugate. If hLH is present in the sample, it will react with the monoclonal antibody to form a complex of colloid gold-monoclonal antibody-hLH. This complex migrates up in a membrane strip chromatographically and through a band of immobilized goat anti-hLH (the test line). Because the antibody of this immobilized goat anti-hLH is able to bind the hLH molecule of the migrating complex, a visible reddish band is formed along the exact location of the immobilized goat anti-hLH antibody. The amount of color seen on the test line is proportional to the amount of hLH present in the urine sample.

Further up the membrane, past the anti-hLH test line, is a control line consisting of a band of immobilized goat anti-mouse IgG. This band of antibody will bind only conjugate and form a colored line, regardless of whether hLH is present in the urine or not. The concentration of goat anti-mouse IgG and colloid gold-antibody conjugate are adjusted to give a color response against which the test line can be compared. Levels of hLH above baseline values will produce color on the test line which is darker than the control line. By observing the appearance of the two lines, the user can determine the status of their LH surge.