QUIK-CHECK OVULATION PREDICTOR

K012252 · ACON Laboratories, Inc. · CEP · Aug 24, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012252
• Device Name: QUIK-CHECK OVULATION PREDICTOR
• Applicant: ACON Laboratories, Inc.
• Product Code: CEP · Clinical Chemistry
• Decision Date: Aug 24, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1485
• Device Class: Class 1

Intended Use

QUIK-CHECK™ Ovulation Predictor Test is a qualitative, one-step, midstream assay for the detection of human Luteinizing Hormone (LH) in urine as an aid in conception by reliably predicting ovulation. The QUIK-CHECK™ Ovulation Predictor Test is intended for use by the lay consumer.

Device Story

QUIK-CHECK™ Ovulation Predictor Test is a midstream, in vitro diagnostic device for home use. It detects Luteinizing Hormone (LH) surge in urine. Principle of operation: lateral flow immunoassay using monoclonal antibody-dye particle conjugates and polyclonal solid-phase antibodies. Urine flows through absorbent device; antibody-antigen complex forms if LH is present; complex binds to anti-LH antibody in test zone. Output: visual pink-rose color band. Interpretation: test band intensity equal to or greater than control band indicates LH concentration >40 mIU/mL (positive surge); lighter band indicates <40 mIU/mL; no band indicates absence of LH. Control band confirms test function. Consumers use the device to identify ovulation timing to assist in conception.

Clinical Evidence

Clinical trial compared QUIK-CHECK™ to ClearPlan Easy® using 100 female volunteers over one menstrual cycle. Samples were tested by both trained lab technicians and consumers. Results: Accuracy between QUIK-CHECK™ and ClearPlan Easy® was >99% (99-100% CI) for lab technicians and 95% (94-96% CI) for consumers. Concordance between lab technician and consumer testing of QUIK-CHECK™ was 95% (94-96% CI).

Technological Characteristics

Lateral flow immunoassay; midstream test format. Employs monoclonal antibody-dye particle conjugates and polyclonal solid-phase antibodies. Detects LH at a threshold of 40 mIU/mL. Visual readout via colorimetric band formation. No electronic components, software, or external power source.

Indications for Use

Indicated for lay consumers to detect human Luteinizing Hormone (LH) in urine to aid in predicting ovulation for conception purposes.

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

• ClearPlan Easy® Ovulation Test (K981207)

Submission Summary (Full Text)

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K012252

#### 510(k) SUMMARY 10.

### Date of Summary:

July 6, 2001

### Product Name:

QUIK-CHECK™ Ovulation Predictor Test

### Sponsor's Name:

ACON Laboratories, Inc. 4108 Sorrento Valley Blvd. San Diego, CA 92121 Establishment Number : 2531491

#### Manufactured by:

ACON Biotech (Hangzhou) Co. Ltd. 118 Tianmushan Rd. Gudang Industrial Park Hangzhou, P.R. China 310023 Owner/Operator Number: 9033096

# Correspondent in the U.S .:

MDC ASSOCIATES Fran White Regulatory Consultant 163 Cabot Street Beverly, MA 01915

### Substantially Equivalent Device:

Product: ClearPlan Easy® Ovulation Test Manufactured by: Unipath K Number: K981207

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### PRODUCT DESCRIPTION:

The QUIK-CHECK™ Ovulation Predictor Test is a midstream test used for the qualitative measurement of Luteinizing Hormone (LH) and the detection of the LH surge in a woman's urine as an aid in reliably predicting ovulation. The ovulation predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The QUIK-CHECK™ ass outside the counter (OTC) device that will be sold under that will be sold under the QUIK-CHECK™ brand and various private labels.

#### INTENDED USE:

QUIK-CHECK™ Ovulation Predictor Test is a qualitative, one-step, midstream assay for the detection of human Luteinizing Hormone (LH) in urine as an aid in conception by reliably predicting ovulation. The QUIK-CHECK™ Ovulation Predictor Test is intended for use by the lay consumer.

# SUMMARY OF TECHNOLOGY:

The QUIK-CHECK™ Ovulation Predictor Test employs a unique combination of monoclonal antibody-dye particle conjugates and polyclonal-solid phase antibodies to selectively identify human Luteinizing Hormone (LH) in urine. As the urine flows through the absorbent portion of the device, the antibody-dye particle conjugate binds to the LH, forming an antibodyantigen complex. This complex binds to the anti-LH antibody in the test zone and produces a pink-rose color band. The color intensity of this band is equal to or greater than that of the control band when the LH concentration is greater than 40 mIU/mL. In urine with LH concentrations of less than 40 mIU/mL, the band in the test zone will appear lighter than the control band. In the absence of LH in urine, no test band will show up in the test zone. The test has also incorporated a control system where a pink-colored band will always appear in the control zone, demonstrating that the test is functioning correctly.

#### PERFORMANCE DATA:

A clinical trial was done to compare the performance of the QUIK-CHECK™ Ovulation Predictor Test to a substantially equivalent product (ClearPlan Easy") manufactured by Unipath. Data clearly demonstrate that the performance of the QUIK-CHECK™ Ovulation Predictor Test is substantially equivalent to the ClearPlan Easy® Test.

### QUIK-CHECK™ Ovulation Predictor Test vs. ClearPlan Easy® Ovulation Test:

100 females tested the QUIK-CHECK™ Ovulation Predictor Test to determine their respective LH surges over a period of ten consecutive days for one menstrual cycle. Each volunteer conducted the testing at home according to the package insert instructions. The urine samples were refrigerated and provided to the study coordinator. The study coordinator tested each sample using the OUIK CHECK™ and the ClearPlan Easy® Tests. The data obtained was recorded as Negative (no surge) or Positive (surge).

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# Summary of Results:

| Tests (tester) | Accuracy |
|---------------------------------------------------------------------------------------|-----------------------|
| QUIK-CHECKTM (Trained Lab Technician) vs. ClearPlan Easy®<br>(Trained Lab Technician) | >99%<br>(99% - 100%*) |
| QUIK-CHECKTM (Consumer) vs. ClearPlan Easy® (Consumer) | 95%<br>(94% - 96%*) |
| QUIK-CHECKTM (Trained Laboratory Technician) vs. QUIK-CHECKTM (Consumer) | 95%<br>(94% - 96%*) |

* 95% confidence Intervals

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of several curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 8 2001

ACON Laboratories, Inc. c/o Ms. Fran White Regulatory Consultant 163 Cabot Street Beverly, MA 01915

Re: K012252 Trade/Device Name: QUIK-CHECK™ Ovulation Predictor Test Regulation Number: 21 CFR 862.1485 Regulatory Class: I, reserved Product Code: CEP Dated: July 6, 2001 Received: July 18, 2001

Dcar Ms. White:

This letter replaces and corrects letter dated August 24, 2001. The device name was incorrect. It was spelled Quick-Check. It should be spelled Quik-Check.

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will and by your ding of substantial equivalence of your device to a legally marketed noalicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mornation on Jour Port Post Stance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: Device Name: QUIK-CHECK™ Ovulation Predictor Test

Indication for Use:

The QUIK-CHECK™ Ovulation Predictor Test is a qualitative, one-step, midstream assay for The QUIR-OHDOR - Orteinizing Hormone (LH) in urine as an aid in conception by reliably the uction of namali Battining sections (1) == )
predicting ovulation. The QUIK-CHECK™ Ovulation Predictor Test is intended for use by the lay consumer.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over The Counter Use (Optional Format 1-2-96)

Kesia Alexander for Ivan Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012252