OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031

K990249 · Phamatech · CEP · Mar 22, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990249
• Device Name: OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031
• Applicant: Phamatech
• Product Code: CEP · Clinical Chemistry
• Decision Date: Mar 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1485
• Device Class: Class 1

Intended Use

A home ovulation predictor test. This kit provides a qualitative result for the detection of Luteinizing Hormone (LH) in urine.

Device Story

OvuStick LH Test (dipstick) and OvuCard LH Test (cassette) are qualitative in vitro diagnostic devices for home use. The device detects Luteinizing Hormone (LH) in urine samples. The user performs the test at home to predict ovulation. The presence of LH is indicated by a visual color change on the test strip or cassette. The user interprets the visual result to identify the LH surge, which helps in timing intercourse to optimize the chance of conception. The device is intended for over-the-counter use.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Qualitative lateral flow immunoassay for LH detection in urine. Available in dipstick (OvuStick) and cassette (OvuCard) formats. Visual readout based on colorimetric change.

Indications for Use

Indicated for home use by individuals to qualitatively detect Luteinizing Hormone (LH) in urine for ovulation prediction.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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MAR 2 2 1994

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Carl Mongiovi Director of Operations PHAMATECH, Inc. 9265 Activity Road, Suites 112/113 San Diego, California 92126

Re: K990249 Trade Name: OvuStick™ LH Test (Dipstick format) OvuCard™ LH Test (Cassette format) Regulatory Class: I Product Code: CEP Dated: March 4, 1999 March 5, 1999 Received:

Dear Mr. Mongiovi:

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 (for the indications for use stated in the enclosure) to leqally marketed predicate 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours.

Steven Sutman

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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## INDICATIONS FOR USE

Applicant: Phamat

510 (k) Number (if known): K

Device Name: OvuStick LH Test (#9030, strip version) & OvuCard LH Test (#9031, cassette version

Indications for Use:

A home ovulation predictor test. This kit provides a qualitative result for the detection of Luteinizing Hormone (LH) in urine.

Jean Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices 996249 510(k) Number _

## PLEASE DO NOT WRITE BELOW THIS LINE

Concurrence of the CDRH Office of Device Evaluation (ODE)

Division Sign-off Division of Clinical Laboratory Devices 510 (k) Number:

Prescription Use: Per 21 CFR 801.109

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Over the Counter: √