DBEST ONE-STEP OVULATION TEST

K974508 · Ameritek, Inc. · CEP · Feb 2, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974508
• Device Name: DBEST ONE-STEP OVULATION TEST
• Applicant: Ameritek, Inc.
• Product Code: CEP · Clinical Chemistry
• Decision Date: Feb 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1485
• Device Class: Class 1

Intended Use

dBest Ovulation Test measures luteinizing hormone (LH), which is always present in women's urine, and increases just before most fertile day of the month. This increase, or "surge" in LH triggers ovulation, which is the release of an egg from ovary. dBest Ovulation Test will help women find the time that when they are most able to become pregnant. For over-the-counter use.

Device Story

dBest Ovulation Test is an in vitro diagnostic device for home use. It detects luteinizing hormone (LH) in urine samples. The device utilizes an immunochromatographic assay to identify the LH surge, which precedes ovulation. The user performs the test by applying urine to the device; a visual indicator provides a qualitative result. By identifying the LH surge, the device assists women in determining their most fertile period to optimize the likelihood of conception. It is intended for over-the-counter use by consumers without physician intervention.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Immunochromatographic assay for qualitative detection of luteinizing hormone (LH) in urine. Lateral flow format. Visual readout.

Indications for Use

Indicated for women seeking to identify their most fertile days for pregnancy planning by detecting the luteinizing hormone (LH) surge in urine. For over-the-counter use.

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
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

FEB - 2 1998

K.C. Yee, Ph.D.
AmeriTek, Inc.
7030 35th Avenue, N.E.
Seattle, Washington 98115

Re: K974508
dBest One-Step Ovulation Test
Regulatory Class: I
Product Code: CEP
Dated: November 22, 1997
Received: December 1, 1997

Dear Dr. Yee:

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 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/dsmamain.html".

Sincerely yours,

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 (if known): k974568

dBest Ovulation Test

Device Name: dBest Ovulation Testing Hormone (LH)

Indications For Use:

dBest Ovulation Test measures luteinizing hormone (LH), which is always present in women's urine, and increases just before most fertile day of the month. This increase, or "surge" in LH triggers ovulation, which is the release of an egg from ovary. dBest Ovulation Test will help women find the time that when they are most able to become pregnant. For over-the-counter use.


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Concurrence of CDRH, Officer of Device Evaluation (ODE)

Prescription Use ☐ OR Over-The-Counter Use ☑

(Optional Format 1-2-96)