(63 days)
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. Fir accounter USC.
dBest Ovulation luteinizing hormone (LH).
This document is an FDA 510(k) clearance letter for a medical device called the "dBest One-Step Ovulation Test." It indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.
Unfortunately, the provided text does not contain the detailed information required to answer your specific questions about acceptance criteria, study design, or performance data.
The letter is a regulatory approval document and focuses on:
- Confirming substantial equivalence.
- Indicating the regulatory class (Class I) and product code (CEP).
- Stating that the device can be marketed.
- Outlining general controls and other FDA regulations applicable to the device.
- Referencing the "Indications For Use" statement (which is included in a subsequent part of the document) but not the actual study data.
Therefore, I cannot provide a table of acceptance criteria, reported performance, sample sizes, ground truth details, or information about MRMC studies based solely on the provided text.
The "Indications for Use" section (part 2 of the input) describes what the device does (measures luteinizing hormone to help women find their most fertile time) but does not provide performance metrics or study details.
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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 Requlatory Class: I Product Code: CEP November 22, 1997 Dated: 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 To determine if it does, you should contact categorization. the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA deboring 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general premarket notification" (21 CFR 807.97). information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Steven Ditman
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 luteinizing 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. Fir accounter USC.
(Division Sign-Off)
Division of Clinical Laboratory Devices.
510(k) Number k 974508
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Officer of Device Evaluation (ODE)
Prescription Use__________________
OR
Over-The-Counter Use ✓
(Optional Format 1-2-96)
§ 862.1485 Luteinizing hormone test system.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.