(63 days)
Not Found
Not Found
No
The summary describes a standard hormone test and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is an ovulation test that measures luteinizing hormone to help women determine their most fertile period. It does not treat or alleviate a disease or condition, which is the definition of a therapeutic device.
No
Explanation: A diagnostic device identifies a disease or condition. This device predicts ovulation for family planning, which is not a diagnosis of a disease or condition.
No
The summary describes a device that measures luteinizing hormone in urine, which implies a physical test strip or other hardware component is involved in the measurement process. It does not explicitly state it is software only.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device "measures luteinizing hormone (LH)" in "women's urine." This involves testing a biological sample (urine) outside of the body to gain information about a physiological state (LH levels and fertility).
- Device Description: The device description confirms that it measures "luteinizing hormone (LH)," reinforcing the in vitro testing aspect.
IVD devices are defined as those intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease or for the determination of the state of health. This device fits this definition by analyzing a urine sample to determine a woman's fertile window, which is related to her state of health and reproductive function.
N/A
Intended Use / 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.
Product codes
CEP
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human figures within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
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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Page 2
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
2
| 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)