(55 days)
A home ovulation predictor test. This kit provides a qualitative result for the detection of Luteinizing Hormone (LH) in urine.
Not Found
This document is a 510(k) clearance letter for an ovulation predictor kit, the OvuStick LH Test and OvuCard LH Test. It focuses on the regulatory clearance process and does not contain detailed information about acceptance criteria or specific study results as would be found in a clinical study report. Therefore, I cannot provide the requested information.
Here's why and what's missing:
- Acceptance Criteria and Device Performance: The document states that the device is "substantially equivalent" to legally marketed predicate devices. It does not provide specific performance metrics (e.g., sensitivity, specificity, accuracy) or the quantitative acceptance criteria linked to those metrics that were used to deem it equivalent.
- Study Details: There is no mention of a specific study to "prove the device meets acceptance criteria." The 510(k) process relies on demonstrating substantial equivalence, often through comparisons to existing devices and supporting data, but it doesn't typically require a standalone comprehensive study detailed in the clearance letter itself.
- Sample Sizes, Data Provenance, Ground Truth, Experts, MRMC/Standalone Studies, Training Set: All of these elements are related to a detailed clinical study, which is not described in this regulatory clearance letter.
In summary, this document is a regulatory approval letter and not a scientific study report.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.
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.
{1}------------------------------------------------
Page 2
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 (770) 488-7655.
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 (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 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 (800) 638-2041 or (301) 443-6597, 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
{2}------------------------------------------------
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
ﻤﺴﺘﺸﻨﻴﺔ
OR
Over the Counter: √
§ 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.