(87 days)
QwikCheck™ Test Strips are for in vitro diagnostic use for the determination of pH and leukocytes (WBCs) in semen. Test results are determined by comparing the color of the test patches to the color chart provided on the bottle label. The test is for professional use only.
Not Found
This document is a 510(k) clearance letter for the QwikCheck™ Test Strips, which are reagent strips for semen analysis. However, it does not contain the detailed acceptance criteria and study data needed to fully answer your request.
Specifically, the letter confirms that the device is substantially equivalent to a legally marketed predicate device, but it does not provide:
- A table of acceptance criteria and reported device performance.
- Details about samples, experts, or ground truth establishment.
- Information regarding standalone performance, MRMC studies, or training set details.
The letter focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study report. To get the information you're looking for, you would typically need to review the original 510(k) submission document itself, or any accompanying performance study reports that were submitted to the FDA for review.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, layered on top of each other. The profiles are abstract and flowing, resembling a wave or a flame.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Medical Electronics Systems Ltd. c/o Ms. Erika B. Ammirati 575 Shirlynn Court Los Altos, California 94022
JUN 1 5 2012
Re: K063864
Trade/Device Name: QwikCheck™ Test Strips (Reagent Strips for Semen Analysis) Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Date: December 28, 2006 Received: December 29, 2006
Dear Ms. Ammirati:
This letter corrects our substantially equivalent letter of March 26, 2007.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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) that do not require approval of a premarket approval application (PMA). 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the
{1}------------------------------------------------
Page 2 - Ms. Erika Ammirati
quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ene m Chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(K) Number (if known): K063864
Device Name: QwikCheck™ Test Strips
Indications for Use:
QwikCheck™ Test Strips are for in vitro diagnostic use for the determination of pH and leukocytes (WBCs) in semen. Test results are determined by comparing the color of the test patches to the color chart provided on the bottle label. The test is for professional use only.
Prescription Use __ (Part 21 CFR 801 Subpart D)
AND/OR
Over -the-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE AS NEEDED)
Concurrence of CIDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K063864
Page 1 of 1
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”