(57 days)
The "Wiener lab. CK-MB DS UV unitest" test system is a quantitative in vitro diagnostic device intended to measure the activity of the MB isoenzyme of creatine phosphokinase in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Not Found
I am sorry, but the provided text does not contain the detailed study information, acceptance criteria, or device performance metrics needed to answer your request. The document is a 510(k) clearance letter from the FDA for a device called "Weiner lab. CK-MB DS UV unitest," which is a creatine phosphokinase/creatine kinase or isoenzymes test system.
While it mentions the device's intended use and substantial equivalence to a predicate device, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about specific studies, such as sample sizes, data provenance, ground truth establishment, or expert qualifications.
- Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.
The letter is primarily a regulatory communication indicating that the device has met the requirements for market clearance, not a technical report detailing performance study results.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Human Services USA. The logo features a stylized graphic of three curved lines that resemble a wave or a flowing ribbon. The words "HUMAN SERVICES - USA" are arranged in a circular fashion around the top of the graphic, and the word "DEPARTMENT" is positioned at the bottom.
JAN 0 3 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Viviana Cetola OC/OA Manager Weiner Laboratorios S.A. I. C. Riobamba 2944 2000 Rosario, Santa Fe Argentina
Re: K023744
Trade/Device Name: Weiner lab. CK-MB DS UV unitest Regulation Number: 21 CFR 862 1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHW Dated: October 28, 2002 Received: November 7, 2002
Dear Dr. Cetola:
-
- 1
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 either class II (Special Controls) or class III (PMA), 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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
And Children Children
{1}------------------------------------------------
Page 2 -
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
| Page | / |
|---|---|
| of | / |
| 510(k) Number (if known): | K023744 |
|---|---|
| Device Name: | Wiener lab. |
CK-MB IS UV UNITESTIndications For Use:
The "Wiener lab. CK-MB DS UV unitest" test system is a quantitative in vitro diagnostic device intended to measure the activity of the MB isoenzyme of creatine phosphokinase in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANUTHER PAGE IF NEBOBO)
Concurrenco of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.169)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.