WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354

K023744 · Wiener Laboratories Saic · JHW · Jan 3, 2003 · Clinical Chemistry

Device Facts

• Record ID: K023744
• Device Name: WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
• Applicant: Wiener Laboratories Saic
• Product Code: JHW · Clinical Chemistry
• Decision Date: Jan 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended 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.

Device Story

The Wiener lab. CK-MB DS UV unitest is an in vitro diagnostic reagent system used to measure CK-MB isoenzyme activity in human serum or plasma samples. The device utilizes a UV-based enzymatic assay principle to quantify CK-MB activity. It is intended for use in clinical laboratory settings by trained laboratory professionals. The output is a quantitative measurement of enzyme activity, which healthcare providers use to assist in the clinical diagnosis and management of myocardial infarction and various muscle diseases, such as Duchenne-type muscular dystrophy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent system for quantitative measurement of CK-MB isoenzyme activity. Utilizes UV-spectrophotometric enzymatic assay principle. Designed for use with clinical chemistry analyzers. No specific materials, connectivity, or software algorithms described.

Indications for Use

Indicated for the quantitative measurement of CK-MB isoenzyme activity in human plasma and serum to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, including progressive Duchenne-type muscular dystrophy.

Regulatory Classification

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.

Submission Summary (Full Text)

{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. 1. 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 [phone]. 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 [phone] or [phone] 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)