CREATINE KINASE (CK-NAC)

K013912 · Jas Diagnostics, Inc. · CGS · Jan 18, 2002 · Clinical Chemistry

Device Facts

• Record ID: K013912
• Device Name: CREATINE KINASE (CK-NAC)
• Applicant: Jas Diagnostics, Inc.
• Product Code: CGS · Clinical Chemistry
• Decision Date: Jan 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

Intended for the In Vitro, quantitative determination of creatine kinase (CK) in human serum on automated chemistry analyzers. Creatine kinase measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Device Story

JAS Creatine Kinase (CK-NAC) Liquid Reagent is an in vitro diagnostic reagent for quantitative CK measurement in human serum. Used on automated chemistry analyzers in clinical laboratory settings by trained laboratory personnel. The reagent facilitates the biochemical assay of CK levels; results are interpreted by clinicians to assist in diagnosing and monitoring myocardial infarction and muscle disorders. The device provides quantitative data to support clinical decision-making regarding patient cardiac and muscular health.

Clinical Evidence

No clinical trials were performed. Substantial equivalence is based on bench testing, specifically correlation studies comparing the subject reagent's performance against predicate devices using human serum samples on automated chemistry analyzers.

Technological Characteristics

Liquid reagent for in vitro quantitative determination of creatine kinase. Operates via biochemical reaction on automated chemistry analyzers. Class II device (21 CFR 862.1215).

Indications for Use

Indicated for the quantitative determination of creatine kinase (CK) in human 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.

Predicate Devices

• Roche Diagnostics CK NAC Reagent for the Roche Cobas Mira analyzers
• Pointe Scientific Creatine Kinase (CK) Reagent

Submission Summary (Full Text)

{0}------------------------------------------------

K013912

## JAS DIAGNOSTICS: 510(K) NOTIFICATION

JAN 1 8 2002

## 510(K) SUMMARY

| Submitter | Name: Attn: David Johnston<br>JAS Diagnostics, Inc.<br>7220 N.W. 58th Street<br>Miami, FL 33166<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Trade Name: JAS Creatine Kinase (CK-NAC) Liquid Reagent<br>Common Name: Creatine Kinase (CK) Reagent<br>Classification Name: 21 CFR 862.1215 |
| Predicate Devices: | -Roche Diagnostics CK NAC Reagent for the Roche Cobas Mira<br>analyzers<br>-Pointe Scientific Creatine Kinase (CK) Reagent (generic) |
| Device Description: | This Reagent is intended for the in vitro quantitative determination<br>of creatine kinase in human serum. |
| Summary of the<br>Similarities to the | Intended Use: All devices are intended for the detection of<br>creatine kinase (CK) in human serum on automated chemistry<br>analyzers. |
| Predicate Devices: | Results Interpretation: Correlation studies on human serum<br>demonstrated acceptable result comparisons between these<br>methods, which all use similar normal ranges. |
| Discussion and<br>Conclusion: | The JAS Creatine Kinase (CK-NAC) Liquid Reagent's intended<br>use is identical to predicate Devices and it's performance<br>acceptable on the automated chemistry analyzers tested. The JAS<br>CK-NAC Liquid Reagent is therefore substantially equivalent to<br>FDA registered Creatine Kinase (CK) Reagents currently in the<br>market. |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three intertwined figures that could be interpreted as snakes or stylized human profiles.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 8 2002

Mr. David Johnston Technical Director JAS Diagnostics, Inc. 7220 N.W. 58th Street Miami, FL 33166

k013912 Re: K015912
Trade/Device Name: Creatine Kinase (CK) Reagent Regulation Number: 21 CFR 862.1215 Regulation Name: 21 Cr R 802.1223
Regulation Name: Creatine Phosphokinase/Creatine Kinase or Isoenzymes Test System Regulatory Class: Class II Product Code: CGS Dated: October 22, 2001 Received: November 27, 2001

Dear Mr. Johnston:

We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 310(x) premained is substantially equivalent (for the indications ferenced above and nave determined in asketed predicate devices marketed in interstate for use stated in the enclosure to regars manent date of the Medical Device Ameral Food. Drug commerce prior to May 26, 1776, the enaounce with the provisions of the Federal Food, Drug, devices that have been icclassified in accession was a proval approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of use tice, 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 If your device is classinod (500 a0010) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and thay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous of Pource in concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of advised that i Driversity over device complies with other requirements of the Act that I DT has made a availations administered by other Federal agencies. You must of any I coural statutes and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 6077, laooning (21 CFR Part 820); and if applicable, the electronic forth in the quality bybelins (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

Page 2 -

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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Butman

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

{3}------------------------------------------------

Page __ 1_ of __ 1____________________________________________________________________________________________________________________________________________________________

K013912

510(k) Number (if known): ____ N/A Device Name: __ Creatine Kinase (CK) REAGENT Indications for Use:

Intended for the In Vitro, quantitative determination of creatine kinase (CK) in human serum on automated chemistry analyzers.

Creatine kinase measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Jan Cooper

(Division.
Division cal Laboratory Devices
510(k) N. K01392

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)