CPK REAGENT

K112416 · Vital Diagnostics (Manufacturing) Ptyltd · CGS · Nov 9, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112416
• Device Name: CPK REAGENT
• Applicant: Vital Diagnostics (Manufacturing) Ptyltd
• Product Code: CGS · Clinical Chemistry
• Decision Date: Nov 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

Vital Diagnostics CPK Reagent is a device intended to measure the activity of the enzyme 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

Vital Diagnostics CPK Reagent is an in vitro diagnostic reagent for quantitative measurement of creatine phosphokinase activity in human serum or plasma samples. Used in clinical laboratory settings by trained personnel. Reagent facilitates biochemical assay to determine CPK levels; results interpreted by clinicians to assist in diagnosis and management of myocardial infarction and various muscle diseases. Provides quantitative data to support clinical decision-making regarding cardiac and muscular health.

Clinical Evidence

No clinical data provided; device is an in vitro diagnostic reagent.

Technological Characteristics

In vitro diagnostic reagent for quantitative enzymatic determination of creatine phosphokinase. Operates via standard biochemical assay principles for clinical chemistry analyzers.

Indications for Use

Indicated for patients requiring measurement of creatine phosphokinase activity in plasma or 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)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Vital Diagnostics (Manufacturing) Pty Ltd. c/o Melita Lambiris Director of regulatory Affairs 189-199 Browns Road Noble Park, Victoria 3174 Australia

NOV - 9 2011

k112416 Re: Re: Trade/Device Name: Vital Diagnostics CPK Reagent Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine Phosphokinase/Creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: CGS Dated: September 14, 2011 Received: October 24, 2011

Dear Ms. Lambiris:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nate roviewed your Doctor Par(c) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass stated in the enactment date of the Medical Device Amendments, or to devices that prof to they 20, 1970, in accordance with the provisions of the Federal Food, Drug, and Cosmetic nave boon rocadoned in of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the detires, and in the 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 ir your device to such additional controls. Existing major regulations affecting your device can be may or sations to Salen active 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 I hat FDA has made a determination that your device complies with other requirements of the Act or that I Drinal statutes and regulations administered by other Federal agencies. You must comply ally I cueral statures and regaranting but not limited to: registration and listing (21 CFR Part with an the rive I requirements, moraling, and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow you to begin matures of your device of your device to a legally premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Virro Diagnostic Device Evaluation and Safety at [phone]. Also, please not the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 800 97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric' s (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the revortine 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 [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

signature

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): k112416

Device Name:

Vital Diagnostics CPK Reagent

Indications for Use:

Vital Diagnostics CPK Reagent is a device intended for the in vitro quantitative determination of creatine phosphokinase activity in human serum or plasma. 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K 112416

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