PATHFAST CK-MB-II, PATHFAST MYO-II

K081360 · Mitsubishi Kagaku Iatron · JHX · Aug 17, 2009 · Clinical Chemistry

Device Facts

• Record ID: K081360
• Device Name: PATHFAST CK-MB-II, PATHFAST MYO-II
• Applicant: Mitsubishi Kagaku Iatron
• Product Code: JHX · Clinical Chemistry
• Decision Date: Aug 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

PATHFAST CK-MB-II test is an in vitro diagnostic test for the quantitative measurement of creatine kinase-MB in heparinized or EDTA whole blood and plasma. Measurements of CK-MB are used in the diagnosis of acute myocardial infarction (MI). This method is for use in clinical laboratory or point of care (POC) settings. The PATHFAST CK-MB Calibrators are for calibration for the PATHFAST system when used for the quantitative determination of creatine kinase-MB in human heparinized or EDTA whole blood and plasma. PATHFAST Myo-II test is an in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized or EDTA whole blood and plasma. Measurements of myoglobin are used in the diagnosis of acute myocardial infarction (MI). This method is for use in clinical laboratory or point of care (POC) settings. The PATHFAST Myo Calibrators are for calibration for the PATHFAST system when used for the quantitative determination of myoglobin in human heparinized or EDTA whole blood and plasma.

Device Story

PATHFAST CK-MB-II and Myo-II are in vitro diagnostic tests for quantitative measurement of CK-MB and myoglobin in whole blood or plasma. Used in clinical laboratory or point-of-care (POC) settings to aid in diagnosis of acute myocardial infarction. System utilizes reagent cartridges and calibrators. Healthcare providers use quantitative results to assess cardiac status and inform clinical decision-making regarding potential MI. Benefits include rapid diagnostic support for cardiac events.

Clinical Evidence

No clinical diagnostic studies were performed. Evidence consists of analytical performance data: precision (intra-assay and inter-assay), linearity, limit of detection/quantitation, analytical specificity (interference and cross-reactivity), and method comparison against the predicate device using patient samples (n=76 for CK-MB, n=126 for Myoglobin). POC precision and method comparison studies were conducted at three sites by trained users.

Technological Characteristics

In vitro diagnostic test system; utilizes reagent cartridges and calibrators for quantitative measurement of CK-MB and myoglobin; compatible with heparinized or EDTA whole blood and plasma samples.

Indications for Use

Indicated for quantitative measurement of CK-MB and myoglobin in heparinized or EDTA whole blood and plasma to aid in the diagnosis of acute myocardial infarction (MI). For use in clinical laboratory or point-of-care (POC) settings.

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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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Mitsubishi Kagaku latron Inc. c/o Judi Smith, LLC P.O Box 103 Baldwin, MD 21013

SEP 1 7 2010

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

k081360 Re: Trade/Device Name: PATHFAST CK-MB-II, PATHFAST MYO-II Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHX, DDR, JIT Dated: July 30, 2009 Received: Aug. 4, 2009

Dear Ms. Smith:

This letter corrects our substantially equivalent letter of August 17, 2009.

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 (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. Iisting 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

GJC.

Courthey Harper, 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

510(k) Number (if known) 081360

Device Name: PATHFAST CK-MB-II, and Myo-II tests

Indications For Use:

PATHFAST CK-MB-II test is an in vitro diagnostic test for the quantitative measurement of creatine kinase-MB in heparinized or EDTA whole blood and plasma. Measurements of CK-MB are used in the aid of diagnosis of acute myocardial infarction. This method is for use in clinical laboratory or point of care (POC) settings. The kit includes the reagent cartridges and calibrators.

PATHFAST Myo-II test is an in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized or EDTA whole blood and plasma. Measurements of myoglobin are used to assist in the aid of diagnosis of myocardial infarction (MI). This method is for use in clinical laboratory or point of care (POC) settings. The kit includes the reagent cartridges and calibrators.

Prescription Use V AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 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) Page 1 of 1

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510(K) K081360