PATHFAST HSCRP

K083412 · Mitsubishi Kagaku Iatron · DCN · Mar 9, 2009 · Immunology

Device Facts

• Record ID: K083412
• Device Name: PATHFAST HSCRP
• Applicant: Mitsubishi Kagaku Iatron
• Product Code: DCN · Immunology
• Decision Date: Mar 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

PATHFAST® hsCRP test, for use with PATHFAST® analyzer, is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in heparinized or EDTA whole blood, plasma, and serum, as an aid in the detection and evaluation of the infection, tissue injury, inflammatory disorders, and associated disorders. This method is for use in clinical laboratory or point of care (POC) settings. PATHFAST® hsCRP Calibrator is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP) method on the PATHFAST® System.

Device Story

PATHFAST hsCRP is an in vitro diagnostic test system for quantitative CRP measurement; utilizes heparinized/EDTA whole blood, plasma, or serum samples. Operates on the PATHFAST analyzer; system performs automated analysis to provide CRP concentration levels. Used in clinical laboratories or point-of-care settings by healthcare professionals. Output assists clinicians in detecting and evaluating infection, tissue injury, and inflammatory conditions. Benefits include rapid diagnostic information to support clinical decision-making regarding patient inflammatory status.

Clinical Evidence

Bench testing only. No clinical data provided in the summary.

Technological Characteristics

In vitro diagnostic immunological test system. Quantitative measurement of CRP. Compatible with PATHFAST analyzer. Sample types: heparinized/EDTA whole blood, plasma, serum. Includes dedicated calibrator for system calibration.

Indications for Use

Indicated for quantitative measurement of C-reactive protein (CRP) in heparinized or EDTA whole blood, plasma, and serum to aid in detection and evaluation of infection, tissue injury, and inflammatory disorders. For use in clinical laboratory or point-of-care (POC) settings.

Regulatory Classification

Identification

A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Predicate Devices

• PATHFAST hsCRP (K083412)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAR 0 9 2009

Mitsubishi Kagaku Iatron Inc. c/o Helen Landicho Vice President of Regulatory Affairs Polymedco, Inc. 701 Fifth Avenue, Floor 42 Seattle, WA 98104

Re: .k083412

> Trade/Device Name: PATHFAST hsCRP Regulation Number: 21CFR Sec. 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN, JIT Dated: February 26, 2009 Received: February 27, 2009

Dear Ms. Landicho:

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 (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial source 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 nother the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 the [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Coy C. Hh

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

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## Indications for Use

510(k) Number (if known): k083412

Device Name: PATHFAST® hsCRP test

Indications For Use:

PATHFAST® hsCRP test, for use with PATHFAST® analyzer, is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in heparinized or EDTA whole blood, plasma, and serum, as an aid in the detection and evaluation of the infection, tissue injury, inflammatory disorders, and associated disorders. This method is for use in clinical laboratory or point of care (POC) settings.

Device Name: PATHFAST® hsCRP Calibrator

Indications For Use:

PATHFAST® hsCRP Calibrator is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP) method on the PATHFAST® System.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) 0人

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety Ko83412 510(k)

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