I-CHROMA CRP TEST

K062981 · Boditech Diagnostics, Inc. · DCN · Jul 13, 2007 · Immunology

Device Facts

• Record ID: K062981
• Device Name: I-CHROMA CRP TEST
• Applicant: Boditech Diagnostics, Inc.
• Product Code: DCN · Immunology
• Decision Date: Jul 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

The i-CHROMA™ CRP test along with i-CHROMA™ Reader is an in vitro diagnostic fluorescence immunoassay that measures C-Reactive Protein in whole blood and serum. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues, infection, and inflammatory disorders.

Device Story

The i-CHROMA CRP test is an in vitro diagnostic fluorescence immunoassay used with the i-CHROMA Reader. It processes whole blood or serum samples to measure C-Reactive Protein (CRP) levels. The system utilizes fluorescence immunoassay technology to quantify CRP concentration, which assists clinicians in assessing tissue injury, infection, and inflammatory conditions. The device is intended for professional use in clinical settings. The reader analyzes the test cartridge, providing quantitative results that support healthcare providers in clinical decision-making regarding patient inflammatory status.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance characteristics of the fluorescence immunoassay system.

Technological Characteristics

Fluorescence immunoassay system consisting of a test cartridge and an optical reader. Measures CRP via immunochemical reaction. Designed for professional use in clinical environments. Standalone diagnostic system.

Indications for Use

Indicated for the quantitative measurement of C-Reactive Protein (CRP) in human whole blood and serum to aid in the evaluation of tissue injury, infection, and inflammatory disorders. For professional use.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUL 1 3 2007

Boditech Diagnostics, Inc. c/o Lehnus & Associates Consulting 150 Cherry Lane Road East Stroudsburg, PA 18301 ATTN: Mr. Gary Lehnus

Re: k062981

> Trade/Device Name: I-Chroma CRP Test Regulation Number: 21 CFR §866.5270 Regulation Name: C-reactive protein immunological test system. Regulatory Class: Class II Product Code: DCN Dated: July 9, 2007 Received: July 10, 2007

Dear Mr. Lehnus:

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) I institution. The FDA finding of substantial equivalence of your device to a legally premated newice 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, n you stons 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). 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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. 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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## Indication for Use

510(k) Number (if known): k062981

Device Name: i-Chroma CRP Test

Indication For Use:

The i-CHROMA™ CRP test along with i-CHROMA™ Reader is an in vitro diagnostic fluorescence immunoassay that measures C-Reactive Protein in whole blood and serum. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues, infection, and inflammatory disorders.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

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

Division Sign-off

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

510(k) K062981