MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER

K062751 · Quantimetrix Corp. · JJT · Oct 3, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062751
• Device Name: MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
• Applicant: Quantimetrix Corp.
• Product Code: JJT · Clinical Chemistry
• Decision Date: Oct 3, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Quantimetrix Corp. Cardiasure Cardiac Markers Control is intended as a means of monitoring serum cardiac analyte monitoring methods to validate measurement of patient serum samples. Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.

Device Story

Quantimetrix Cardiasure Cardiac Markers Control is an in vitro diagnostic quality control material. It is used by laboratory personnel to monitor the performance of serum cardiac analyte testing methods. The control is processed alongside patient serum samples to validate the accuracy and precision of the analytical system. By comparing observed control values against established intralaboratory parameters, clinicians ensure the reliability of patient test results. The device serves as an integral component of routine diagnostic quality assurance procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid-stable quality control material containing cardiac analytes. Designed for use with serum-based diagnostic assays. No specific materials of construction, energy sources, or software algorithms are applicable as this is a chemical control reagent.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory testing procedures for cardiac markers, including C-reactive protein (CRP), Homocysteine, Digoxin, NT-proBNP, and Troponin I, in clinical laboratory settings.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing or supporting another, often interpreted as representing care and support.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jennifer Morais, Ph.D. R&D Manager Quantimetrix Corporation 2005 Manhattan Beach Blvd. Redondo Beach, CA 90278

## CT - 3 2006

Re: k062751 Trade/Device Name: Quantimetrix Cardiac Markers Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJT Dated: September 14, 2006 Received: September 14, 2006

Dear Dr. Morais:

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. 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 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).

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

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 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 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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Albert G. A.

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

Enclosure

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

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): k062751

Device Name:

Quantimetrix Cardiasure Cardiac Markers Control

## Indication for Use:

The Quantimetrix Corp. Cardiasure Cardiac Markers Control is intended as a means of monitoring serum cardiac analyte monitoring methods to validate measurement of patient serum samples. Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.

| Prescription Use | |
|------------------|--|
|------------------|--|

(Per 21 CFR 801. 109) OR Over-The-Counter UsePLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurence of CDRH, Office of In Vitro Diagnostic Device (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device

2-9