CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160

K080607 · Roche Diagnostics Corp. · JIX · May 12, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080607
• Device Name: CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
• Applicant: Roche Diagnostics Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: May 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Calibrator for automated systems (C.f.a.s.) Proteins is for use in the calibration of the quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.

Device Story

Calibrator for Automated Systems (C.f.a.s.) Proteins is a liquid, ready-to-use calibrator consisting of pooled human sera with chemical and biological additives. It is used in clinical chemistry laboratories to calibrate quantitative Roche assays on Roche automated analyzers. The device provides lot-specific analyte concentrations used to establish calibration curves for clinical chemistry testing. It is operated by laboratory technicians or clinical staff. The output is a set of reference values used by the analyzer to calculate patient sample concentrations, ensuring accuracy and traceability to reference materials like CRM 470. It benefits patients by ensuring the accuracy of diagnostic test results.

Clinical Evidence

No clinical data. Bench testing only. Stability was validated through real-time shelf-life testing (up to 25 months), simulated shipping, and open-bottle stability studies. Acceptance criteria were defined as ±10% recovery of the assigned value. Traceability for Alpha-1 Acid Glycoprotein was established against ERM-DA470 (CRM 470).

Technological Characteristics

Liquid, ready-to-use pooled human serum matrix with chemical/biological additives. Traceable to CRM 470. Stability: 24-month shelf life at 2-8°C. Standalone calibrator material for use with Roche automated chemistry systems.

Indications for Use

Indicated for use in the calibration of quantitative Roche clinical chemistry assays on Roche automated analyzers. For prescription use.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Calibrator for Automated Systems (C.f.a.s.) Proteins (k011226)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Roche Diagnostics Corp. c/o Ms. Kathie Cunningham, Regulatory Affairs Consultant 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250-3831

MAY 12 2008

Re: k080607

Trade/Device Name: Calibrator for automated systems (C.f.a.s.) Proteins Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: March 3, 2008 Received: March 4, 2008

Dear Ms. Cunningham:

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).

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

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 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

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

## Indication for Use

510(k) Number (if known): K080607

Device Name:

Calibrator for automated systems (C.f.a.s.) Proteins

Indication For Use:

Calibrator for automated systems (C.f.a.s.) Proteins is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.

Prescription Use _ XXX (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)

Carol Benson

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

510(k) K080607