MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)

K033501 · Roche Diagnostics Corp. · JIX · Nov 20, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033501
• Device Name: MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
• Applicant: Roche Diagnostics Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Nov 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Calibrator for Automated Systems (C.f.a.s.) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

Device Story

Calibrator for Automated Systems (C.f.a.s.) is a lyophilized human serum-based calibrator containing chemical additives and biological materials. It is used in clinical chemistry laboratories to calibrate quantitative Roche diagnostic methods on Roche clinical chemistry analyzers. The device provides known concentrations of analytes, allowing the analyzer to establish a calibration curve. This process ensures the accuracy and reliability of patient sample measurements performed by the analyzer. Healthcare providers use the resulting quantitative data to make clinical decisions regarding patient diagnosis and monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lyophilized human serum base with chemical additives. Formulated for calibration of Roche clinical chemistry analyzers. Standalone calibrator product.

Indications for Use

Indicated for the calibration of quantitative Roche methods on Roche clinical chemistry analyzers. No specific patient population, age, or gender restrictions are defined; intended for professional use in clinical laboratory settings.

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.

Submission Summary (Full Text)

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NOV 2 0 2003

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# 510(k) Summary - Calibrator for Automated Systems (C.f.a.s.)

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br><br>Contact person: Sherri L. Coenen<br><br>Date prepared: November 3, 2003 |
| Device Name | Proprietary name: Calibrator for Automated Systems (C.f.a.s.)<br><br>Common name: Calibrator for Automated Systems (C.f.a.s.)<br><br>Classification name: Calibrator, Multi-analyte mixture |
| Device<br>description | The Calibrator for Automated Systems (C.f.a.s.) is a lyophilized human serum<br>calibrator with chemical additives and materials of biological origin. The<br>concentration of the calibrator components have been adjusted to ensure<br>optimal calibration of the appropriate Roche methods on clinical chemistry<br>analyzers. |

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## 510(k) Summary - Calibrator for Automated Systems

(C.f.a.S.), continued

Intended use Calibrator for Automated Systems (C.f.a.s.) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet. の 2006年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には1000年に10000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 We claim substantial equivalence to the currently marketed Calibrator for Predicate Device Automated Systems (C.f.a.s.)(K990460).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 0 2003

Ms. Sherri L. Coenen Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: k033501

> Trade/Device Name: Calibrator for Automated Systems (C.f.a.s.) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: November 3, 2003 Received: November 5, 2003

Dear Ms. Coenen:

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 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/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

510(k) Number (if known): N/A

Device Name: Calibrator for Automated Systems (C.f.a.s.)

Indications For Use:

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

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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V OR Over-The-Counter Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Alberto Cuté

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**Division Sign-Off** for Team Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k033501