CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)

K040245 · Roche Diagnostics Corp. · JIX · Mar 24, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040245
• Device Name: CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)
• Applicant: Roche Diagnostics Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Mar 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The C.f.a.s. PAC is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

Device Story

C.f.a.s. PAC is a lyophilized, multi-analyte calibrator consisting of human serum with added biological materials; used to calibrate quantitative Roche clinical chemistry methods on Roche analyzers. The product is reconstituted with distilled/deionized water by laboratory personnel. It provides known values for Prealbumin, Antistreptolysin O (ASLO), and Ceruloplasmin, allowing the analyzer to establish a calibration curve for patient sample testing. By ensuring accurate calibration, the device enables reliable quantitative measurement of these analytes in patient serum, supporting clinical diagnosis and monitoring of conditions associated with these proteins.

Clinical Evidence

No clinical data. Performance evaluation was limited to bench testing regarding value assignment and stability.

Technological Characteristics

Lyophilized human serum matrix; multi-analyte calibrator; requires reconstitution with 1.0 mL distilled/deionized water; single-level concentration; intended for use on Roche clinical chemistry analyzers.

Indications for Use

Indicated for the calibration of quantitative Roche clinical chemistry assays on Roche analyzers. No specific patient population, age, or gender restrictions are defined as this is a laboratory calibrator product.

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 Lipids (k011658)

Submission Summary (Full Text)

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K040245

mar 2 4 2004

.

# 510(k) Summary

| 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<br>9115 Hague Road<br>Indianapolis, IN 46250<br>317-521-3723 |
| | Contact Person: Theresa M. Ambrose |
| | Date Prepared: February 2, 2004 |
| Device Name | Proprietary name: Calibrator for Automated Systems Prealbumin-ASLO-<br>Ceruloplasmin (C.f.a.s. PAC ) |
| | Common name: C.f.a.s. PAC |
| | Classification name: Calibrator, Multi-analyte mixture |
| Predicate<br>device | The C.f.a.s. PAC is substantially equivalent to the currently marketed C.f.a.s.<br>Lipids (K011658). |
| Device<br>Description | The C.f.a.s. PAC is a lyophilized product consisting of human serum with<br>biological materials added as required to obtain desired component levels.<br>Values for constituent analytes are provided in product labeling. |
| Intended use | The C.f.a.s. PAC is intended for use in the calibration of quantitative Roche<br>methods on Roche clinical chemistry analyzers as specified in the enclosed<br>value sheet. |
| | Continued on next page |
| Comparison to | The C.f.a.s. PAC is substantially equivalent to the currently marketed C.f.a.s. |
| predicate<br>device | Lipids (K011658). The below tables compare C.f.a.s. PAC with the predicate<br>device, C.f.a.s. Lipids (K011658). |

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# 510(k) Summary, Continued

### Similarities

| Characteristic | C.f.a.s. PAC | Predicate device<br>C.f.a.s. Lipids (K011658) |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | C.f.a.s. PAC is intended<br>for use in the calibration<br>of quantitative Roche<br>methods on Roche<br>clinical chemistry<br>analyzers as specified in<br>the enclosed value sheet. | C.f.a.s. Lipids is intended<br>for use in the calibration of<br>quantitative Roche<br>methods on Roche clinical<br>chemistry analyzers as<br>specified in the enclosed<br>value sheet. |
| Format | Lyophilized | same |
| Matrix | Human serum | same |
| Handling | Reconstitute with exactly<br>1.0 mL distilled/<br>deionized water.<br>Carefully close the bottle<br>and dissolve the contents<br>completely by occasional<br>gentle swirling within 30<br>minutes. | same |
| Levels | Single level | same |

Continued on next page

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## 510(k) Summary, Continued

:

#### Differences

:

| Characteristic | C.f.a.s. PAC | Predicate device<br>C.f.a.s. Lipids (K011658) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analytes | • Prealbumin<br>• Antistreptolysin O<br>(ASLO)<br>• Ceruloplasmin | • Apolipoprotein Al<br>• Apolipoprotein B<br>• HDL-cholesterol<br>• LDL-cholesterol |
| Stability | Unopened: stable up to<br>the stated expiration date<br>Reconstituted:<br>• 15 to 25 °C:<br>8 hours<br>• 2 to 8 °C:<br>2 days<br>• -15 to -25 °C: 2 weeks<br>(when frozen once) | Unopened: stable up to the<br>stated expiration date<br>Reconstituted:<br>• 15 to 25 °C:<br>8 hours<br>• 2 to 8 °C<br>5 days<br>• -15 to -25 °C<br>4 weeks<br>(when frozen once) |

and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of

Performance Characteristics

· The C.f.a.s. PAC was evaluated for value assignment and stability.

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Public Health Service

MAR 2 4 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Theresa M. Ambrose, Ph.D. DABCC, FACB, RAC Regulatory Principal Centralized Diagnostics Regulatory Submissions Roche Diagnostics Corp. 9115 Hague Rd. Indianapolis, IN 46250

Re: k040245

> Trade/Device Name: C.f.a.s. PAC Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: February 2, 2004 Received: February 03, 2004

Dear Dr. Ambrose :

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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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/dsma/dsmamain.html.

Sincerely yours.

Seain M. Cooper, US, DVM.

Yean M. Cooper, MS, 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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## Indications for Use Statement

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

K040245

Device Name: C.f.a.s. PAC

Indications For Use: The C.f.a.s. PAC is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _____________

(Optional Format 1-2-96)

Carol Benson

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040245