CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF

K040264 · Roche Diagnostics Corp. · JIX · Apr 2, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040264
• Device Name: CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF
• Applicant: Roche Diagnostics Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Apr 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

C.f.a.s. (Calibrator for automated systems) PUC (Proteins in Urine/CSF) is 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. PUC is a liquid, single-level calibrator; buffered aqueous matrix containing human and ovine serum components. Used in clinical chemistry laboratories to calibrate Roche analyzers for albumin, total protein, and U/CSF protein assays. Provides known target values for instrument calibration; ensures accuracy of quantitative patient sample measurements. Operates via immunoturbidimetric or turbidimetric detection methods on compatible Roche/Hitachi or Cobas Integra systems.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid, single-level calibrator; buffered aqueous matrix with human and ovine serum components. Traceable to CRM 470 (albumin) and NIST bovine serum albumin (total/U/CSF protein). Designed for use on Roche/Hitachi and Cobas Integra clinical chemistry analyzers.

Indications for Use

Indicated for use as a calibrator for quantitative Roche clinical chemistry assays measuring albumin, total protein, and U/CSF protein on Roche/Hitachi and Cobas Integra systems.

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

• Roche Diagnostic Calibrator for Automated Systems (C.f.a.s.) Proteins (K011226)

Submission Summary (Full Text)

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APR = 2 2004

# 510(k) Summary

According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence.

Submitter name, address, contact

Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 (317) 521 - 3831

Contact Person: Sherri L Coenen

Date Prepared: February 3, 2004

Proprietary name: Calibrator for Automated Systems Proteins in Urine/CSF Device Name (C.f.a.s. PUC)

Common name: C.f.a.s. PUC

Classification name: Calibrator, Multi-analyte mixture

Device Description The Calibrator for Automated Systems Proteins in Urine/CSF (C.f.a.s. PUC) consists of a buffered aqueous solution with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in product labeling.

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1

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510(k) Summary, Continued

| Intended use | C.f.a.s. (Calibrator for automated systems) PUC (Proteins in Urine/CSF) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet. |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence | The Calibrator for Automated Systems Proteins in Urine/CSF (C.f.a.s. PUC) is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the Roche Diagnostic Calibrator for Automated Systems (C.f.a.s.) Proteins (K011226). The intended use of both devices is the establishment of calibration curves for their respective test systems. |

Substantial equivalence - similarities
The following table compares the Calibrator for Automated Systems Proteins in Urine/CSF (C.f.a.s. PUC) with the predicate device.

| Feature | C.f.a.s. PUC | C.f.a.s. Proteins (Predicate Device) |
|---------|--------------|--------------------------------------|
|---------|--------------|--------------------------------------|

| Feature | C.f.a.s. PUC | C.f.a.s. Proteins<br>(Predicate Device) |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Cfas PUC is for use in the<br>calibration of quantitative<br>Roche methods on Roche<br>clinical chemistry analyzers<br>as specified in the enclosed<br>value sheet. | Cfas Proteins is for use in the<br>calibration of quantitative<br>Roche methods on Roche<br>clinical chemistry analyzers<br>as specified in the enclosed<br>value sheet. |
| Format | Liquid ready-for-use<br>calibrator based on a<br>buffered aqueous solution.<br>Concentrations of calibrator<br>components have been<br>adjusted to ensure optimal<br>calibration. | Liquid ready-for-use<br>calibrator based on stabilized<br>human serum. Concentrations<br>of calibrator components<br>have been adjusted to ensure<br>optimal calibration. |
| Stability | Unopened: Stable at 2-<br>8°C until expiration date. Opened: Stable for 4<br>weeks at 2-8°C. | Unopened: Stable at 2-<br>8°C until expiration date. Opened: Stable for 4<br>weeks at 2-8°C. |
| Levels | Single Level | Single Level |

...

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# 510(k) Summary, Continued

Substantial equivalence – differences

Comparison of proposed Calibrator for Automated Systems Proteins in Urine/CSF (C.f.a.s. PUC) and predicate device.

| Feature | C.f.a.s. PUC | C.f.a.s. Proteins<br>(Predicate Device) |
|---------|---------------------------|-----------------------------------------|
| Matrix | Buffered aqueous solution | Stabilized human serum |

| Constituent Analytes | |
|----------------------|-----------------------------------------|
| C.f.a.s. PUC | C.f.a.s. Proteins<br>(Predicate Device) |
| Albumin | α1-antitrypsin |
| Total Protein | Antistreptolysin O |
| Urine/ CSF Protein | C3c |
| | C4 |
| | Ceruloplasmin |
| | C-Reactive Protein (Latex) |
| | Ferritin |
| | Haptoglobin |
| | IgA |
| | IgG |
| | IgM |
| | Prealbumin |
| | Transferrin |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

APR - 2 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sherri L. Coenen Regulatory Affairs Associate Regulatory Submissions Roche Diagnostics Corp. 9115 Hague Rd. Indianapolis, IN 46250

K040264 Re:

Trade/Device Name: Calibrator for Automated Systems Proteins in Urine/ CSF (C.f.a.s. PUC) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: February 3, 2004 Received: February 4, 2004

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 docs 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,

Jean M. Cooper, MS, DVM.

Jean 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

510(k) Number (if known):___K040264

Device Name: Calibrator for Automated Systems Proteins in Urine/CSF (C.f.a.s. PUC)

Indications For Use:

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

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Alberto GuM

Division Sign

Office of In Vitro Diagnostic Device Evaluation and Safety

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