ELECSYS ANTI-TSHR CALCHECK

K080643 · Roche Diagnostics · JJX · Aug 22, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080643
• Device Name: ELECSYS ANTI-TSHR CALCHECK
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

For use in the verification of the calibration established by the Elecsys Anti-TSHR reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys Anti-TSHR CalCheck is a lyophilized quality control material; consists of human anti-TSHR antibodies in human serum matrix. Used to verify calibration of Elecsys Anti-TSHR reagent on Elecsys and cobas e immunoassay analyzers. Provided at three concentration levels (1 mL each). Reconstituted with distilled/deionized water by laboratory personnel. Value assignment performed using multiple analyzer platforms (Elecsys 2010/cobas e 411 and MODULAR ANALYTICS E170/cobas e 601); target values calculated as median of determined values. Components tested free of HBsAg, HIV, and HCV antibodies.

Clinical Evidence

No clinical data. Bench testing only. Stability testing protocols and acceptance criteria were found acceptable. Value assignment performed using multiple analyzer platforms.

Technological Characteristics

Lyophilized human serum matrix containing human anti-TSHR antibodies. Three levels provided. Reconstituted with 1.0 mL distilled/deionized water. Stability: Unopened 2-8°C until expiration; reconstituted 5 hours at 15-25°C. Traceable to NIBSC 1st IS 90/672 standard.

Indications for Use

Indicated for use as a quality control material to verify calibration of the Elecsys Anti-TSHR reagent on Elecsys and cobas e immunoassay analyzers.

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.

Predicate Devices

• Elecsys C-Peptide CalCheck (k040157)

Submission Summary (Full Text)

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K080643

AUG 2 2 2008

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics<br>9115 Hague Road<br>Indianapolis, IN 46250<br>317-521-2458 |
| | Contact Person: Stephanie Greeman |
| | Date Prepared: March 5, 2008 |
| Device Name | Proprietary name: Elecsys Anti-TSHR CalCheck |
| | Common name: Anti-TSHR CalCheck |
| | Classification name: Single (specified) analyte controls (assayed and unassayed) |
| Predicate device | The Elecsys Anti-TSHR CalCheck is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys C-Peptide CalCheck (K040157). |
| Device Description | The Elecsys Anti-TSHR CalCheck is a lyophilized product consisting of human anti-TSHR antibodies in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels. |
| Intended use | For use in the verification of the calibration established by the Elecsys Anti-TSHR reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
| | Continued on next page |

510(k) Summary

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## 510(k) Summary, Continued

Comparison Table

The table below compares Elecsys Anti-TSHr CalCheck with the predicate device, Elecsys C-Peptide Calcheck (K040157).

| Characteristic | Elecsys C- Peptide CalCheck<br>(K040157) | Elecsys Anti-TSHR CalCheck |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the verification of the<br>calibration established by the<br>Elecsys C-Peptide reagent on the<br>indicated Elecsys and cobas e<br>immunoassay analyzers. | For use in the verification of the<br>calibration established by the Elecsys<br>Anti-TSHR reagent on the indicated<br>Elecsys and cobas e immunoassay<br>analyzers. |
| Levels | Three | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute with exactly 1.0 mL<br>distilled or deionized water and<br>allow standing closed for 15<br>minutes, then mixing gently. | Same |
| Stability | Unopened:<br>• Store at 2-8°C until expiration<br>date<br>Reconstituted:<br>• 20 - 25°C : 4 hrs | Unopened:<br>• Store at 2-8°C until expiration date<br>Reconstituted:<br>• 15 - 25°C : 5 hrs |
| Matrix | equine serum matrix | Human serum |

The Elecsys Anti-TSHR CalCheck was evaluated for value assignment and Performance Characteristics stability. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Roche Diagnostics c/o Ms. Stephanie Greeman 9115 Hague Road Indianapolis, IN 46250

AUG 2 2 2008

Re: k080643

> Trade Name: Elecsys Anti-TSHR CalCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I (reserved) Product Codes: JJX Dated: July 29, 2008 Received: July 31, 2008

Dear Ms. Greeman:

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yéan 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

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## Indication for Use

510(k) Number (if known):

K080643

Device Name: Elecsys Anti-TSHR CalCheck

Indication For Use:

For use in the verification of the calibration established by the Elecsys Anti-TSHR reagent on the indicated Elecsys and cobas e immunoassay analyzers.

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 (OVD)

CA

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

510(k) */C080643*