ELECSYS TSH CALCHECK 5

K093836 · Roche Diagnostics · JJX · Apr 15, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093836
• Device Name: ELECSYS TSH CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys TSH CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys TSH reagent on the indicated Elecsys cobas e immunoassay analyzers.

Device Story

Elecsys TSH CalCheck 5 is a lyophilized, assayed control material consisting of human TSH in equine serum matrix; used for calibration verification and assay range verification of TSH reagents on Elecsys and cobas e immunoassay analyzers. Product is reconstituted with distilled or deionized water by laboratory personnel. Value assignment is performed using multiple analyzers (Elecsys 2010/cobas e411 and MODULAR ANALYTICS E170/cobas e601) with target values derived from the median of observed results. Traceable to WHO 2nd IRP 80/558. Healthcare providers use the output to verify the performance of the TSH assay range and calibration curve, ensuring accuracy of patient TSH measurements.

Clinical Evidence

No clinical data. Performance evaluation was limited to bench testing, specifically focusing on value assignment and stability of the control material.

Technological Characteristics

Lyophilized human TSH in equine serum matrix. Five levels of concentration. Standardized to WHO 2nd IRP 80/558. Compatible with Elecsys and cobas e immunoassay analyzers. Storage: 2-8°C unopened; 20-25°C for 4 hours reconstituted.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys TSH reagent on Elecsys and cobas e immunoassay analyzers. No specific patient population, age, or gender restrictions are defined as this is an in vitro diagnostic control material.

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 CalCheck TSH (k963147)

Submission Summary (Full Text)

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K093836

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APR 1 6 _ J10

## 510(k) Summary 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 Roche Diagnostics name, address, 9115 Hague Road, P.O. Box 50416 contact Indianapolis, IN 46250-0416 317-521-3577 Contact Person: Kelly Colleen O'Maine Adams Phone: [phone] Fax: [phone] Email: [e-mail] Secondary Contact: Stephanie Greeman Phone: [phone] Fax: [phone] Email: [e-mail] Date Prepared: March 17, 2010 Device Name Proprietary name: Elecsys TSH CalCheck 5 Common name: TSH CalCheck 5 Classification name: Single (specified) analyte controls (assayed and unassayed) Predicate The Elecsys TSH CalCheck 5 is substantially equivalent to other products in device commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys CalCheck TSH (K963147). Device The Elecsys TSH CalCheck 5 is a lyophilized product consisting of Description TSH in equine serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Intended use The Elecsys TSH CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys TSH reagent on the indicated Elecsys cobas e immunoassay analyzers.

Continued on next page

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# 510(k) Summary, Continued

| Comparison<br>Table | The table below compares Elecsys TSH CalCheck 5 with the predicate<br>device, Elecsys CalCheck TSH (K963147). | |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Elecsys CalCheck TSH<br>(K963147) | Elecsys TSH CalCheck 5 |
| Intended Use | For use in the verification of the<br>calibration established by the<br>Elecsys TSH reagent on the<br>indicated Elecsys and cobas e<br>immunoassay analyzers. | The Elecsys TSH CalCheck 5 is an<br>assayed control for use in<br>calibration verification and for use<br>in the verification of the assay range<br>established by the Elecsys TSH<br>reagent on the indicated Elecsys<br>cobas e immunoassay analyzers. |
| Levels | Three | Five |
| Format | Lyophilized | Same |
| Handling | Reconstitute the contents of Check<br>1, Check 2 and Check 3 with<br>exactly 1.0 mL distilled or<br>deionized water. Allow the bottle to<br>stand closed for 15 minutes. Mix<br>gently by inversion to ensure<br>homogeneity. | Reconstitute Check 1, Check 2,<br>Check 3, Check 4, and Check 5<br>with exactly 1.0 mL distilled or<br>deionized water. Allow to stand<br>closed for 15 minutes, then mix<br>gently by inversion. |
| Stability | Unopened:<br>• Store at 2-8°C until expiration<br>date<br>Reconstituted:<br>• 20 - 25°C : 4 hrs | Same |
| Matrix | Equine serum matrix | Same |

Performance
Characteristics

The Elecsys TSH CalCheck 5 was evaluated for value assignment and stability.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, in blue. The caduceus is surrounded by a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The logo is simple and clean, with a focus on the department's name and the national affiliation.

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

APR 3 0 2010

Roche Diagnostics Roche Professional Diagnostics c/o Ms. Kelly Colleen O'Maine Adams Regulatory Affairs Consultant 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250-0416

Re: k093836 Trade Name: Elecsys TSH CalCheck 5 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I reserved Product Codes: JJX Dated: February 08, 2010 Received: February 12, 2010

Dear Ms. O'Maine Adams:

This letter corrects our substantially equivalent letter of April 15, 2010.

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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Signature

Courtney C. Harper, Ph.D. 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):

Device Name: Elecsys TSH CalCheck 5

Indication For Use:

The Elecsys TSH CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys TSH reagent an the indicated Elecsys and cobas e immunoassay analyzers.

Prescription Use X (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) K093836

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