ELECSYS T3 CALCHECK 5

K111552 · Roche Diagnostics · JJX · Jul 21, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111552
• Device Name: ELECSYS T3 CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jul 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys T3 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 T3 quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.

Device Story

Elecsys T3 CalCheck 5 is a lyophilized, human serum-based control material containing spiked L-3,3,5-Triiodothyronine (T3). Used in clinical laboratory settings on Elecsys and cobas e immunoassay analyzers (e.g., 2010, E170, e411, e601, e602). Operators are laboratory technicians. The device is reconstituted with distilled/deionized water and processed by the analyzer to verify calibration and assay measuring range. Output consists of measured T3 concentrations compared against target values/ranges provided by the manufacturer. This verification ensures the accuracy and reliability of patient T3 test results, aiding clinicians in diagnosing and monitoring thyroid function.

Clinical Evidence

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

Technological Characteristics

Lyophilized human serum matrix; T3 analyte; five concentration levels; reconstituted with 1.0 mL distilled/deionized water; stored at 2-8°C unopened; stable for 4 hours at 20-25°C after reconstitution. Used on Elecsys and cobas e immunoassay analyzers.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys T3 quantitative assay on Elecsys and cobas e immunoassay analyzers. Prescription use only.

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 T3 CalCheck (K963167)

Submission Summary (Full Text)

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| | JUL 2 1 2011 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Summary | K111552 |
| 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, P.O. Box 50416<br>Indianapolis, IN 46250-0416<br>317-521-3577 |
| | Contact Person: Kelly French<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| | Secondary Contact: Stephanie Greeman<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| | Date Prepared: June 2, 2011 |
| Device Name | Proprietary name: Elecsys T3 CalCheck 5<br>Common name: T3 CalCheck 5<br>Classification name: Single (specified) analyte controls (assayed and<br>unassayed) |
| Predicate<br>device | The Elecsys T3 CalCheck 5 is substantially equivalent to other products in<br>commercial distribution intended for similar use. We claim equivalency to the<br>currently marketed T3 CalCheck (K963167). |
| Device<br>Description | The Elecsys T3 CalCheck 5 is a lyophilized product consisting of T3 in<br>human serum matrix. During manufacture, the analyte is spiked into the<br>matrix at the desired concentration levels. |
| Intended use | The Elecsys T3 CalCheck 5 is an assayed control for use in calibration<br>verification and for use in the verification of the assay range established by<br>the Elecsys T3 quantitative assay reagent on the indicated Elecsys and cobas<br>e immunoassay analyzers, for in vitro diagnostic use only. |

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## 510(k) Summary, Continued

#### The table below compares Elecsys T3 CalCheck 5 with the predicate device, Comparison Elecsys T3 CalCheck (K963167). The predicate shows that T3 CalCheck 5 is Table substantially equivalent to T3 CalCheck, with several key similarities, especially the analyte. The shaded fields indicate similar characteristics between the candidate device and the predicate device.

| Characteristic | Elecsys T3 CalCheck 5<br>(Candidate Device) | Elecsys T3 CalCheck<br>(K963167) |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys T3 Calcheck 5<br>is an assayed control for<br>use in calibration<br>verification and for use in<br>the verification of the<br>assay range established by<br>the Elecsys T3 quantitative<br>assay reagent on the<br>indicated Elecsys and<br>cobas e immunoassay<br>analyzers. | For use in the verification of<br>the calibration established by<br>the Elecsys T3 regent on<br>indicated Elecsys and cobas e<br>immunoassay analyzers. |
| Analyte | T3 | T3 |
| Levels | Five | Three |
| Assay Measuring<br>Range | 0.300 - 10.0 nmol/L | 0.300 - 10.0 nmol/L |
| Check Target<br>Values | Check 1: ≤ 0.2 nmol/L<br>Check 2: 2.0 nmol/L<br>Check 3: 5 nmol/L<br>Check 4: 8 nmol/L<br>Check 5: 10 nmol/L | Check 1: 0 ng/ml<br>Check 2: 1.6 ng/ml<br>Check 3: 5.8 ng/ml |
| Format | Lyophilized | Lyophilized |
| Handling | Reconstitute Check 1,<br>Check 2, Check 3, Check<br>4, and Check 5 with<br>exactly 1.0 mL distilled or<br>deionized water. Allow to<br>stand closed for 15<br>minutes, then mix gently<br>by inversion. | Reconstitute Check 1, Check<br>2, and Check 3 with exactly<br>1.0 mL distilled or deionized<br>water. Allow to stand closed<br>for 15 minutes, then mix<br>gently by inversion. |
| Stability | Unopened:<br>• Store at 2-8°C until<br>expiration date<br>Reconstituted:<br>• 20-25°C: 4 hours | Unopened:<br>• Store at 2-8°C until<br>expiration date<br>Reconstituted:<br>• 15-25°C: 4 hours |
| Matrix | Human serum matrix | Human serum matrix |

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# 510(k) Summary, Continued

Performance The Elecsys T3 CalCheck 5 was evaluated for value assignment and Characteristics stability.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure with stylized feathers.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

**JUL 2 1. 2011**

Roche Diagnostics c/o Ms. Kelly French Manager, Regulatory Affairs 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250-0416

Re: k11552

·

Trade Name: Elecsys T3 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: June 2, 2011 Received: June 3, 2011

Dear Ms. French:

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 10 woo varior 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 Acts requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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 [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C.C.

Courtney 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):

KIII FRA

Device Name: Elecsys T3 CalCheck 5

Indication For Use:

The Elecsys T3 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 T3 reagent on 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)

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Richard Glenn Coffey

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

510(k) K 111 552