ELECSYS TSH CALSET W/MODELS 04738551

K060754 · Roche Diagnostics Corp. · JIT · Apr 18, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060754
• Device Name: ELECSYS TSH CALSET W/MODELS 04738551
• Applicant: Roche Diagnostics Corp.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Apr 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Elecsys TSH CalSet is used for calibrating the quantitative Elecsys TSH assay on the Elecsys immunoassay analyzers.

Device Story

Elecsys TSH CalSet; calibrator set for TSH immunoassays; used in clinical laboratory settings by laboratory professionals. Input: equine serum matrix (Cal 1) and human serum matrix with added human TSH (Cal 2). Output: calibration values for TSH assay quantification. Modification: transition from recombinant yeast-derived TSH to human-derived TSH; increased open-vial stability claim. Device supports clinical decision-making by ensuring accurate TSH measurement for thyroid function assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Calibrator set consisting of equine serum matrix (Cal 1) and human serum matrix with added human TSH (Cal 2). Used for immunoassay calibration. Stability claim increased for open-vial usage.

Indications for Use

Indicated for the calibration of quantitative Elecsys TSH assays on Elecsys immunoassay analyzers. No specific patient population, age, or disease state contraindications are defined for this 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

• Elecsys TSH CalSet (K961491)

Submission Summary (Full Text)

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K060754

APE 1 8 2006

## 510(k) Summary - Elecsys TSH CalSet

| 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 Rd<br>Indianapolis IN 46250<br>[phone]<br>Contact person: Kay A. Taylor<br>Date prepared: March 17, 2006 |
| Device Name | Proprietary name: Elecsys TSH CalSet<br>Common name: Calibrator<br>Classification name: Calibrator, Secondary |
| Device description | The Elecsys TSH CalSet consists of equine serum matrix (Cal 1) and a human serum matrix with human TSH (Cal 2) in two concentration ranges. The Elecsys TSH CalSet is supplied in ready for use liquid format. |

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## 510(k) Summary - Elecsys® TSH CalSet, continued

| Intended use | Elecsys TSH CalSet is used for calibrating the quantitative Elecsys TSH<br>assay on the Elecsys immunoassay analyzers. | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Predicate<br>Device | The Elecsys TSH CalSet is equivalent to other devices legally marketed in the<br>United States. We claim equivalence to the Elecsys TSH CalSet (K961491). | |
| Device<br>Comparison | The table below compares the device features of the Elecsys TSH CalSet<br>(modified) and original (K961491). | |

| Topic | Elecsys TSH CalSet<br>(K961491) | Elecsys TSH CalSet<br>(Modified Device) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Used for calibrating the quantitative<br>Elecsys TSH assay on the Elecsys<br>2010 immunoassay analyzer. | Used for calibrating the quantitative<br>Elecsys TSH assay on the Elecsys<br>immunoassay analyzers. |
| Traceability | Assay standardized against the 2nd IRP<br>WHO reference standard 80/558 | Same |
| Levels | Two | Same |
| Storage Form | Liquid | Same |
| Matrix | Horse serum matrix with added<br>recombinant TSH | Equine serum matrix with added TSH<br>(human). |
| Stability | Unopened:<br>ο at 2-8°C up to the stated<br>expiration date.<br>Opened:<br>ο 4 weeks at at 2-8°C<br>ο on the analyzer up to a maximum<br>of five hours in total. | Unopened:<br>ο at 2-8°C up to the stated<br>expiration date.<br>Opened:<br>ο after opening in aliquots at 2-8°C<br>for 12 weeks.<br>ο on 1010/2010 at 20-25°C up to 5<br>hours<br>ο on E170 use only once. |
| Target<br>Concentrations | Cal 1: 0 µIU/mL<br>Cal 2: 1.5 µIU/mL | Same |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 3 2006

Ms. Kay A. Taylor Regulatory Affairs Principal Roche Diagnostics Corp. 9115 Haguc Road Indianapolis, IN 46250

Re: k060754 Trade/Device Name: Elecsys TSH CalSet Regulation Number: 21 CFR8862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: March 17, 2006 Received: March 21, 2006

Dear Ms. Taylor:

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 C FR 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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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/industry/support/index.html.

Sincerely yours,

Albert Gutt

Alberto Gutierrez, 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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## Indications for Use

510(k) Number (if known): K060754

Device Name: Elecsys TSH CalSet

Indications For Use:

The Elecsys TSH CalSet is used for calibrating the quantitative Elecsys TSH assay on the Elecsys immunoassay analyzers.

Prescription Use XXXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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