ELECSYS ANTI-TPO CALSET

K103171 · Roche Diagnostics · JIX · Feb 11, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103171
• Device Name: ELECSYS ANTI-TPO CALSET
• Applicant: Roche Diagnostics
• Product Code: JIX · Clinical Chemistry
• Decision Date: Feb 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Elecsys® Anti-TPO CalSet is used for calibrating the quantitative Elecsys Anti-TPO assay on the Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys® Anti-TPO CalSet is a lyophilized calibrator for the quantitative Elecsys Anti-TPO assay. It consists of sheep anti-TPO antibodies in a human serum matrix at two concentration levels (approx. 35 IU/mL and 350 IU/mL). The product requires reconstitution with distilled or deionized water before use. It is intended for use by laboratory professionals on Roche Elecsys and cobas e immunoassay analyzers. The device includes barcode cards and sheets to provide lot-specific calibration values to the analyzer. By calibrating the assay, the device ensures accurate quantitative determination of thyroid peroxidase antibodies, which aids clinicians in the diagnosis of autoimmune thyroid diseases.

Clinical Evidence

No clinical data. Bench testing only, including stability studies for unopened lyophilized, opened reconstituted, and on-board stability to support expiration claims.

Technological Characteristics

Lyophilized sheep anti-TPO antibodies in human serum matrix. Two levels: approx. 35.0 IU/mL and 350 IU/mL. Traceable to NIBSC 66/387. Reconstituted with 1.5 mL distilled/deionized water. Used on Elecsys and cobas e immunoassay analyzers. No software or electronic components.

Indications for Use

Indicated for use as a calibrator for the quantitative Elecsys Anti-TPO assay on specified Roche immunoassay analyzers. No specific patient population or contraindications 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® Anti-TPO test system (k051890)

Submission Summary (Full Text)

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# Elecsys® Anti-TPO CalSet 510(k) Summary ורו30/ 1 FEB 11 1 1 1

| 510(k) Summary | FEB 11 2011 K103171 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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><br>Contact Person: Sarah Baumann<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br><br>Secondary Contact: Stephanie Greeman<br>Phone: [phone]<br>Email: [e-mail]<br><br>Date Prepared: October 26, 2010 |
| Device name | Proprietary name: Elecsys® Anti-TPO CalSet<br>Common name: Anti-TPO CalSet<br>Classification name: Calibrator, Secondary |
| Predicate<br>device | The Elecsys® Anti-TPO CalSet is substantially equivalent to other products in<br>commercial distribution intended for similar use. We claim equivalency to the<br>currently marketed Elecsys® Anti-TPO CalSet (cleared as part of the Elecsys®<br>Anti-TPO test system on K051890). |
| Device<br>description | The Elecsys® Anti-TPO CalSet is a lyophilized product consisting of sheep<br>anti-TPO antibodies in a human serum matrix. During manufacture, the<br>analyte is spiked into the matrix at the desired concentration levels. |
| Intended use | Elecsys Anti-TPO CalSet is used for calibrating the quantitative Elecsys<br>Anti-TPO assay on the Elecsys and cobas e immunoassay analyzers. |
| Reason for<br>submission | The Elecsys® Anti-TPO CalSet is being changed from a liquid to lyophilized<br>material. The formulation of the candidate device (Elecsys® Anti-TPO<br>CalSet, lyophilized) is identical to that of the predicate device, Elecsys®<br>Anti-TPO CalSet (liquid, and cleared as part of the Elecsys® Anti-TPO test<br>system on K051890). |

Continued on next page

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### 510(k) Summary. Continued

The Elecsys® Anti-TPO CalSet is currently sold to customers as part of the Comparison table Elecsys® Anti-TPO assay kit. Upon clearance of the modified Elecsys® Anti-TPO CalSet device, it will be packaged and sold separately from the Elecsys® Anti-TPO assay kit.

> Table 1 below compares Elecsys® Anti-TPO CalSet (K103171) with the predicate device, Elecsys® Anti-TPO CalSet (cleared as part of the Elecsys® Anti-TPO Test System on K051890).

| Characteristic | Elecsys® Anti-TPO CalSet<br>(Candidate Device, K103171) | Elecsys® Anti-TPO CalSet<br>(K051890) |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Elecsys Anti-TPO CalSet is used for<br>calibrating the quantitative Elecsys<br>Anti-TPO assay on the Elecsys and<br>cobas e immunoassay analyzers. | The Elecsys Anti-TPO immunoassay is for the in<br>vitro quantitative determination of antibodies to<br>thyroid peroxidase in human serum and plasma. The<br>anti-TPO determination is used as an aid in the<br>diagnosis of autoimmune thyroid diseases. |
| | | The electrochemiluminescence assay "ECLIA" is<br>intended for use on the Roche Elecsys 1010/2010<br>and MODULAR ANALYTICS E170 (Elecsys<br>module) immunoassay analyzers.1 |
| Material Form<br>(Format) | Lyophilized | Liquid |
| Analyte | Anti-TPO Antibodies (Sheep) | Same |
| Traceability | NIBSC (National Institute for<br>Biological Standards and Controls)<br>66/387 International Standard | Same |
| Matrix | Human serum | Same |
| Levels and<br>Corresponding<br>Concentrations | Two<br>Calibrator 1: approx. 35.0 IU/mL<br>Calibrator 2: approx. 350 IU/mL | Two<br>Calibrator 1: approx. 35.0 IU/mL<br>Calibrator 2: approx. 350 IU/mL |
| Stability | Unopened:<br>• Store at 2-8°C until expiration date<br><br>Reconstituted:<br>• at 2-8°C: 7 days<br>• at -20 °C: 8 weeks (freeze only once)<br>• on the analyzers at 20-25 °C: use<br>only once | Unopened:<br>• Store at 2-8°C until expiration date<br><br>Opened:<br>• at 2-8°C: 6 weeks<br>• at 20-25 °C on Elecsys 1010/2010: up to 5 hours<br>• MODULAR ANALYTICS E170: use only once |

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¹ The Elecsys® Anti-TPO CalSet was originally cleared as part of the Elecsys® Anti-TPO test system on K051890 and is currently sold to customers as part of the Elecsys Anti-TPO assay kit. As such, the Intended Use of the assay reagent kit is listed in Table 1. Upon clearance of the modified Elecsys® Anti-TPO CalSet device, it will be packaged and sold separately from the assay kit.

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## 510(k) Summary, Continued

The Elecsys® Anti-TPO CalSet is currently sold to customers as part of the Comparison table, continued Elecsys® Anti-TPO assay kit. Upon clearance of the modified Elecsys® Anti-TPO CalSet device, it will be packaged and sold separately from the Elecsys® Anti-TPO assay kit. Table 1 below compares Elecsys® Anti-TPO CalSet (K103171) with the predicate device, Elecsys® Anti-TPO CalSet (cleared as part of the Elecsys®

Anti-TPO Test System on K051890).

| Characteristic | Elecsys® Anti-TPO CalSet<br>(Candidate Device, K103171) | Elecsys® Anti-TPO CalSet<br>(K051890) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Handling | Dissolve carefully the contents of one<br>bottle by adding exactly 1.5 mL of<br>distilled or deionized water and allow<br>to stand closed for 15 minutes to<br>reconstitute. Mix carefully, avoiding<br>the formation of foam. Transfer the<br>reconstituted calibrator into the empty<br>labeled snap-cap bottles supplied. | The reagents in the kit are ready for use and<br>supplied in the bottles compatible with the system.<br>Elecsys 1010/2010 analyzers: The Elecsys<br>calibrators Cal1 and Cal2 and the Elecsys controls²<br>PC A-TPO1 and PC A-TPO2 should only be left<br>on the analyzers at 20-25°C during<br>calibration/quality control. After use, close the<br>bottles as soon as possible and store at 2-8°C. |
| | Elecsys 2010 and cobas e 411<br>analyzers: The calibrators should only<br>be left on the analyzers during<br>calibration at 20-25°C. Perform only<br>one calibration procedure per aliquot.<br>If necessary, freeze in aliquots; see<br>section on MODULAR ANALYTICS<br>E170 and cobas e 601 analyzers. | Ensure that no calibration and control solution is<br>trapped in the opened snap-cap. Because of<br>possible evaporation effects, not more than 5<br>calibration/quality control procedures per bottle set<br>should be performed. |
| | MODULAR ANALYTICS E170 and<br>cobas e 601 analyzers: Unless the<br>entire volume is necessary for<br>calibration on the analyzer, transfer<br>aliquots of the reconstituted calibrator<br>into empty snap-cap bottles (CalSet<br>Vials). Attach the supplied labels to<br>these additional bottles. Store the<br>aliquots for later use at -20°C. Perform<br>only one calibration procedure per<br>aliquot. | MODULAR ANALYTICS E170 analyzer: Unless<br>the entire volume is necessary for calibration and<br>quality control on the analyzer, transfer aliquots of<br>the ready-for-use calibrators and controls into<br>empty snap-cap bottles (CalSet Vials/ControlSet<br>Vials). Attach the supplied labels to these<br>additional bottles. Store the aliquots for later use at<br>2-8°C. Perform only one calibration or control<br>procedure per aliquot. |
| | | All information required for correct operation is<br>read in via the respective reagent barcodes. |

#### Table 1. Comparison of Candidate and Predicate Devices, continued

Continued on next page

² The control materials originally sold with the Elecsys® Anti-TPO test system (PC A-TPO1 and PC A-TPO2) are no longer included in the assay kit. A new control material, Elecsys® PreciControl ThyroAB, was cleared on K092320 and includes the appropriate levels of anti-TPO for quality control of the Elecsys® Anti-TPO assay.

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【

# 510(k) Summary, Continued

| Performance<br>characteristics | The Elecsys® Anti-TPO CalSet was evaluated for value assignment, stability, and reconstitution. |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The data demonstrate that the performance of the Elecsys® Anti-TPO CalSet is substantially equivalent to that of the predicate device, Elecsys® Anti-TPO CalSet (cleared as part of the Elecsys® Anti-TPO Test System on K051890). |

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of a bird in flight, with its wings spread. The bird is composed of three curved lines, and it appears to be soaring upwards.

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

FEB 1 1 201

Roche Diagnostics c/o Ms. Sarah Baumann Regulatory Affairs Consultant 9115 Hague Road Indianapolis. IN 46250-0416

Re: k103171

Trade/Device Name: Elecsys® Anti-TPO CalSet Regulation Number: 21 CFR 8862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIX Dated: January 06, 2011 Received: January 07, 2011

Dear Ms. Baumann:

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 class II (Special Controls), 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

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Page 2 - Ms. Sarah Baumann

CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device 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). 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 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,

ia m Clark

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Indications for Use Form

510(k) Number (if known): K/ 0 3/7/

Device Name: Elecsys Anti-TPO CalSet

Indications for Use: Elecsys Anti-TPO CalSet is used for calibrating the quantitative Elecsys Anti-TPO assay on the Elecsys and cobas e immunoassay analyzers.

Prescription Use Over-The-Counter Use × Prescription Ose
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

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

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

Geena Philip

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

510(k) /0.3/7/

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