ELECSYS PRECICONTROL THYROAB

K092320 · Roche Diagnostics · JJY · Nov 3, 2009 · Clinical Chemistry

Device Facts

• Record ID: K092320
• Device Name: ELECSYS PRECICONTROL THYROAB
• Applicant: Roche Diagnostics
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Elecsys PreciControl ThyroAB is used for quality control of the Elecsys Anti-TSHR, Anti-TPO and Anti-Tg immunoassays on the Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys PreciControl ThyroAB is a lyophilized quality control material consisting of human monoclonal anti-TSHR and sheep polyclonal anti-TPO and anti-TG antibodies in a human serum matrix. It is used by laboratory technicians on Elecsys and cobas e immunoassay analyzers to monitor the performance of specific thyroid-related immunoassays. The product is reconstituted with distilled or deionized water before use. By providing known concentrations of analytes, the control allows clinicians to verify the accuracy and precision of the analyzer system, ensuring reliable diagnostic results for patients undergoing thyroid antibody testing.

Clinical Evidence

Bench testing only. No clinical data. Stability studies confirmed shelf-life and open-vial stability. Performance verified across twelve Elecsys/cobas e immunoassay analyzers using duplicate testing to establish target values and ranges. Traceability established against NIBSC standards (60/972 for Anti-TSHR, 66/387 for Anti-TPO, 65/93 for Anti-TG).

Technological Characteristics

Lyophilized human serum matrix; contains human monoclonal anti-TSHR, sheep polyclonal anti-TPO, and sheep polyclonal anti-TG. Reconstituted with 2.0 mL distilled/deionized water. Analyzers: Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601. Stability: 15-month shelf life at 2-8°C; reconstituted stability varies by analyte (up to 5 hours on-analyzer).

Indications for Use

Indicated for use as a quality control serum to monitor the precision of laboratory testing procedures for Anti-TSHR, Anti-TPO, and Anti-TG immunoassays. For 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 PreciControl ThyroAB (k080092)

Submission Summary (Full Text)

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K092320

# 510(k) Summary—Elecsys PreciControl ThyroAB

. ·

NOV - 3 2009

| Introduction | In accordance with 21`CFR 807.92, Roche Diagnostics hereby submits<br>official notification as required by Section 510(k) of the Federal Food, Drug<br>and Cosmetics Act of our intention to market the device described in this<br>Premarket Notification [510(k)]. |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>Name, Address,<br>Contact | Roche Diagnostics<br>9115 Hague Road<br>Indianapolis, IN 46250 |
| | Contact Person: Sarah Baumann<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| | Secondary Contact: Stephanie Greeman<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>Date Prepared: July 30, 2009 |
| Submission<br>Purpose | PreciControl ThyroAB is used for quality control of specified Elecsys<br>immunoassays on the Elecsys and cobas e immunoassay analyzers. This<br>product contains control material for numerous Elecsys assays in one<br>convenient solution. |
| | Changes to PreciControl ThyroAB consist of the addition of<br>anti-thyroperoxidase (Anti-TPO) and anti-thyroglobulin (Anti-TG) antibodies<br>to extend the current functionality. |
| Device Name | Proprietary name: Elecsys PreciControl ThyroAB<br>Common name: PreciControl ThyroAB<br>Classification name: Multi-Analyte Controls, All Kinds (assayed and<br>Unassayed) |
| | Continued on next page |

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:

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## 510(k) Summary—Elecsys PreciControl ThyroAB, Continued

| Device<br>Description | The Elecsys PreciControl ThyroAB is a lyophilized product consisting of<br>antibodies in a human serum matrix. During manufacture, the antibodies are<br>spiked into the matrix at the desired concentration levels. | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Intended Use | Elecsys PreciControl ThyroAB is used for quality control of the Elecsys<br>Anti-TSHR, Anti-TPO and Anti-Tg immunoassays on the Elecsys and<br>cobas e immunoassay analyzers. | | |
| Predicate<br>Device | The modified Elecsys PreciControl ThyroAB is substantially equivalent to<br>other products in commercial distribution intended for similar use. We claim<br>equivalency to the currently marketed Elecsys PreciControl ThyroAB<br>(K080092). | | |
| Device<br>Comparison—<br>Similarities | The table below presents the similarities between the modified Elecsys<br>PreciControl ThyroAB and the predicate device, Elecsys PreciControl<br>ThyroAB (K080092). | | |
| | Characteristic | Predicate Device<br>Elecsys PreciControl<br>ThyroAB<br>(K080092) | Elecsys PreciControl<br>ThyroAB |
| Characteristic | Predicate Device<br>Elecsys PreciControl<br>ThyroAB<br>(K080092) | Elecsys PreciControl<br>ThyroAB | |
| Intended use | Elecsys PreciControl<br>ThyroAB is used for<br>quality control of the<br>Elecsys Anti-TSHR<br>immunoassay on the<br>Elecsys and cobas e<br>immunoassay analyzers. | Elecsys PreciControl<br>ThyroAB is used for<br>quality control of the<br>Elecsys Anti-TSHR, Anti-TPO and Anti-Tg<br>immunoassays on the<br>Elecsys and cobas e<br>immunoassay analyzers. | |
| | | | |
| Analyte<br>concentration | Anti-TSHR (IU/L):<br>Level 1 = 4<br>Level 2 = 16 | Anti-TSHR (IU/L):<br>Level 1 = 4<br>Level 2 = 16<br>Anti-TPO (IU/mL):<br>Level 1 = 35<br>Level 2 = 100<br>Anti-TG (IU/mL):<br>Level 1 = 100<br>Level 2 = 200 | |
| Antibody source<br>and type | Anti-TSHR: Human<br>monoclonal | Anti-TSHR: Human<br>monoclonal<br>Anti-TPO: Sheep<br>polyclonal<br>Anti-TG: Sheep<br>polyclonal | |
| Handling | Dissolve carefully the<br>contents of one bottle by<br>adding exactly 2.0 mL of<br>distilled water and allow<br>to stand closed for 15<br>minutes to reconstitute.<br>Mix carefully, avoiding<br>the formation of foam. | Dissolve carefully the<br>contents of one bottle by<br>adding exactly 2.0 mL of<br>distilled or deionized<br>water and allow to stand<br>closed for 30 minutes to<br>reconstitute. Mix<br>carefully, avoiding the<br>formation of foam. | |

Elecsys and cobas e

-Elecsys 2010 -MODULAR ANALYTICS E170

-cobas e 411 -cobas e 601 Lyophilized

Human Serum

immunoassay analyzers:

Analyzer System

Format Matrix

Continued on next page

Same

Same

Same

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## 510(k) Summary—Elecsys PreciControl ThyroAB, Continued

Device Comparison-Differences

The table below presents the differences between the modified Elecsys PreciControl ThyroAB and the predicate device, Elecsys PreciControl ThyroAB (K080092).

Continued on next page

CONFIDENTIAL

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#### 510(k) Summary-Elecsys PreciControl ThyroAB, Continued

| Device<br>Comparison—<br>Differences<br>(continued) | The table below presents the differences between the modified Elecsys<br>PreciControl ThyroAB and the predicate device, Elecsys PreciControl<br>ThyroAB (K080092). |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Characteristic | Predicate Device<br>Elecsys PreciControl<br>ThyroAB<br>(K080092) | Elecsys PreciControl<br>ThyroAB |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stability | Unopened:<br>Store at 2-8°C until expiration<br>date | Unopened:<br>Store at 2-8°C until expiration<br>date |
| | Reconstituted:<br>on the analyzer at 20-25°C:<br>up to 3 hrs<br>at -20°C: 3 months (freeze<br>only once)<br><br>After Thawing:<br>use only once. | Reconstituted:<br>on the analyzer at 20-25 °C:<br>up to 5 hrs<br>at -20°C: 1 month (freeze<br>only once)<br>or at 2-8°C for 3 day<br>(for Anti-TG & Anti-TPO<br>only) |

Performance Characteristics

The Elecsys PreciControl ThyroAB was evaluated for value assignment, stability, and duration of reconstitution.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Roche Diagnostics c/o Ms. Sarah Baumann Regulatory Affairs Cousultant 9115 Hague Road, PO Box 50410 ~ Indianapolis, Indiana 46250-4016

NOV - 3 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Re: k092320

> Trade Name: Elecsys PreciControl-ThyroAB Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJY Dated: September 30, 2009 Received: October 01, 2009

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 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); 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 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/ResourcesforYou/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):

Ko92320

Device Name: Elecsys PreciControl ThyroAB

Indication For Use:

Elecsys PreciControl ThyroAB is used for quality control of the Elecsys Anti-TSHR, Anti-TPO and Anti-Tg immunoassays on the 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)

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

510(k) k092320 k092320

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