ELECSYS PRECICONTROL TROPONIN T

K031990 · Roche Diagnostics Corp. · JJX · Aug 20, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031990
• Device Name: ELECSYS PRECICONTROL TROPONIN T
• Applicant: Roche Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys® PreciControl Troponin T is used for quality control of the Elecsys Troponin T (Cardiac T®) immunoassay on the Elecsys immunoassay system.

Device Story

Elecsys PreciControl Troponin T is a lyophilized quality control product; consists of two levels (Low and High) of recombinant human Troponin T in human serum matrix. Used on Elecsys immunoassay systems to monitor assay performance. Requires reconstitution with 2 mL distilled water; 15-minute standing time. Provides target concentration values for Troponin T to verify system accuracy and precision. Used by laboratory personnel in clinical settings.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized quality control material; recombinant human Troponin T in human serum matrix. Two levels (Low/High). Reconstituted with 2 mL distilled water. Storage 2–8°C. Compatible with Elecsys immunoassay systems.

Indications for Use

Indicated for quality control of the Elecsys Troponin T (Cardiac T) immunoassay on Elecsys immunoassay systems.

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 Cardiac (K983492)

Submission Summary (Full Text)

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Revised 8/14/03

## AUG 2 0 2003

K031990

## 510(k) Summary

According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 Roche Diagnostics Corporation Submitter name, address, 9115 Hague Road contact Indianapolis, IN 46250 (317) 521 - 3723 Contact Person: Kay Taylor (for Theresa M. Ambrose) Date Prepared: August 14, 2003 And And And And And And And Commend Commend Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments o Proprietary name: Elecsys® PreciControl Troponin T Device Name Common name: Calibration Verification Material Classification name: Single (specified) analyte controls (assayed and unassayed) and the state of the state of the state of the state of the first and the The Elecsys PreciControl Troponin T is substantially equivalent to the Predicate Device currently marketed Elecsys PreciControl Cardiac (K983492). Device The Elecsys PreciControl Troponin T is a lyophilized manufactured using Description recombinant human Troponia T in human serum matrix. The analyte is spiked into the matrix to the correct concentration levels.

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# 510(k) Summary, Continued

| Intended use | The Elecsys® PreciControl Troponin T is used for quality control of the<br>Elecsys Troponin T (Cardiac T®) immunoassay on the Elecsys immunoassay<br>system. |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to<br>predicate<br>device | The Elecsys® PreciControl Troponin T is substantially equivalent to other<br>products in commercial distribution intended for similar use. Most notably, it<br>is substantially equivalent to the currently marketed Elecsys® PreciControl<br>Cardiac (K983492).<br><br>The intended use of both devices are the same; as they are both intended for<br>use as the quality control of Elecsys® immunoassays. The proposed product<br>is a single-analyte version of the multi-analyte predicate device. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is surrounded by the words "U.S. Department of Health & Human Services" in a circular arrangement.

Public Health Service

AUG 2 0 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Theresa M. Ambrose, Ph.D., FACB Regulatory Principal Centralized Diagnostics Regulatory Submissions Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250

Re: k031990

Trade/Device Name: Elecsys® PreciControl Troponin T Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: June 25, 2003 Received: June 27, 2003

Dear Dr. Ambrose:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

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/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Revised &/14/03

## Indications for Use Statement

510(k) Number (if known): N/A

Device Name:

Elecsys PreciControl Troponin T

Indications For Use:

### PreciControl Troponia T is used for quality control of the Elecsys Troponin T (CARDIAC T) immunoassay of the Elecsys immunoassay systems.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Carol C. Benum / B. Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k031990