ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC

K032089 · Roche Diagnostics Corp. · JJY · Jul 30, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032089
• Device Name: ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 30, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

PreciControl Cardiac is used for quality control of the Elecsys CK-MB, Digoxin, Myoglobin, and NT-proBNP immunoassays on the Elecsys immunoassay systems.

Device Story

Elecsys PreciControl Cardiac; quality control material for immunoassay analyzers; monitors precision/accuracy of Troponin T, CK-MB, Myoglobin, pro-BNP, Digoxin assays. Modification: deletion of Troponin T; addition of pro-BNP and Digoxin. Used in clinical laboratory settings by laboratory personnel. Output: control values compared against expected ranges to verify system performance; ensures reliability of patient diagnostic results.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized preparation of pooled human sera. Analyte concentrations are established for CK-MB, Digoxin, Myoglobin, and NT-proBNP. Designed for use on Elecsys immunoassay analyzers. Stability: 3 hours at 20-25°C, 3 days at 2-8°C, 3 months at -20°C.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision and accuracy of Elecsys immunoassay analyzers for the analytes Troponin T, CK-MB, Myoglobin, pro-BNP, and Digoxin.

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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510(k) Summary - Elecsys® PreciControl Cardiac k032089

| 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 Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br><br>Contact person: Sherri L. Coenen<br><br>Date prepared: July 2, 2003 |
| Device Name | Proprietary name: Roche Diagnostics Elecsys® PreciControl Cardiac<br><br>Common name: Elecsys® PreciControl Cardiac<br><br>Classification name: Multi-analyte Controls (assayed and unassayed) |
| Device<br>description | Roche Diagnostics Elecsys® PreciControl Cardiac is a bilevel lyophilized<br>preparation of pooled human sera containing CK-MB, Digoxin, Myoglobin,<br>and NT-proBNP for monitoring accuracy and precision on Elecsys<br>immunoassay analyzers. |
| Intended use | PreciControl Cardiac is used for quality control of the Elecsys CK-MB,<br>Digoxin, Myoglobin, and NT-proBNP immunoassays on the Elecsys<br>immunoassay systems. |
| Predicate<br>Device | We claim substantial equivalence to the currently marketed Elecsys®<br>PreciControl Cardiac. (K983492). |

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## 510(k) Summary - COBAS Integra Creatinine plus ver.2, continued

continued

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Reagent Summary The following table describes the similarities and differences between the Elecsys® PreciControl Cardiac and the predicate device.

| Topic | Elecsys® PreciControl Cardiac<br>(K983492) | Elecsys® PreciControl Cardiac<br>(Modified Device) |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | PreciControl Cardiac is used for<br>quality control of the Elecsys CK-<br>MB, Myoglobin and Troponin T<br>(CARDIAC T) immunoassays on<br>Elecsys immunoassay systems. | PreciControl Cardiac is used for<br>quality control of the Elecsys-CK-<br>MB, Digoxin, Myoglobin, and NT-<br>proBNP immunoassays on the<br>Elecsys immunoassay systems. |
| Analyzer<br>System | Elecsys® immunoassay analyzers | Same |
| Reagent<br>Format | lyophilized, based on human serum | Same |
| Analyte<br>Concentration<br>PC CARD 1 | CK-MB: approximately 5 ng/ml<br>Myoglobin: approximately 80 ng/ml<br>Troponin T: approximately 0.15<br>ng/ml | CK-MB: Same<br>Myoglobin: Same<br>Digoxin: approximately 1.2 ng/ml<br>NT-proBNP: approximately 0.15<br>ng/ml |
| Analyte<br>Concentration<br>PC CARD 2 | CK-MB: approximately 50 ng/ml<br>Myoglobin: approximately 1000<br>ng/ml<br>Troponin T: approximately 5 ng/ml | CK-MB: Same<br>Myoglobin: Same<br>Digoxin: approximately 3 ng/ml<br>NT-proBNP: approximately 5 ng/ml |
| Stability | 3 hrs at 20 - 25° C<br>3 days at 2 - 8° C<br>3 months at -20° C (only freeze once) | Same |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

JUL 3 0 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sherri L. Coenen MT(ASCP) Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: k032089

Trade/Device Name: Elecsys® PreciControl Cardiac Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: July 2, 2003 Received: July 7, 2003

Dear Ms. Coenen:

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 Sutman

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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## Indications for Use Statement

510(k) Number (if known): N/A Ko 3 2 0 8 9

Device Name: Elecsys® PreciControl Cardiac

Indications For Use:

PreciControl Cardiac is used for quality control of the Elecsys CK-MB, Digoxin, Myoglobin, and NT-proBNP immunoassays on the Elecsys immunoassay systems.

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032089

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use _________________ (Per 21 CFR 801.109)

(Optional Format 1-2-96)