ELECSYS CALCHECK TROPONIN T

K984372 · Boehringer Mannheim Corp. · JJY · Dec 14, 1998 · Clinical Chemistry

Device Facts

• Record ID: K984372
• Device Name: ELECSYS CALCHECK TROPONIN T
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Boehringer Mannheim Elecsys® CalCheck™ Troponin T is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Troponin T assay.

Device Story

Elecsys CalCheck Troponin T is a calibration verification material used in clinical laboratory settings to ensure accuracy of Elecsys Troponin T assays. The device consists of three levels of solutions (low, mid, high) containing bovine serum albumin, human recombinant Troponin T, stabilizers, and preservatives. The low level is near the assay's lower detection limit; the middle level is at the clinically critical point; the high level is near the upper limit of the measuring range. Laboratory technicians use these solutions to verify that the analyzer's calibration remains within specified parameters. This verification process helps ensure the reliability of Troponin T measurements, which are critical for clinical decision-making regarding cardiac events.

Clinical Evidence

Bench testing only. The device was evaluated for value assignment and stability.

Technological Characteristics

Calibration verification material composed of bovine serum albumin, human recombinant Troponin T, stabilizers, and preservatives. Formulated into three concentration levels (low, mid, high). Designed for use with Elecsys immunoassay analyzers.

Indications for Use

Indicated for periodic verification of calibration for the Elecsys Troponin T assay. Solutions provided in three levels (low, mid, high) covering the assay measuring range, including the lower detection limit and clinically critical points.

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 CalCheck Troponin T (K984372)

Submission Summary (Full Text)

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DEC 1 4 1998

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K984372

## 510(k) Summary

| 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<br>name, address,<br>contact | Boehringer Mannheim Corporation<br>9115 Hague Road<br>Indianapolis, IN 46250<br>(317) 845 - 3723 |
| | Contact Person: Priscilla A. Hamill |
| | Date Prepared: December 3, 1998 |
| Device name | Proprietary name: Elecsys CalCheck Troponin T |
| | Common name: Calibration Verification Material |
| | Classification name: Single (specified) analyte controls (assayed + unassayed) |
| Predicate<br>device | The Boehringer Mannheim Elecsys CalCheck Troponin T is substantially equivalent to the currently marketed Elecsys CalCheck Troponin T. |
| Device<br>description | The Boehringer Mannheim Elecsys CalCheck Troponin T is manufactured using bovine serum albumin, human recombinant Troponin T, stabilizers, and preservatives. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels. |
| | Continued on next page |

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## 510(k) Summary, Continued

| Intended use | The Boehringer Mannheim Elecsys® CalCheck™ Troponin T is used to<br>verify the calibration assignment for the Boehringer Mannheim Elecsys<br>Troponin T assay. |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to<br>predicate<br>device | The Boehringer Mannheim Elecsys® CalCheck™ Troponin T is substantially<br>equivalent to other products in commercial distribution intended for similar<br>use. Most notably, it is substantially equivalent to the currently marketed<br>Elecsys® CalCheck™ Troponin T.<br><br>Both products are intended to be used for the verification of calibration for<br>analytes on the Elecsys immunoassay analyzers. |
| Performance<br>Characteristics | The Elecsys® CalCheck™ Troponin T was evaluated for value assignment<br>and stability. |

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DEC 1 4 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Priscilla A. Hamill Regulatory Affairs Consultant Boehringer Mannheim Corporation 9115 Hague Road Indianapolis Indiana 46250-0457

Re: K984372 Elecsys CalCheck Troponin T Trade Name: Regulatory Class: I Product Code: JJY Dated: December 3, 1998 Received: December 7, 1998

Dear Ms. Hamill:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral controls provisions of the Act include requirements for annual registration, listinq 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K984372 510(k) Number (if known): N/A

Device Name: Boehringer Mannheim Elecsys® CalCheck™ Troponin T

Indications For Use:

Elecsys CalCheck Troponin T calibration verification solutions comprise three levels - low, mid. and high - each with a defined Troponin T concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.

The Elecsys CalCheck Troponin T is intended for use in periodic verification of the calibration of the Elecsys Troponin T assay.

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number k984372