CARDIAC TROPONIN-I (TROP) CALIBRATOR

K973668 · Dade Intl., Inc. · JIT · Oct 20, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973668
• Device Name: CARDIAC TROPONIN-I (TROP) CALIBRATOR
• Applicant: Dade Intl., Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Oct 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Cardiac Troponin-I 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.

Device Story

Cardiac Troponin-I (TROP) Calibrator is a five-level frozen product containing cardiac troponin-I in a buffered bovine protein matrix. It is used to calibrate the TROP method for the Dimension® RxL clinical chemistry system with a heterogeneous immunoassay module. The device provides reference points (0, 2, 8, 25, and 55 ng/mL) to ensure accurate measurement of cardiac troponin-I in human specimens, which aids clinicians in diagnosing cardiac conditions. It is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Five-level frozen calibrator; matrix: buffered bovine protein; analyte: cardiac troponin-I; concentrations: 0, 2, 8, 25, 55 ng/mL; volume: 2.0 mL per vial; intended for use with Dimension® RxL clinical chemistry system.

Indications for Use

Indicated for use as a calibrator in a test system to establish reference points for measuring cardiac troponin-I in human specimens.

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

• Stratus® Cardiac Troponin-I Calibrators

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "DADE" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The letters are evenly spaced and aligned horizontally.

Image /page/0/Picture/2 description: The image shows the text "K9736068" in a handwritten style on the top. Below this text is a black rectangular box with the words "DADE INTERNATIONAL" written in white letters. The text in the black box is in all caps and appears to be a company or brand name.

Chemistry Systems P.O. Box 6101 Newark, DE 19714

## Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter's Name: | Rebecca S. Ayash<br>Dade International Inc.<br>Building 500, Mailbox 514<br>P.O. Box 6101<br>Newark, DE 19714-6101<br>Phone: [phone]<br>FAX: [phone] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | 9/24/97 |
| Device Name: | Cardiac Troponin-I (TROP) Calibrator |
| Classification Name: | Calibrator, secondary |
| Predicate Device: | Stratus® Cardiac Troponin-I Calibrators |

Device Description: The Cardiac Troponin-I (TROP) Calibrator is a five level frozen product with target concentrations of 0, 2, 8, 25, and 55 ng/mL containing cardiac troponin-l in a buffered bovine protein matrix. The kit consists of five vials; two at each level.

Intended Use: The TROP Calibrator is intended to be used to calibrate the TROP Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

## Comparison to Predicate Device:

| | Dimension® RxL TROP Calibrator | Stratus® Cardiac Troponin-I Calibrators |
|--------------|--------------------------------|-----------------------------------------|
| Intended Use | Calibrator | Calibrator |
| Analyte | cardiac troponin-l | cardiac troponin-l |
| Matrix | buffered bovine protein | buffered bovine protein |
| Form | frozen | frozen |
| Volume | 2.0 mL per vial | 2.0 mL per vial |
| Values | Assigned | Nominal |
| Levels | 5 levels | 6 levels |

Comments on Substantial Equivalence: Both the TROP Calibrator for the Dimension® RxL system and the Stratus® Cardiac Troponin-I Calibrators are manufactured using the same matrix and contain cardiac troponin-1 as the analyte source. Both products are intended to be used as calibrators for cardiac troponin-l assays.

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Conclusion: The TROP Calibrator for the Dimension® RxL system is substantially equivalent to the Stratus ® Cardiac Troponin-I Calibrators based on the comparison summarized on the previous page.

Rebecca S. Aycock

Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 9/24/97

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 20 1997

Rebecca S. Ayash . Regulatory Affairs and Compliance Manger Dade International, Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101

K973668 Re : Cardiac Troponin-I (TROP) Calibrator Requlatory Class: II Product Code: JIT September 24, 1997 Dated: Received: September 25, 1997

Dear Ms. Ayash:

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 general 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/dsmamain.html".

Sincerely yours,
Steven Gutman

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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## Indications Statement

Device Name: Cardiac Troponin-I (TROP) Calibrator

Indications for Use: The Cardiac Troponin-I 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.

Rebecca S. Ayersh

Rebecca S. Ayas Regulatory Affairs and Compliance Manager Date: 9/24/97

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K 973668
510(k) Number

**Division Sign-Off**

Office of Device Evaluation

- prescription use
(per 21 CFR 801.19)

- OVER-THE-COUNTER USE