DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR

K983693 · Dade Behring, Inc. · JIT · Nov 4, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983693
• Device Name: DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Nov 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Cardiac Troponin-I (TROP) Calibrator is intended to be used to calibrate the Cardiac Troponin-I Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

Device Story

Dimension® RxL Cardiac Troponin-I (TROP) Calibrator is a five-level frozen product; contains native human troponin complex in buffered bovine protein matrix. Used to calibrate TROP method on Dimension® RxL clinical chemistry system with heterogeneous immunoassay module. Provides assigned target concentrations (0, 2, 9, 25, 55 ng/mL) to establish calibration curve for clinical chemistry analyzer. Used in clinical laboratory settings by trained laboratory personnel. Output is calibration data used by the analyzer to quantify cardiac troponin-I levels in patient samples; assists clinicians in diagnosing cardiac conditions.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Five-level frozen calibrator; matrix: buffered bovine protein; analyte: native human troponin-I complex; volume: 3.0 mL per vial; intended for use with Dimension® RxL clinical chemistry system heterogeneous immunoassay module.

Indications for Use

Indicated for calibration of the Cardiac Troponin-I assay on the Dimension® RxL clinical chemistry system. No specific patient population, age, or gender restrictions are defined for this in vitro diagnostic calibrator.

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

• Dimension® RxL Cardiac Troponin-I Calibrator (K973668)

Submission Summary (Full Text)

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**NOV 4 1998**

# DADE BEHRING

DADE BEHRING INC. 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 Behring 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: | 10/20/98 |
| Device Name: | Dimension® RxL Cardiac Troponin-I (TROP) Calibrator |
| Classification Name: | Calibrator, secondary |
| Predicate Device: | Dimension® RxL Cardiac Troponin-I Calibrator<br>(K973668) |

Device Description: Dimension® Cardiac Troponin-I (TROP) Calibrator is a five level frozen product with target concentrations of 0, 2, 9, 25, and 55 ng/mL containing native human troponin complex in a buffered bovine protein matrix. The kit consists of five vials; two at each level.

Intended Use: 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 (Modified) | Dimension® RxL TROP Calibrator | |
|-------------------------------------------|---------------------------------|-------------------------|
| Intended Use | Calibrator | Calibrator |
| Analyte | Native human troponin-I complex | Cardiac troponin-I |
| Matrix | Buffered bovine protein | Buffered bovine protein |
| Form | Frozen | Frozen |
| Volume | 3.0 mL per vial | 2.0 mL per vial |
| Values | Assigned | Assigned |
| Levels | 5 levels | 5 levels |

Comments on Substantial Equivalence: Modified Dimension® RxL Cardiac Troponin I Calibrator is equivalent to the Dimension® RxL Cardiac Troponin-I Calibrator currently

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marketed. Both products are manufactured using a buffered bovine protein matrix but differ in analyte source. Both products are intended to be used as calibrators for the Dimension® RxL Cardiac Troponin-I assay.

Conclusion: The modified Dimension® RxL Cardiac Troponin I Calibrator is substantially equivalent to the Dimension® RxL Cardiac Troponin-I Calibrator currently marketed by Dade Behring based on the comparison summarized above.

Rebecca S. Ayash

Rebecca Regulatory Affairs and Compliance Manager Date: 10/20/98

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its head turned to the left and its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.

NOV 4 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rebecca S. Ayash Regulatory Affairs and Compliance Manager DADE BEHRING, INC. Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101

Re: кавзеяз Dimension® RxL Cardiac Troponin-I (TROP) Trade Name: Requlatory Class: II Product Code: JIT Dated: October 20, 1998 Received: October 21, 1998

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral 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 misbrandinq 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 requlations 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 Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will yerify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 requlations.

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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 regulation (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/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

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Enclosure

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## Indications Statement

Device Name: Dimension® RxL Cardiac Troponin-1 (TROP) Calibrator

Indications for Use: The Cardiac Troponin-I (TROP) Calibrator is intended to be used to calibrate the Cardiac Troponin-I Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

Rebecca S. Ayash

Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 10/20/98

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Concurrence of CDRH, Office of Device Evaluation (ODE)

K 983693
510(k) Number

510(k) Number

Division Sign-Off
Office of Device Evaluation

prescription use