OPUS TROPONIN I CALIBRATOR

K991176 · Dade Behring, Inc. · JIT · Jul 1, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991176
• Device Name: OPUS TROPONIN I CALIBRATOR
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jul 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

For calibration of the Opus™ Troponin I assay used for the quantitative measurement of cardiac troponin I in human serum and heparinized plasma.

Device Story

Opus™ Troponin I Calibrator is a six-level frozen in vitro diagnostic product; contains native human troponin complex in buffered bovine protein matrix. Used in clinical laboratory settings to calibrate Opus™ Troponin I assay test modules. Provides assigned concentration values (0, 2, 8, 18, 25, 30, 55 ng/mL) to establish calibration curves for quantitative measurement of cardiac troponin I in human serum and heparinized plasma samples. Enables accurate clinical assessment of cardiac troponin levels by healthcare providers.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Six-level frozen liquid calibrator; contains native human troponin complex in buffered bovine protein matrix. Designed for use with Opus™ Troponin I assay test modules.

Indications for Use

Indicated for the calibration of Opus™ Troponin I Test Modules for the quantitative measurement of cardiac troponin I in human serum and heparinized plasma.

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 Troponin I Calibrator

Submission Summary (Full Text)

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K991176

### JUL - 1 1999

# 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 |
|----------------------|--------------------------------------|
| | Dade Behring Inc. |
| | Building 500, Mailbox 514 |
| | P.O. Box 6101 |
| | Newark, DE 19714-6101 |
| | Phone: [phone] |
| | FAX: [phone] |
| Date of Preparation: | 4/6/99 |
| Device Name: | Opus™ Troponin Calibrator |
| Classification Name: | Calibrator, secondary |
| Predicate Device: | Dimension® RxL Troponin I Calibrator |

Device Description: Opus™ Troponin I Calibrator is a six level frozen product with target concentrations of 0, 2, 8, 18, 25, 30, and 55 ng/mL containing native human troponin complex in a buffered bovine protein matrix. The kit consists of six vials packaged as one set.

Intended Use: For calibration of the Opus™ Troponin I assay used for the quantitative measurement of cardiac troponin I in human serum and heparinized plasma.

#### Comparison to Predicate Device:

| | Opus™ Troponin I Calibrator | Dimension® RxI. Troponin I Calibrator |
|--------------|-------------------------------|---------------------------------------|
| Intended Use | calibrator | calibrator |
| Analyte | native human troponin complex | native human troponin complex |
| Matrix | buffered bovine protein | buffered bovine protein |
| Form | frozen | frozen |
| Volume | 1.0 mL per vial | 3.0 mL per vial |
| Values | assigned | assigned |
| Levels | 6 levels | 5 levels |

Comments on Substantial Equivalence: Both the Opus™ Troponin I Calibrator and the Dimension® RxL Troponin I Calibrator are manufactured using the same matrix and contain native human troponin complex as the analyte source. Both products are intended to be used as calibrators for cardiac troponin I assays.

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Conclusion: The Opus™ Troponin I Calibrator is substantially equivalent to the Dimension® RxL Troponin I Calibrator based on the comparison summarized on the previous page.

Rebecca S. Ayash

Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 4/6/99

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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 is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three stylized human profiles facing right, layered on top of each other. The profiles are black against a white background.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL - 1 1999

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

Re: K991176

> Trade Name: Opus™ Troponin I Calibrator Regulatory Class: II Product Code: JIT Dated: June 11, 1999 Received: June 15, 1999

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, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, 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 verify such assumptions. Failure to comply with the GMP regulation 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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#### Page 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 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 vours.

Steven Putman

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

## K991176

Device Name: Opus™ Troponin I Calibrator

Indications for Use: The Opus™ Troponin I Calibrator is an in vitro diagnostic product intended to be used to calibrate Opus™ Troponin I Test Modules.

Stan Cooper
(Division Sign-Off)

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

Rebecca S. Apsh

Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 4/6/99

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K991176

510(k) Number

Division Sign-Off Office of Device Evaluation

Prescription Use