STRATUS CS TROP CALPAK

K981100 · Dade Behring, Inc. · JIT · Apr 16, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981100
• Device Name: STRATUS CS TROP CALPAK
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Apr 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The TROP CalPak is an in vitro diagnostic product used to calibrate the cardiac troponin I method on the Stratus® CS STAT fluorometric analyzer. This calibrator is a device intended to establish a point of reference that is used in the determination of troponin I values.

Device Story

The Stratus® CS TROP CalPak is a calibration product for the Stratus® CS STAT fluorometric analyzer. It consists of a buffered bovine protein matrix containing cardiac troponin I at approximately 45 ng/mL, housed in a plastic cartridge with reagent wells. The device is used in a clinical laboratory setting to calibrate the analyzer's cardiac troponin I assay. By establishing a reference point for troponin I values, the calibrator ensures the accuracy of the analyzer's measurements, which are used by clinicians to assess cardiac health and support clinical decision-making regarding cardiac events.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Buffered bovine protein matrix containing cardiac troponin I (approx. 45 ng/mL). Form factor is a plastic cartridge containing reagent wells. Designed for use with the Stratus® CS STAT fluorometric analyzer.

Indications for Use

Indicated for use as an in vitro diagnostic calibrator for the cardiac troponin I method on the Stratus® CS STAT fluorometric analyzer to establish a reference point for determining troponin I values.

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® troponin I calibrator

Submission Summary (Full Text)

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# 1981100

## APR 16 1998

# DADE BEHRING

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

#### Stratus® CS TROP CalPak

### Summary of Safety and Effectiveness

The Stratus® CS TROP CalPak is an in vitro diagnostic product used to calibrate the cardiac troponin I method on the Stratus® CS STAT fluorometric analyzer.

The TROP CalPak is a buffered bovine protein matrix product with cardiac troponin I at an approximate concentration of 45 ng/mL. The CalPak is a plastic cartridge which contains the calibrator material in reagent wells.

The TROP CalPak is substantially equivalent to the Stratus® troponin I calibrator as they are both intended to be used as calibrators for similar cardiac troponin I methods.

Carolyn K. George

Carolyn K. George Regulatory Affairs and Compliance Manager

March 24, 1998

Date

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR | 6 1998

Carolyn K. George . Requlatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714

K981100 Re : Stratus® CS TROP CalPak Regulatory Class: II Product Code: JIT Dated: March 24, 1998 March 26, 1998 Received:

Dear Ms. George:

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 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 your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ 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 Druq 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 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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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/dsmamain.html".

sincerely yours,
Steven Sitman

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: Dade Behring TROP CalPak

Indications for Use: The TROP CalPak is an in vitro diagnostic product used to calibrate the cardiac troponin I method on the Stratus® CS STAT fluorometric analyzer. This calibrator is a device intended to establish a point of reference that is used in the determination of troponin I values.

Carolyn K. George

Carolyn K. George Regulatory Affairs and Compliance Manager

March 24, 1998

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Date

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Concurrence of CDRH, Office of Device Evaluation (ODE)

K981/100

510(k) Number

Division Sign-Off, Office of Device Evaluation

prescription use

Division Sign Off

(Division Sign-Off)
DivicLaboratory,
510(k) Number
K981100

0000006