STRATUS CS CKMB CALPAK

K981097 · Dade Behring, Inc. · JIT · Apr 16, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981097
• Device Name: STRATUS CS CKMB 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 CKMB CalPak is an in vitro diagnostic product used to calibrate the CKMB 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 CKMB values.

Device Story

Stratus® CS CKMB CalPak is an in vitro diagnostic calibrator; liquid, buffered bovine protein matrix containing CKMB at ~135 ng/mL. Provided in a single-use plastic cartridge with reagent wells. Used in clinical laboratory settings to calibrate the CKMB method on the Stratus® CS STAT fluorometric analyzer. Establishes a point of reference for CKMB value determination; ensures accuracy of subsequent patient sample testing. Operated by laboratory personnel.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid, buffered bovine protein matrix; CKMB concentration ~135 ng/mL. Single-use plastic cartridge form factor. Designed for use with Stratus® CS STAT fluorometric analyzer.

Indications for Use

Indicated for use as an in vitro diagnostic calibrator for the CKMB method on the Stratus® CS STAT fluorometric analyzer to establish a point of reference for CKMB value determination.

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® CKMB calibrator

Submission Summary (Full Text)

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K981097

## DADE BEHRING

APR 1 6 1998

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 CKMB CalPak

## Summary of Safety and Effectiveness

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

The CKMB CalPak is a liquid, buffered bovine protein matrix product with CKMB at an approximate concentration of 135 ng/mL. The CalPak is a plastic cartridge which contains the calibrator material in reagent wells. It is a single-use product.

The CKMB CalPak is substantially equivalent to the Stratus® CKMB calibrator as they are both intended to be used as calibrators for similar CKMB 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 1 6 1998

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

Re: K981097 Stratus® CS CKMB CalPak Regulatory Class: II Product Code: JIT Dated: March 24, 1998 Received: March 26, 1998

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 The general controls provisions of the Act 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. ਦੇ 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 requlatory 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 regulations.

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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 leqally 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 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: Stratus® CS CKMB CalPak

Indications for Use: The CKMB CalPak is an in vitro diagnostic product used to calibrate the CKMB 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 CKMB values.

Carolyn K. George

Carolyn K. George Regulatory Affairs and Compliance Manager

March 24, 1998

Date

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Concurrence of CDRH, Office of Device Evaluation (ODE)

K981097

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510(k) Number

Division Sign-Off Office of Device Evaluation

prescription use

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