STRATUS CS MYO CALPAK

K981101 · Dade Behring, Inc. · JIT · Apr 15, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981101
• Device Name: STRATUS CS MYO CALPAK
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Apr 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The MYO CalPak is an in vitro diagnostic product used to calibrate the myoglobin 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 myoglobin values.

Device Story

The Stratus® CS MYO CalPak is a single-use, liquid, buffered bovine protein matrix containing myoglobin at approximately 850 ng/mL. It is housed in a plastic cartridge with reagent wells. The device is used in a clinical laboratory setting to calibrate the myoglobin assay on the Stratus® CS STAT fluorometric analyzer. By establishing a point of reference for the analyzer, it ensures the accuracy of myoglobin measurements, which are used by clinicians to assess patient myoglobin levels.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid, buffered bovine protein matrix; myoglobin concentration ~850 ng/mL; single-use plastic cartridge with reagent wells; designed for use with Stratus® CS STAT fluorometric analyzer.

Indications for Use

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

Submission Summary (Full Text)

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# 1981101 DADE BEHRING

APR 1 5 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 MYO CalPak

### Summary of Safety and Effectiveness

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

The MYO CalPak is a liquid, buffered bovine protein matrix product with myoglobin at an approximate concentration of 850 ng/mL. The CalPak is a plastic cartridge which contains the calibrator material in reagent wells. It is a single-use product.

The MYO CalPak is substantially equivalent to the Stratus® myoglobin calibrator as they are both intended to be used as calibrators for similar myoglobin methods.

Carolyn K. George

Carolyn K. George Regulatory Affairs and Compliance Manager

March 25, 1998

Date

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three overlapping profiles, suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 5 1998

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

Re: K981101 Stratus® CS MYO CalPak Regulatory Class: II Product Code: JIT Dated: March 25, 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 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. ਰ 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 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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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/dsmamain.html".

Sincerely yours,
Steven Bitman

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 MYO CallPak

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

Carolyn K. George
Carolyn K. George

Regulatory Affairs and Compliance Manager

March 25, 1998
Date

Date

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K 98/1101

510(k) Number

Division Sign-Off

Office of Device Evaluation

prescription use

0000000