MYOGLOBIN FLEX REAGENT CARTRIDGE

K984191 · Dade Behring, Inc. · DDR · Dec 10, 1998 · Immunology

Device Facts

• Record ID: K984191
• Device Name: MYOGLOBIN FLEX REAGENT CARTRIDGE
• Applicant: Dade Behring, Inc.
• Product Code: DDR · Immunology
• Decision Date: Dec 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5680
• Device Class: Class 2

Intended Use

The Myoglobin (MYO) method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is used to quantitatively measure myoglobin (MYO) in human serum and plasma as an aid in the rapid diagnosis of acute myocardial infarction.

Device Story

The Myoglobin Flex™ reagent cartridge is an in vitro diagnostic assay for use on the Dimension® RxL clinical chemistry system. It utilizes a one-step sandwich enzyme immunoassay principle. Patient serum or plasma samples are incubated with chromium dioxide particles coated with myoglobin-specific monoclonal antibodies and a conjugate reagent consisting of β-galactosidase-labeled monoclonal antibodies. A particle/myoglobin/conjugate sandwich forms; unbound components are removed via magnetic separation and washing. The bound β-galactosidase catalyzes the hydrolysis of the chromogenic substrate chlorophenol red-β-d-galactopyranoside (CPRG) into chlorophenol red (CPR). The rate of color change, measured at 577nm, is directly proportional to the myoglobin concentration in the sample. The device is intended for use in clinical laboratory settings to assist healthcare providers in the rapid diagnosis of acute myocardial infarction.

Clinical Evidence

Clinical performance was evaluated via a split-sample comparison between the Dimension® RxL MYO method and the Stratus® Myoglobin assay. Testing involved 204 clinical patient samples with concentrations ranging from 10 to 1000 ng/mL. Results showed a correlation coefficient of 0.992, a slope of 1.04, and an intercept of -4.15 ng/mL.

Technological Characteristics

Sandwich format monoclonal antibody immunoassay. Solid support: chromium dioxide particles. Detection: colorimetric rate measurement at 577 nm and 700 nm. Energy source: Dimension® RxL system instrumentation. Connectivity: integrated into the Dimension® RxL clinical chemistry system.

Indications for Use

Indicated for the quantitative measurement of myoglobin in human serum and plasma to aid in the rapid diagnosis of acute myocardial infarction.

Regulatory Classification

Identification

A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

Predicate Devices

• Stratus® Myoglogobin Fluorometric Enzyme Immunoassay

Submission Summary (Full Text)

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#### DADE BEHRING INC. P O. Box 6101 Newark DE 19714

# Dade Behring

### 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.

Rebecca S. Ayash Submitter's Name: Dade Behring Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark, DE 19714-6101

Date of Preparation: 11/20/98

Device Name: Myoglobin Flex™ reagent cartridge

Classification Name: Myoglobin Immunological Test System

Predicate Device: Stratus® Myoglogobin Fluorometric Enzyme Immunoassay

Device Description: The MYO method for the Dimension® RxL system with the heterogeneous immunoassay module is a one-step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles (CrO-) coated with monoclonal antibodies specific for myoglobin and conjugate reagent (ß-galactosidase labeled monoclonal antibodies specific for myoglobin). A particle/MYO/coniugate sandwich forms during the incubation period. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ß-galactosidase is combined with the chromogenic substrate chlorophenol redß-d-galactopyranoside (CPRG) and catalyzes the hydrolysis of CPRG to the chromophore, chlorophenol red (CPR). The concentration of MYO present in the patient sample is directly proportional to the rate of color change measured at 577nm due to formation of CPR.

Intended Use: The Myoglobin (MYO) method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is used to quantitatively measure myoglobin (MYO) in human serum and plasma as an aid in the rapid diagnosis of acute myocardial infarction.

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#### Comparison to Predicate Device:

| ltem | Dimension® RxL MYO | Stratus® Myoglobin |
|---------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Technology | Sandwich format monoclonal<br>antibody immunoassay | Sandwich format monoclonal<br>antibody immunoassay |
| Detection | Colorimetric rate measurement<br>at 577 nm and 700nm | Front surface fluorometry<br>measurement |
| Solid Support | Chrome | Glass fiber paper |
| Specimen Type | Serum or plasma | Serum or plasma |
| Intended Use | For the quantitative<br>determination of myoglobin in<br>serum and plasma | For the quantitative<br>determination of myoglobin in<br>serum and plasma |
| Indications for Use | To aid in the rapid diagnosis of<br>acute myocardial infarction | To aid in the rapid diagnosis of<br>acute myocardial infarction |

Comments on Substantial Equivalence: Split sample comparison between the MYO method on the Dimension® RxL system and the Stratus® Myoglobin assay gave a correlation coefficient of 0.992, slope of 1.04, and an intercept of -4.15 ng/mL when tested with 204 clinical patient samples ranging from 10 -- 1000 ng/mL.

Conclusion: The MYO Method for the Dimension® RxL system with the heterogeneous immunoassay module is substantially equivalent in principle and performance to the Stratus ® Myoglobin assay based on the split sample comparison summarized above.

Rebecca S. Ayash

Rebecca S. Avash Regulatory Affairs and Compliance Manager Date: 11/20/98

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 0 1998

Ms. Rebecca Ayash Requlatory Affairs & Compliance Manager Dade Behring Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714

K984191 Re : Myoglobin Flex Reagent Cartridge Trade Name: Requlatory Class: II Product Code: DDR Dated: November 20, 1998 Received: November 23, 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, 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. 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 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 regulations.

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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 requlation (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 requlation 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 Sutman

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: Myoglobin (MYO) Flex™ reagent cartridge

Indications for Use: The MYO method for the Dimension® RxL with the heterogeneous immunoassay module is a device used to quantitatively measure myoglobin in human serum and plasma as an aid in the rapid diagnosis of acute myocardial infarction.

Rebecca S. Cupsh

Rebecca S. Avash Regulatory Affairs and Compliance Manager Date: 11/20/98

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K984191
510(k) Number

At. An Awm

ision Sian-Off Office of Device Evaluation

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