MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST

K982679 · Spectral Diagnostics, Inc. · DDR · Oct 7, 1998 · Immunology

Device Facts

• Record ID: K982679
• Device Name: MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST
• Applicant: Spectral Diagnostics, Inc.
• Product Code: DDR · Immunology
• Decision Date: Oct 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5680
• Device Class: Class 2

Intended Use

The Multiquant® Quantitative Myoglobin Test is intended for use for as an in vitro diagnostic product to measure by immunochemical techniques the myoglobin ( an oxygen storage protein found in muscle) in serum and plasma. Measurement of myoglobin aids in the rapid diagnosis of heart disease.

Device Story

The Multiquant® Quantitative Myoglobin Test is an automated latex immunoturbidometric assay used in clinical laboratory settings. It processes serum or plasma samples by combining them with assay buffer and monoclonal/polyclonal antibodies covalently bound to polystyrenesupercarboxylated latex particles. Myoglobin in the specimen crosslinks the latex beads, increasing solution turbidity. The device measures this turbidity at 600nm; the signal is proportional to myoglobin concentration. Healthcare providers use these quantitative results to assist in the early diagnosis and monitoring of acute myocardial infarction (AMI). By detecting elevated myoglobin levels, which typically rise 2-3 hours post-symptom onset, the test facilitates timely clinical decision-making for patients presenting with cardiac symptoms.

Clinical Evidence

Bench testing only. Methods correlation study against the predicate Stratus® Myoglobin Fluorometric Assay (N=172) yielded a correlation coefficient of 0.99 and a regression equation of y = 1.04x + 0.0 over a range of 7.6 to 496.3 ng/mL. Precision testing reported within-run precision of 3.59% and 2.03%, and between-run precision of 6.48% and 2.74% for samples containing 32.08 mg/mL and 288.72 mg/mL myoglobin, respectively.

Technological Characteristics

Automated latex immunoturbidometric assay. Utilizes monoclonal and polyclonal antibodies bound to polystyrenesupercarboxylated latex particles. Measurement principle: turbidity increase measured at 600nm proportional to myoglobin concentration. Designed for serum and plasma analysis.

Indications for Use

Indicated for the measurement of myoglobin in serum and plasma to aid in the rapid diagnosis of heart disease in patients suspected 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

• Dade-Behring Stratus® Myoglobin Fluorometric Assay

Submission Summary (Full Text)

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## OCT 7 1998

L982679

Spectral Diagnostics Inc. Multiquant® Quantitative Myoglobin Test 510(k) Notification

## PREMARKET NOTIFICATION 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Myoglobin is an oxygen-binding heme protein with a molecular weight of 17,800 daltons. normally found in cardiac and skeletal tissue which serves as an oxygen-storing pigment necessary for a high level of oxidative phosphorylation. It constitutes about 2% of the total muscle protein and is located in the cell. Cell injury or death during acute myocardial infarction (AMI) has been shown to release myoglobin into the blood. Blood myoglobin reaches the upper limit of normal approximately 2-3 hours after the onset of symptoms. The concentration of myoglobin has been shown to peak at 9-12 hours and to return to normal within 24-36 hours after an AMI.1-2 A number of reports have been published detailing the clinical utility of myoglobin in the early diagnosis and monitoring of AMI.36

The Spectral Diagnostics Multiquant® Quantitative Myoglobin Test is an automated latex immunoturbidometric method. The test utilizes a monoclonal antibody and a polyclonal antibody each covalently bound to polystyrenesupercarboxylated latex particles. When serum or plasma and assay buffer are combined with the latex particles, myoglobin in the specimen crosslinks adjacent latex beads and produces an increase in the turbidity of the solution. The turbidity, measured at 600nm, is proportional to the concentration of myoglobin present in the serum or plasma.

The safety and effectiveness of the Spectral Diagnostics Multiquant® Quantitative Myoglobin Test is demonstrated by its substantial equivalency to Dade-Behring Stratus® Myoglobin Fluorometric Assay. Both tests for myoglobin are used to measure myoglobin in serum and plasma and both use immochemical technologies. In a methods correlation against the Stratus® Myoglobin Fluorometric Assay the correlation coefficient was 0.99 and a regression equation of Multiquant® = 1.04(Stratus ) + 0.0, N= 172, r = 0.99 , range = 7.6 to 496.3 ng/mL was obtained with serum samples. Within run precision and between run precision were 3.59% and 6.48% respectively for a sample containing 32.08 mg/mL myoglobin and 2.03% and 2.74% respectively for a sample containing 288.72 mg/mL.

References

1. Chapelle, J.P. et al., Serum myoglobin determinations in the assessment of acute myocardial infarction. Eur.Heart Journal. 3:122 (1982)

2. Kagen, L. et al., Myoglobinemia following myocardial infarction. Am.J.Med. 58:177 (1975)

3. Ohman, E.M. et al., Early detection of acute myocardial infarction: Additional diagnostic information from serum concentrations of myoglobin in patients without ST elevation. Br.Heart J. 63:335 (1990)

4. Mair, J. et al., Rapid diagnosis of myocardial infarction by immunoturbidimetric myoglobin measurement. Lancet 337:1343 (1991)

5. Tucker, J.F., et al., Value of serial myoglobin levels in the early diagnosis of patients admitted for acute myocardial infarction, Ann.Emerg.Med. 24:704 (1994)

6. Gibler, W.B., et al. Myoglobin as an early indicator of acute myocardial infarction. Ann.Emerg.Med. 16:851 (1987)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 7 1998

Joseph Laurino, Ph.D. Director of Operations Spectral Diagnostics Inc. 135-2 The West Mall Toronto, Ontario Canada M9C 1C2

Re : K982679 Multiquant® Quantitative Myoglobin Test Regulatory Class: II Product Code: DDR Dated: July 29, 1998 Received: July 31, 1998

Dear Dr. Laurino:

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. 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 Druq 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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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 Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Spectral Diagnostics Inc. Multiquant® Quantitative Myoglobin Test 510(k) Notification

K982679

510(k) Number (if Known) : Not Known at this time

Device Name : Multiquant® Quantitative Myoglobin Test

## Indications for Use:

The Multiquant® Quantitative Myoglobin Test is intended for use for as an in vitro diagnostic product to measure by immunochemical techniques the myoglobin ( an oxygen storage protein found in muscle) in serum and plasma. Measurement of myoglobin aids in the rapid diagnosis of heart disease.

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

Image /page/3/Figure/7 description: The image shows a form titled "Concurrence of CDRH, Office of Device Evaluation (ODE)". The form has two options: "Prescription Use (Per 21 CFR 801.109)" and "Over-The Counter Use (Optional Format 1-2-96)". The prescription use option has been selected. There is a signature at the bottom of the form labeled "(Division Sign-Off)" and "Division of Clinical Laboratory Devices".

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K982679