CARDIOQUANT TROPONIN I TEST

K992127 · Spectral Diagnostics, Inc. · MMI · Oct 4, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992127
• Device Name: CARDIOQUANT TROPONIN I TEST
• Applicant: Spectral Diagnostics, Inc.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Oct 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The CardioQuant™ Troponin I Test is intended for use for as an in vitro diagnostic product to measure by immunochemical techniques the cardiac troponin I in serum and plasma. Measurement of troponin I aids in the rapid diagnosis of heart disease.

Device Story

CardioQuant™ Troponin I Test is an automated latex immunoturbidometric assay. Input: serum or plasma samples combined with assay buffer. Mechanism: monoclonal and polyclonal antibodies bound to polystyrene supercarboxylated latex particles cross-link with troponin I in the specimen, increasing solution turbidity. Output: turbidity measured at 600nm, proportional to troponin I concentration. Used in clinical laboratory settings to assist healthcare providers in diagnosing acute myocardial infarction (AMI) by detecting elevated troponin I levels, which typically rise 4-6 hours post-chest pain onset and remain elevated for up to 14 days.

Clinical Evidence

Bench testing only. Method correlation study against the Stratus® Troponin I Fluorometric Assay (N=281, range 0-35.4 ng/mL) yielded a correlation coefficient of 0.87 and regression equation of CardioQuant™ = 0.18(Stratus) + 0. Within-assay precision was 4.0% at 5.3 ng/mL and 2% at 16.7 ng/mL. Total assay precision was 4.7% at 5.3 ng/mL and 1.4% at 16.7 ng/mL.

Technological Characteristics

Automated latex immunoturbidometric assay. Reagents consist of monoclonal and polyclonal antibodies covalently bound to polystyrene supercarboxylated latex particles. Measurement performed via turbidimetry at 600nm. Designed for use with serum and plasma specimens.

Indications for Use

Indicated for the measurement of cardiac troponin I in serum and plasma to aid in the diagnosis of heart disease, including acute myocardial infarction.

Regulatory Classification

Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Predicate Devices

• Dade-Behring Stratus® Troponin I Fluorometric Assay

Submission Summary (Full Text)

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Spectral Diagnostics Inc. CardioQuant™ Troponin I Test 510(k) Notification

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

Troponin I (TnI) is part of the troponin complex which, together with tropomyosin, forms the main component that regulates the Cat2-sensitive ATP-ase activity of actomyosin in striated muscle (skeletal and cardiac)'. Different isoforms of TnI exist in the skeletal and cardiac muscles (sTnI and cTnl, respectively) with distinct immunologic epitopes that allow the production of cardiacspecific Tal antibodies . Cardias troponio I has been established as a useful tool in the diagnosis of acute myocardial infarction (AMI)35. Cell injury from AMI has been shown to result in a level of blood troponin I above the upper limit of normal in approximately 4 to 6 hours after the onset of chest pain. Maximum concentrations are reached at 24 to 48 hours with the levels of troponin I remaining elevated for up to 14 days .

The Spectral Diagnostics CardioQuant 1 Troponin 1 Test is an automated latex immunoturbidometric method. The test utilizes monoclonal and polyclonal antibodies each covalently bound to polystyrene supercarboxylated latex particles. When serum or plasma and assay buffer are combined with the latex particles, troponin I in the specimen cross-links adjacent latex beads and produces an increase in the turbidity of the solution. The turbidity, measured at 600mm, is proportional to the concentration of troponin I present in the serum or plasma.

The safety and effectiveness of the Spectral Diagnostics CardioQuant™ Troponin I Test is demonstrated by its substantial equivalency to Dade-Behring Stratus® Troponin I Fluorometric Assay. Both tests for troponin I are used to measure the cardiac marker in serum and plasma and both use immunochemical technologies. In a methods correlation against the Stratus® Troponin I Fluorometric Assay the correlation coefficient was 0.87 and the regression equation of CardioQuant™ = 0.18( Stratus ) + 0, N= 281, range = 0 to 35.4 ng/mL. was obtained with serum samples. Within assay precision and total assay precision were 4.0 % and 4.7% respectively for a sample containing 5.3 ng/mL troponin I and 2 % and 1.4 % respectively for a sample containing 16.7 ng/mL.

#### References

1. Mehegan, J.P. And Tobacman, L.S. Cooperative interaction between troponin molecules bound to the cardiac thin filament. J.Biol.Chem. 266:966 (1991)

2. Ebashi,S., Ca2+ and the contractile proteins. J.Mol.Cell.Cardiol. 16:129 (1984)

3. Bodor, S.G., et al., Development of monoclonal antibody for an assay of cardiac troponin I and preliminary results in suspected cases of myocardial infarction. Clin. Chem. 38:2203 (1992) 4. Adams, J.E., et al, Biochemical markers of myocardial injury. Is MB creatin kinase the choice

for the 1990's. Circulation 88:750 (1993)

5. Hamm, C.W., Cardiac-specific Troponins in Acute Coronary Syndromes, in Heart Disease, a textbook of Cardiovascular Medicine, ed. Braunwald, E. ,W.B. Saunders Co. Update 3 (1977) 6. Hamm, C.W., et al., Emergency room triage of patients with acute chest pain by means of rapid testing for cardiac troponin T or troponin I. New Eng.J.Med. 337:1648 (1997)

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 4 1999

Spectral Diagnostics Inc. c/o Francee S. Boches, Ph.D. Boches Consulting 5550 N.W. 102 Place Miami, Florida 33178

K992127 Re:

> Trade Name: Cardioquant Troponin I Test Regulatory Class: II Product Code: MMI Dated: September 9, 1999 Received: September 9, 1999

Dear Dr. Boches:

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 Regulations, 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 regulatory 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/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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Spectral Diagnostics Inc. CardioQuant™ Troponin I Test 510(k) Notification

# 14992127

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

Device Name : CardioQuant™ Troponin I Test

### Indications for Use:

The CardioQuant™ Troponin I Test is intended for use for as an in vitro diagnostic product to measure by immunochemical techniques the cardiac troponin I in serum and plasma. Measurement of troponin I aids in the rapid diagnosis of heart disease.

Decan Cooper

(Division Sign-Off)
Division of Clinical La
510(k) Number 1992127

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

a series and service and services and services and services and segment and the sent and the sent and the sent of the sent of the second the second the second the second the

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Over-The Counter Use (Optional Format 1-2-96)

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