K Number

Device Name

CARDIOQUANT TROPONIN I TEST

Manufacturer

SPECTRAL DIAGNOSTICS, INC.

Date Cleared

1999-10-04

(103 days)

Product Code

MMI

Regulation Number

862.1215

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 Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard immunoturbidometric assay based on chemical reactions and turbidity measurement, with no mention of AI or ML components.

Therapeutic

No.
The device is an in vitro diagnostic product used to measure cardiac troponin I, which aids in the diagnosis of heart disease. It does not perform any therapeutic function.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the CardioQuant™ Troponin I Test "is intended for use for as an in vitro diagnostic product."

SaMD (Software as a Medical Device)

The device description clearly outlines a hardware-based immunoturbidometric method involving latex particles, antibodies, and turbidity measurement at a specific wavelength (600mm). This indicates a physical, in vitro diagnostic test, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states:

"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."

This statement directly identifies the device as an in vitro diagnostic product.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

MMI

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

correlation coefficient was 0.87
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.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Dade-Behring Stratus® Troponin I Fluorometric Assay

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.

(a)
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.(b)
Classification. Class II.

Summary

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 .

References

Mehegan, J.P. And Tobacman, L.S. Cooperative interaction between troponin molecules bound to the cardiac thin filament. J.Biol.Chem. 266:966 (1991)
Ebashi,S., Ca2+ and the contractile proteins. J.Mol.Cell.Cardiol. 16:129 (1984)
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)

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)

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.

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 (770) 488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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

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:

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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