(32 days)
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No
The description focuses on standard immunoassay technology and a fluorometric analyzer, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is described as an "in vitro diagnostic product" and an "in vitro diagnostic test" for measuring cardiac troponin I, which is used for diagnosis and risk stratification, not for providing direct therapy.
Yes
The device is described as an "in vitro diagnostic product" and an "in vitro diagnostic test" used for the "diagnosis and treatment of myocardial infarction."
No
The device description clearly states it is an "in vitro diagnostic product" and describes a "two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology" and an "optical system". These are hardware components and chemical processes, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states it is an "in vitro diagnostic product" and describes its use for measuring cardiac troponin I in plasma for the diagnosis and treatment of myocardial infarction and risk stratification. This clearly falls under the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description further reinforces this by calling it an "in vitro diagnostic test" and explaining the technology used to measure a substance in a biological sample.
N/A
Intended Use / Indications for Use
The TROP TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic product for the measurement of cardiac troponin I in heparinized plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Product codes
MMI
Device Description
The Cardiac Troponin I (TROP) TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic test for the measurement of cardiac troponin I. This troponin assay is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. The enzymatic rate of the bound fraction increases directly with the concentration of cardiac troponin I in the sample. The reaction rate is measured by an optical system that monitors the reaction rate via front surface fluorescence.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
A split sample comparison study was conducted between the two systems with the following results:
n: 211
Slope: 0.90
Intercept: 0.12
Correlation Coefficient: 0.988
Range of Samples: 0.0 - 43.30 ng/mL
Key Metrics
Correlation Coefficient: 0.988
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
1981098 DADE BEHRING
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 Cardiac Troponin I TestPak
Summary of Safety and Effectiveness
The Cardiac Troponin I (TROP) TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic test for the measurement of cardiac troponin I.
This troponin assay is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. The enzymatic rate of the bound fraction increases directly with the concentration of cardiac troponin I in the sample. The reaction rate is measured by an optical system that monitors the reaction rate via front surface fluorescence.
The cardiac troponin I assay performed with the TROP TestPak is substantially equivalent to the cardiac troponin I assay performed on the Dade Stratus® analyzer, which was cleared by the FDA through the 510(k) process. Both methodologies are processed on automated systems, use the same source antibodies and have a fluorometric detection system.
A split sample comparison study was conducted between the two systems with the following results:
| n | Slope | Intercept | Correlation
Coefficient | Range of
Samples |
|-----|-------|-----------|----------------------------|---------------------|
| 211 | 0.90 | 0.12 | 0.988 | 0.0 - 43.30 ng/mL |
Carolyn K. George
Carolyn K. George Regulatory Affairs and Compliance Manager
March 25, 1998
Date
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an emblem that features a stylized image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 27 1998
Carolyn K. George Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714
Re : K981098 Stratus® CS Cardiac Troponin I (TROP) TestPak Regulatory Class: II Product Code: MMI March 25, 1998 Dated: 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 The general controls provisions of the Act 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 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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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/dsmamain.html".
Sincerely yours,
Steven Litman
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
3
Stratus® CS Cardiac Troponin I (TROP) TestPak Device Name:
Indications for Use: The TROP TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic product for the measurement of cardiac troponin I in heparinized plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Carolyn K. George
Carolyn K. George Regulatory Affairs and Compliance Manager
March 25, 1998
Date
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Veronical Calvin for A Montgomery.
Division Sheriff
Division of Citin Devices 510(k) Number
510(k) Number
Division Sign-Off Office of Device Evaluation
prescription use
00000000