(28 days)
Not Found
No
The description details a standard immunoassay technology and data analysis performed by a microprocessor, with no mention of AI or ML.
No.
The device is an in vitro diagnostic product designed to measure cardiac troponin I, which is used in the diagnosis and risk stratification of myocardial infarction and acute coronary syndromes, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is "an in vitro diagnostic product for the measurement of cardiac troponin I in heparinized plasma" and that "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." This clearly indicates its use in diagnosing medical conditions.
No
The device description clearly details a physical test kit (TestPak) with wells, glass fiber paper, antibodies, and reagents, which are hardware components. While the analyzer has a microprocessor for data analysis, the core medical device being described in the TestPak is a physical in vitro diagnostic product.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The cardiac troponin I (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."
This statement directly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The cardiac troponin I (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 (comma separated list FDA assigned to the subject device)
MMI
Device Description
The TROP TestPak consists of a plastic cartridge with five wells and a small square of glass fiber paper embedded in it. The method utilizes a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody specifica for cardiac troponin I is added to the center portion of a square piece of glass fiber paper in the TROP TestPak. Sample is then added onto the paper where it reacts with the immobilized troponin antibody. After a short incubation, a conjugate consisting of enzyme-labeled antibody directed against a distinct antigenic site on the cardiac troponin I molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound antigen, forming an antibodyantigen-labeled antibody sandwich. The unbound, labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone of the TestPak. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of caridac troponin I in the sample. The reaction rate is measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
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 QC data collected supports the recommended change in QC frequency and indicates the change will not adversely affect performance of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Stratus® CS Cardiac Troponin I (TROP) TestPak (K981098)
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
§ 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
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.
| Submitter's Name: | Rebecca S. Ayash
Dade Behring Inc.
Building 500, Mailbox 514
P.O. Box 6101
Newark, DE 19714-6101 |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | 11/13/98 |
| Device Name: | Stratus® CS Cardiac Troponin I (TROP) TestPak |
| Classification Name: | Immunoassay Method, Troponin Subunit |
| Predicate Device: | Stratus® CS Cardiac Troponin I (TROP) TestPak (K981098) |
Device Description: The TROP TestPak consists of a plastic cartridge with five wells and a small square of glass fiber paper embedded in it. The method utilizes a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody specifica for cardiac troponin I is added to the center portion of a square piece of glass fiber paper in the TROP TestPak. Sample is then added onto the paper where it reacts with the immobilized troponin antibody. After a short incubation, a conjugate consisting of enzyme-labeled antibody directed against a distinct antigenic site on the cardiac troponin I molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound antigen, forming an antibodyantigen-labeled antibody sandwich. The unbound, labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone of the TestPak. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of caridac troponin I in the sample. The reaction rate is measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
This device was previously cleared under K981098. Subsequently, the product insert has been modified to change the recommended frequency of quality control from daily to weekly.
Intended Use: The cardiac troponin I (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.
1
Comparison to Predicate Device:
| Feature | Stratus CS® TROP (modified) | Stratus CS® MYO (K981098) |
|---|---|---|
| Principle of procedure | Two-site sandwich assay | Two-site sandwich assay |
| Type of measurement | Fluorometric | Fluorometric |
| Solid Phase | Glass fiber paper | Glass fiber paper |
| Sample Type | Heparinized plasma | Heparinized plasma |
| Monoclonal Antibodies | ||
| Tag/Capture | 2B1.9/2F6.6 | 2B1.9/2F6.6 |
| Recommended QC Frequency | At least once each week | At least daily |
| Intended Use | For the quantitative | |
| measurement of cardiac | ||
| troponin l | For the quantitative | |
| measurement of cardiac | ||
| troponin l | ||
| Indications for Use | For use in the diagnosis 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 | For use in the diagnosis 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 |
Comments on Substantial Equivalence: Both the assays are in vitro immunoassays with intended uses for the measurement of cardiac troponin I in heparinized plasma. The modified device differs from the device cleared under K981098 only in the recommended change in QC frequency in the product labeling.
Conclusion: The QC data collected supports the recommended change in QC frequency and indicates the change will not adversely affect performance of the device.
Reicca Sayph
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 11/13/98
2
2098 Gaither Road
Rockville MD 20850
Food and Drug Administration
Image /page/2/Picture/2 description: The image shows a partial view of a seal or emblem, likely associated with a government or organizational entity. The emblem features a stylized eagle or bird-like figure with its wings spread, rendered in a minimalist, line-art style. The text "DEPARTMENT OF HEALTH & HUMAN" is visible, suggesting the emblem belongs to a health or human services department. The text "USA" is also visible, indicating that the emblem is associated with the United States of America.
DEC 1 4 1998
Ms. Rebecca S. Ayash Regulatory Affairs and Compliance Manager Dade Behring Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101
Re : K984093 Stratus® CS Cardiac Troponin I (TROP) TestPak Trade Name: Regulatory Class: II Product Code: MMI Dated: November 13, 1998 Received: November 16, 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 qeneral 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.
3
Paqe 2
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 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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: Stratus® CS Cardiac Troponin I (TROP) TestPak
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.
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 11/13/98
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K984093
510(k) Number
Division Sign Off
Division Sign-Off Office of Device Eyaluation
prescription use