(50 days)
Not Found
No
The summary describes a standard in vitro diagnostic immunoassay for measuring cardiac troponin I. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic test used for measurement of a biomarker to aid in diagnosis and risk stratification, not for providing therapy.
Yes
The "Intended Use" states that the method "can be used as an aid in the diagnosis of myocardial infarction."
No
The device is an in vitro diagnostic test, which is a physical test kit (immunoassay) and not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The description explicitly states it is an "in vitro diagnostic test" and describes its use for measuring cardiac troponin I in plasma to aid in the diagnosis of myocardial infarction and risk stratification.
- Device Description: The device is described as an "in vitro immunoassay."
These points clearly indicate that the device is intended to be used outside of the body to examine specimens (in this case, heparinized plasma) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Stratus® CS Acute Care™ Troponin I method is an in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of myocardial infarction. Cardiac troponin I can also be used 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
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 2 4 2003
Summary of Safety and Effectiveness Information
This safety and effectiveness summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | George M. Plummer
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|--------------------------|----------------------------------------------------------------------------------|
| Date of Preparation: | October 31, 2003 |
| Name of Product: | Stratus® CS ™ Troponin I TestPak |
| FDA Classification Name: | Immunoassay Method, Troponin Subunit |
| Predicate Device: | Dade Behring Stratus® CS cTnI TestPak(K984093/K981098) |
Intended Use:
The Stratus® CS Acute Care™ Troponin I method is an in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of myocardial infarction. Cardiac troponin I can also be used as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Comparison to Predicate Device:
The Stratus® CS Acute Care™ Troponin I TestPak is substantially equivalent in intended use, principle and performance to the current Dade Behring Stratus® CS cTnI TestPak. Both assays are in vitro immunoassays with an intended use as an aid in the diagnosis of acute myocardial infarction and risk stratification of patients with acute coronary syndrome.
There are no formulation or design changes associated with the Stratus® CS cTnI TestPak labeling change. The two products are identical and use the same manufacturing processes. Only the insert sheets contain different information. The table on the next page summarizes the changes in the revised product insert sheet.
1
| Item | Revised Insert Sheet Change |
|---|---|
| Method Name | |
| (throughout insert sheet) | Stratus® CS Acute Care™ Troponin I |
| Test Steps | Clarification of steps performed automatically allowed removal of |
| Results section | |
| Interpretation of Results | 1. Added National Academy of Clinical Biochemistry statement |
- Added statement on results interpretation in conjunction with
medical history - Moved some statements from the Diagnosis of AMI section
- Added statements on institutions establishing own reference
interval and other conditions which can led to myocardial injury |
| Reference Interval | Presentation of 97.5th and 99th percentile results instead of the 95th
percentile |
| Risk Stratification | Added American College of Cardiology (ACC)/AHA definition for
short term risk of death/non-fatal MI |
| Diagnosis of AMI | 1. Added sensitivity/specificity graph - Added EU Society of Cardiology/ACC statement on MI
definition - Added functional sensitivity information at 99th percentile |
| Performance
Characteristics | Added plasma pool reproducibility data |
| Correlation Data | Added performance comparison versus Dade Behring Dimension®
clinical chemistry system |
| Recovery | Clarified titles in chart |
| Bibliography | Added references |
The source data used to support the insert sheet changes is listed below:
-
- The lower risk stratification concentration for 0.1ng/mL is based on recommendations from the American College of Cardiology (ACC), American Heart Association and multiple hospital clinical studies.
-
- Internal and external reference interval studies provided the stated 97.5th and 99th percentiles
-
- Low-end, functional sensitivity precision studies indicate a high sensitivity method
Conclusion:
The Stratus® CS Acute Care™ Troponin I TestPak is substantially equivalent in principle and performance to the current Dade Behring Stratus® CS cTnI TestPak
George M. Plummer Regulatory Affairs and Compliance Manager October 31, 2003
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human figures inside, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 4 2003
Mr. George M. Plummer Affairs & Compliance Manager Dade Behring, Inc. Chemistry/Immunochemistry Glasgow Business Community P.O. Box 6101 - Bldg. 500 Newark, DE 19714
K033487 Re:
Trade/Device Name: Stratus® CS Acute Care™ Troponin I TestPak Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: October 31, 2003 Received: November 21, 2003
Dear Mr. Plummer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications For Use Statement
510(k) Number (if known): K 033487
Device Name:
Stratus® CS Acute Care™ Troponin I TestPak
Indications for Use:
The Stratus® CS Acute Care™ Troponin I method is an in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of myocardial infarction. Cardiac troponin I can also be used as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) L Over-The-Counter Use Prescription Use OR (Optional Format 1-2-96) (Per 21 CRF 801.109) Division Sign-Off
Office of In Vitro Diagnost. J. J. Evaluation and Safety
510(k) 1033487