(68 days)
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No
The summary describes a fluorometric enzyme immunoassay and calibrators, which are laboratory-based diagnostic tools, and explicitly states "Not Found" for mentions of AI, DNN, or ML. The predicate device is the same technology.
No.
The device is used for risk stratification (diagnosis/prognosis), not for treating a condition.
Yes
Explanation: The device is used to diagnose patients with acute coronary syndromes.
No
The device description explicitly states "Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay and Stratus® Cardiac Troponin-I Calibrators," which are hardware components (reagents and calibrators) used in a laboratory setting, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Device Description: It explicitly mentions "Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay and Stratus® Cardiac Troponin-I Calibrators." Immunoassays are laboratory tests performed on biological samples (like blood) to detect and measure specific substances. This is a hallmark of IVD devices.
- Intended Use / Indications for Use: The intended use is to "aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality." This involves analyzing a biological sample (likely blood, given the Troponin-I assay) to provide information about a patient's health status and risk. This is a diagnostic purpose.
- Predicate Device: The predicate device is the "Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay and Stratus® Cardiac Troponin-I Calibrators" (K951890). This is a known IVD device used for measuring cardiac troponin-I in biological samples. The proposed device is a modification of this existing IVD.
The fact that it's a fluorometric enzyme immunoassay designed to measure a biomarker (Cardiac Troponin-I) in a biological sample for diagnostic purposes (risk stratification) clearly places it within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The proposed device is limited to modifications in the indications for use. The additional indication for use is to 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)
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Device Description
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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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
FEB 10 1997
510(k) Summary of Safety and Effectiveness Information Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay and Stratus® Cardiac Troponin-I Calibrators December 3, 1996
Dade International Inc. 2173 N.W. 99th Avenue Miami, FL 33172 Contact Person: Radha Goolabsingh at 305-392-5621 or by facsimile at 305-392-5622.
Trade or Proprietary Name: Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay and Stratus® Cardiac Troponin-I Calibrators
| Common or Usual Name: | Troponin-I Test System |
|---|---|
| Classification Name: | None |
| Registration Number: | Manufacturer |
| Dade International Inc. | |
| 2173 N.W. 99th Avenue | |
| Miami, FL 33172 | |
| (formerly at 9750 N.W. 25 Street, Miami, FL 33172) | |
| 1025506 |
Dade International Inc.
1851 Delaware Parkway
Miami, Florida 33125
1017272 |
The proposed Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay and Stratus® Cardiac Troponin-I Calibrators is substantially equivalent in intended use and technological characteristics to the Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay and Stratus® Cardiac Troponin-I Calibrators, manufactured by Dade International Inc., Miami, FL, previously cleared under Document Control No., K951890. The proposed device is limited to modifications in the indications for use. The additional indication for use is to aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.