(101 days)
CARDIAC T ® Troponin T Rapid Assay
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No
The summary describes a rapid immunoassay based on a "sandwich" principle with a gold sol particle label, which is a standard biochemical detection method and does not mention or imply the use of AI or ML.
No
The device aids in diagnosis by detecting cardiac troponin T, but it does not directly treat or alleviate a medical condition.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for the qualitative determination of cardiac troponin T... [and] has been shown to aid in the diagnosis of acute myocardial infarction (injury)." This directly indicates its role in diagnosis.
No
The device description clearly indicates a physical assay that uses whole blood and a gold sol particle label, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative determination of cardiac troponin T in anticoagulated venous or arterial whole blood." This involves testing a biological sample (blood) outside of the body to gain information about a patient's health status.
- Device Description: The description details a "test principle is based on the dual monoclonal antibody 'sandwich' principle using a poly(streptavidan)-biotin capture system with a gold sol particle label." This describes a laboratory-based assay method used to analyze a biological sample.
- Sample Type: The test uses "anticoagulated venous or arterial whole blood," which is a biological specimen.
These characteristics are all hallmarks of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CARDIAC T Rapid Assay is intended for the qualitative determination of cardiac troponin T in anticoagulated venous or arterial whole blood. The measurement of cardiac troponin T has been shown to aid in the diagnosis of acute myocardial infarction (injury).
Product codes
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Device Description
The CARDIAC T ® Troponin T Rapid Assay (2nd generation) test principle is based on the dual monoclonal antibody "sandwich" principle using a poly(streptavidan)-biotin capture system with a gold sol particle label. The test is initiated by the addition of whole blood to the CARDIAC T Rapid Assay, which separates red blood cells from plasma.
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
Method Comparison: 335 individual patient results were compared between the the assays demonstrating agreement in 156 of 179 cases
Interfering substances: Evaluated for hemolysis, icterus, biotin, Intralipid and 31 common pharmaceutical compounds. No interference at the levels tested
Key Metrics
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Predicate Device(s)
We claim substantial equivalence to the currently marketed CARDIAC T ® Troponin T Rapid Assay.
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.
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510(k) Summary CARDIAC T® Troponin T Rapid Assay Modification
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| 1) Submitter name, address, contact | Boehringer Mannheim Corporation |
| 9115 Hague Rd. | |
| Indianapolis, IN 46250 | |
| (317) 845-2324 |
Contact Person: John D. Stevens
Date Prepared: October 29, 1996 |
| 2) Device name | Proprietary name: CARDIAC T ® Troponin T Rapid Assay
Common name: troponin test
Classification name: Immunoassay method, troponin subunit |
| 3) Predicate device | We claim substantial equivalence to the currently marketed CARDIAC T ® Troponin T Rapid Assay. |
| 4) Device Description | The CARDIAC T ® Troponin T Rapid Assay (2nd generation) test principle is based on the dual monoclonal antibody "sandwich" principle using a poly(streptavidan)-biotin capture system with a gold sol particle label. The test is initiated by the addition of whole blood to the CARDIAC T Rapid Assay, which separates red blood cells from plasma. |
| 5) Intended use | The CARDIAC T Rapid Assay is intended for the qualitative determination of cardiac troponin T in anticoagulated venous or arterial whole blood. The measurement of cardiac troponin T has been shown to aid in the diagnosis of acute myocardial infarction (injury). |
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510(k) Summary, CARDIAC T® Troponin T Rapid Assay Modification, Continued
The Boehringer Mannheim CARDIAC T® Troponin T Rapid Assay (2nd 6) Comparison generation) is substantially equivalent to other products in commercial to predicate device distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed CARDIAC To Troponin T Rapid Assay.
The following table compares the CARDIAC T® Troponin T Rapid Assay (2nd generation) with the predicate device, CARDIAC To Troponin T Rapid Assay. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device is provided in attachment 6.
Similarities:
| Feature | 2nd generation Rapid Assay | 1st generation Rapid Assay |
|---|---|---|
| Intended use | Aid in the diagnosis of acute | |
| myocardial infarction (injury) | Same | |
| Sample type | Whole blood containing | |
| EDTA or Heparin | Same | |
| Sample | ||
| volume | 130 - 160 µL | Same |
| Reaction test | ||
| principle | Dual monoclonal antibody | |
| "sandwich" principle | Same |
Differences:
| Feature | 2nd generation Rapid Assay | 1st generation Rapid Assay |
|---|---|---|
| antibodies | MAK M11-7 and MAK M-7 | MAK 1B10 and MAK M-7 |
| Cut - off | $\geq 0.08$ ng/mL | $\geq 0.20$ ng/mL |
| Read time | 15 - 30 minutes | 20 - 45 minutes |
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510(k) Summary, CARDIAC T ® Troponin T Rapid Assay
Modification, Continued
6) Comparison to predicate device, (cont.)
Performance Characteristics:
| Feature | 2nd generation Rapid Assay | 1st generation Rapid Assay |
|---|---|---|
| Cut-off | ≥0.08 ng/mL | ≥0.20 ng/mL |
| Method | ||
| Comparison | 335 individual patient results | |
| were compared between the | ||
| the assays demonstrating | ||
| agreement in 156 of 179 | ||
| cases | ||
| Interfering | ||
| substances | Evaluated for hemolysis, | |
| icterus, biotin, Intralipid and | ||
| 31 common pharmaceutical | ||
| compounds. No interference | ||
| at the levels tested | Evaluated for interference | |
| from hemolysis, icterus, | ||
| biotin, Intralipid and 31 | ||
| common pharmaceutical | ||
| compounds. No interference at | ||
| the levels tested |