(101 days)
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).
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.
Here's a summary of the acceptance criteria and the study details for the CARDIAC T® Troponin T Rapid Assay Modification, based on the provided text:
Acceptance Criteria and Device Performance
The core of the acceptance criteria for the modified device (2nd generation) is its substantial equivalence to the predicate device (1st generation) in terms of intended use, sample type, sample volume, and reaction principle. The key performance characteristic that serves as an acceptance criterion is the agreement in method comparison.
| Acceptance Criteria | Reported Device Performance (2nd generation CARDIAC T® Troponin T Rapid Assay) |
|---|---|
| Method Comparison Agreement with 1st generation Rapid Assay | Agreement in 156 of 179 cases (87.2%) when compared against individual patient results from the 1st generation assay. |
| Interfering Substances | No interference observed from hemolysis, icterus, biotin, Intralipid, and 31 common pharmaceutical compounds at the levels tested. (Matches predicate's performance) |
| Cut-off (Design Specification) | ≥0.08 ng/mL (This is a design difference from the predicate, not a performance criterion for agreement) |
| Read Time (Design Specification) | 15 - 30 minutes (This is a design difference from the predicate, not a performance criterion for agreement) |
Study Details
2. Sample Size and Data Provenance
- Test set sample size: 335 individual patient results were used for the method comparison.
- Data provenance: Not explicitly stated, but clinical samples are implied for patient results. No mention of country of origin or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable (N/A): This type of study does not involve human expert interpretation of images or other subjective data for ground truth establishment. The "ground truth" is essentially the result obtained from the predicate device (1st generation CARDIAC T® Troponin T Rapid Assay).
4. Adjudication Method
- None: An adjudication method is not relevant for this type of laboratory assay comparison study. The comparison is objective, based on the quantitative/qualitative results of the two assays.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: An MRMC comparative effectiveness study was not performed. This type of study is for evaluating human reader performance, typically with and without AI assistance, which is not applicable to a diagnostic assay comparison.
6. Standalone (Algorithm Only) Performance
- Yes (inherently): The study directly evaluates the standalone performance of the 2nd generation assay by comparing its results to a referent method (the 1st generation assay) without human-in-the-loop assistance for the assay itself. The device is a diagnostic assay, and its performance is inherently standalone.
7. Type of Ground Truth Used
- Reference standard/Predicate device results: The ground truth for this comparison study is the result obtained from the currently marketed and accepted 1st generation CARDIAC T® Troponin T Rapid Assay. The study assesses the agreement of the 2nd generation assay with this established method.
8. Sample Size for the Training Set
- Not Applicable (N/A): The provided information describes a clinical validation study for a medical device (immunoassay), not a machine learning or AI algorithm development. Therefore, there is no "training set" in the context of AI. The assay itself is a chemical/biological system.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable (N/A): As there is no training set in the AI sense, this question is not relevant. The performance of the 2nd generation assay is compared against the established performance of the legally marketed 1st generation assay to demonstrate substantial equivalence.
{0}------------------------------------------------
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 Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2324Contact Person: John D. StevensDate Prepared: October 29, 1996 |
| 2) Device name | Proprietary name: CARDIAC T ® Troponin T Rapid AssayCommon name: troponin testClassification 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). |
Continued on next page
il
7
{1}------------------------------------------------
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 acutemyocardial infarction (injury) | Same |
| Sample type | Whole blood containingEDTA or Heparin | Same |
| Samplevolume | 130 - 160 µL | Same |
| Reaction testprinciple | 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 |
Continued on next page
{2}------------------------------------------------
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 |
| MethodComparison | 335 individual patient resultswere compared between thethe assays demonstratingagreement in 156 of 179cases | |
| Interferingsubstances | Evaluated for hemolysis,icterus, biotin, Intralipid and31 common pharmaceuticalcompounds. No interferenceat the levels tested | Evaluated for interferencefrom hemolysis, icterus,biotin, Intralipid and 31common pharmaceuticalcompounds. No interference atthe levels tested |
§ 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.