(65 days)
Not Found. (The predicate device names are listed, but no K/DEN numbers are provided in the predicate section)
Not Found
No
The summary describes a quantitative immunoassay for cardiac troponin I, which is a standard laboratory test and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic (IVD) tool for determining cardiac troponin I levels, which aids in the diagnosis and risk stratification of cardiac conditions, not a device that treats or prevents disease.
Yes
The device is described as being "for in vitro diagnostic use" and its purpose is to aid "in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes." This clearly indicates its role in disease diagnosis.
No
The device is an in vitro diagnostic assay (method and calibrator) for quantitative determination of cardiac troponin I, which requires a physical laboratory system (ADVIA Centaur® system) to perform the analysis. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The ADVIA Centaur® Tnl-Ultra (Tnl-Ultra) method is for in vitro diagnostic use in the quantitative determination of cardiac troponin I in serum and heparinized and EDTA plasma."
- "The ADVIA Centaur® Tnl-Ultra Calibrator is for the in vitro diagnostic use in the calibration of the Tnl-Ultra assay on the ADVIA Centaur® system."
This language clearly indicates that the device is intended for use outside of the body to diagnose conditions.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in the quantitative determination of cardiac troponin I in serum, heparinized or EDTA plasma using ADVIA Centaur® system.
Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk mortality, myocaridal infarction or increased probability of ischemic events requiring urgent revascularization procedures.
The ADVIA Centaur® TnI-Ultra Calibrator is for the in vitro diagnostic use in the calibration of the TnI-Ultra assay on the ADVIA Centaur® system.
Product codes (comma separated list FDA assigned to the subject device)
MMI, JIT
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The document presents data on Imprecision, Correlation, Interfering substances, Analytical Range, Minimum Detectable Concentration, 99th Percentile Distribution, and Expected Results.
Imprecision:
- Total CV (%) for ADVIA Centaur® TnI-Ultra levels (ng/mL): 0.1 (4.6%), 0.24 (3.5%), 0.85 (2.7%), 3.91 (2.8%), 14.47 (3.4%), 37.8 (3.5%).
- Within-run CV (%) for ADVIA Centaur® TnI-Ultra levels (ng/mL): 0.1 (3.2%), 0.24 (2.6%), 0.85 (1.6%), 3.91 (1.5%), 14.47 (1.5%), 37.8 (1.8%).
- The troponin I concentration at a total CV of 10% was determined to be 0.042 ng/mL.
- Functional Sensitivity (20% total C.V.) was calculated as
§ 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 3 0 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Troponin I (TnI-Ultra) Assay for Bayer ADVIA Centaur®
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
1. Intended Use
For in vitro diagnostic use in the quantitative determination of cardiac troponin I in serum, heparinized or EDTA plasma using ADVIA Centaur® system.
1053020
Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk mortality, myocaridal infarction or increased probability of ischemic events requiring urgent revascularization procedures.
The ADVIA Centaur® TnI-Ultra Calibrator is for the in vitro diagnostic use in the calibration of the TnI-Ultra assay on the ADVIA Centaur® system.
2. Predicate Devices
| Product Name | Reagent REF | Calibrator REF |
|---|---|---|
| ACS:180® and ADVIA | ||
| Centaur® Cardiac Troponin I | ||
| (cTnI) Assay | ACS:180 | |
| 07572636 (50 test) | ||
| 00370639 (300 test) | ||
| ADVIA Centaur | ||
| 07640356 (100 tests) | ||
| 0595168 (500 tests) | Kit component |
3. Device / Method
| Product Name | Reagent REF | Calibrator REF |
|---|---|---|
| ADVIA Centaur® TnI-Ultra | ||
| Assay | 02789602 (100 tests) | |
| 02790309 (500 tests) | Kit component |
1
4. Imprecision
| ADVIA Centaur®
| TnI-Ultra | ADVIA Centaur® cTnI* | ACS:180 cTnI* | |||
|---|---|---|---|---|---|
| Level | |||||
| (ng/mL) | Total | ||||
| CV (%) | Level | ||||
| (ng/mL) | Total | ||||
| CV (%) | Level | ||||
| (ng/mL) | Total | ||||
| CV (%) | |||||
| 0.1 | 4.6 | 0.94 | 6.6 | 0.8 | 7.5 |
| 0.24 | 3.5 | 2.38 | 5.0 | 1.37 | 6.7 |
| 0.85 | 2.7 | 3.72 | 3.0 | 15.73 | 5.0 |
| 3.91 | 2.8 | 8.08 | 4.4 | 33.83 | 5.3 |
| 14.47 | 3.4 | 13.29 | 3.9 | 43.01 | 5.8 |
| 37.8 | 3.5 | 15.95 | 3.9 | ||
| 43.62 | 3.6 |
| ADVIA Centaur®
TnI-Ultra | Within-run
CV(%) | ADVIA Centaur® cTnI* | Within-run
CV(%) |
|-----------------------------|---------------------|----------------------|---------------------|
| Level
(ng/mL) | | Level
(ng/mL) | |
| 0.1 | 3.2 | 0.94 | 4.6 |
| 0.24 | 2.6 | 2.38 | 2.3 |
| 0.85 | 1.6 | 3.72 | 2.6 |
| 3.91 | 1.5 | 8.08 | 1.9 |
| 14.47 | 1.5 | 13.29 | 1.4 |
| 37.8 | 1.8 | 15.95 | 2.3 |
| | | 43.62 | 2.4 |
| ACS:180 cTnI* | |
|---|---|
| Level | |
| (ng/mL) | Within-run |
| CV(%) | |
| 0.8 | 4.4 |
| 1.37 | 4.2 |
| 15.73 | 2.2 |
| 33.83 | 2.3 |
| 43.01 | 3.0 |
| * data from |
instructions for use
The troponin I concentration at a total CV of 10% was determined to be 0.042 ng/mL.
Functional Sensitivity (20% total C.V.) was calculated as