(92 days)
Bayer ACS:180® cTnI Assay
Bayer ACS:180 cTnI Assay, Bayer ACS:180® cTnI
No
The summary describes a quantitative immunoassay for measuring cardiac Troponin I. There is no mention of AI, ML, or any computational methods that would suggest their use in the analysis or interpretation of the results. The performance studies focus on standard analytical metrics like imprecision, correlation, and interference.
No.
This device is for in vitro diagnostic use, meaning it measures substances in human samples to aid in diagnosis, not to treat a condition.
Yes
The intended use states that the device aids in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment-elevation, acute coronary syndromes when used in conjunction with other clinical data.
No
The device is an in vitro diagnostic assay that measures cardiac Troponin I in biological samples, indicating it is a chemical reagent-based test and not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ADVIA IMS® Troponin I Ultra (TnI-Ultra) method is for in vitro diagnostic use..."
The "Device Description" section also states: "The ADVIA IMS® Troponin I Ultra (TnI-Ultra) method is for in vitro diagnostic use..."
These statements clearly indicate that the device is intended for use in examining specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease or other conditions.
N/A
Intended Use / Indications for Use
The ADVIA IMS® Troponin I Ultra (Tnl-Ultra) method is for in vitro diagnostic use to quantitatively measure the cardiac Troponin I in human serum and plasma (lithium heparin). When used in conjunction with other clinical data such as presenting symptoms and diagnostic procedures, measurements of cardiac Troponin I aid in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with non-ST segment-elevation, acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.
The ADVIA IMS® Tnl-Ultra Calibrator is for the in vitro diagnostic use in the calibration of the Tnl-Ultra assay on the ADVIA IMS® system
Product codes
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
Details on individual studies are provided in sections 4-10 in the summary and relate to the following:
- Imprecision: Comparative data between ADVIA IMS® TnI-Ultra and Bayer ACS:180 cTnI Assay with Total CV(%) for various levels in ng/mL.
- Correlation: Regression analysis (Passing Bablok and Linear Regression) between ADVIA IMS® and Bayer ACS:180 for serum samples (N=97) over a range of 0.01 to 49.6 ng/mL.
- Interfering substances: Evaluation of interference from Albumin, Bilirubin, Hemoglobin, and Triglyceride on recovery.
- Analytical Range: 0.01 ng/mL (0.01 µg/L) to 50 ng/mL (50 µg/L).
- Minimum Detectable Concentration: 0.01 ng/mL for ADVIA IMS® TnI-Ultra, compared to 0.10 ng/mL for Bayer ACS:180® cTnI.
- 99th Percentile Distribution and Functional Sensitivity: Upper 99th percentile Troponin I value is 0.04 ng/mL from 337 healthy serum samples. Functional Sensitivity (10% total C.V.) is 0.03 ng/mL.
- Expected Results: AMI cutoff value is based on data for the Bayer HealthCare ACS:180 Troponin I assay. Healthy Blood Donors (N=337) had results
§ 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 1 4 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Troponin I Ultra (TnI-Ultra) Assay for Bayer ADVIA IMS®
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: K052503
1. Intended Use
The ADVIA IMS® Troponin I Ultra (Tnl-Ultra) method is for in vitro diagnostic use to quantitatively measure the cardiac Troponin I in human serum and plasma (lithium heparin). When used in conjunction with other clinical data such as presenting symptoms and diagnostic procedures, measurements of cardiac Troponin I aid in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with non-ST segment-elevation, acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.
2. Predicate Device
| Product Name | Reagent REF | Calibrator REF |
|---|---|---|
| Bayer ACS:180® cTnI Assay | 07572636 (50 tests) | |
| 00370639 (300 tests) | Included with Reagents |
3. Device / Method
| Product Name | Reagent REF | Calibrator REF |
|---|---|---|
| ADVIA IMS® Troponin I | ||
| Ultra (TnI-Ultra) Assay | 02157487 | 06504521 |
1
4. Imprecision
| ADVIA IMS® TnI-Ultra
| Assay | Bayer ACS:180 cTnI Assay | ||
|---|---|---|---|
| Level | |||
| (ng/mL) | Total CV(%) | Level | |
| (ng/mL) | Total CV(%) | ||
| 1.55 | 5.7 | 0.80 | 7.5 |
| 14.06 | 2.2 | 1.37 | 6.7 |
| 32.93 | 2.7 | 15.73 | 5.0 |
| 0.21 | 5.4 | 33.83 | 5.3 |
| 9.05 | 2.7 | 43.01 | 5.8 |
5. Correlation (Y= ADVIA IMS®, X = Bayer ACS:180®)
| Specimen type | Comparative
System (X) | N | Regression
Equation | Syx
(ng/mL) | R | Sample
Range
(ng/mL) |
|------------------------------|---------------------------|----|------------------------|----------------|-------|----------------------------|
| Serum
(Passing Bablok) | Bayer
ACS:180 | 97 | $1.01 * X - 0.01$ | N/A | | 0.01 to 49.6 |
| Serum
(Linear Regression) | Bayer
ACS:180 | 97 | $0.90 * X + 0.43$ | 2.64 | 0.954 | 0.01 to 49.6 |
6. Interfering substances
| Interference | Interference
Conc.
mg/dL | Recovery
(ng/mL) | | %
Deviation |
|--------------|--------------------------------|---------------------|----------|----------------|
| | | Expected | Observed | |
| Albumin | 6500 | 9.32 | 9.5 | 1.9 |
| Bilirubin | 20 | 22.9 | 20.6 | -3.3 |
| Hemoglobin | 500 | 22.9 | 21.0 | -4.7 |
| Triglyceride | 1000 | 22.7 | 20.1 | -3.8 |
7. Analytical Range
0.01 ng/mL (0.01 µg/L) to 50 ng/mL (50 µg/L)
2
8. Minimum Detectable Concentration
| ADVIA IMS® TnI-
Ultra
(ng/mL) | Bayer ACS:180® cTnI
(ng/mL) |
|-------------------------------------|--------------------------------|
| 0.01 | 0.10 |
9. 99th Percentile Distribution and Functional Sensitivity
Based on 337 serum samples from apparently healthy donors, the upper 99th percentile Troponin I value is 0.04 ng/mL.
Functional Sensitivity (10% total C.V.) is 0.03 ng/mL for ADVIA IMS® TnI-Ultra Assay.
10. Expected Results
:
The AMI cutoff value is based on the data for the Bayer HealthCare ACS:180 Troponin I assay, to which ADVIA IMS® TnI-Ultra method is equivalent.
| Sample | N | Range
µg/L (ng/mL) |
|----------------------|-----|-----------------------|
| Healthy Blood Donors | 337 |