Predicate Devices

CARDIAC T® Troponin T Enzymun Test assay

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard immunoassay with electrochemiluminescence detection and calibration based on a master curve and 2-point calibration. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No
This device is for in vitro diagnostic (IVD) use, specifically for the quantitative determination of troponin T in human serum and plasma to aid in the diagnosis of acute myocardial infarction. It does not directly treat or prevent a disease; rather, it provides diagnostic information.

Diagnostic

Yes
The device is described as aiding in the "diagnosis of acute myocardial infarction (AMI)" by measuring Troponin T levels, which are critical serological findings for confirming and monitoring the course of an infarction, especially when other clinical signs are atypical.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a hardware-based immunoassay system involving microparticles, electrodes, and electrochemiluminescence detection. It is not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states "For the in vitro quantitative determination of troponin T in human serum and plasma." The term "in vitro" is a key indicator of an IVD.
Sample Type: The device analyzes "human serum and plasma," which are biological samples taken from the body.
Purpose: The purpose is to measure a specific analyte (troponin T) in these samples to aid in the "Diagnosis of acute myocardial infarction (AMI)." This is a diagnostic purpose performed outside of the body.
Device Description: The description details a laboratory-based assay ("two step sandwich with streptavidin microparticles and electrochemiluminescence detection") performed on the sample.

All of these points align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For the in vitro quantitative determination of troponin T in human serum and plasma.
Diagnosis of acute myocardial infarction (AMI) is generally based on the presence of at least two of three classic findings: clinical symptoms, diagnostic ECG, and serological findings of abnormal levels of total CK, LD or their isoenzymes. Often, due to the presence of clinical symptoms and changes in the ECG, the CK, CK-MB, LD and LD1 serve primarily to confirm and monitor the course of the infarction. At other times, when chest pain is atypical, or ECG changes are non-diagnostic or absent, these markers provide important diagnostic information. Limitations to these serum markers include a relatively narrow diagnostic window, difficulty in interpreting small increases and a lack of cardiac specificity. Troponin T can be an effective serum marker whose cardiac specificity and wide diagnostic window makes it a valuable tool in the diagnosis of AMI.2,4

Troponin T has been shown to be elevated in all patients with AMI who are diagnosed by World Health Organization (WHO) criteria.1 Troponin T frequently appears in serum as early as one to three hours after the onset of pain.2,5 The sensitivity of troponin T reaches 100% within hours and remains at a high sensitivity level until day five. After 48 hours the CK-MB assay is frequently of little diagnostic value.1 Troponin T also remains elevated longer than total LD.3 Its levels can be measured for up to 14 days.5 Thus, the diagnostic window is broader due to the length of time troponin T is elevated in serum. The time interval of elevation in serum ranges from three hours to > 14 days.1,5
The specificity and sensitivity of troponin T measurements aid in both the early and late diagnosis of AMI. 6 Troponin T elevations have also been measured in patients with the clinical diagnosis of unstable angina due to the sensitivity of troponin T for detecting minor myocardial damage. In cases of AMI with minimal cardiac damage, low elevations of CK and CK-MB are difficult to interpret due to the presence of normal levels of these enzymes in the blood, and their lack of cardiac specificity. The specificity of troponin T to cardiac tissue is of value in these difficult patients. 4,6

Product codes

Not Found

Device Description

The Elecsys ® Troponin T test principle is based on a two step sandwich with streptavidin microparticles and electrochemiluminescence detection.
Total duration of assay: 9 minutes.
1st incubation: 15 ul of sample, a biotinylated monoclonal troponin T-specific antibody and a monoclonal troponin T-specific antibody labeled with a ruthenium complex react to form a sandwich complex
2nd incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin
The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier
Results are determined via a calibration curve which is instrument- specifically generated by 2-point calibration and a master curve provided via the reagent bar code

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)

NCCLS (Modified) Precision:
Sample: CC1, N=60, Mean=0.103, within run %CV=5.12, total run %CV=7.23
Sample: CC2, N=60, Mean=2.506, within run %CV=2.94, total run %CV=5.77
Sample: HS1, N=60, Mean=5.992, within run %CV=2.93, total run %CV=5.42
Sample: HS2, N=60, Mean=1.298, within run %CV=2.35, total run %CV=4.15
Sample: HS3, N=60, Mean=0.439, within run %CV=2.90, total run %CV=4.56

Sensitivity: Lower Detection Limit: 0.01 ng/ml
Assay range (LDL to highest standard): 0.01 - 25.0 ng/ml

Method Comparison:
vs. Cardiac T Troponin T (Least Squares), N = 54, y = -0.033 + 0.996x, r = 0.969
(Passing/Bablok), N = 54, y = 0.0094 + 0.96x, r = 0.969

Interfering substances: No interference up to:
Hemoglobin: 1.5 g/dl
Lipemia: 1500 mg/dl
Bilirubin: 36 mg/dl
Biotin: 100 mg/dl

Specificity (% cross reaction to 2,000 ng/ml):
s troponinT: 0.001
c troponin I: 0.002
s tropomyosin: 0.001
c myosin light chain: 0.003

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sensitivity: Lower Detection Limit: 0.01 ng/ml
Specificity:
% cross reaction (to 2,000 ng/ml)
s troponinT: 0.001
c troponin I: 0.002
s tropomyosin: 0.001
c myosin light chain: 0.003

Predicate Device(s)

CARDIAC T® Troponin T Enzymun Test assay

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

| | JUN 11 1996
510(k) Summary | |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 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) 845-2000 | |
| | Contact Person: LeeAnn Chambers | |
| | Date Prepared: April 12, 1996 | |
| 2) Device name | Proprietary name: Elecsys Troponin T | |
| | Common name: troponin test | |
| 3) Predicate
device | We claim substantial equivalence to the CARDIAC T® Troponin T Enzymun
Test assay. | |
| 4) Device
Description | The Elecsys ® Troponin T test principle is based on a two step sandwich with
streptavidin microparticles and electrochemiluminescence detection. | |
| | Total duration of assay: 9 minutes.
1st incubation: 15 ul of sample, a biotinylated monoclonal troponin T-specific antibody and a monoclonal troponin T-specific antibody labeled with a ruthenium complex react to form a sandwich complex2nd incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidinThe reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier | |
| | Continued on next page | |

ക്കുന്നു.
അവലംബം

അവലംബം
അത്തി

سمب

ﺳﮯ

ﺳﺴﺴﺴ

22

1

510(k) Summary, Continued

ा में बना दें कि दे दिया था।

संस्थान
संस्थान
संस्थान
संस्थान

Image /page/1/Picture/1 description: The image is a solid black square. The square is centered in the image and takes up most of the space. There are no other objects or features in the image. The black color is uniform throughout the square.

| 4) Device
Description,
cont. | • Results are determined via a calibration curve which is instrument-
specifically generated by 2-point calibration and a master curve provided
via the reagent bar code | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 5) Intended use | For the in vitro quantitative determination of troponin T in human serum and
plasma. | |
| 5) Indications
for use | Diagnosis of acute myocardial infarction (AMI) is generally based on the
presence of at least two of three classic findings: clinical symptoms,
diagnostic ECG, and serological findings of abnormal levels of total CK, LD
or their isoenzymes. Often, due to the presence of clinical symptoms and
changes in the ECG, the CK, CK-MB, LD and LD1 serve primarily to
confirm and monitor the course of the infarction. At other times, when chest
pain is atypical, or ECG changes are non-diagnostic or absent, these markers
provide important diagnostic information. Limitations to these serum
markers include a relatively narrow diagnostic window, difficulty in
interpreting small increases and a lack of cardiac specificity. Troponin T can
be an effective serum marker whose cardiac specificity and wide diagnostic
window makes it a valuable tool in the diagnosis of AMI.2,4

Troponin T has been shown to be elevated in all patients with AMI who are
diagnosed by World Health Organization (WHO) criteria.1 Troponin T
frequently appears in serum as early as one to three hours after the onset of
pain.2,5 The sensitivity of troponin T reaches 100% within hours and remains
at a high sensitivity level until day five. After 48 hours the CK-MB assay is
frequently of little diagnostic value.1 Troponin T also remains elevated longer
than total LD.3 Its levels can be measured for up to 14 days.5 Thus, the
diagnostic window is broader due to the length of time troponin T is elevated
in serum. The time interval of elevation in serum ranges from three hours to

14 days.1,5 | |

Continued on next page

2

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510(k) Summary. Continued

5) Indications The specificity and sensitivity of troponin T measurements aid in both the for use, (cont.) early and late diagnosis of AMI. 6 Troponin T elevations have also been measured in patients with the clinical diagnosis of unstable angina due to the sensitivity of troponin T for detecting minor myocardial damage. In cases of AMI with minimal cardiac damage, low elevations of CK and CK-MB are difficult to interpret due to the presence of normal levels of these enzymes in the blood, and their lack of cardiac specificity. The specificity of troponin T to cardiac tissue is of value in these difficult patients. 4,6 References 1. Katus HA, Scheffold T, Remppis A. And Zehlein J. Proteins of the troponin complex. Laboratory Medicine. 1992;23(No. 5):311-317. 2. Katus HA, Remppis A, Neumann FJ, et al. Diagnostic efficiency of troponin T measurements in acute myocardial infarction. Circulation. 1991;83(No. 3):902-912. 3. Katus HA, et al. Enzyme linked immuno assay of cardiac troponin T for the detection of acute myocardial infarction in patients. J Mol Cell Cardiol 1989;21:1349-1353. 4. Remppis A, Katus HA, Scheffold T, et al. Diagnostic efficiency of troponin T measurements in acute myocardial infarction. Eur Heart J 11. 1990;(suppl):351. 5. Mair J, Artner-Dworzak E, Puschendorf B, and Dienstl F. Plasma troponin T in acute myocardial infarction. Eur Heart J 11. 1990;(suppl):351. Mair J, Artner-Dworzak E, Lechleitner P, et al. Cardiac troponin T in diagnosis of acute myocardial infarction. Clin Chem. 1991;37(No. 6):845-854. 6) Comparison The Boehringer Mannheim Elecsys Troponin T is substantially equivalent to to predicate other products in commercial distribution intended for similar use. Most device notably it is substantially equivalent to the currently marketed Cardiac T Troponin T Enzymun-Test.

Continued on next page

3

510(k) Summary, Continued

Comparison to predicate device (cont.)

The following table compares the Elecsys Troponin T with the predicate device, Cardiac T Troponin T Enzymun Test. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device in provided in attachment 6.

Similarities:

· Intended use: immunoassay for the in vitro quantitative determination of troponin T
· The same antibodies are used for both assays monoclonal anti-troponin T antibodies (mouse)
· Capture principle: streptavidin / biotin
· Two-step sandwich immunoassay
· for use as an adjunct to other diagnostic procedures and test currently used (i.e., WHO criteria or current clinical pathway for the diagnosis of myocardial injury

Differences:

| Feature | Elecsys Troponin T | Cardiac T Troponin T
Enzymun Test |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Reaction test
principle | streptavidin microparticles and
electrochemiluminescence
technology | streptavidin-coated tubes and
enzyme immunoassay
technology |
| Sample type | human serum and plasma | human serum |
| Sample
volume | 15µl | 140µl |
| Instrument
required | Elecsys 2010 | ES 300 |
| Calibration | a two point calibration renewal
is recommended every 7 days
or 1 month if the same reagent
lot is used and the reagent pack
is consumed within 7 days | a full calibration curve run is
recommended every 2 weeks |

Continued on next page

4

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510(k) Summary, Continued

F. Substantial

Performance Characteristics:

equivalence,

(cont.)

க்கத்துகள்

இங்கிலாந்துக்கு

இக்கிய

Feature	Elecsys Troponin T	Cardiac T Troponin T Enzymun Test
NCCLS (modified.)
Precision
Sample	CC1 CC2 HS1 HS2 HS3
N	60 60 60 60 60	60 60 60
Mean	0.103 2.506 5.992 1.298 0.439	0.062 0.326 2.144
wi/in run %CV	5.12 2.94 2.93 2.35 2.90	8.6 2.3 1.3
total run %CV	7.23 5.77 5.42 4.15 4.56	18.2 6.6 4.4
Sensitivity	Lower Detection Limit:
0.01 ng/ml	Lower Detection Limit:
0.02 ng/ml
Assay range
(LDL to highest
standard)	0.01 - 25.0 ng/ml	0.02 - 15.0 ng/ml
Method
Comparison	vs. Cardiac T Troponin T (Least Squares)
N = 54
y = -0.033 + 0.996x
r = 0.969

(Passing/Bablok)
N = 54
y = 0.0094 + 0.96x
r = 0.969 | vs. Cardiac T ELISA Troponin T: