(56 days)
No
The summary describes a standard immunoassay for measuring troponin T and does not mention any AI or ML components.
No.
The device is an immunoassay used for in vitro quantitative determination of troponin T, aiding in diagnosis and risk stratification, but it does not directly treat or prevent a disease and thus is not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section states that the device "can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g., acute myocardial infarction." This explicitly indicates a diagnostic purpose.
No
The device description clearly states it is an immunoassay using streptavidin micro particles and electrochemiluminescence detection, which are hardware components and chemical reagents, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Immunoassay for the in vitro quantitative determination of troponin T in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details a laboratory test ("two step sandwich immunoassay") performed on biological samples ("human TnT in serum or plasma"). This is characteristic of an IVD.
- Analyzers: The test is intended for use on "Roche Elecsys family of immunoassay analyzers," which are laboratory instruments used for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of troponin T in human serum and plasma. Elecsys Troponin T can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g., acute myocardial infarction. The test is further indicated for the risk stratification of patients presenting with acute coronary syndrome and for cardiac risk in patients with chronic renal failure. The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of immunoassay analyzers.
Indications For Use:
Immunoassay for the in vitro quantitative determination of troponin T in human serum and plasma. The minutioussey for the in 'niv quanassay "ECLIA" is intended for use on the Roche Elecsys family of immunoassay analyzers.
Elecsys Troponin T can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g., acute myocardial infarction. The test is further indicated for the risk stratification lucinity neerosis, brg, assno coronary syndrome and for cardiac risk in patients with chronic renal or patients presenting that be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T.
Product codes
MMI
Device Description
The Elecsys Troponin T STAT is a two step sandwich immunoassay with streptavidin micro particles and electrochemiluminescence detection, for the measurement of human TnT in serum or plasma.
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)
Comparison to predicate device: The Elecsys Troponin T STAT is substantially equivalent to the currently marketed Elecsys ® Troponin T STAT (K984105). The below tables compare Elecsys® Troponin T STAT with the predicate device, Elecsys® Troponin T STAT (K984105).
Precision:
Within-run (human serum)
• 1.1% CV at 0.47 ng/mL
• 1.1% CV at 2.63 ng/mL
• 1.4% CV at 11.5 ng/mL
Within-run (PreciControl)
• 4.2% CV at 0.10 ng/mL
• 3.0% CV at 5.07 ng/mL
Total (human serum)
• 5.8% CV at 0.47 ng/mL
• 5.4% CV at 2.63 ng/mL
• 5.7% CV at 11.5 ng/mL
Within-run (PreciControl)
• 9.3% CV at 0.10 ng/mL
• 6.0% CV at 5.07 ng/mL
Hook effect: No hook effect up to 400 ng/mL
Analytical sensitivity: Lower detection limit: 0.01 ng/mL, Lowest concentration giving 10 % CV: 0.03 ng/mL
Limitations – interference: No interference from
• icterus up to 27 mg/dL bilirubin
• hemolysis up to 0.1 g/dL,
• Lipemia up to 1500 mg/dL Intralipid
• Biotin up to 50 ng/mL
• Rheumatoid factor up to 2000 U/mL
Falsely depressed results are obtained when using samples with higher hemoglobin concentrations.
Plasma samples collected with heparin or oxalate/fluoride revealed sample-dependent low TnT values compared to results obtained on serum samples.
Contains additives to minimize the effects of interference due to:
• Monoclonal mouse antibodies
• Antibodies to streptavidin
Extremely high titers of antibodies to ruthenium can cause interference.
Results should be assessed in conjunction with the patient's medical history, clinical examination, and other findings.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
| MAY 17 2004 | 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. |
| Submitter | |
| name, address, | |
| contact | Roche Diagnostics |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| 317-521-3723 | |
| Contact Person: Theresa M. Ambrose | |
| Date Prepared: May 11, 2004 | |
| Device Name | Proprietary name: Elecsys Troponin T ® STAT test |
| Common name: Troponin T test | |
| Classification name: Immunoassay method, troponin subunit | |
| Predicate | |
| device | The Elecsys Troponin T STAT is substantially equivalent to the currently marketed Elecsys ® Troponin T STAT (K984105). |
| Device | |
| Description | The Elecsys Troponin T STAT is a two step sandwich immunoassay with streptavidin micro particles and electrochemiluminescence detection, for the measurement of human TnT in serum or plasma. |
| Intended use | Immunoassay for the in vitro quantitative determination of troponin T in human serum and plasma. Elecsys Troponin T can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g., acute myocardial infarction. The test is further indicated for the risk stratification of patients presenting with acute coronary syndrome and for cardiac risk in patients with chronic renal failure. The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of immunoassay analyzers. |
| Comparison to | |
| predicate | |
| device | The Elecsys Troponin T STAT is substantially equivalent to the currently |
| marketed currently marketed Elecsys ® Troponin T STAT (K984105). The | |
| below tables compare Elecsys® Troponin T STAT with the predicate device, | |
| Elecsys® Troponin T STAT (K984105) |
1
| Character-
istic | Elecsys® Troponin T STAT
(modified intended use) | Predicate device Elecsys®
Troponin T STAT
(K984105) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Immunoassay for the in vitro quantitative
determination of troponin T in human serum and
plasma. Elecsys Troponin T can be used as an aid
in the differential diagnosis of acute coronary
syndrome to identify necrosis, e.g., acute
myocardial infarction. The test is further
indicated for the risk stratification of patients
presenting with acute coronary syndrome and for
cardiac risk in patients with chronic renal failure.
The test may also be useful for the selection of
more intensive therapy and intervention in
patients with elevated levels of cardiac Troponin
T. The electrochemiluminescence immunoassay
"ECLIA" is intended for use on the Roche
Elecsys family of immunoassay analyzers. | Immunoassay for the in
vitro quantitative
determination of troponin T
in human serum and plasma.
The
electrochemiluminescence
immunoassay "ECLIA" is
intended for use on the
Roche Elecsys family of
immunoassay analyzers. |
| Character-
istic | Elecsys® Troponin T STAT
(modified intended use) | Predicate device Elecsys®
Troponin T STAT
(K984105) |
| Indications
for Use | Troponin T (TnT) is a component of the
contractile apparatus of the striated musculature.
Although the function of TnT is the same as in all
striated muscles, TnT originating exclusively
from the myocardium (cardiac TnT, molecular
weight 39.7 kD) clearly differs from skeletal
muscle TnT. As a result of its high tissue
sensitivity, cardiac troponin T (cTnT) is a
cardiospecific, highly sensitive marker for
myocardial damage. In cases of acute myocardial
infarction, troponin T levels rise about 3-4 hours
after the occurrence of cardiac symptoms and can
remain elevated for up to 14 days.
The determination of cTnT in serum is an
important component in the diagnosis of
myocardial ischemia, e.g. AMI and myocarditis,
as well as in monitoring the course of unstable
angina pectoris and assessing the associated risk.
Comparative studies on 770 patients confirm the
prognostic utility of cTnT. It has also been
shown that cTnT-positive patients benefit
particularly from antithrombotic therapy
strategies (e.g. low molecular weight heparin,
GPIIb/IIIa antagonists).
Elevated serum cTnT values are detectable in
about 30% of patients suffering from renal failure
(e.g. chronic hemodialysis patients). The cTnT
detected in these patients is of cardiac origin. It
has been demonstrated e.g. with RT-PCR, that
cTnT is not expressed in regenerated skeletal
musculature of patients with renal failure.
Clinical data increasingly demonstrate that such
patients have a high risk of subsequently
suffering cardiovascular complications. | Same |
| Characteristic | Elecsys® Troponin T STAT
(modified intended use) | Predicate device Elecsys®
Troponin T STAT (K984105) |
| Assay principle | Electrochemiluminescent
immunoassay | Same |
| Traceability/
standardization | Standardized against the 2nd
generation Elecsys Troponin T
test | Same |
| Calibration interval | Elecsys 2010
• After 1 month when using
the same reagent lot
• After 7 days when using the
same reagent kit on the
analyzer
Elecsys 1010
• With every reagent kit
• After 7 days (20-25 °C)
• After 3 days (25-32 °C) | Same |
| Sample type | Human serum, EDTA and
citrate plasma. | Same |
| Reagent stability | Unopened
• Up to the stated expiration
date at 2-8 °C
After opening
• 12 weeks at 2-8°C
• 8 weeks on Elecsys 2010
• 8 weeks on Elecsys 1010
(20-25 °C; up to 20 hours
opened in total) | Same |
| Calibrator | Elecsys Troponin T STAT
CalSet | Same |
| Controls | Elecsys PreciControl Troponin
T or Elecsys PreciControl
Cardiac. | Same |
| Duration of assay | 9 minutes | same |
| Characteristic | Elecsys® Troponin T STAT
(modified intended use) | Predicate device Elecsys®
Troponin T STAT
(K984105) |
| Measuring range | 0.010 - 25.00 ng/mL | Same |
| Precision | Within-run (human serum)
• 1.1% CV at 0.47 ng/mL
• 1.1% CV at 2.63 ng/mL
• 1.4% CV at 11.5 ng/mL
Within-run (PreciControl)
• 4.2% CV at 0.10 ng/mL
• 3.0% CV at 5.07 ng/mL
Total (human serum)
• 5.8% CV at 0.47 ng/mL
• 5.4% CV at 2.63 ng/mL
• 5.7% CV at 11.5 ng/mL
Within-run (PreciControl)
• 9.3% CV at 0.10 ng/mL
• 6.0% CV at 5.07 ng/mL | Same |
| Hook effect | No hook effect up to 400 ng/mL | Same |
| Analytical sensitivity | Lower detection limit: 0.01 ng/mL
Lowest concentration giving
10 % CV: 0.03 ng/mL | Same |
Continued on next page
2
Predicate device (continued)
Continued on next page
3
Predicate device (continued)
4
The performance characteristics of the Elecsys® Troponin T STAT test and Substantial the predicate device are compared in the table below. equivalence: performance characteristics
Continued on next page
5
| Characteristic | Elecsys® Troponin T STAT
(modified intended use) | Predicate device Elecsys®
Troponin T STAT
(K984105) |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Limitations –
interference | No interference from | Same |
| | • icterus up to 27 mg/dL
bilirubin | |
| | • hemolysis up to 0.1 g/dL, | |
| | • Lipemia up to 1500 mg/dL
Intralipid | |
| | • Biotin up to 50 ng/mL | |
| | • Rheumatoid factor up to
2000 U/mL | |
| | Falsely depressed results are
obtained when using samples
with higher hemoglobin
concentrations. | |
| | Plasma samples collected
with heparin or
oxalate/fluoride revealed
sample-dependent low TnT
values compared to results
obtained on serum samples. | |
| | Contains additives to
minimize the effects of
interference due to
• Monoclonal mouse
antibodies
• Antibodies to streptavidin | |
| | Extremely high titers of
antibodies to ruthenium can
cause interference. | |
| | Results should be assessed in
conjunction with the
patient's medical history,
clinical examination, and
other findings | |
Substantial equivalence: performance characteristics (continued)
6
.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, represented by three stylized lines forming the body and head, and two lines forming the legs and feet.
MAY 1 7 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Theresa M. Ambrose, PhD, DABCC, FACB, RAC Regulatory Principial Roche Diagnostics Corp. 9115 Hague Road Indianapolis, IN 46250
Re: K040733 Trade/Device Name: Elecsys Troponin T STAT Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinasc or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: March 19, 2004 Reccived: March 22, 2004
Dear Dr. Ambrosc:
We have reviewed your Scction 510(k) premarket notification of intent to market the device we nave roved your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreased of the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de neces that have been that do not require approval of a premarket approval application (PMA). and Oosmetee Prove, market the device, subject to the general controls provisions of the Act. The r ou may, arovisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I DI Hab Intace a s and regulations administered by other Federal agencies. You must on any I caerar statutes and st including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice SFR Part 867, 140 million the quality systems (QS) regulation (21 CFR Part 820).
8
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known):___K040733
Device Name: Elecsys Troponin T STAT
Indications For Use:
Immunoassay for the in vitro quantitative determination of troponin T in human serum and plasma. The minutioussey for the in 'niv quanassay "ECLIA" is intended for use on the Roche Elecsys family of immunoassay analyzers.
Elecsys Troponin T can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g., acute myocardial infarction. The test is further indicated for the risk stratification lucinity neerosis, brg, assno coronary syndrome and for cardiac risk in patients with chronic renal or patients presenting that be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T.
Prescription Use X = (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Hanlonge
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040733