(12 days)
Not Found
No
The summary describes a standard immunoassay and analyzer, with no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is used for in vitro quantitative determination of troponin T for diagnostic purposes, not for treating or preventing a disease.
Yes
The device is described as an "aid in the differential diagnosis of acute coronary syndrome to identify necrosis" and for "risk stratification," which are diagnostic purposes. It measures a biomarker (troponin T) to provide information about a patient's health status.
No
The device is an immunoassay reagent kit intended for use on specific hardware analyzers (Roche Elecsys family). It is a chemical assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use 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 "two step sandwich immunoassay" for the measurement of human TnT in serum or plasma, which are biological samples tested outside of the body.
- Purpose: The test is used to aid in the diagnosis of acute coronary syndrome, risk stratification, and therapy selection, all of which are diagnostic purposes performed on samples taken from a patient.
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.
Product codes
MMI
Device Description
The Elecsys® Troponin T STAT assay 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)
The document provides precision data for the device.
Within-run (human serum)
• 4.5% CV at 0.047 ng/mL
• 2.0% CV at 0.652 ng/mL
• 2.9% CV at 6.08 ng/mL
Within-run (PreciControl)
• 2.2% CV at 0.137 ng/mL
• 2.5% CV at 2.89 ng/mL
Total (human serum)
• 6.2% CV at 0.047 ng/mL
• 4.6% CV at 0.652 ng/mL
• 5.6% CV at 6.08 ng/mL
Within-run (PreciControl)
• 3.5% CV at 0.137 ng/mL
• 4.7% CV at 2.89 ng/mL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical sensitivity: Lower detection limit: 0.01 ng/mL
Lowest concentration giving 10 % CV: 0.03 ng/mL
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
JUL 1 1 2005
510(k) Summary – Elecsys® Troponin T STAT Assay
| 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 Rd Indianapolis IN 46250 (317) 521-3723 |
| Contact person: Theresa M. Ambrose | |
| Date prepared: June 28, 2005 | |
| Device Name | Proprietary name: Elecsys® Troponin T STAT Assay |
| Common name: Troponin T Test | |
| Classification name: Immunoassay method, troponin subunit | |
| Device Description | The Elecsys® Troponin T STAT assay 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. |
| Predicate Device | We claim substantial equivalence to the Elecsys ® Troponin T STAT reagent currently marketed on the Elecsys 2010 and MODULAR ANALYTICS E170. (K040733). |
| Continued on next page |
Confidential
1
510(k) Summary – Elecsys® Troponin T STAT Assay, Continued
The table below indicates the similarities and differences between the Substantial modified Elecsys® Elecsys Troponin T STAT and its predicate device equivalency -(current Troponin T STAT, K040733). device comparison
| Characteristic | Current Elecsys® Troponin T STAT
(3rd Gen.) (K040733) | Modified device Elecsys®
Troponin T STAT (4th Gen.) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | Same |
| Indications for Use | 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. | Same |
| | | |
| Assay principle | Electrochemiluminescent
immunoassay | Same |
| Traceability/
standardization | Standardized against the 2nd generation Troponin T test | Standardized against the 3rd generation Elecsys Troponin T test; traceable to the 2nd generation test |
| Calibration frequency | 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) | 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) |
| Sample type | Human serum, K3-EDTA and Na-
citrate plasma. | Human serum, K2- and K3-EDTA,
Li-heparin, and Na-citrate plasma |
| 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. | Elecsys PreciControl Troponin T |
| Duration of assay | 9 minutes | Same |
2
Special 510(k): Device Modification – Elecsys® Troponin T
STAT ,Continued
:
3
Special 510(k): Device Modification – Elecsys® Troponin T STAT ,Continued
.
| 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 | ||
| Total (PreciControl) | ||
| • 9.3% CV at 0.10 ng/mL | ||
| • 6.0% CV at 5.07 ng/mL | Within-run (human serum) | |
| • 4.5% CV at 0.047 ng/mL | ||
| • 2.0% CV at 0.652 ng/mL | ||
| • 2.9% CV at 6.08 ng/mL | ||
| Within-run (PreciControl) | ||
| • 2.2% CV at 0.137 ng/mL | ||
| • 2.5% CV at 2.89 ng/mL | ||
| Total (human serum) | ||
| • 6.2% CV at 0.047 ng/mL | ||
| • 4.6% CV at 0.652 ng/mL | ||
| • 5.6% CV at 6.08 ng/mL | ||
| Within-run (PreciControl) | ||
| • 3.5% CV at 0.137 ng/mL | ||
| • 4.7% CV at 2.89 ng/mL | ||
| Concentration at 10% | ||
| CV: | 0.03 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 |
4
Special 510(k): Device Modification – Elecsys® Troponin T
STAT ,Continued
| 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 | Same |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Falsely depressed results are obtained
when using samples with higher
hemoglobin concentrations. | Same |
| | Plasma samples collected with
heparin or oxalate/fluoride revealed
sample-dependent low TnT values
compared to results obtained on
serum samples. | Plasma samples collected using
tubes containing oxalate/fluoride
revealed sample-dependent low
TnT values when compared to
results obtained on serum samples. |
| | Contains additives to minimize the
effects of interference due to
• Monoclonal mouse antibodies
• Antibodies to streptavidin | Same |
| | Extremely high titers of antibodies to
ruthenium can cause interference. | Same |
| | Results should be assessed in
conjunction with the patient's medical
history, clinical examination, and
other findings | Same |
. I
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 1 2005
Theresa M. Ambrose, Ph.D., RAC Regulatory Principal Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250
Re: K051752
Trade/Device Name: Roche Elecsys® Troponin T STAT Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: June 28, 2005 Received: June 29, 2005
Dear Dr. Ambrose:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, 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, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
6
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter will and in your is of your 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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Carol C. Benson
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K051752-
Device Name: Roche Elecsys ® Troponin T STAT
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.
Prescription Use XXX (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)
| Division Sign-Off Office of In Vitro Diagnostic Device Page 1 of 1 Evaluation and Safety | |
|---|---|
| Confidential | 510(k) K051752 |
22