ELECSYS TROPONIN T STAT TEST

K040733 · Roche Diagnostics Corp. · MMI · May 17, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040733
• Device Name: ELECSYS TROPONIN T STAT TEST
• Applicant: Roche Diagnostics Corp.
• Product Code: MMI · Clinical Chemistry
• Decision Date: May 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

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.

Device Story

Elecsys Troponin T STAT is an in vitro diagnostic immunoassay for quantitative Troponin T measurement in human serum/plasma. Device utilizes electrochemiluminescence immunoassay (ECLIA) technology on Roche Elecsys analyzers. Input: patient serum/plasma sample. Process: sandwich immunoassay using biotinylated monoclonal anti-Troponin T antibody and ruthenium-labeled monoclonal anti-Troponin T antibody; magnetic streptavidin-coated microparticles capture sandwich complex on electrode surface; voltage application triggers chemiluminescent reaction. Output: light signal intensity measured via photomultiplier; concentration calculated proportional to area under light curve. Used in clinical laboratory settings by professional operators. Output assists clinicians in diagnosing acute myocardial infarction, stratifying ACS/renal failure patient risk, and guiding therapeutic interventions.

Clinical Evidence

No new clinical trials were conducted. Substantial equivalence for the expanded claims is supported by a review of 10 peer-reviewed clinical literature references (e.g., FRISC II substudy, CAPTURE study, meta-analyses). These studies demonstrate the prognostic value of Troponin T in patients with unstable coronary artery disease, acute coronary syndromes, and end-stage renal disease, supporting its use for risk stratification and therapeutic decision-making.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence (ECLIA) detection; streptavidin-coated microparticles; ruthenium-labeled antibodies. Analyzers: Roche Elecsys family. Sample types: serum, EDTA plasma, citrate plasma. Measuring range: 0.010–25.00 ng/mL. Assay duration: 9 minutes. Standardized against 2nd generation Elecsys Troponin T test.

Indications for Use

Indicated for patients presenting with acute coronary syndrome (ACS) or chronic renal failure. Used as an aid in differential diagnosis of ACS to identify necrosis (e.g., acute myocardial infarction), for risk stratification of ACS patients, for cardiac risk assessment in chronic renal failure, and for selecting intensive therapy/intervention in patients with elevated cardiac Troponin T.

Regulatory Classification

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.

Predicate Devices

• Elecsys® Troponin T STAT (K984105)

Submission Summary (Full Text)

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K040733

| 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<br>name, address,<br>contact | Roche Diagnostics<br>9115 Hague Road<br>Indianapolis, IN 46250<br>317-521-3723 |
| | Contact Person: Theresa M. Ambrose<br>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<br>device | The Elecsys Troponin T STAT is substantially equivalent to the currently marketed Elecsys ® Troponin T STAT (K984105). |
| Device<br>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<br>predicate<br>device | The Elecsys Troponin T STAT is substantially equivalent to the currently<br>marketed currently marketed Elecsys ® Troponin T STAT (K984105). The<br>below tables compare Elecsys® Troponin T STAT with the predicate device,<br>Elecsys® Troponin T STAT (K984105) |

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| Character-<br>istic | Elecsys® Troponin T STAT<br>(modified intended use) | Predicate device Elecsys®<br>Troponin T STAT<br>(K984105) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | Immunoassay for the in vitro quantitative<br>determination of troponin T in human serum and<br>plasma. Elecsys Troponin T can be used as an aid<br>in the differential diagnosis of acute coronary<br>syndrome to identify necrosis, e.g., acute<br>myocardial infarction. The test is further<br>indicated for the risk stratification of patients<br>presenting with acute coronary syndrome and for<br>cardiac risk in patients with chronic renal failure.<br>The test may also be useful for the selection of<br>more intensive therapy and intervention in<br>patients with elevated levels of cardiac Troponin<br>T. The electrochemiluminescence immunoassay<br>"ECLIA" is intended for use on the Roche<br>Elecsys family of immunoassay analyzers. | Immunoassay for the in<br>vitro quantitative<br>determination of troponin T<br>in human serum and plasma.<br>The<br>electrochemiluminescence<br>immunoassay "ECLIA" is<br>intended for use on the<br>Roche Elecsys family of<br>immunoassay analyzers. |
| Character-<br>istic | Elecsys® Troponin T STAT<br>(modified intended use) | Predicate device Elecsys®<br>Troponin T STAT<br>(K984105) |
| Indications<br>for Use | Troponin T (TnT) is a component of the<br>contractile apparatus of the striated musculature.<br>Although the function of TnT is the same as in all<br>striated muscles, TnT originating exclusively<br>from the myocardium (cardiac TnT, molecular<br>weight 39.7 kD) clearly differs from skeletal<br>muscle TnT. As a result of its high tissue<br>sensitivity, cardiac troponin T (cTnT) is a<br>cardiospecific, highly sensitive marker for<br>myocardial damage. In cases of acute myocardial<br>infarction, troponin T levels rise about 3-4 hours<br>after the occurrence of cardiac symptoms and can<br>remain elevated for up to 14 days.<br>The determination of cTnT in serum is an<br>important component in the diagnosis of<br>myocardial ischemia, e.g. AMI and myocarditis,<br>as well as in monitoring the course of unstable<br>angina pectoris and assessing the associated risk.<br>Comparative studies on 770 patients confirm the<br>prognostic utility of cTnT. It has also been<br>shown that cTnT-positive patients benefit<br>particularly from antithrombotic therapy<br>strategies (e.g. low molecular weight heparin,<br>GPIIb/IIIa antagonists).<br>Elevated serum cTnT values are detectable in<br>about 30% of patients suffering from renal failure<br>(e.g. chronic hemodialysis patients). The cTnT<br>detected in these patients is of cardiac origin. It<br>has been demonstrated e.g. with RT-PCR, that<br>cTnT is not expressed in regenerated skeletal<br>musculature of patients with renal failure.<br>Clinical data increasingly demonstrate that such<br>patients have a high risk of subsequently<br>suffering cardiovascular complications. | Same |
| Characteristic | Elecsys® Troponin T STAT<br>(modified intended use) | Predicate device Elecsys®<br>Troponin T STAT (K984105) |
| Assay principle | Electrochemiluminescent<br>immunoassay | Same |
| Traceability/<br>standardization | Standardized against the 2nd<br>generation Elecsys Troponin T<br>test | Same |
| Calibration interval | Elecsys 2010<br>• After 1 month when using<br>the same reagent lot<br>• After 7 days when using the<br>same reagent kit on the<br>analyzer<br>Elecsys 1010<br>• With every reagent kit<br>• After 7 days (20-25 °C)<br>• After 3 days (25-32 °C) | Same |
| Sample type | Human serum, EDTA and<br>citrate plasma. | Same |
| Reagent stability | Unopened<br>• Up to the stated expiration<br>date at 2-8 °C<br>After opening<br>• 12 weeks at 2-8°C<br>• 8 weeks on Elecsys 2010<br>• 8 weeks on Elecsys 1010<br>(20-25 °C; up to 20 hours<br>opened in total) | Same |
| Calibrator | Elecsys Troponin T STAT<br>CalSet | Same |
| Controls | Elecsys PreciControl Troponin<br>T or Elecsys PreciControl<br>Cardiac. | Same |
| Duration of assay | 9 minutes | same |
| Characteristic | Elecsys® Troponin T STAT<br>(modified intended use) | Predicate device Elecsys®<br>Troponin T STAT<br>(K984105) |
| Measuring range | 0.010 - 25.00 ng/mL | Same |
| Precision | Within-run (human serum)<br>• 1.1% CV at 0.47 ng/mL<br>• 1.1% CV at 2.63 ng/mL<br>• 1.4% CV at 11.5 ng/mL<br>Within-run (PreciControl)<br>• 4.2% CV at 0.10 ng/mL<br>• 3.0% CV at 5.07 ng/mL<br>Total (human serum)<br>• 5.8% CV at 0.47 ng/mL<br>• 5.4% CV at 2.63 ng/mL<br>• 5.7% CV at 11.5 ng/mL<br>Within-run (PreciControl)<br>• 9.3% CV at 0.10 ng/mL<br>• 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<br>Lowest concentration giving<br>10 % CV: 0.03 ng/mL | Same |

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#### Predicate device (continued)

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#### Predicate device (continued)

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The performance characteristics of the Elecsys® Troponin T STAT test and Substantial the predicate device are compared in the table below. equivalence: performance characteristics

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| Characteristic | Elecsys® Troponin T STAT<br>(modified intended use) | Predicate device Elecsys®<br>Troponin T STAT<br>(K984105) |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Limitations –<br>interference | No interference from | Same |
| | • icterus up to 27 mg/dL<br>bilirubin | |
| | • hemolysis up to 0.1 g/dL, | |
| | • Lipemia up to 1500 mg/dL<br>Intralipid | |
| | • Biotin up to 50 ng/mL | |
| | • Rheumatoid factor up to<br>2000 U/mL | |
| | Falsely depressed results are<br>obtained when using samples<br>with higher hemoglobin<br>concentrations. | |
| | Plasma samples collected<br>with heparin or<br>oxalate/fluoride revealed<br>sample-dependent low TnT<br>values compared to results<br>obtained on serum samples. | |
| | Contains additives to<br>minimize the effects of<br>interference due to<br>• Monoclonal mouse<br>antibodies<br>• Antibodies to streptavidin | |
| | Extremely high titers of<br>antibodies to ruthenium can<br>cause interference. | |
| | Results should be assessed in<br>conjunction with the<br>patient's medical history,<br>clinical examination, and<br>other findings | |

Substantial equivalence: performance characteristics (continued)

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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).

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#### 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 [phone]. 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 [phone] or [phone] 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

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### 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
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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040733