TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM

K052503 · Bayer Healthcare, LLC · MMI · Dec 14, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052503
• Device Name: TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
• Applicant: Bayer Healthcare, LLC
• Product Code: MMI · Clinical Chemistry
• Decision Date: Dec 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

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. 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

Device Story

ADVIA IMS® Troponin I Ultra (TnI-Ultra) assay is an in vitro diagnostic test for human serum and lithium heparin plasma. Device measures cardiac Troponin I levels to assist clinicians in diagnosing AMI and risk-stratifying patients with acute coronary syndromes. Operated by laboratory personnel on the ADVIA IMS® system. Output is a quantitative concentration (ng/mL) used alongside clinical symptoms and diagnostic procedures to inform medical decision-making regarding mortality risk and revascularization needs. Benefits include improved sensitivity and lower minimum detectable concentration compared to previous generation assays, facilitating earlier detection of cardiac events.

Clinical Evidence

Bench testing only. Performance evaluated via imprecision studies (Total CV 2.2-5.7%), correlation studies (N=97, R=0.954), and interference testing (albumin, bilirubin, hemoglobin, triglyceride). Analytical range established from 0.01 to 50 ng/mL. Functional sensitivity (10% CV) is 0.03 ng/mL. 99th percentile distribution determined from 337 healthy donors (0.04 ng/mL). AMI cutoff (≥ 1.5 ng/mL) validated against 112 AMI patients.

Technological Characteristics

In vitro diagnostic immunoassay for use on the ADVIA IMS® system. Quantitative measurement of cardiac Troponin I. Analytical range: 0.01 to 50 ng/mL. Functional sensitivity: 0.03 ng/mL. System utilizes specific reagents and calibrators for the ADVIA IMS® platform.

Indications for Use

Indicated for quantitative measurement of cardiac troponin I in human serum and lithium heparin plasma to aid in diagnosis of acute myocardial infarction (AMI) and risk stratification of patients with non-ST segment-elevation acute coronary syndromes.

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

• Bayer ACS:180® cTnI Assay

Submission Summary (Full Text)

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# 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)<br>00370639 (300 tests) | Included with Reagents |

#### 3. Device / Method

| Product Name | Reagent REF | Calibrator REF |
|--------------------------------------------------|-------------|----------------|
| ADVIA IMS® Troponin I<br>Ultra (TnI-Ultra) Assay | 02157487 | 06504521 |

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# 4. Imprecision

| ADVIA IMS® TnI-Ultra<br>Assay | Bayer ACS:180 cTnI Assay | | |
|-------------------------------|--------------------------|------------------|-------------|
| Level<br>(ng/mL) | Total CV(%) | Level<br>(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<br>System (X) | N | Regression<br>Equation | Syx<br>(ng/mL) | R | Sample<br>Range<br>(ng/mL) |
|------------------------------|---------------------------|----|------------------------|----------------|-------|----------------------------|
| Serum<br>(Passing Bablok) | Bayer<br>ACS:180 | 97 | $1.01 * X - 0.01$ | N/A | | 0.01 to 49.6 |
| Serum<br>(Linear Regression) | Bayer<br>ACS:180 | 97 | $0.90 * X + 0.43$ | 2.64 | 0.954 | 0.01 to 49.6 |

# 6. Interfering substances

| Interference | Interference<br>Conc.<br>mg/dL | Recovery<br>(ng/mL) | | %<br>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)

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## 8. Minimum Detectable Concentration

| ADVIA IMS® TnI-<br>Ultra<br>(ng/mL) | Bayer ACS:180® cTnI<br>(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<br>µg/L (ng/mL) |
|----------------------|-----|-----------------------|
| Healthy Blood Donors | 337 | < 0.04 |
| AMI patients | 112 | ≥ 1.5 |

Andres Holle Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 Date

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 4 2005

Mr. Andres Holle Manager, Regulatory Affairs Bayer HealthCare Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591

Re: k052503 Trade/Device Name: Troponin I Ultra Assay and Calibrator for the ADVIA IMS® System Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI, JIT Dated: November 7, 2005 Received: November 9, 2005

Dear Mr. Holle:

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 Amendmants, 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 I.C. 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 not Incun 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 pratis e requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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/industry/support/index.html.

Sincerely vours.

Alberto Gutierrez

Alberto Gutierrez, Ph.D. 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): K052503

Device Name: Troponin I Ultra Assay and Calibrator for the ADVIA IMS® System

Indications For Use:

The ADVIA IMS® Troponin I Ultra (Tn!-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 seament-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

Prescription Use
(Part 21 CFR 801 Subpart D)

(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)

| | Carol Benson |
|--|--------------|
| | |
| | K052503 |

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