ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345

K021814 · Beckman Coulter, Inc. · MMI · Sep 27, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021814
• Device Name: ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345
• Applicant: Beckman Coulter, Inc.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Sep 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The Access AccuTnl assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac troponin I determination aids in the risk stratification of patients with unstable angina or 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.

Device Story

Access AccuTnl is a paramagnetic particle, chemiluminescent immunoassay system; measures cardiac troponin I (cTnl) levels in human serum and plasma. Used in clinical laboratory settings; operated by laboratory personnel. System transforms chemiluminescent signals into quantitative cTnl concentrations. Output provided to clinicians to aid in diagnosis/treatment of myocardial infarction and cardiac muscle damage; also used for risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes. Enables assessment of relative risk for mortality, myocardial infarction, or urgent revascularization needs. Benefits include improved patient management through objective cardiac risk assessment.

Clinical Evidence

Clinical performance evaluated using relative risks (RR) and odds ratios (OR) for double (death/MI) and triple (death/MI/urgent revascularization) composite endpoints. Data analyzed at three cutoffs (97.5th percentile, 99th percentile, and 10% CV imprecision) across three follow-up periods (30 days, 42 days, 10 months). All RR and OR values were statistically significant across all cutoffs and follow-up periods, supporting the device's utility in patient risk stratification.

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Analyzers: Access and Access 2 Immunoassay Systems. Quantitative measurement of cardiac troponin I. No changes to assay reagents from predicate.

Indications for Use

Indicated for patients with unstable angina or non-ST segment elevation acute coronary syndromes to aid in risk stratification for mortality, myocardial infarction, or ischemic events requiring urgent revascularization. Also indicated to aid in diagnosis and treatment of myocardial infarction and cardiac muscle damage.

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

• AccuTnl™ and AccuTnI Calibrators on the Access® Immunoassay System (K010429)

Submission Summary (Full Text)

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SEP 2 7 2002

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

K021814/

# Submitter's Name and Address

Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: [phone] Fax: [phone] Contact: Brent Taber

Date Prepared: May 31, 2002

#### Device Names

| Proprietary Name: | AccuTnl™ and AccuTnl Calibrators on the Access® |
|----------------------|-------------------------------------------------|
| | Immunoassay Systems |
| Common Name: | Troponin I Enzyme Immunoassay |
| Classification Name: | Immunoassay, Troponin Subunits |

#### Predicate Device

AccuTnl™ and AccuTnI Calibrators on the Access® Immunoassay System Beckman Coulter, Inc. Chaska, MN 55318

510(k) Number: K010429

# Device Description

The Access AccuTnl reagents, AccuTnl calibrators, and the Access and Access 2 Immunoassay Analyzers comprise the Access Immunoassay Systems for the quantitative determination of cardiac troponin I in human serum and plasma.

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Image /page/1/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle with two curved white lines inside, resembling a wave or an eye. To the right of the symbol are the words "BECKMAN" stacked on top of "COULTER" in a bold, sans-serif font.

### Intended Use

The Access AccuTnl assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin | (cTnl) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage.

Cardiac troponin I determination aids in the risk stratification of patients with unstable angina or non-ST seqment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.

# Summary of Analytical Studies

No changes have been made to the assay reagents submitted under K010429. The 510(k) Summary for K010429 summarizes analytical studies including precision, analytical sensitivity, dilution recovery (linearity), method comparison, matched sample comparison, analytical specificity, stability, reference intervals, and equimolarity.

#### Summary of Clinical Performance

Relative Risks (RR), Odds Ratios (OR), and clinical sensitivity and specificity were calculated relative to three Access AccuTnl cutoffs (97.5TH and 99TH percentiles of the reference range, and the median concentration at 10% CV imprecision), three follow-up periods (30 days, 42 days, and 10 months), and two endpoints (double composite endpoint consisting of death or myocardial infarction and triple composite endpoint consisting of death or myocardial infarction or urgent revascularization).

At the 97.5 Th percentile of the reference range, relative risks and odds ratios for the double and triple composite endpoints ranged from 1.68 to 3.61 for all three follow-up periods. All relative risks and odds ratios were statistically significant for both composite endpoints and the three follow-up periods.

At the 9911 percentile of the reference range, relative risks and odds ratios for the double and triple composite endpoints ranged from 1.58 to 3.18 for all three follow-up periods. All relative risks and odds ratios were statistically significant for both composite endpoints and the three follow-up periods.

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Image /page/2/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized oval shape on the left, with two curved lines inside. To the right of the oval is the text "BECKMAN" in a bold, sans-serif font, stacked above the text "COULTER" in the same font.

At the median concentration at 10% CV imprecision, relative risks and odds ratios for the double and triple composite endpoints ranged from 1.62 to 3.60 for all three follow-up periods. All relative risks and odds ratios were statistically significant for both composite endpoints and the three follow-up periods.

The data demonstrate that the Access AccuTnl assay can be utilized to stratify patients for potential adverse cardiac events (double and triple composite endpoints) using three cutoffs at three follow-up periods.

#### Conclusion

Access AccuTnl and AccuTnl calibrators on the Access Immunoassay Systems, with the addition of a risk stratification for use to the intended use, is substantially equivalent to Access AccuTnl and AccuTnl calibrators on the Access Immunoassay System with indications as an aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage (K010429).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 7 2002

Mr. Brent Taber Senior Regulatory Specialist Beckman Coulter Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084

Re: k021814

> Trade/Device Name: AccuTnI™ and AccuTnI Calibrators on the Access® Immunoassay Systems Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase ot isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: August 15, 2002 Received: August 16, 2002

Dear Mr. Taber:

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 the Code of Federal Regulations. Title 21, Parts 800 to 898. 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 complics 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

Page of

510(k) Number (if known): JJ (x) 8/

Device Name: AccuTnl™ and AccuTnl Calibrators on the Access® Immunoassay Systems

#### Indications For Use:

The Access AccuTnl assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage.

Cardiac troponin I determination aids in the risk stratification of patients with unstable angina or 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.

Sean Cooper

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number K021814

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The Counter Use ____________

(Optional Format 1-2-96)