ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM

K121214 · Beckman Coulter, Inc. · MMI · Jun 14, 2013 · Clinical Chemistry

Device Facts

• Record ID: K121214
• Device Name: ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
• Applicant: Beckman Coulter, Inc.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Jun 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The Access AccuTnI+3 Reagent is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction. The Access AccuTnI+3 Calibrators are intended to calibrate the Access AccuTnI+3 Reagent for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction. The Access 2 Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Device Story

The Access AccuTnI+3 system is an automated, paramagnetic particle, chemiluminescent immunoassay used in clinical laboratories to measure cardiac troponin I (cTnI) in human serum and plasma. The system utilizes mouse monoclonal anti-human cTnI antibodies on magnetic particles and an alkaline phosphatase conjugate to form a sandwich immunoassay. The Access 2 Immunoassay System processes samples, performs the assay, and provides quantitative results to clinicians. The device includes a thermal algorithm to monitor and manage internal instrument temperature, ensuring result accuracy within specified ambient ranges. Clinicians use these results to aid in the diagnosis of myocardial infarction. The system benefits patients by providing rapid, quantitative cardiac biomarker data to support timely clinical decision-making.

Clinical Evidence

Prospective multicenter study of 1,929 patients presenting with chest pain/ischemic symptoms. Adjudicated diagnosis based on 2007 Universal Definition of MI. Sensitivity/specificity evaluated at 0.03 ng/mL (feasibility cutoff), 0.02 ng/mL (99th percentile URL), and 0.04 ng/mL. At 0.03 ng/mL, baseline sensitivity was 87.4% (95% CI: 82.6-91.2) and specificity 89.3% (95% CI: 87.7-90.7). At 0.02 ng/mL, baseline sensitivity was 92.1% (95% CI: 88.1-95.1) and specificity 84.3% (95% CI: 82.5-86.0).

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Reagents: mouse monoclonal anti-human cTnI antibodies, alkaline phosphatase conjugate, TRIS/ACES buffered saline, BSA matrix, ProClin 300. System: automated discrete photometric chemistry analyzer. Connectivity: microcomputer-controlled, random/continuous access. Software: Version 3.3 includes thermal algorithm for temperature management.

Indications for Use

Indicated for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma to aid in the diagnosis of myocardial infarction. For use by clinical laboratory professionals on the Access 2 Immunoassay System.

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

• ADVIA Centaur TnI-Ultra Assay and ADVIA Centaur TnI-Ultra Calibrators (K053020)
• Access 2 Immunoassay System (K922823/A007)

Submission Summary (Full Text)

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#### 510(k) Summary

# JUN 1 4 2013

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

The assigned 510(k) number is k121214

#### Submitted By:

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

#### Contact Person:

Kerrie Oetter 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: [phone] Fax: [phone]

#### Date Prepared:

June 12, 2013

#### Device Name:

Proprietary / Trade Name: Access AccuTn1+3 Reagent for use on the Access 2 Immunoassay Systems Common Name: Troponin I Enzyme Immunoassay Classification Name: Immunoassay, Troponin Subunits Classification Regulation: 21 CFR 862.1215 Classification Product Code: MMI

Proprietary / Trade Name: Access AccuTnI+3 Calibrator Common Name: Calibrator Classification Name: Calibrator Classification Regulation: 21 CFR 862.1150 Subsequent Product Code: JIT

Proprietary / Trade Name: Access 2 Immunoassay System Common Name: Discrete photometric chemistry analyzer for clinical use Classification Name: Discrete photometric chemistry analyzer for clinical use Classification Regulation: 21 CFR 862.2160 Classification Product Code: JJE

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### Predicate Devices:

The Access AccuTnl+3 Reagent and AccuTnl+3 Calibrators claim substantial equivalence to the ADVIA Centaur TnI-Ultra™ Assay and ADVIA Centaur TnI-Ultra™ Calibrators for the Siemens ADVIA Centaur® System. FDA 510(k) Number K053020, cleared December 30, 2005.

The Access 2 Immunoassay System claims substantial equivalence to the Access 2 Immunoassay System (K922823/A007), cleared July 2, 2001.

#### Device Description:

The Access AccuTnl+3 reagents, AccuTnl+3 calibrators and the Access 2 Immunoassay System compose the Access Immunoassay System for the quantitative determination of cardiac troponin I (cTn!) in human serum and plasma.

The Access AccuTnI+3 reagent packs contain specific reagents for the in vitro diagnostic measurement of cTnI including:

- Paramagnetic particles coated with mouse monoclonal anti-human cardiac . troponin I suspended in TRIS buffered saline, with surfactant, bovine serum albumin (BSA) matrix. <0.1% sodium azide, and 0.1% ProClin® 300.
- 0.1N NaOH. .
- . TRIS buffered saline, surfactant, <0.1% sodium azide and 0.1% ProClin 300.
- Mouse monoclonal anti-human cTnI alkaline phosphatase conjugate . diluted in ACES buffered saline, with surfactant, BSA matrix, protein (bovine, goat, mouse), <0.1% sodium azide, and 0.25% ProClin 300.

The Access AccuTnl+3 Calibrator set contains multi-point calibrators for use with the Access AccuTnI+3 assay. Individual vials contain zero or approximately 0.3. 1.2, 5.0, 25 and 100 ng/mL (ug/L) of recombinant cardiac troponin I complex. respectively, in a buffered BSA matrix, with surfactant, <0.1% sodium azide, and 0.1% ProClin 300.

The Access 2 Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

#### Intended Use:

The Access AccuTnI+3 Reagent is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction.

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The Access AccuTnI+3 Calibrators are intended to calibrate the Access AccuTnI+3 Reagent for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction.

The Access 2 Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

#### Comparison to the Predicates:

The Access AccuTnI+3 Reagent and Access AccuTnl+3 Calibrators and the predicate device, ADVIA Centaur® TnI-Ultra™ Assay and ADVIA Centaur® · Tnl-Ultra™ Calibrators, were compared. The information for the predicate device was derived from the predicate device 510(k) Summary and product labeling.

#### Similarities between the Access AccuTnI+3 Reagent and Access AccuTnI+3. Calibrators and the Predicate

| Characteristic | Predicate Device<br>ADVIA Centaur® TnI-UltraTM<br>K053020 | New Device<br>Access AccuTnI+3 Reagent and<br>Access AccuTnI+3Calibrators |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Intended Use | An <i>in vitro</i> diagnostic method for the<br>quantitative measurement of cardiac<br>TnI in serum and plasma to aid in the<br>diagnosis of myocardial infarction. | same |
| Assay Principle | Chemiluminescent sandwich<br>immunoassay | same |
| Test System | Automated immunoassay instrument | same |
| Sample Type | Serum and heparinized plasma | same |
| Reagent Pack<br>configuration | Reagents ready to use and separated in<br>a single reagent pack | same |
| Primary Reagent<br>Materials | Solid phase magnetic particles, anti-<br>cTnI antibodies | same |

### Differences between the Access AccuTnI+3 Reagent and Calibrator and the Predicate

| Characteristic | Predicate Device<br>ADVIA Centaur® TnI-Ultra™<br>K053020 | New Device<br>Access AccuTnl+3 Reagent and Access<br>AccuTnl+3 Calibrators |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample Type | EDTA plasma | No EDTA plasma claim |
| Immunoassay<br>Instrument | ADVIA Centaur | Access 2 Immunoassay System |
| Calibrator<br>Materials | Bovine cTnI in goat serum | Recombinant troponin complex in buffered<br>BSA |
| Calibrators:<br>number and type | Two Lyophilized : high and low (use<br>with Master Curve) | Six Liquid: approximately 0, 0.3, 1.2, 5.0,<br>25 and 100 ng/mL with no master curve |
| | Predicate Device | New Device |
| Characteristic | ADVIA Centaur® Tnl-Ultra™<br>K053020 | Access AccuTnI+3 Reagent and Access<br>AccuTnI+3 Calibrators |
| Specific Reagent<br>Materials | Polyclonal goat anti-cTnI antibody<br>labeled with acridinium ester, 2<br>biotinylated mouse monoclonal anti-<br>cTnI antibodies, magnetic particles<br>conjugated with streptavidin | Mouse monoclonal anti-human cTnI<br>alkaline phosphatase conjugate, magnetic<br>particles coated with mouse monoclonal<br>anti-human cTnI |
| Sample Volume | 100μl | 55μl |
| Analytical<br>Measuring Range | 0.008 ng/mL to 50 ng/mL | 0.02 ng/mL to 100 ng/mL |
| Acute Myocardial<br>Infarction (AMI)<br>Cutoff | 0.9 ng/mL per WHO-defined cutoff | 0.03ng/mL based on clinical trial outcome |
| Expected Results<br>(Upper Reference<br>Limit) | 99th percentile of 0.04 ng/mL; range of<br>0.02- 0.06 ng/mL | 99th percentile of 0.02 with a 95%<br>Confidence Interval (CI) of 0.01- 0.05<br>ng/mL |
| Precision | Total CV of 10% at a level of 0.042<br>ng/mL | Total CV of ≤8% at concentrations >0.075<br>ng/mL. SD ≤0.006 at concentrations<br>≤0.075 ng/mL |
| Indications for<br>Use Statement | The ADVIA Centaur® Tnl-Ultra (Tnl<br>Ultra) is for <i>in vitro</i> diagnostic use-in<br>the quantitative determination of<br>cardiac Troponin in human serum and<br>heparinized and EDTA plasma.<br>Cardiac troponin I determinations aid<br>in the diagnosis of acute myocardial<br>infarction and in the risk stratification<br>of patients with non-ST segment<br>elevation acute coronary syndromes<br>with respective to relative risk<br>mortality, myocardial infarction or<br>increased probability of ischemic<br>events requiring urgent<br>revascularization procedures.<br>The ADVIA Centaur® TnI-Ultra<br>Calibrator is for the <i>in-vitro</i> diagnostic<br>use in the calibration of the TnI-Ultra<br>assay on the ADVIA Centaur®<br>System. | The Access AccuTnI+3 assay is a<br>paramagnetic particle, chemiluminescent<br>immunoassay for the quantitative<br>determination of cardiac troponin I (cTnI)<br>levels in human serum and plasma using<br>the Access 2 Immunoassay System to aid<br>in the diagnosis of myocardial infarction.<br>The Access AccuTnI+3 Calibrators are<br>intended to calibrate the Access<br>AccuTnI+3 assay for the quantitative<br>determination of cardiac troponin I (cTnI)<br>levels in human serum and plasma using<br>the Access 2 Immunoassay System to aid<br>in the diagnosis of myocardial infarction. |

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The Access 2 Immunoassay System and the previously cleared version of the Access 2 Immunoassay System were compared.

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| Characteristic | Predicate Device<br>Access 2 System<br>K922823/A007 | New Device<br>Access 2 Immunoassay System |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Indication for Use | The Access 2 Immunoassay system is<br>an in vitro diagnostic device used for<br>the quantitative, semi-quantitative, or<br>qualitative determination of various<br>analyte concentrations found in human<br>body fluids. | same |
| Operating<br>Principle | Micro computer controlled, random<br>and continuous access | same |
| Assay Type | Enzyme immunoassays | same |
| Detection | Chemiluminescent | same |
| Modules | Carousel, pipettor, analytical, fluidic,<br>electronic/systems computer/peripheral | same |

## Similarities between the Access 2 Immunoassay System and the Predicate

# Differences between the Access 2 Immunoassay System and the Predicate

| Characteristic | Predicate Device<br>Access 2 Immunoassay System<br>K922823/A007 | New Device<br>Access 2 Immunoassay System |
|---------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Thermal algorithm<br>capability | Not present | Present |
| Assay Protocol<br>File (APF) | AccuTnl APF | AccuTnl APF with addition of the thermal<br>algorithm and "U" command |
| Software | Version 2.4-3.2 | Version 3.3: added capability to implement<br>the thermal algorithm and "U" Command;<br>added result suppression when instrument<br>internal case temperature is outside 18° to<br>36°C |
| Operating<br>Temperature | 18°C to 32°C ambient | 18°C to 28°C ambient<br>18°C to 36°C |

Conclusion: The information provided above demonstrates that the new device, the Access AccuTnI+3 Reagent and Access AccuTnI+3 Calibrators, have the same intended use as the predicate device. The Access 2 instrument has the same intended use as the predicate device. In addition, verification and validation testing, the clinical and analytical data, the clinical use of the product reflected in current MI diagnostic guidelines, and other scientific information provided in this submission demonstrate that the Access AccuTnI+3 Reagent, Access AccuTnI+3 Calibrators on the Access 2 Immunoassay Systems is as safe and effective as the predicate devices. Taken together, this information establishes the substantial equivalence of Beckman Coulter's products to predicates.

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#### 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 consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 14, 2013

Beckman Coulter, Inc. C/O Kerrie Oetter 1000 Lake Hazeltine Drive CHASKA MN 55318-1084

Re: K121214

Trade/Device Name: Access AccuTnl+3 Reagent and Access AccuTnl+3 Calibrators for use on the Access 2 Immunoassay Systems

Regulation Number: 21 CFR 862.1215

· Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: II Product Code: MMI, JIT, JJE Dated: June 04, 2013 Received: June 06, 2013

#### Dear Ms. Oetter:

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 .- Please note: - GDRH-does not-evaluate-information-related-to-contract-liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Ms. Oetter

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Courtney Hillias, Ph.D.

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use Form

510(k) Number (if known): k121214

Device Name: Access AccuTnl+3 Reagent and Access AccuTnl+3 Calibrators for use on the Access 2 Immunoassay Systems

Indications for Use:

The Access AccuTnl+3 Reagent is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction.

The Access AccuTnl+3 Calibrators are intended to calibrate the Access AccuTnl+3 Reagent for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction.

The Access 2 Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Prescription Use x Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Ruth A. Chešler/S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

k121214 510(k)