ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

K121790 · Beckman Coulter, Inc. · MMI · Sep 25, 2013 · Clinical Chemistry

Device Facts

• Record ID: K121790
• Device Name: ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
• Applicant: Beckman Coulter, Inc.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Sep 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The Access AccuTnl+3 Reagent for use on the UniCel Dxl Access Immunoassay Systems is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the UniCel Dx1 Acess Immunoassay Systems to aid in the diagnosis of myocardial infarction. The Access AccuTnI+3 Calibrators for use on the UniCel DxI Access Immunoassay Systems are intended to calibrate the Access AccuTn1+3 Reagent for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the UniCel DxI Access Immunoassay Systems to aid in the diagnosis of myocardial infarction. The UniCel Dxl 800 Access 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, chemiluminescent, paramagnetic particle-based immunoassay for measuring cardiac troponin I (cTnl) in human serum and plasma. The system utilizes mouse monoclonal anti-human cTnl antibodies on magnetic particles and an alkaline phosphatase conjugate to detect cTnl. The UniCel DxI 800 analyzer processes samples, performs the assay, and provides quantitative results. It is intended for use in clinical laboratory settings by trained personnel. The system includes a thermal algorithm that monitors internal case temperature (18°C to 36°C) and suppresses results if the temperature is outside the specified range to ensure analytical performance. Clinicians use the quantitative cTnl output to aid in the diagnosis of myocardial infarction. The device benefits patients by providing accurate, automated cardiac biomarker quantification to facilitate timely clinical intervention.

Clinical Evidence

Prospective multicenter study of 1,929 patients presenting with chest pain/ischemic symptoms. Adjudicated diagnosis based on 2007 Universal Definition of Myocardial Infarction. Sensitivity at 0.03 ng/mL cut-off ranged from 84.2% (baseline) to 93.5% (1-3h post-presentation). Specificity ranged from 89.2% to 91.0%. NPV was 97.4-99.1%. 99th percentile upper reference limit established at <0.03 ng/mL in 527 healthy subjects.

Technological Characteristics

Paramagnetic particle-based chemiluminescent sandwich immunoassay. Reagents: mouse monoclonal anti-cTnI antibodies, alkaline phosphatase conjugate, TRIS/ACES buffered saline, surfactants, BSA, sodium azide, ProClin 300. Instrument: UniCel DxI 800 (microcomputer-controlled, random-access). Detection: luminometer. Connectivity: standalone, non-wireless. Software: includes thermal normalization algorithm. Calibration: multi-point, required every 56 days.

Indications for Use

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

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

• TnI-Ultra™ Assay and ADVIA Centaur TnlUitra Calibrators (K053020)
• UniCel DxI 800 Access Immunoassay System (K023764)

Submission Summary (Full Text)

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#### 510(k) Summary

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 K121790

#### Submitted By:

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

## Contact Person:

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

### Date Prepared:

September 23, 2013

#### Device Name:

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

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

Proprietary / Trade Name: UniCel Dx1 800 Access 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 Product Code: JJE

SEP 2 5 2013

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#### Predicate Device:

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

The UniCel Dx1 800 Access Immunoassay System claims substantial equivalence to the UniCel DxI 800 Access Immunoassay System (K023764), cleared January 28, 2003.

#### Device Description:

The Access AccuTnI+3 Reagents, AccuTn1+3 Calibrators and the UniCel Dx1 800 Access Immunoassay System compose the Access Immunoassay System for the quantitative determination of cardiac troponin I (cTnl) in human serum and plasma.

The Access AccuTnl+3 Reagent packs contain specific reagents for the in virro diagnostic measurement of cTnl including:

- · Paramagnetic particles coated with mouse monoclonal anti-human cardiac troponin I (cTnl) 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 AccuTnI+3 Calibrator set contains multi-point calibrators for use with the Access AccuTnI+3 assay. Each vial contains zero and approximately 0.2, 0.9, 3.7, 20 and 80 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 UniCel DxI 800 Access 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 AccuTnl+3 Reagent for use on the UniCel Dxl Access Immunoassay Systems is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the UniCel Dx1 Acess Immunoassay Systems to aid in the diagnosis of myocardial infarction.

The Access AccuTnI+3 Calibrators for use on the UniCel DxI Access Immunoassay Systems are intended to calibrate the Access AccuTn1+3 Reagent for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the UniCel DxI Access Immunoassay Systems to aid in the diagnosis of myocardial infarction.

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The UniCel DxI 800 Access 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 Predicate:

The Access AccuTnl+3 Reagent and Access AccuTnl+3 Calibrators for use on the UniCel DxI Access Immunoassay Systems and the predicate device, ADVIA Centaur® TnI-Ultra™Assay and ADVIA Centaur TnI-Ultra Calibrators, were compared. The information for the predicate device was derived from the predicate device 510(k) Summary and product labeling.

| Characteristic | Predicate Device<br>ADVIA Centaur® TnI-Ultra™<br>K053020 | New Device<br>Access AccuTnI+3 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Intended Use | An <i>in vitro</i> diagnostic method for the<br>quantitative measurement of cardiac TnI<br>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 a<br>single reagent pack | same |
| Primary Reagent<br>Materials | Solid phase magnetic particles, anti- cTnI<br>antibodies | same |

#### Similarities between the Access AccuTn1+3 Reagent and Calibrator and the Predicate

#### Differences between the Access AccuTn1+3 Reagent and Calibrator and the Predicate

| Characteristic | Predicate Device<br>ADVIA Centaur® TnI-Ultra™<br>K053020 | New Device<br>Access AccuTnl+3 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Sample Type | EDTA plasma | No EDTA plasma claim |
| Immunoassay<br>Instrument | ADVIA Centaur | UniCel Dxl Immunoassay System |
| Calibrator<br>Materials | Bovine cTnI in goat serum | Recombinant troponin complex in buffered<br>BSA |
| Calibrators:<br>number and<br>type | Two Lyophilized : high and low (use with<br>Master Curve) | Six Liquid: 0 and approximately 0.2, 0.9,<br>3.7, 20 and 80 ng/mL with no master curve |
| Specific<br>Reagent<br>Materials | Polyclonal goat anti-cTnl antibody labeled<br>with acridinium ester, 2 biotinylated mouse<br>monoclonal anti-cTnI antibodies, magnetic<br>particles conjugated with streptavidin | Mouse monoclonal anti-human cTnl<br>alkaline phosphatase conjugate, magnetic<br>particles coated with mouse monoclonal<br>anti-human cTnl |
| Indications for<br>Use | Cardiac troponin I determinations aid in the<br>diagnosis of acute myocardial infarction and<br>in the risk stratification of patients with non-<br>ST segment elevation acute coronary<br>syndromes with respective to relative risk<br>mortality, myocardial infarction or increased<br>probability of ischemic events requiring<br>urgent revascularization procedures. | No risk stratification indication |

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| Characteristic | Predicate Device<br>ADVIA Centaur® TnI-Ultra™<br>K053020 | New Device<br>Access AccuTnI+3 |
|---------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Sample<br>Volume | 100μL | 55μL |
| Analytical<br>Measuring<br>Range | 0.008 ng/mL to 50 ng/mL | 0.03 ng/mL to 80 ng/mL |
| Acute<br>Myocardial<br>Infarction<br>(AMI) Cutoff | 0.78 ng/mL per WHO-defined cutoff | 0.03 ng/mL based on clinical trial outcome |
| Expected<br>Results (Upper<br>Reference<br>Limit) | 99th percentile of 0.04 ng/mL; range of 0.02-<br>0.06 ng/mL | 99th percentile upper reference limit<br>(URL) is < 0.03 ng/mL with a 97.5% upper<br>confidence limit of 0.04 ng/mL |
| Precision | Total CV of 10% at a level of 0.03 ng/mL | Total CV of ≤8% at concentrations >0.075<br>ng/mL. SD ≤0.006 at concentrations<br>≤0.075 ng/mL |

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

The UniCel Dxl 800 Access Immunoassay System and the previously cleared version of the UniCel Dx1 800 Access Immunoassay System were compared.

| Characteristic | Predicate Device<br>UniCel Dx1 800 Access<br>Immunoassay System<br>K023764 | New Device<br>UniCel DxI 800 Access<br>Immunoassay System |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Indications for Use | The UniCel Dxl 800 Access<br>Immunoassay System is an in vitro<br>diagnostic device used for the<br>quantitative, semi-quantitative, or<br>qualitative determination of various<br>analyte concentrations found in<br>human body fluids. | same |
| Operating Principle | Micro computer controlled, random<br>and continuous access | same |
| Assay Type | Enzyme immunoassays | same |
| Detection | Chemiluminescent | same |
| Modules | SPU, sample/reagent storage,<br>pipettor, bulk feeder, analytical,<br>carriage, substrate, pick and place,<br>fluidics, electronic/systems<br>computer, peripheral | same |

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#### Similarities between the UniCel DxI 800 Access Immunoassay System and the Predicate

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| Differences between the UniCel DxI 800 Access Immunoassay System and the Predicate | | |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Predicate Device<br>UniCel DxI 800 Access<br>Immunoassay System<br>K023764 | New Device<br>UniCel DxI 800 Access<br>Immunoassay System |
| Thermal algorithm<br>capability | Not present | Present |
| Assay Protocol<br>File (APF) | AccuTnl APF | AccuTnI+3 APF with addition of the<br>thermal algorithm |
| Software | Version 2.4-4.4 | Version 4.5: added capability to implement<br>the thermal algorithm; added result<br>suppression when instrument internal case<br>temperature is outside 18° to 36°C |
| Operating<br>Temperature | 18°C to 32°C ambient | 18°C to 30°C ambient<br>18°C to 36°C instrument case temperature |

Conclusion: The information provided above demonstrates that the new device, the Access AccuTn1+3 Reagent and Access AccuTnl+3 Calibrators for use on the UniCel DxI Access Immunoassay System, have the same intended use as the predicate device. The UniCel Dx1 800 Access Immunoassay System 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 UniCel Dx1 Access 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 is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administratio 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 25, 2013

Beckman Coulter Inc. c/o Kerrie Oetter 1000 Lake Hazeltine Dr. CHASKA MN 55318-1084

Re: K121790

Trade/Device Name: Access AccuTnl+3 Reagent, Access AccuTnI+3 Calibrator, UniCel 1 Dx1 800 Access Immunoassay System

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: September 04, 2013 Received: September 11, 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: CDRH 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 Parts 801 and 809); medical device 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 regulations (21 CFR Parts 801 and 809), please contact 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. 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.hum.

Sincerely yours,

# Carol C. Benson -S for

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): K121790

Device Name: Access AccuTnl+3 Reagent, Access AccuTnl+3 Calibrator and UniCel Dxl 800 Access 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 UniCel Dxl Access Immunoassay Systems 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 1 (cTnl) levels in human serum and plasma using the UniCel Dxl Access Immunoassay Systems to aid in the diagnosis of myocardial infarction.

The UniCel Dxl 800 Access 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 × (Part 21 CFR 801 Subpart D)

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

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

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

Ruth A. Chesler -S

Division Sign-Off Office of In Vitro Devices and Radiologic Health Evaluation and Safety 510(k)_k)_____________________________________________________________________________________________________________________________________________________________________

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