DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

K190298 · Beckman Coulter Biomedical GmbH · CDD · Oct 4, 2019 · Clinical Chemistry

Device Facts

• Record ID: K190298
• Device Name: DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
• Applicant: Beckman Coulter Biomedical GmbH
• Product Code: CDD · Clinical Chemistry
• Decision Date: Oct 4, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Intended Use

The DxA 5000 is a high-speed, modular, automated sample handling system that performs preanalytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.

Device Story

The DxA 5000 is a high-throughput laboratory automation system that integrates pre- and post-analytical sample processing with analytical instruments. It identifies, tracks, centrifuges, decaps, routes, and stores sample tubes via a track system. It presents tubes to the UniCel DxI 800 Access Immunoassay System, which performs quantitative chemiluminescent immunoassays. The DxI 800 uses paramagnetic particle solid-phase technology and chemiluminescent detection to measure analyte concentrations. The system is operated by laboratory personnel in a clinical setting. The automation system improves workflow efficiency by consolidating analytical instruments into a unified workstation. The output is quantitative analyte concentration data, which assists clinicians in diagnosing and treating conditions related to iron metabolism, folate deficiency, and thyroid function.

Clinical Evidence

No clinical data. Bench testing included a method comparison study evaluating 96-114 patient samples per analyte (Ferritin, Folate, TSH, Vitamin B12) processed by both the DxA 5000 and the predicate Power Processor. Results showed high correlation (R=0.981-0.999) and slopes near 1.0, confirming comparable performance.

Technological Characteristics

Modular, track-based laboratory automation system. Features include laser-based liquid level detection, barcode-based sample identification, and touch-screen console interfaces. Connectivity via LIS/Remisol software. Supports multiple tube sizes and refrigerated/non-refrigerated storage. Software runs on Microsoft Windows embedded Standard 7 (64-Bit).

Indications for Use

Indicated for use in clinical laboratories as a high-speed, modular, automated sample handling system for pre-analytical and post-analytical processing, sorting, routing, and presentation of human serum, plasma, and red blood cell samples to connected analytical instruments for the quantitative or qualitative determination of analytes including ferritin, folate, TSH, and vitamin B12.

Regulatory Classification

Identification

A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Predicate Devices

• Power Processor Sample Processing System With Generic Connections (K110413)
• Access Ferritin assay (K926221)
• Access Folate assay (K060774)
• Access HYPER sensitive hTSH assay (K042281)
• Access Vitamin B12 assay (K955436)
• UniCel DxI 800 Access Immunoassay System (K023764)

Submission Summary (Full Text)

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October 4, 2019

Beckman Coulter Biomedical GmbH Amanda Brown Manager Regulatory Affairs Sauerbruchstr. 50 Munich, 81377 Germany

Re: K190298

Trade/Device Name: Access Vitamin B12 Access Ferritin Access Folate Access TSH (3rd IS) DxA 5000 DxI 800 Access Immunoassay System Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 Test System Regulatory Class: Class II Product Code: CDD, JMG, CGN, JLW, JJE Dated: August 8, 2019 Received: August 21, 2019

Dear Amanda Brown:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) k190298

### Device Name

DxA 5000, DxI 800 Access Immunoasay System, Access Folate, Access TSH (3rd IS), Access Vitamin B12

### Indications for Use (Describe)

The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and postanalytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.

The DxI 800 Access Immunoassay System is a microcomputer controlled, random and continuous access analyzer that includes an external computer. This computer stores the system user interface (UI) software and allows the operator to interface with and direct the instrument software. The UniCel DxI 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for the quantitative or qualitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxI 800 System is an in vitro diagnostic device for use in the clinical laboratory.

The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism.

The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum and plasma (heparin) or red blood cells using the Access Immunoassay Systems. Folate levels in serum and plasma (heparin) or red blood cells are used to assess folate status. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. This assay is capable of providing 3rd generation TSH results. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/5/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circular shape with two white curved lines inside, resembling a stylized eye or a wave pattern. To the right of the symbol, the words "BECKMAN" are stacked above the word "COULTER" in a bold, sans-serif font.

#### 1.0 Submitted By:

Amanda Brown, RAC Manager Regulatory Affairs Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 81377 Munich Germany Telephone: [phone] Email: [e-mail]

#### 2.0 Date Submitted:

February 8, 2019

#### 3.0 Device Name(s):

#### 3.1 Proprietary Names

DxA 5000

Dxl 800 Access Immunoassay System Access Ferritin Access Folate Access TSH (3rd IS) Access Vitamin B12

#### 3.2 Common Name

Laboratory Automation System

#### 3.2 Classification Name

| Name | Regulation<br>Number | Product<br>Code | Device<br>Class | Review<br>Panel |
|-------------------------------------------------------------|----------------------|-----------------|-----------------|-----------------------|
| Discrete photometric chemistry<br>analyzer for clinical use | 862.2160 | JJE | I | Clinical<br>Chemistry |
| Ferritin immunological test<br>system | 866.5340 | JMG | II | Clinical<br>Chemistry |
| Folic acid test system | 862.1295 | CGN | II | Clinical<br>Chemistry |
| Thyroid stimulating hormone<br>test system | 862.1690 | JLW | II | Clinical<br>Chemistry |
| B12 test system | 862.1810 | CDD | II | Clinical<br>Chemistry |

Page 5-1 Confidential

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Image /page/6/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape with two white curved lines inside, resembling a stylized wave or ribbon. To the right of the oval is the company name, "BECKMAN COULTER," with "BECKMAN" stacked on top of "COULTER" in a bold, sans-serif font.

#### 4.0 Legally Marketed Device

| Candidate(s) | Predicate | Manufacturer | Document Number |
|--------------|---------------------------------------------|--------------------------|-----------------|
| DxA 5000 | Power Processor Sample<br>Processing System | Beckman Coulter,<br>Inc. | K110413 |

#### 5.0 Device Description

The DxA system is a high throughput automated sample handling system which can perform the pre and post analytical processing of sample tubes. DxA can identify and track samples, perform centrifugation, decapping, delivery of samples to connected analyzers, recapping, storing in either non-refrigerated or refrigerated storage, and sorting to output racks.

The DxA integrates perianalytic (pre and post analysis) functions with analytical instruments (Beckman Coulter, and other manufacturer's) via a track system to provide fully integrated testing solutions.

#### 6.0 Intended Use

The DxA 5000 is a high-speed, modular, automated sample handling system that performs preanalytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.

#### 7.0 Indications for Use

The DxA 5000 is a high-speed, modular, automated sample handling system that performs preanalytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.

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Image /page/7/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape with two white curved lines inside, placed to the left of the company name. The text "BECKMAN" is on the top line and "COULTER" is on the bottom line, both in a bold, sans-serif font.

The UniCel Dxl 800 Access Immunoassay System is a microcomputer controlled, random and continuous access analyzer that includes an external computer. This computer stores the system user interface (UI) software and allows the operator to interface with and direct the instrument software. The UniCel Dxl 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel Dxl 800 System is an in vitro diagnostic device for use in the clinical laboratory.

The Access Ferritin assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism.

The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of human thyroidstimulating hormone (thyrotropin, TSH, hTSH) levels in human serum using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of vitamin B12 in human serum and plasma (heparin) using Access lmmunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

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Image /page/8/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the company name "BECKMAN" in bold black letters above "COULTER" also in bold black letters. The logo is simple and modern, with a clear emphasis on the company name.

### Comparison to the Predicate

### Predicate Device Name and 510k information:

Power Processor Sample Processing System (k110413) Beckman Coulter UniCel® Dxl 800 Access® Immunoassay System (k023764) Beckman Coulter Access® Ferritin assay (k926221) Beckman Coulter Access® Folate assay (k060774) Beckman Coulter Access® HYPER sensitive hTSH assay (k042281) Beckman Coulter Access® Vitamin B12 assay (k955436)

The DxA 5000 has the following similarities to the previously cleared Power Processor Sample Processing System (K110413).

| Characteristic | Power Processor | DxA 5000 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The basic Power Processor is an<br>automated sample handling system<br>which processes sample tubes from<br>the pre-centrifugation, pre-sorting<br>step to presentation of centrifuged<br>and decapped samples into Generic<br>or Personality Racks for specific<br>instruments. The Power Processor<br>can be configured with optional<br>software and hardware to allow<br>processing of sample tubes on<br>Generic Connection Instruments.<br>The Power Processor performs all<br>pre-analytical sample tube<br>preparation, and then sorts the<br>sample tubes directly to Generic<br>Connection Modules where the<br>samples are pipetted by the<br>Generic Connection instrument for<br>testing. After the samples are<br>pipetted, the tubes can route to<br>other instruments for additional<br>testing or to Outlet Racks. | The DxA 5000 is a high-speed,<br>modular, automated sample<br>handling system that performs<br>pre-analytical and post-<br>analytical sample processing<br>and storage. The automation<br>system also sorts, routes, and<br>presents sample tubes to<br>analyzers for analysis. The<br>DxA 5000 also consolidates a<br>variety of analytical<br>instruments, such as an<br>Immunoassay analyzer, into a<br>unified workstation on a track<br>system. |
| | | |
| System Design | Open LAS architecture enables<br>multiple analyzer connections,<br>including 3rd party systems.<br>Scalable, modular configuration. | Same |
| Fundamental<br>Technology | Centralized operation and<br>monitoring of decentralized<br>equipment. | Same |
| Sample Transfer<br>Method | Onboard sampling is the physical<br>transfer of the sample tube/rack<br>from the automation track to the<br>analyzer's sample load and<br>identification area.<br><br>Outboard sampling capability reads<br>the barcode for the analyzer and<br>signals the analyzer's existing LAS<br>communications interface to<br>perform direct track sampling. | Same |
| Host<br>Communications | The ability to interface with a<br>Laboratory Information System (LIS)<br>device to receive patient<br>identification and test requests via<br>a communications protocol to<br>provide sample tracking via bar<br>code labeling. | The ability to interface with a<br>Laboratory Information<br>System (LIS) device via<br>Remisol to receive patient<br>identification and test<br>requests (based on bar code<br>labeling) and to provide<br>sample tracking via a<br>communications protocol. |
| Operating<br>Environment | Operating Software Microsoft<br>Windows XP, Computer Console<br>with Single User Interface. | Main Console: Microsoft<br>Windows embedded Standard<br>7 (64-Bit) with one user<br>interface per system.<br> |
| Sample<br>Identification | Identification of patient tubes and<br>sample programming using bar<br>codes. | Same |
| Control panel | Buttons and 2 character display | Touch screen based control on<br>each module console |
| Racks per Inlet | 4 racks that hold 50 tubes each | 36 tubes per rack, 4 racks per<br>drawer, 3 drawers |
| Immunoassay<br>Analyzer<br>Connection | Unicel Dxl 800 Access Immunoassay<br>System | Same |
| Assay<br>Performance | Access Ferritin Assay<br>Access Folate Assay<br>Access HYPERsensitive hTSH Assay<br>Access Vitamin B12 Assay | Same |
| Throughput | 450 tubes per hour (with 2<br>centrifuges). | Up 1200 tubes per hour |
| Sample<br>Containers | Primary and secondary Tubes | Same |
| Aliquotter | Yes | No |
| Centrifugation | Tube sizes must be all the same. | Can support multiple tube<br>sizes |
| De-capping | Yes | Same |
| Sample<br>Identification | Barcode | Same |
| Sample Storage | Yes | Same |
| Volume<br>Detection | Yes- (Combination of infrared<br>sensor and pressure sensor) | Yes- (Laser- Liquid Level<br>Detection) |

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Image /page/9/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the words "BECKMAN" and "COULTER" in bold, black font. The words are stacked on top of each other, with "BECKMAN" on the top line and "COULTER" on the bottom line.

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Image /page/10/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, and the words "BECKMAN COULTER" in black, with "BECKMAN" on top of "COULTER". The font is bold and sans-serif.

| Characteristic | Power Processor connected to<br>Beckman Coulter UniCel® Dxl 800<br>Access® Immunoassay System | DxA 5000 connected to<br>Beckman Coulter UniCel® Dxl<br>800 Access® Immunoassay System |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dxl 800<br>Indications for<br>Use | The UniCel Dxl 800 Access<br>Immunoassay System with<br>laboratory automation connection<br>is a microcomputer-controlled,<br>random and continuous access<br>analyzer that includes an external<br>computer. This computer stores<br>the system user interface (UI)<br>software and allows the operator<br>to interface with and direct the<br>instrument software. The UniCel<br>Dxl 800 System uses enzyme<br>immunoassays (utilizing<br>paramagnetic particle solid phase<br>and chemiluminescent detection) | The UniCel Dxl 800 Access<br>Immunoassay System is a<br>microcomputer controlled,<br>random and continuous access<br>analyzer that includes an<br>external computer. This<br>computer stores the system<br>user interface (UI) software<br>and allows the operator to<br>interface with and direct the<br>instrument software. The<br>UniCel Dxl 800 System uses<br>enzyme immunoassays<br>(utilizing paramagnetic<br>particle solid phase and |

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Image /page/11/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, and the words "BECKMAN COULTER" in black, bold letters. The text is placed to the right of the red circle.

| | for determination of various<br>analytes, such as Vitamin B12,<br>Ferritin, Folate and hTSH along with<br>other various enzyme<br>immunoassays assays that may be<br>adaptable to the analyzer<br>depending on the reagent used to<br>induce the enzyme immunoassay<br>reaction. The UniCel Dxl 800<br>System is an in vitro diagnostic<br>device for use in the clinical<br>laboratory. | chemiluminescent detection)<br>for the quantitative, semi-<br>quantitative or qualitative<br>determination of various<br>analyte concentrations found<br>in human body fluids. The<br>UniCel Dxl 800 System is an in<br>vitro diagnostic device for use<br>in the clinical laboratory. |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Main<br>Automation<br>Connection<br>Software | Prep Link software | Remisol software |
| Sample<br>Identification | Barcode | Same |

| Characteristic | Power Processor connected to<br>Beckman Coulter UniCel® Dxl 800<br>Access® Immunoassay System<br>with Ferritin assay | DxA 5000 connected to<br>Beckman Coulter UniCel® Dxl<br>800 Access® Immunoassay<br>System with Ferritin assay |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Beckman Coulter<br>Access® Ferritin<br>assay Indications<br>for Use | The Access Ferritin assay is a<br>paramagnetic particle,<br>chemiluminescent assay for the<br>quantitative determination of<br>ferritin levels in human serum and<br>plasma (heparin) using the Access<br>Immunoassay Systems.<br>Measurements of ferritin aid in the<br>diagnosis of diseases affecting iron<br>metabolism. | The Access Ferritin assay is a<br>paramagnetic particle,<br>chemiluminescent<br>immunoassay for the<br>quantitative determination of<br>ferritin levels in human serum<br>and plasma (heparin) using the<br>Access Immunoassay Systems. |
| Sample<br>Identification | Barcode | Same |

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Image /page/12/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape on the left side, with two white curved lines running through it. To the right of the oval is the company name, "BECKMAN" in bold, black, sans-serif font, stacked on top of "COULTER", also in bold, black, sans-serif font.

| Characteristic | Power Processor connected to<br>Beckman Coulter UniCel® Dxl 800<br>Access® Immunoassay System<br>with Folate assay | DxA 5000 connected to<br>Beckman Coulter UniCel® Dxl<br>800 Access® Immunoassay<br>System with Folate assay |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Beckman Coulter<br>Access® Folate<br>assay Indications<br>for Use | The Access Folate assay is a<br>paramagnetic particle,<br>chemiluminescent immunoassay<br>for the quantitative determination<br>of folic acid levels in human serum,<br>plasma (heparin) and red blood<br>cells using the Access Immunoassay<br>Systems. Folic acid measurements<br>are used in the diagnosis and<br>treatment of megaloblastic anemia. | The Access Folate assay is a<br>paramagnetic particle,<br>chemiluminescent<br>immunoassay for the<br>quantitative determination of<br>folic acid levels in human<br>serum and plasma (heparin) or<br>red blood cells using the<br>Access Immunoassay Systems.<br>Folate levels in serum and<br>plasma (heparin) or red blood<br>cells are used to assess folate<br>status. The serum folate level<br>is an indicator of recent folate<br>intake. A low RBC folate value<br>can indicate a prolonged<br>folate deficiency. |
| Sample<br>Identification | Barcode | Same |

| Characteristic | Power Processor connected to<br>Beckman Coulter UniCel® Dxl 800<br>Access® Immunoassay System<br>with hTSH assay | DxA 5000 connected to<br>Beckman Coulter UniCel® Dxl<br>800 Access® Immunoassay<br>System with hTSH assay |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Beckman Coulter<br>Access® hTSH<br>assay Indications<br>for Use | The Access HYPER sensitive HTSH<br>assay is a paramagnetic particle,<br>chemiluminescent assay for the<br>quantitative determination of<br>human thyroid-stimulating<br>hormone (thyrotropin, hTSH) levels<br>in human serum using the Access<br>Immunoassay Systems.<br>Measurements of thyroid<br>stimulating hormone produced by | The Access TSH (3rd IS) assay<br>is a paramagnetic particle,<br>chemiluminescent<br>immunoassay for the<br>quantitative determination of<br>human thyroid-stimulating<br>hormone (thyrotropin, TSH,<br>hTSH) levels in human serum<br>and plasma using the Access<br>Immunoassay Systems. This |

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Image /page/13/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the company name in black, bold font. The word "BECKMAN" is on the top line, and "COULTER" is on the bottom line.

| | the anterior pituitary are used in<br>the diagnosis of thyroid or pituitary<br>disorders. | assay is capable of providing<br>3rd generation TSH results. |
|--------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Sample<br>Identification | Barcode | Same |

| Characteristic | Power Processor connected to<br>Beckman Coulter UniCel® Dxl 800<br>Access® Immunoassay System<br>with B12 assay | DxA 5000 connected to<br>Beckman Coulter UniCel® Dxl<br>800 Access® Immunoassay<br>System with B12 assay |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Beckman Coulter<br>Access® B12<br>assay Indications<br>for Use | The Access Vitamin B12 assay is a<br>paramagnetic particle,<br>chemiluminescent assay for the<br>quantitative determination of<br>vitamin B12 in human serum and<br>plasma (heparin) using Access<br>Immunoassay Systems.<br>Measurements obtained by this<br>device are used in the diagnosis<br>and treatment of anemias of<br>gastrointestinal malabsorption. | The Access Vitamin B12 assay<br>is a paramagnetic particle,<br>chemiluminescent<br>immunoassay for the<br>quantitative determination of<br>vitamin B12 levels in human<br>serum and plasma (heparin)<br>using the Access Immunoassay<br>Systems. |
| Sample<br>Identification | Barcode | Same |

#### 8.0 Summary of Performance Data

The acceptance criteria were met for all method comparisons thereby demonstrating the following:

- Equivalence between the predicate lab automation system Power Processor and the candidate one, DxA 5000 in terms of the DTS barcode identification process.
- Equivalence between the predicate lab automation system Power Processor and the candidate one, DxA 5000 in terms of pre-analytical processing.

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A method comparison study was performed utilizing CLSI EP09 for the following assays; TSH (3rd IS) Ferritin, Folate and B12. For all method comparisons, results were within the specifications when the candidate was compared to the predicate.

The above referenced assays are representative of the assay methodologies available for use with the connected system, however performance is not limited to use with these assays.

Performance data from testing shows that all software design, development and verification activities have been completed, and supports a finding of substantial equivalency of DxA 5000 to the Power Processor Sample Processing System.