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.

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.

AI/ML Overview

This document focuses on the substantial equivalence of the DxA 5000 automated sample handling system and related immunoassay tests (Ferritin, Folate, TSH, Vitamin B12) to previously cleared devices. It describes engineering performance studies rather than clinical efficacy studies. Therefore, many of the typical clinical study criteria requested (like multi-reader multi-case studies, effect size of human improvement with AI, number of experts for ground truth, sample size for training sets) are not applicable or detailed in this submission.

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document states that "The acceptance criteria were met for all method comparisons thereby demonstrating the following:"

Acceptance Criteria / Performance Aspect	Reported Device Performance
Equivalence (DTS barcode identification process)	Equivalence between the predicate lab automation system Power Processor and the candidate one, DxA 5000 in terms of the DTS barcode identification process was demonstrated. (Specific metrics for "equivalence" are not detailed in the provided text, but it's stated as "met").
Equivalence (pre-analytical processing)	Equivalence between the predicate lab automation system Power Processor and the candidate one, DxA 5000 in terms of pre-analytical processing was demonstrated. (Specific metrics for "equivalence" are not detailed, but it's stated as "met").
Method Comparison (TSH, Ferritin, Folate, B12 Assays)	For all method comparisons (TSH (3rd IS), Ferritin, Folate and B12 assays), results were within the specifications when the candidate (DxA 5000 connected to UniCel DxI 800 Access Immunoassay System) was compared to the predicate (Power Processor connected to UniCel DxI 800 Access Immunoassay System). (Specific specifications are not provided, but compliance is affirmed).
Software Design, Development, and Verification	All software design, development, and verification activities have been completed. (This is a qualitative statement of completion rather than a specific performance metric).

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify the exact sample sizes used for the method comparison studies. It mentions that the studies utilized CLSI EP09, which is a guideline for method comparison and bias estimation using patient samples, but the number of samples is not disclosed.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). However, given it's a 510(k) submission for an in vitro diagnostic device, the studies are typically conducted in a controlled laboratory setting, often in a prospective manner or using banked samples that meet specific criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in the document. The acceptance criteria and performance relate to the comparability of the new automation system and immunoassay tests against predicate devices, not against a "ground truth" established by experts for diagnostic accuracy in a clinical setting in the way an AI imaging device might. The "ground truth" here is the performance of the predicate device/system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are typically used in studies where human readers are interpreting data (e.g., medical images) and their interpretations need to be reconciled to establish a consensus ground truth. This is an engineering/analytical performance study for a laboratory automation system and immunoassay tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. MRMC studies are relevant for imaging devices where human readers are involved in the diagnostic process. This document concerns a laboratory automation system and immunoassay tests, not an AI-assisted diagnostic imaging tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The studies described are for the performance of the integrated system (DxA 5000 connected to the DxI 800 Access Immunoassay System running specific assays). While the system operates largely automatically (an "algorithm only" in the sense that the mechanical and analytical processes are automated), its performance is compared to a human-operated predicate system or another automated system. This is not an "AI algorithm only" study in the context of diagnostic decision support, but rather an automated analytical system comparison.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the performance of the legally marketed predicate devices/systems:

Power Processor Sample Processing System (K110413) for the DxA 5000's automation features.
Beckman Coulter UniCel® DxI 800 Access® Immunoassay System (K023764), Access® Ferritin assay (K926221), Access® Folate assay (K060774), Access® HYPER sensitive hTSH assay (K042281), and Access® Vitamin B12 assay (K955436) for the immunoassay performance in conjunction with the automation system.

The study aimed to demonstrate that the new device system yielded results "within specifications" when compared to the predicate, implying the predicate's performance served as the benchmark or "ground truth" for equivalence.

8. The sample size for the training set

This information is not applicable and not provided. This is a 510(k) submission for laboratory equipment and assays, not a machine learning/AI device requiring a "training set" in the computational sense. The "development" for such systems involves rigorous engineering, analytical validation, and verification based on established chemical, biological, and mechanical principles.

9. How the ground truth for the training set was established

This information is not applicable for the reasons stated in point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a bold, sans-serif font, with the word "ADMINISTRATION" underneath in a smaller font.

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.

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

{3}------------------------------------------------

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)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{4}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{5}------------------------------------------------

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: +49 (0) 89 579589-3611 Email: abrown2@beckman.com

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	RegulationNumber	ProductCode	DeviceClass	ReviewPanel
Discrete photometric chemistryanalyzer for clinical use	862.2160	JJE	I	ClinicalChemistry
Ferritin immunological testsystem	866.5340	JMG	II	ClinicalChemistry
Folic acid test system	862.1295	CGN	II	ClinicalChemistry
Thyroid stimulating hormonetest system	862.1690	JLW	II	ClinicalChemistry
B12 test system	862.1810	CDD	II	ClinicalChemistry

Page 5-1 Confidential

{6}------------------------------------------------

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 SampleProcessing System	Beckman Coulter,Inc.	K110413

5.0 Device Description

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

{7}------------------------------------------------

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.

{8}------------------------------------------------

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 anautomated sample handling systemwhich processes sample tubes fromthe pre-centrifugation, pre-sortingstep to presentation of centrifugedand decapped samples into Genericor Personality Racks for specificinstruments. The Power Processorcan be configured with optionalsoftware and hardware to allowprocessing of sample tubes onGeneric Connection Instruments.The Power Processor performs allpre-analytical sample tubepreparation, and then sorts thesample tubes directly to GenericConnection Modules where thesamples are pipetted by theGeneric Connection instrument fortesting. After the samples arepipetted, the tubes can route toother instruments for additionaltesting or to Outlet Racks.	The DxA 5000 is a high-speed,modular, automated samplehandling system that performspre-analytical and post-analytical sample processingand storage. The automationsystem also sorts, routes, andpresents sample tubes toanalyzers for analysis. TheDxA 5000 also consolidates avariety of analyticalinstruments, such as anImmunoassay analyzer, into aunified workstation on a tracksystem.

System Design	Open LAS architecture enablesmultiple analyzer connections,including 3rd party systems.Scalable, modular configuration.	Same
FundamentalTechnology	Centralized operation andmonitoring of decentralizedequipment.	Same
Sample TransferMethod	Onboard sampling is the physicaltransfer of the sample tube/rackfrom the automation track to theanalyzer's sample load andidentification area.Outboard sampling capability readsthe barcode for the analyzer andsignals the analyzer's existing LAScommunications interface toperform direct track sampling.	Same
HostCommunications	The ability to interface with aLaboratory Information System (LIS)device to receive patientidentification and test requests viaa communications protocol toprovide sample tracking via barcode labeling.	The ability to interface with aLaboratory InformationSystem (LIS) device viaRemisol to receive patientidentification and testrequests (based on bar codelabeling) and to providesample tracking via acommunications protocol.
OperatingEnvironment	Operating Software MicrosoftWindows XP, Computer Consolewith Single User Interface.	Main Console: MicrosoftWindows embedded Standard7 (64-Bit) with one userinterface per system.
SampleIdentification	Identification of patient tubes andsample programming using barcodes.	Same
Control panel	Buttons and 2 character display	Touch screen based control oneach module console
Racks per Inlet	4 racks that hold 50 tubes each	36 tubes per rack, 4 racks perdrawer, 3 drawers
ImmunoassayAnalyzerConnection	Unicel Dxl 800 Access ImmunoassaySystem	Same
AssayPerformance	Access Ferritin AssayAccess Folate AssayAccess HYPERsensitive hTSH AssayAccess Vitamin B12 Assay	Same
Throughput	450 tubes per hour (with 2centrifuges).	Up 1200 tubes per hour
SampleContainers	Primary and secondary Tubes	Same
Aliquotter	Yes	No
Centrifugation	Tube sizes must be all the same.	Can support multiple tubesizes
De-capping	Yes	Same
SampleIdentification	Barcode	Same
Sample Storage	Yes	Same
VolumeDetection	Yes- (Combination of infraredsensor and pressure sensor)	Yes- (Laser- Liquid LevelDetection)

{9}------------------------------------------------

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.

{10}------------------------------------------------

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 toBeckman Coulter UniCel® Dxl 800Access® Immunoassay System	DxA 5000 connected toBeckman Coulter UniCel® Dxl800 Access® Immunoassay System
Dxl 800Indications forUse	The UniCel Dxl 800 AccessImmunoassay System withlaboratory automation connectionis a microcomputer-controlled,random and continuous accessanalyzer that includes an externalcomputer. This computer storesthe system user interface (UI)software and allows the operatorto interface with and direct theinstrument software. The UniCelDxl 800 System uses enzymeimmunoassays (utilizingparamagnetic particle solid phaseand chemiluminescent detection)	The UniCel Dxl 800 AccessImmunoassay System is amicrocomputer controlled,random and continuous accessanalyzer that includes anexternal computer. Thiscomputer stores the systemuser interface (UI) softwareand allows the operator tointerface with and direct theinstrument software. TheUniCel Dxl 800 System usesenzyme immunoassays(utilizing paramagneticparticle solid phase and

{11}------------------------------------------------

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 variousanalytes, such as Vitamin B12,Ferritin, Folate and hTSH along withother various enzymeimmunoassays assays that may beadaptable to the analyzerdepending on the reagent used toinduce the enzyme immunoassayreaction. The UniCel Dxl 800System is an in vitro diagnosticdevice for use in the clinicallaboratory.	chemiluminescent detection)for the quantitative, semi-quantitative or qualitativedetermination of variousanalyte concentrations foundin human body fluids. TheUniCel Dxl 800 System is an invitro diagnostic device for usein the clinical laboratory.
MainAutomationConnectionSoftware	Prep Link software	Remisol software
SampleIdentification	Barcode	Same

Characteristic	Power Processor connected toBeckman Coulter UniCel® Dxl 800Access® Immunoassay Systemwith Ferritin assay	DxA 5000 connected toBeckman Coulter UniCel® Dxl800 Access® ImmunoassaySystem with Ferritin assay
Beckman CoulterAccess® Ferritinassay Indicationsfor Use	The Access Ferritin assay is aparamagnetic particle,chemiluminescent assay for thequantitative determination offerritin levels in human serum andplasma (heparin) using the AccessImmunoassay Systems.Measurements of ferritin aid in thediagnosis of diseases affecting ironmetabolism.	The Access Ferritin assay is aparamagnetic particle,chemiluminescentimmunoassay for thequantitative determination offerritin levels in human serumand plasma (heparin) using theAccess Immunoassay Systems.
SampleIdentification	Barcode	Same

{12}------------------------------------------------

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 toBeckman Coulter UniCel® Dxl 800Access® Immunoassay Systemwith Folate assay	DxA 5000 connected toBeckman Coulter UniCel® Dxl800 Access® ImmunoassaySystem with Folate assay
Beckman CoulterAccess® Folateassay Indicationsfor Use	The Access Folate assay is aparamagnetic particle,chemiluminescent immunoassayfor the quantitative determinationof folic acid levels in human serum,plasma (heparin) and red bloodcells using the Access ImmunoassaySystems. Folic acid measurementsare used in the diagnosis andtreatment of megaloblastic anemia.	The Access Folate assay is aparamagnetic particle,chemiluminescentimmunoassay for thequantitative determination offolic acid levels in humanserum and plasma (heparin) orred blood cells using theAccess Immunoassay Systems.Folate levels in serum andplasma (heparin) or red bloodcells are used to assess folatestatus. The serum folate levelis an indicator of recent folateintake. A low RBC folate valuecan indicate a prolongedfolate deficiency.
SampleIdentification	Barcode	Same

Characteristic	Power Processor connected toBeckman Coulter UniCel® Dxl 800Access® Immunoassay Systemwith hTSH assay	DxA 5000 connected toBeckman Coulter UniCel® Dxl800 Access® ImmunoassaySystem with hTSH assay
Beckman CoulterAccess® hTSHassay Indicationsfor Use	The Access HYPER sensitive HTSHassay is a paramagnetic particle,chemiluminescent assay for thequantitative determination ofhuman thyroid-stimulatinghormone (thyrotropin, hTSH) levelsin human serum using the AccessImmunoassay Systems.Measurements of thyroidstimulating hormone produced by	The Access TSH (3rd IS) assayis a paramagnetic particle,chemiluminescentimmunoassay for thequantitative determination ofhuman thyroid-stimulatinghormone (thyrotropin, TSH,hTSH) levels in human serumand plasma using the AccessImmunoassay Systems. This

{13}------------------------------------------------

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 inthe diagnosis of thyroid or pituitarydisorders.	assay is capable of providing3rd generation TSH results.
SampleIdentification	Barcode	Same

Characteristic	Power Processor connected toBeckman Coulter UniCel® Dxl 800Access® Immunoassay Systemwith B12 assay	DxA 5000 connected toBeckman Coulter UniCel® Dxl800 Access® ImmunoassaySystem with B12 assay
Beckman CoulterAccess® B12assay Indicationsfor Use	The Access Vitamin B12 assay is aparamagnetic particle,chemiluminescent assay for thequantitative determination ofvitamin B12 in human serum andplasma (heparin) using AccessImmunoassay Systems.Measurements obtained by thisdevice are used in the diagnosisand treatment of anemias ofgastrointestinal malabsorption.	The Access Vitamin B12 assayis a paramagnetic particle,chemiluminescentimmunoassay for thequantitative determination ofvitamin B12 levels in humanserum and plasma (heparin)using the Access ImmunoassaySystems.
SampleIdentification	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.

{14}------------------------------------------------

Image /page/14/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.

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.

Regulation Number and Section

§ 862.1810 Vitamin B

12 test system.(a)
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.(b)
Classification. Class II.