The basic Power Express is an automated sample handling system which processes sample tubes from the precentrifugation, pre-sorting step to presentation of centrifuged and decapped samples into Generic or Personality Racks for specific instruments. The Power Express can be configured with optional software to allow processing of sample tubes on Generic Connection Instruments. The Power Express performs all pre-analytical sample tube preparation, and then sorts the sample tubes directly to Generic Connection Modules where the samples are pipetted by the Generic Connection instrument for testing. After the samples are pipetted, the tubes can route to other instruments for additional testing or to Outlet Racks.

The UniCel DxI 800 Access Immunoasav System with laboratory automation is a microcomputer-controlled. random and continuous access analyzer that includes an external 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 determination of various analytes, such as Vitamin B12. Ferritin, Folate and hTSH along with other various enzyme immunoassays assays that may be adaptable to the analyzer depent used to induce the enzyme immunoassay reaction. 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 HYPER sensitive hTSH assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, 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 Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption.

Device Description

The Power Express is Beckman Coulter's Power Processor Sample Processing System with the modifications noted in this premarket submission. The Power Express and the Power Processor Sample Processing System are scalable laboratory automation systems (LAS) designed to streamline peri-analytical processes in the clinical laboratory.

The Power Express is an automated sample handling system which processes sample tubes from the pre-centrifugation, pre-sorting steps to presentation of centrifuged and decapped samples into racks for chemistry, immunoassay, hematology, and coagulation systems. The Power Express is designed to free laboratory personnel from biohazard exposure and routine sample preparation.

The Power Express software can be configured with optional hardware to allow processing of sample tubes on physically connected analyzers using common communication protocols (Generic Connection Instruments). The Power Express performs pre-analytical sample tube preparation then sorts the sample tubes directly to the optional hardware interface between the LAS and analyzer (Generic Connection Module) where the samples are pipetted by the analyzer for testing. After the samples are pipetted, the tubes can be routed to other instruments for additional testing or to Outlet Racks.

A basic Power Express System is comprised of a Line Control Computer, a system console with Cennexus software, Inlet Module, Centrifugation Module, Decapper Module, track transport system and Outlet Module. Additional modules may be added for aliquot capability, sample capping, and ambient or refrigerated storage.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the efficacy of new clinical features from scratch. This influences the nature of the "acceptance criteria" and "study" described. The document largely asserts that the modifications to the Power Processor system did not introduce new risks to the performance of the integrated assays, and therefore formal V&V testing was sufficient rather than full clinical studies.

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

The document does not explicitly present a table of "acceptance criteria" in the traditional sense of numerical thresholds for clinical performance (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" can be inferred from the statement that "all software design, development and verification activities have been completed and passed to supports equivalency of Power Express to the Power Processor V5.0 Sample Processing System." The performance reported is that the device "functions as intended, meeting the requirements of the design specifications."

Let's infer acceptance criteria based on the modifications and the intent of substantial equivalence:

Acceptance Criterion (Inferred)	Reported Device Performance (Implied)
Functional Equivalence of Software: All new and modified software features (Sample Management, Data Management, Set-up, Analyzer Connections, Host Interface Communications, Communication with Line Control Software, Sample Routing Logic, Sample Storage, Error Recovery) perform their intended functions as safely and effectively as the predicate's software.	"Software design testing of: Sample Management, Data Management, Set-up, Analyzer Connections, Host Interface Communications, Communication with Line Control Software, Sample Routing Logic, Sample Storage, Error Recovery" completed and passed. This implies the software functions as intended and supports the system's overall operation for sample processing and immunoassay integration.
System Operations: The overall system, including new hardware components (e.g., increased throughput, new control panel, more modules), processes samples reliably and correctly.	"System verification and validation testing of: System Functions, System operations, Maintenance, Error conditions, Error codes, Problem description and solution in the system instructions for use" completed and passed. This indicates that the integrated system operates as designed, handles various operational scenarios, and maintains user guidance for errors. The comparison table confirms improved throughput (1200 tubes/hour vs. 450 tubes/hour) and enhanced features (e.g., touch screen, improved cybersecurity, mixed tube sizes, dual aliquots, more centrifuges).
Assay Performance Maintenance: The performance of the integrated Access Immunoassays (Ferritin, Folate, HYPERsensitive hTSH, Vitamin B12) is not adversely affected by the Power Express system.	The document states, "Based on the risk analysis, the modifications to the Power Processor did not introduce any new risks to the performance of the assays through the chemistry analyzer connections; therefore there was no requirement for Verification and Validation Testing." This implies that the prior proven performance of these assays when run on the predicate system is maintained, and no new studies were deemed necessary to re-verify assay performance due to the nature of the system modifications. The device "functions as intended, meeting the requirements of the design specifications."
Safety and Effectiveness: The Power Express is as safe and effective as the predicate device.	"Performance testing of the device demonstrates that the device functions as intended... The changes to the device do not constitute a new intended use and any differences in technological characteristics have been tested to demonstrate that the device is as safe and effective as the predicate and do not raise different questions of safety and effectiveness."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for test sets in the context of clinical or performance data for the assays themselves. The testing described is primarily software and system verification and validation (V&V). These are typically internal engineering tests rather than studies involving patient samples in a clinical setting with formal sample sizes as understood in clinical trials.

Sample Size for Test Set: Not specified, as the testing was primarily V&V of the automated system's components and software.
Data Provenance: Not applicable in the context of system V&V. This would typically be relevant for clinical studies involving patient data. This was internal Beckman Coulter testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the type of V&V testing described. "Ground truth" in this context would likely refer to expected system behaviors, software outputs, or known operational parameters, which would be established by the device's design specifications and engineering teams, rather than by external clinical experts.

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

Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert opinions on diagnosis or outcome. For system V&V, "adjudication" would be a matter of comparing test results against predefined functional requirements and expected outputs, often automated or reviewed by a single test engineer or a team.

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

Not applicable. An MRMC study is relevant for imaging devices or diagnostic tools where human interpretation is involved. The Power Express is an automated sample processing system and immunoassay platform; its function is to prepare samples and run assays, not to assist human interpretation of complex data in the way AI assistance might.

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

Yes, the testing described is effectively "standalone" for the automated system. The Power Express system, as an automated sample handling and processing system, operates without direct human intervention in its core tasks (centrifugation, decapping, sorting, routing, pipetting, running assays on connected instruments). The performance data mentioned refers to the verification and validation of this automated system's functionality and software.

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

The "ground truth" for the verification and validation (V&V) described would be the design specifications and functional requirements of the Power Express system. This includes:

Expected software behaviors and outputs.
Correct execution of mechanical tasks (e.g., decapping, sorting, pipetting).
Correct communication protocols with connected instruments and the LIS.
Adherence to performance metrics like throughput.
The known performance characteristics of the integrated commercial assays (Ferritin, Folate, hTSH, Vitamin B12) which were previously established and not re-evaluated.

8. The sample size for the training set

Not applicable. The Power Express is an automated sample processing system, not an AI or machine learning model that requires a "training set" of data. The software within the system is likely rule-based or deterministic, rather than learned.

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

Not applicable, as there is no "training set" for this type of device.

Summary

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

September 16, 2014

BECKMAN COULTER, INC. NANETTE CANEPA STAFF REGULATORY AFFAIRS 250 S. KRAEMER BLVD., MAIL CODE E1.SE.01 BREA CA 92821

Re: K140496 Trade/Device Name: Access Vitamin B12 Assay Access Ferritin Assay Access Folate Assay Access HYPERsensitive hTSH Assay Power Express Sample Processing System Generic Connection Module Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: II Product Code: CDD, DBF, CGN, JLW, JJE Dated: August 14, 2014 Received: August 18, 2014

Dear Ms. Canepa:

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 (reporting of

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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.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809). please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Courtney H. Lias -S

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

510(k) Number (if known) K140496

Device Name

Power Express Sample Processing System with Generic Connection Module and Access Immunoassay System Reagents

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.

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510(k) Summary Power Express

1.0 Submitted By:

Nanette Canepa Staff Regulatory Affairs Beckman Coulter, Inc. 250 S. Kraemer Blvd., Mail Code E1.SE.01 Brea, California 92821 Telephone: (714) 961-3136 FAX: (714) 961-4234

2.0 Date Submitted:

September 12, 2014

3.0 Device Name(s):

3.1 Proprietary Name

Access Vitamin B12 Assay Access Ferritin Assay Access Folate Assay Access HYPERsensitive hTSH Assay Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents

3.2 Common Name

Access Vitamin B12 Assay Access Ferritin Assay Access Folate Assay Access HYPERsensitive hTSH Assay Laboratory Automation System

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3.3 Classification Name

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

4.0 Predicate Device:

The Power Express claims substantial equivalence to the Power Processor Sample Processing System with Generic Connection Module V5.0 currently in commercial distribution, FDA 510(k) Number K110413.

Candidate(s)	Predicate	Manufacturer	DocketNumber
Power Express	Power Processor Sample Processing System with Generic Connection Module V5.0Access Ferritin AssayAccess Folate AssayAccess HYPERsensitive hTSH AssayAccess Vitamin B12 Assay	BeckmanCoulter, Inc.	K110413

5.0 Descrintion:

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6.0 Indications for Use:

The basic Power Express is an automated sample handling system which processes sample tubes from the pre-centrifugation, pre-sorting step to presentation of centrifuged and decapped samples into Generic or Personality Racks for specific instruments. The Power Express can be configured with optional hardware to allow processing of sample tubes on Generic Connection Instruments. The Power Express performs all pre-analytical sample tube preparation, and then sorts the sample tubes directly to Generic Connection Modules where the samples are pipetted by the Generic Connection instrument for testing. After the samples are pipetted, the tubes can route to other instruments for additional testing or to Outlet Racks.

The UniCel DxI 800 Access Immunoassay System with laboratory automation connection 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 determination of various analytes, such as Vitamin B12, Ferritin, Folate and hTSH along with other various enzyme immunoassays assays that may be adaptable to the analyzer depending on the reagent used to induce the enzyme immunoassay reaction. The UniCel DxI 800 System is an in vitro diagnostic device for use in the clinical laboratory.

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The Access HYPER sensitive hTSH assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of human thyroidstimulating hormone (thyrotropin. 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.

7.0 Comparison to the Predicate: (Description of the Modification to the Legally Marketed Device)

The modifications to the Power Processor include an upgrade to the process control software and upgrades to the hardware which were implemented using Beckman Coulter design controls. The list of similarities and differences between the Power Processor and the Power Express are listed in the table below.

The following table provides a summary of the similarities between the Power Express and the Power Processor.

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Aspect /Characteristic	Power Processor Sample Processing System withGeneric Connection Module	PowerExpress
		Software Version 5.0 (K110413)
	The basic Power Processor is an automated samplehandling system which processes sample tubes fromthe pre-centrifugation, pre-sorting step to presentationof centrifuged and decapped samples into Generic orPersonality Racks for specific instruments.
Intended Use	The Power Processor can be configured with optionalsoftware and hardware to allow processing of sampletubes on Generic Connection Instruments. The PowerProcessor performs all pre-analytical sample tubepreparation then sorts the sample tubes directly toGeneric Connection Modules where the samples arepipetted by the Generic Connection Instrument fortesting. After the samples are pipetted, the tubes canroute to other instruments for additional testing or toOutlet Racks.	Same(replacing thename withPowerExpress)
System Design	Open LAS architecture enables multiple analyzerconnections, including 3rd party systems. Scalable,modular configuration.	Same
SampleTransferMethod	Onboard sampling is the physical transfer of thesample tube/rack from the automation track to theanalyzer's sample load and identification area.Outboard sampling capability using the analyzer'sexisting LAS communications interface and GenericConnection Module.	Same
FundamentalTechnology	Centralized operation and monitoring of decentralizedequipment.	Same
ChemistryAnalyzerConnection	Unicel DxI 800 Access Immunoassay System	Same
AssayPerformance	Access Ferritin AssayAccess Folate AssayAccess HYPERsensitive hTSH AssayAccess Vitamin B12 Assay	Same
Aspect/Characteristic	Power Processor Sample ProcessingSystem with Generic Connection Module -Software Version 5.0	Power Express
SystemModules	The basic Power Processor System iscomprised of a line controller computer, asystem console with PrepLink™ software, inletmodule, hematology module, centrifugationmodule, decapper module, track transportsystem, and output module. The GenericConnection module is an optional module toenable analyzer connectivity.	Same, except forreplacement ofPrepLink softwarewith Cennexus.No hematologymodule.
SampleIdentification	Identification of patient tubes and sampleprogramming using bar codes.	Same, except fortube tracking usingshort range RFIDreaders detectingembedded chips inthe sample carrier.
SampleHandling	Processes multiple tube sizes/typessimultaneously; sorts and maps samples forrouting, storage, and retrieval; performsintelligent sample routing based on systemstatus for LX/DxC/IDC (DxI), connections.Generic connection modules process only asingle tube size.	Same, exceptBeckman Coulter LXand DxC instrumentsare connected usingthe Genericconnection interface
OperatingEnvironment	Operating Software Microsoft Windows XP,Computer Console with Single User Interface.	Operating SoftwareMicrosoft Windows7 Computer Consolewith Single UserInterface
HostCommunication	The ability to interface with a LIS device toreceive patient identification and test requestsvia a communications protocol to providesample tracking via bar code labeling.	ASTM protocol withLIS Defined aliquotsand Host Query.
Throughput	450 tubes per hour (with 2 centrifuges).	1200 tubes per hour(with 4 centrifuges),and addition of 2lanes/ track tomanage morecarriers at sametrack velocity.
Control panel	Buttons and 2 character display.	Touch screen basedcontrol on eachmodule GUI withLCD.
Cyber security	Field Service Engineers login with password.	Field ServiceEngineers, Users,Supervisors loginwith password.
Aspect/Characteristic	Power Processor Sample ProcessingSystem with Generic Connection Module -Software Version 5.0	Power Express
		Microsoft Defenderfor anti-spyware.
		Fault tolerantcapability with dualmodules for thecritical hardwarefunctions.
Racks per Inlet	4 racks that hold 50 tubes each.	Up to 8 racks thathold up to 50 tubeseach.
Storage units	3 storage units of the same type.	Up to 4 ambient orrefrigerated storageunits.
Centrifuge	Tube sizes must be all the same.	Supports mixed tubesizes.
Inlet/Outlets	200 tubesNo drawer - open platform.	400 tubesAccess throughdrawers (2 drawers ineach of theinlet/outlets).
Track lanes	2 lanes.	4 lanes.
Aliquotter	Manual tray fillingSingleSystem defined secondary tube labeling.	Bulk feederDual units Systemand LIS definedsecondary tubelabeling.
Centrifuges	2 centrifuges.	4 centrifuges.
PrimaryDecapper	Single unit (Rocker).	Dual unit (Rotary).
SecondaryDecapper	Single unit (Rocker).	Single unit (Rotary).
Recapper	Single unit.	Dual unit.

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The following table provides a summary of the differences between the Power Express and the Power Processor.

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Summarv of Performance Data: 8.0

Based on the risk analysis, the modifications to the Power Processor did not introduce any new risks to the performance of the assays through the chemistry analyzer connections; therefore there was no requirement for Verification and Validation Testing.

To address the modifications to the Power Processor, performance data from verification and validation testing demonstrated that all software design, development and verification activities have been completed and passed to supports equivalency of Power Express to the Power Processor V5.0 Sample Processing System. Evidence is demonstrated through

Software design testing of:

Sample Management
Data Management
Set-up ●
Analyzer Connections ●
. Host Interface Communications
Communication with Line Control Software ●
Sample Routing Logic ●
Sample Storage ●
Error Recovery ●

System verification and validation testing of:

System Functions
System operations
Maintenance
. Error conditions
Error codes
Problem description and solution in the system instructions for use

9.0 Conclusion:

As summarized, the Power Express is substantially equivalent to the originally cleared Power Processor Sample Processing System. Performance testing of the device demonstrates that the device functions as intended, meeting the requirements of the design specifications. The changes to the device do not constitute a new intended use and any differences in technological characteristics have been tested to demonstrate that the device is as safe and effective as the predicate and do not raise different questions of safety and effectiveness.

The 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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.