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

K140496 · Beckman Coulter, Inc. · CDD · Sep 16, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140496
• Device 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
• Applicant: Beckman Coulter, Inc.
• Product Code: CDD · Clinical Chemistry
• Decision Date: Sep 16, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Intended 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 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 Immunoassay 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.

Device Story

Power Express is a scalable, modular laboratory automation system (LAS) for clinical laboratories; automates pre-analytical sample preparation including pre-centrifugation, centrifugation, decapping, and sorting. Input: patient sample tubes. Transformation: system transports tubes via track system to modules; performs automated preparation; routes samples to Generic Connection Modules for pipetting by connected analyzers (e.g., UniCel DxI 800). Output: processed samples presented to analyzers or routed to outlet racks. Operation: managed by Line Control Computer and Cennexus software; operator interfaces via touch-screen GUI. Benefits: streamlines peri-analytical processes; reduces manual labor; minimizes biohazard exposure for laboratory personnel. Clinical decision-making: provides automated, standardized sample preparation for downstream diagnostic assays, ensuring consistent input for clinical chemistry and immunoassay testing.

Clinical Evidence

Bench testing only. Verification and validation activities performed based on risk analysis to assess impact of hardware and software modifications. No clinical data required for this modification.

Technological Characteristics

Modular LAS architecture; track transport system with 4 lanes; RFID sample tracking; touch-screen GUI; Windows 7 OS. Connectivity: ASTM protocol with LIS-defined aliquots and host query. Throughput: 1200 tubes/hour with 4 centrifuges. Fault-tolerant design with dual modules for critical hardware. Software: Cennexus control software; Microsoft Defender anti-spyware. Sterilization: N/A (not applicable).

Indications for Use

Indicated for clinical laboratory use to automate sample processing, including transport, centrifugation, and preparation for in vitro diagnostic testing.

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 Connection Module V5.0 (K110413)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| 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) |

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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: [phone] FAX: [phone]

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

#### 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 | Docket<br>Number |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------------------|
| Power Express | Power Processor Sample Processing System with Generic Connection Module V5.0<br>Access Ferritin Assay<br>Access Folate Assay<br>Access HYPERsensitive hTSH Assay<br>Access Vitamin B12 Assay | Beckman<br>Coulter, Inc. | K110413 |

#### 5.0 Descrintion:

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.

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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.

#### 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 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 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.

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 anemias of gastrointestinal malabsorption.

### 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 /<br>Characteristic | Power Processor Sample Processing System with<br>Generic Connection Module | Power<br>Express |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| | | Software Version 5.0 (K110413) |
| | The basic Power Processor is an automated sample<br>handling system which processes sample tubes from<br>the pre-centrifugation, pre-sorting step to presentation<br>of centrifuged and decapped samples into Generic or<br>Personality Racks for specific instruments. | |
| Intended Use | The Power Processor can be configured with optional<br>software and hardware to allow processing of sample<br>tubes on Generic Connection Instruments. The Power<br>Processor performs all pre-analytical sample tube<br>preparation then sorts the sample tubes directly to<br>Generic Connection Modules where the samples are<br>pipetted by the Generic Connection Instrument for<br>testing. After the samples are pipetted, the tubes can<br>route to other instruments for additional testing or to<br>Outlet Racks. | Same<br>(replacing the<br>name with<br>Power<br>Express) |
| System Design | Open LAS architecture enables multiple analyzer<br>connections, including 3rd party systems. Scalable,<br>modular configuration. | Same |
| Sample<br>Transfer<br>Method | Onboard sampling is the physical transfer of the<br>sample tube/rack from the automation track to the<br>analyzer's sample load and identification area.<br>Outboard sampling capability using the analyzer's<br>existing LAS communications interface and Generic<br>Connection Module. | Same |
| Fundamental<br>Technology | Centralized operation and monitoring of decentralized<br>equipment. | Same |
| Chemistry<br>Analyzer<br>Connection | Unicel DxI 800 Access Immunoassay System | Same |
| Assay<br>Performance | Access Ferritin Assay<br>Access Folate Assay<br>Access HYPERsensitive hTSH Assay<br>Access Vitamin B12 Assay | Same |
| Aspect/<br>Characteristic | Power Processor Sample Processing<br>System with Generic Connection Module -<br>Software Version 5.0 | Power Express |
| System<br>Modules | The basic Power Processor System is<br>comprised of a line controller computer, a<br>system console with PrepLink™ software, inlet<br>module, hematology module, centrifugation<br>module, decapper module, track transport<br>system, and output module. The Generic<br>Connection module is an optional module to<br>enable analyzer connectivity. | Same, except for<br>replacement of<br>PrepLink software<br>with Cennexus.<br>No hematology<br>module. |
| Sample<br>Identification | Identification of patient tubes and sample<br>programming using bar codes. | Same, except for<br>tube tracking using<br>short range RFID<br>readers detecting<br>embedded chips in<br>the sample carrier. |
| Sample<br>Handling | Processes multiple tube sizes/types<br>simultaneously; sorts and maps samples for<br>routing, storage, and retrieval; performs<br>intelligent sample routing based on system<br>status for LX/DxC/IDC (DxI), connections.<br>Generic connection modules process only a<br>single tube size. | Same, except<br>Beckman Coulter LX<br>and DxC instruments<br>are connected using<br>the Generic<br>connection interface |
| Operating<br>Environment | Operating Software Microsoft Windows XP,<br>Computer Console with Single User Interface. | Operating Software<br>Microsoft Windows<br>7 Computer Console<br>with Single User<br>Interface |
| Host<br>Communication | The ability to interface with a LIS device to<br>receive patient identification and test requests<br>via a communications protocol to provide<br>sample tracking via bar code labeling. | ASTM protocol with<br>LIS Defined aliquots<br>and Host Query. |
| Throughput | 450 tubes per hour (with 2 centrifuges). | 1200 tubes per hour<br>(with 4 centrifuges),<br>and addition of 2<br>lanes/ track to<br>manage more<br>carriers at same<br>track velocity. |
| Control panel | Buttons and 2 character display. | Touch screen based<br>control on each<br>module GUI with<br>LCD. |
| Cyber security | Field Service Engineers login with password. | Field Service<br>Engineers, Users,<br>Supervisors login<br>with password. |
| Aspect/<br>Characteristic | Power Processor Sample Processing<br>System with Generic Connection Module -<br>Software Version 5.0 | Power Express |
| | | Microsoft Defender<br>for anti-spyware. |
| | | Fault tolerant<br>capability with dual<br>modules for the<br>critical hardware<br>functions. |
| Racks per Inlet | 4 racks that hold 50 tubes each. | Up to 8 racks that<br>hold up to 50 tubes<br>each. |
| Storage units | 3 storage units of the same type. | Up to 4 ambient or<br>refrigerated storage<br>units. |
| Centrifuge | Tube sizes must be all the same. | Supports mixed tube<br>sizes. |
| Inlet/Outlets | 200 tubes<br>No drawer - open platform. | 400 tubes<br>Access through<br>drawers (2 drawers in<br>each of the<br>inlet/outlets). |
| Track lanes | 2 lanes. | 4 lanes. |
| Aliquotter | Manual tray filling<br>Single<br>System defined secondary tube labeling. | Bulk feeder<br>Dual units System<br>and LIS defined<br>secondary tube<br>labeling. |
| Centrifuges | 2 centrifuges. | 4 centrifuges. |
| Primary<br>Decapper | Single unit (Rocker). | Dual unit (Rotary). |
| Secondary<br>Decapper | 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.