(201 days)
Not Found
No
The document describes an automated sample handling system and immunoassay analyzers. There is no mention of AI or ML in the intended use, device description, or performance studies. The software described is focused on sample management, data management, and communication protocols, not learning or predictive capabilities.
No
The device is described as an automated sample handling system and an in vitro diagnostic device for determining various analytes; it does not directly treat or diagnose patients.
Yes
The text describes the "UniCel DxI 800 Access Immunoassay System" which "uses enzyme immunoassays... for determination of various analytes, such as Vitamin B12, Ferritin, Folate and hTSH" and states it "is an in vitro diagnostic device for use in the clinical laboratory." It also details specific diagnostic uses for the Access Ferritin, Folate, HYPERsensitive hTSH and Vitamin B12 assays, such as aiding in the "diagnosis of diseases affecting iron metabolism" or "diagnosis of thyroid or pituitary disorders."
No
The device description explicitly details hardware components such as a Line Control Computer, system console, Inlet Module, Centrifugation Module, Decapper Module, track transport system, and Outlet Module. While software is mentioned as a component, the device is clearly a physical sample handling system with integrated software, not a software-only device.
Based on the provided text, here's the analysis of whether the Power Express is an IVD:
Analysis:
- The "Intended Use / Indications for Use" section explicitly states: "The UniCel DxI 800 System is an in vitro diagnostic device for use in the clinical laboratory."
- The Power Express is described as an automated sample handling system that processes samples for instruments like the UniCel DxI 800.
- The Power Express performs pre-analytical sample preparation and sorts tubes directly to Generic Connection Modules where samples are pipetted by the analyzer for testing.
- The predicate device listed is the "Power Processor Sample Processing System with Generic Connection Module V5.0; Access Ferritin Assay; Access Folate Assay; Access HYPERsensitive hTSH Assay; Access Vitamin B12 Assay". The Access assays are clearly described as IVD assays.
Conclusion:
While the Power Express itself is a sample handling system and not a device that directly performs diagnostic testing on patient samples, it is an integral part of an in vitro diagnostic system. It is designed to prepare and present samples to IVD analyzers (like the UniCel DxI 800) for diagnostic testing. Therefore, the Power Express, as described in the context of its intended use with IVD analyzers, is considered a component of an IVD system and is subject to regulatory oversight as such.
The text doesn't explicitly state "The Power Express is an in vitro diagnostic device," but its function and integration with explicitly labeled IVD devices strongly indicate that it falls under the scope of IVD regulation as a component or accessory.
Answer: Yes, the Power Express is part of an In Vitro Diagnostic (IVD) system.
N/A
Intended Use / 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 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
CDD, DBF, CGN, JLW, JJE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three human profiles facing to the right. The profiles are stacked on top of each other, with the first profile being the largest and the third profile being the smallest.
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
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
5
3.3 Classification Name
| Name | Regulation
Number | Product
Code | Device
Class | Review
Panel |
|-------------------------------------------------------------|----------------------|-----------------|-----------------|-----------------------|
| Vitamin B12 test system | 862.1810 | CDD | II | Clinical
Chemistry |
| Ferritin immunological test
system | 866.5340 | DBF | II | Immunology |
| Folic acid test system | 862.1295 | CGN | II | Clinical
Chemistry |
| Thyroid stimulating hormone
test system | 862.1690 | JLW | II | Clinical
Chemistry |
| Discrete photometric chemistry
analyzer for clinical use | 862.2160 | JJE | I | Clinical
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
Number |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------------------|
| Power Express | Power Processor Sample Processing System with Generic Connection Module V5.0
Access Ferritin Assay
Access Folate Assay
Access HYPERsensitive hTSH Assay
Access Vitamin B12 Assay | Beckman
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.
6
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.
7
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.
8
| Aspect /
Characteristic | Power Processor Sample Processing System with
Generic Connection Module | Power
Express |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| | | Software Version 5.0 (K110413) |
| | The basic Power Processor 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. | |
| Intended Use | The Power Processor can be configured with optional
software and hardware to allow processing of sample
tubes on Generic Connection Instruments. The Power
Processor performs all pre-analytical sample tube
preparation 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. | Same
(replacing the
name with
Power
Express) |
| System Design | Open LAS architecture enables multiple analyzer
connections, including 3rd party systems. Scalable,
modular configuration. | Same |
| Sample
Transfer
Method | Onboard sampling is the physical transfer of the
sample tube/rack from the automation track to the
analyzer's sample load and identification area.
Outboard sampling capability using the analyzer's
existing LAS communications interface and Generic
Connection Module. | Same |
| Fundamental
Technology | Centralized operation and monitoring of decentralized
equipment. | Same |
| Chemistry
Analyzer
Connection | Unicel DxI 800 Access Immunoassay System | Same |
| Assay
Performance | Access Ferritin Assay
Access Folate Assay
Access HYPERsensitive hTSH Assay
Access Vitamin B12 Assay | Same |
| Aspect/
Characteristic | Power Processor Sample Processing
System with Generic Connection Module -
Software Version 5.0 | Power Express |
| System
Modules | The basic Power Processor System is
comprised of a line controller computer, a
system console with PrepLink™ software, inlet
module, hematology module, centrifugation
module, decapper module, track transport
system, and output module. The Generic
Connection module is an optional module to
enable analyzer connectivity. | Same, except for
replacement of
PrepLink software
with Cennexus.
No hematology
module. |
| Sample
Identification | Identification of patient tubes and sample
programming using bar codes. | Same, except for
tube tracking using
short range RFID
readers detecting
embedded chips in
the sample carrier. |
| Sample
Handling | Processes multiple tube sizes/types
simultaneously; sorts and maps samples for
routing, storage, and retrieval; performs
intelligent sample routing based on system
status for LX/DxC/IDC (DxI), connections.
Generic connection modules process only a
single tube size. | Same, except
Beckman Coulter LX
and DxC instruments
are connected using
the Generic
connection interface |
| Operating
Environment | Operating Software Microsoft Windows XP,
Computer Console with Single User Interface. | Operating Software
Microsoft Windows
7 Computer Console
with Single User
Interface |
| Host
Communication | The ability to interface with a LIS device to
receive patient identification and test requests
via a communications protocol to provide
sample tracking via bar code labeling. | ASTM protocol with
LIS Defined aliquots
and Host Query. |
| Throughput | 450 tubes per hour (with 2 centrifuges). | 1200 tubes per hour
(with 4 centrifuges),
and addition of 2
lanes/ track to
manage more
carriers at same
track velocity. |
| Control panel | Buttons and 2 character display. | Touch screen based
control on each
module GUI with
LCD. |
| Cyber security | Field Service Engineers login with password. | Field Service
Engineers, Users,
Supervisors login
with password. |
| Aspect/
Characteristic | Power Processor Sample Processing
System with Generic Connection Module -
Software Version 5.0 | Power Express |
| | | Microsoft Defender
for anti-spyware. |
| | | Fault tolerant
capability with dual
modules for the
critical hardware
functions. |
| Racks per Inlet | 4 racks that hold 50 tubes each. | Up to 8 racks that
hold up to 50 tubes
each. |
| Storage units | 3 storage units of the same type. | Up to 4 ambient or
refrigerated storage
units. |
| Centrifuge | Tube sizes must be all the same. | Supports mixed tube
sizes. |
| Inlet/Outlets | 200 tubes
No drawer - open platform. | 400 tubes
Access through
drawers (2 drawers in
each of the
inlet/outlets). |
| Track lanes | 2 lanes. | 4 lanes. |
| Aliquotter | Manual tray filling
Single
System defined secondary tube labeling. | Bulk feeder
Dual units System
and LIS defined
secondary tube
labeling. |
| Centrifuges | 2 centrifuges. | 4 centrifuges. |
| Primary
Decapper | Single unit (Rocker). | Dual unit (Rotary). |
| Secondary
Decapper | Single unit (Rocker). | Single unit (Rotary). |
| Recapper | Single unit. | Dual unit. |
9
The following table provides a summary of the differences between the Power Express and the Power Processor.
10
11
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.