(84 days)
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. 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, 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 Dxl 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 Dxl 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 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 HYPERsensitive 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 anemias of gastrointestinal malabsorption.
The Power Processor is a scalable laboratory automation system (LAS) designed to streamline pre-analytical processes in the clinical laboratory. A basic Power Processor System is comprised of a Line Control Computer, Preplink™ Computer, Inlet Module, Hematology Module, Centrifugation Module, Decapper Module, and Outlet Module. In the basic configuration, patient sample tubes are loaded onto the Power Processor system to be sorted to a Hematology Module, or to be centrifuged, decapped, and sorted to Personality Racks for further processing on other instruments. Additional modules may be added for aliquot capability, sample capping, and refrigerated storage.
The Power Processor is an open architecture system that can connect to a variety of clinical analyzers. Connection modules are extensions of the Power Processor track system that link with an analyzer's existing LAS interface. Connection modules support one of two types of sample transfer methods: onboard or outboard sampling. Onboard sampling physically transfers the sample tube/rack from the automation track to the analyzer's sample load and identification area. With outboard sampling, the connection unit performs the sample bar code read function, presents the sample ID to the connected analyzer, and then signals for direct sampling of the open tube by the connected instrument at an aspiration point on the automation track. The Power Processor Generic Connection Module is specifically designed to support the outboard sampling method based on point-in-space pipetting technology aligned with the CSLI guidelines. This method is used to establish connection with Beckman Coulter's UniCel Dxl 800 Immunoassay System. Power Processor software version 3.5 establishes a dynamic or "smart" connection with UniCel Dxl 800 System to enable sample routing based on reagent and calibration status.
The provided text describes the Beckman Coulter Power Processor Sample Processing System with a Generic Connection Module. However, it does not contain specific acceptance criteria in a quantitative table format, nor does it detail a study that explicitly "proves the device meets acceptance criteria" with numerical performance metrics against those criteria.
Instead, the document states: "Performance data from validation testing (system, software) supports equivalency. In addition, methods comparison studies were conducted with a representative assay menu to evaluate a representative connected system using on-line sample preparation against an unconnected analyzer using off-line centrifygation. These studies demonstrated good correlation between the Power Processor with GC module and UniCel Dxl 800 connection and the stand-alone UniCel Dxl 800 System."
This indicates that the primary study conducted was a methods comparison study to demonstrate substantial equivalence to an existing, stand-alone system. It does not provide the specific performance data from these studies or pre-defined acceptance criteria against which the results were measured.
Therefore, many of the requested sections regarding specific performance metrics, sample sizes for test/training sets, ground truth establishment, or expert involvement cannot be extracted from this document.
Here's a breakdown of what can be inferred or directly stated from the provided text, while acknowledging the significant gaps in the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in a quantitative table. The implicit acceptance criterion is "good correlation" with the stand-alone UniCel Dxl 800 System for the representative assays tested.
- Reported Device Performance: The document only states "demonstrated good correlation" between the Power Processor with GC module and UniCel Dxl 800 connection, and the stand-alone UniCel Dxl 800 System for various immunoassays (Vitamin B12, Ferritin, Folate, hTSH). No specific performance metrics (e.g., accuracy, precision, bias, correlation coefficients, sensitivity, specificity) are provided.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Good correlation with stand-alone UniCel Dxl 800 System | "Demonstrated good correlation" for representative assays (Vitamin B12, Ferritin, Folate, hTSH). Specific metrics not provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "methods comparison studies" but does not give the number of samples or cases used.
- Data Provenance: Not specified. It's not mentioned if the samples were from a specific country, or if the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. This type of device (laboratory automation system for immunoassays) typically relies on quantitative measurements from established methods as its "ground truth" or reference, rather than expert interpretation of an image or clinical case. The comparison was against results from a stand-alone, legally marketed immunoassay system.
- Qualifications of Experts: Not applicable for establishing ground truth in this context.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., radiology reads) where multiple experts might disagree. For a quantitative immunoassay system, the "ground truth" is provided by the reference method's quantitative output.
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
- MRMC Study: No, an MRMC study was not done.
- Effect Size: Not applicable. This device is a laboratory automation system, not an AI-assisted diagnostic tool that aids human readers in interpreting cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the entire study effectively evaluates the "standalone" performance of the Power Processor with GC Module in conjunction with the UniCel Dxl 800 System, compared to the predicate stand-alone UniCel Dxl 800 System. The device's function is automated sample processing and connection to an analyzer, not an algorithm providing a diagnostic output that requires human interpretation. The "good correlation" refers to the agreement of results generated by the automated system versus the manual/stand-alone system.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" used for the comparison was the results obtained from the legally marketed predicate device (Beckman Coulter UniCel® Dxl 800 Access® Immunoassay System) operating in a stand-alone configuration with off-line centrifugation. This is a form of reference method comparison.
8. The Sample Size for the Training Set
- Sample Size: Not specified. The document does not mention "training sets" in the context of machine learning or AI. The validation studies focused on system, software, and methods comparison.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable. No training set or machine learning components are described in the provided text. The device performs automated sample handling and preparation for immunoassays.
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Beckman Coulter, Inc. Section 510(k) Notification Power Processor Sample Processing System with Generic Connection Modules
Confidential
510(k) Summary [As Required by 21 CFR 807.92]
MAY 2 7 2009
Submitter and Contact Information:
| Submitter | Contact Person |
|---|---|
| Beckman Coulter, Inc. | Mary Beth Tang |
| Clinical Systems Business Center | Staff Regulatory Affairs Specialist |
| 200 S. Kraemer Boulevard | Phone: 714-961-3777 |
| Brea, CA 92821 | Fax: 714-961-4234 |
Date Prepared
March 3, 2009
Device Name(s):
Trade Name:
Power Processor Sample Processing System Generic Connection Module
Common Name:
Laboratory Automation System
Classification Names:
Discrete photometric chemistry analyzer for clinical use [862.2160]
Legally Marketed (Predicate) Devices:
| Predicate Device | 510(k) Number |
|---|---|
| Siemens (Dade Behring) StreamLAB® Analytical WorkCell/Sample TransferModule | K043546 |
| Beckman Coulter UniCel® Dxl 800 Access® Immunoassay System | K023764 |
| Beckman Coulter Access® Ferritin Assay | K926221 |
| Beckman Coulter Access® Folate Assay | K060774 |
| Beckman Coulter Access® HYPERsensitive hTSH Assay | K042281 |
| Beckman Coulter Access® Vitamin B12 Assay | K955436 |
Intended Use
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. 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, 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 Dxl 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 Dxl
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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 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 HYPERsensitive 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, chemilyminescent 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.
Device Description
The Power Processor is a scalable laboratory automation system (LAS) designed to streamline pre-analytical processes in the clinical laboratory. A basic Power Processor System is comprised of a Line Control Computer, Preplink™ Computer, Inlet Module, Hematology Module, Centrifugation Module, Decapper Module, and Outlet Module. In the basic configuration, patient sample tubes are loaded onto the Power Processor system to be sorted to a Hematology Module, or to be centrifuged, decapped, and sorted to Personality Racks for further processing on other instruments. Additional modules may be added for aliquot capability, sample capping, and refrigerated storage.
The Power Processor is an open architecture system that can connect to a variety of clinical analyzers. Connection modules are extensions of the Power Processor track system that link with an analyzer's existing LAS interface. Connection modules support one of two types of sample transfer methods: onboard or outboard sampling. Onboard sampling physically transfers the sample tube/rack from the automation track to the analyzer's sample load and identification area. With outboard sampling, the connection unit performs the sample bar code read function, presents the sample ID to the connected analyzer, and then signals for direct sampling of the open tube by the connected instrument at an aspiration point on the automation track. The Power Processor Generic Connection Module is specifically designed to support the outboard sampling method based on point-in-space pipetting technology aligned with the CSLI guidelines. This method is used to establish connection with Beckman Coulter's UniCel Dxl 800 Immunoassay System. Power Processor software version 3.5 establishes a dynamic or "smart" connection with UniCel Dxl 800 System to enable sample routing based on reagent and calibration status.
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Substantial Equivalence Comparison
The Power Processor with Generic Connection (GC) Module is substantially equivalent in Intended Use and design characteristics to the primary predicate device. The secondary predicate serves as a representative analyzer connection for the outboard sampling method; in this configuration, the UniCel Dxl 800 with Power Processor System and GC Module demonstrates substantial equivalence to the predicate UniCel Dxl 800 Immunoassay System through an evaluation of assay performance.
Summary of Performance Data
Performance data from validation testing (system, software) supports equivalency. In addition, methods comparison studies were conducted with a representative assay menu to evaluate a representative connected system using on-line sample preparation against an unconnected analyzer using off-line centrifygation. These studies demonstrated good correlation between the Power Processor with GC module and UniCel Dxl 800 connection and the stand-alone UniCel Dxl 800 System.
Conclusion
The information provided in this submission supports a substantial equivalence determination, and therefore 510(k) premarket notification clearance of the Power Processor Sample Processing System with Generic Connection Module.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars forming its wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter.
Public Health Service
MAY 2 7 2009
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Beckman Coulter, Inc c/o Mary B. Tang Staff Regulatory Affairs Specialist 200 South Kraemer Blvd. Brea, CA 92821
Re: K090588
Trade/Device Name: Power Processor Sample Processing System with Generic Connection Module, Model: 4210
Regulation Number: 21CFR Sec.-862.1810 Regulation Name: Vitamin B12 test system. Regulatory Class: Class II Product Code: CDD, DBF, CGN, JLW, JJE Dated: March 3, 2009 Received: March 4, 2009
Dear Ms. Tang:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page - 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
G.C.H.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K090588
Device Name: Power Processor Sample Processing System with Generic Connection Module and Access Immunoassay System Reagents
Indication For Use:
The basic Power Processor is an automated sample handling system which processes sample tubes from the pre-centrifugation, pre-sorting step to presentation of centrifyged and decapped samples into Generic or Personality Racks for specific instruments. 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, 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 Dxl 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 Dxl 800 System is an in vitro diagnostic device for use in the clinical laboratory.
Prescription Use _____________ (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Diyision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090588
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Indication for Use
(continued)
510(k) Number (if known): K090588
Device Name: Power Processor Sample Processing System with Generic Connection Module and Access Immunoassav System Reagents
Indication For Use:
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 HYPERsensitive 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 anemias of gastrointestinal malabsorption.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090588
§ 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.