(235 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 "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is described as an in vitro diagnostic device used in a clinical laboratory to analyze human body fluids and aid in the diagnosis of diseases, not to directly treat or mitigate them.
Yes
The DxA 5000 described functions as an automated sample handling system that prepares samples for analysis, and it explicitly consolidates analytical instruments like the DxI 800 Access Immunoassay System. The DxI 800 itself is described as an "in vitro diagnostic device for use in the clinical laboratory" that performs quantitative or qualitative determination of various analyte concentrations in human body fluids. Furthermore, the document details specific assays (Ferritin, Folate, TSH, Vitamin B12) performed by these systems, and states that measurements obtained are used for "diagnosis of diseases affecting iron metabolism," "assess folate status," "diagnosis of thyroid or pituitary disorders," and "diagnosis and treatment of gastrointestinal malabsorption." This directly indicates its role in disease diagnosis.
No
The device description clearly outlines a high-speed, modular, automated sample handling system with physical components like a track system, centrifuges, decappers, and storage units. While it includes software for control and interfacing, it is fundamentally a hardware system with integrated software, not a software-only device.
Based on the provided text, here's the breakdown:
-
DxA 5000: The DxA 5000 is described as a "high-speed, modular, automated sample handling system that performs pre-analytical and postanalytical sample processing and storage." It sorts, routes, and presents sample tubes to analyzers. While it's part of a system that includes IVD devices, the DxA 5000 itself is a sample handling and automation system, not a device that performs diagnostic testing on human samples. Therefore, the DxA 5000 is not an IVD.
-
DxI 800 Access Immunoassay System: The text explicitly states, "The UniCel DxI 800 System is an in vitro diagnostic device for use in the clinical laboratory." This device performs enzyme immunoassays for the quantitative or qualitative determination of various analyte concentrations found in human body fluids. Therefore, the DxI 800 Access Immunoassay System is an IVD.
-
Access Ferritin assay, Access Folate assay, Access TSH (3rd IS) assay, Access Vitamin B12 assay: These are described as "paramagnetic particle, chemiluminescent immunoassay" for the quantitative determination of specific analytes in human body fluids. Their intended use is for aiding in the diagnosis of diseases or assessing folate status. These are assays (reagents and methods) used with the Access Immunoassay Systems. While they are components of the diagnostic process and are used in vitro, the term "IVD" typically refers to the device or system that performs the test. However, the assays themselves are considered IVD products as they are intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
In summary:
- DxA 5000: No, it is a sample handling and automation system.
- DxI 800 Access Immunoassay System: Yes, it is explicitly stated as an IVD.
- Access Ferritin, Folate, TSH, and Vitamin B12 assays: Yes, these are IVD products (assays) used with the IVD system.
Therefore, when considering the entire system described, the DxI 800 Access Immunoassay System and the associated assays are IVDs. The DxA 5000 is a crucial part of the automated workflow but is not the diagnostic device itself.
N/A
Intended Use / Indications for Use
The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.
The DxI 800 Access Immunoassay System is a microcomputer controlled, random and continuous access analyzer that includes an external computer. This computer stores the system user interface (UI) software and allows the operator to interface with and direct the instrument software. The UniCel DxI 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for the quantitative or qualitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxI 800 System is an in vitro diagnostic device for use in the clinical laboratory.
The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism.
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum and plasma (heparin) or red blood cells using the Access Immunoassay Systems. Folate levels in serum and plasma (heparin) or red blood cells are used to assess folate status. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. This assay is capable of providing 3rd generation TSH results. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption.
Product codes (comma separated list FDA assigned to the subject device)
CDD, JMG, CGN, JLW, JJE
Device Description
The DxA system is a high throughput automated sample handling system which can perform the pre and post analytical processing of sample tubes. DxA can identify and track samples, perform centrifugation, decapping, delivery of samples to connected analyzers, recapping, storing in either non-refrigerated or refrigerated storage, and sorting to output racks.
The DxA integrates perianalytic (pre and post analysis) functions with analytical instruments (Beckman Coulter, and other manufacturer's) via a track system to provide fully integrated testing solutions.
The UniCel Dxl 800 Access Immunoassay System is a microcomputer controlled, random and continuous access analyzer that includes an external computer. This computer stores the system user interface (UI) software and allows the operator to interface with and direct the instrument software. The UniCel Dxl 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel Dxl 800 System is an in vitro diagnostic device for use in the clinical laboratory.
The Access Ferritin assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
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.
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum using the Access Immunoassay Systems.
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.
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
in vitro diagnostic device for use in the clinical laboratory.
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)
The acceptance criteria were met for all method comparisons thereby demonstrating the following:
- Equivalence between the predicate lab automation system Power Processor and the candidate one, DxA 5000 in terms of the DTS barcode identification process.
- Equivalence between the predicate lab automation system Power Processor and the candidate one, DxA 5000 in terms of pre-analytical processing.
A method comparison study was performed utilizing CLSI EP09 for the following assays; TSH (3rd IS) Ferritin, Folate and B12. For all method comparisons, results were within the specifications when the candidate was compared to the predicate.
Performance data from testing shows that all software design, development and verification activities have been completed, and supports a finding of substantial equivalency of DxA 5000 to the Power Processor Sample Processing System.
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.
K110413, K023764, K926221, K060774, K042281, K955436
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a bold, sans-serif font, with the word "ADMINISTRATION" underneath in a smaller font.
October 4, 2019
Beckman Coulter Biomedical GmbH Amanda Brown Manager Regulatory Affairs Sauerbruchstr. 50 Munich, 81377 Germany
Re: K190298
Trade/Device Name: Access Vitamin B12 Access Ferritin Access Folate Access TSH (3rd IS) DxA 5000 DxI 800 Access Immunoassay System Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 Test System Regulatory Class: Class II Product Code: CDD, JMG, CGN, JLW, JJE Dated: August 8, 2019 Received: August 21, 2019
Dear Amanda Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
1
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
3
Indications for Use
510(k) Number (if known) K190298
Device Name
DxA 5000, DxI 800 Access Immunoasay System, Access Folate, Access TSH (3rd IS), Access Vitamin B12
Indications for Use (Describe)
The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and postanalytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.
The DxI 800 Access Immunoassay System is a microcomputer controlled, random and continuous access analyzer that includes an external computer. This computer stores the system user interface (UI) software and allows the operator to interface with and direct the instrument software. The UniCel DxI 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for the quantitative or qualitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxI 800 System is an in vitro diagnostic device for use in the clinical laboratory.
The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism.
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum and plasma (heparin) or red blood cells using the Access Immunoassay Systems. Folate levels in serum and plasma (heparin) or red blood cells are used to assess folate status. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. This assay is capable of providing 3rd generation TSH results. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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Image /page/5/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circular shape with two white curved lines inside, resembling a stylized eye or a wave pattern. To the right of the symbol, the words "BECKMAN" are stacked above the word "COULTER" in a bold, sans-serif font.
1.0 Submitted By:
Amanda Brown, RAC Manager Regulatory Affairs Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 81377 Munich Germany Telephone: +49 (0) 89 579589-3611 Email: abrown2@beckman.com
2.0 Date Submitted:
February 8, 2019
3.0 Device Name(s):
3.1 Proprietary Names
DxA 5000
Dxl 800 Access Immunoassay System Access Ferritin Access Folate Access TSH (3rd IS) Access Vitamin B12
3.2 Common Name
Laboratory Automation System
3.2 Classification Name
| Name | Regulation
Number | Product
Code | Device
Class | Review
Panel |
|-------------------------------------------------------------|----------------------|-----------------|-----------------|-----------------------|
| Discrete photometric chemistry
analyzer for clinical use | 862.2160 | JJE | I | Clinical
Chemistry |
| Ferritin immunological test
system | 866.5340 | JMG | II | Clinical
Chemistry |
| Folic acid test system | 862.1295 | CGN | II | Clinical
Chemistry |
| Thyroid stimulating hormone
test system | 862.1690 | JLW | II | Clinical
Chemistry |
| B12 test system | 862.1810 | CDD | II | Clinical
Chemistry |
Page 5-1 Confidential
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Image /page/6/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape with two white curved lines inside, resembling a stylized wave or ribbon. To the right of the oval is the company name, "BECKMAN COULTER," with "BECKMAN" stacked on top of "COULTER" in a bold, sans-serif font.
4.0 Legally Marketed Device
| Candidate(s) | Predicate | Manufacturer | Document Number |
|---|---|---|---|
| DxA 5000 | Power Processor Sample | ||
| Processing System | Beckman Coulter, | ||
| Inc. | K110413 |
5.0 Device Description
The DxA system is a high throughput automated sample handling system which can perform the pre and post analytical processing of sample tubes. DxA can identify and track samples, perform centrifugation, decapping, delivery of samples to connected analyzers, recapping, storing in either non-refrigerated or refrigerated storage, and sorting to output racks.
The DxA integrates perianalytic (pre and post analysis) functions with analytical instruments (Beckman Coulter, and other manufacturer's) via a track system to provide fully integrated testing solutions.
6.0 Intended Use
The DxA 5000 is a high-speed, modular, automated sample handling system that performs preanalytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.
7.0 Indications for Use
The DxA 5000 is a high-speed, modular, automated sample handling system that performs preanalytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.
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Image /page/7/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape with two white curved lines inside, placed to the left of the company name. The text "BECKMAN" is on the top line and "COULTER" is on the bottom line, both in a bold, sans-serif font.
The UniCel Dxl 800 Access Immunoassay System is a microcomputer controlled, random and continuous access analyzer that includes an external computer. This computer stores the system user interface (UI) software and allows the operator to interface with and direct the instrument software. The UniCel Dxl 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel Dxl 800 System is an in vitro diagnostic device for use in the clinical laboratory.
The Access Ferritin assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism.
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of human thyroidstimulating hormone (thyrotropin, TSH, hTSH) levels in human serum using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of vitamin B12 in human serum and plasma (heparin) using Access lmmunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
8
Image /page/8/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the company name "BECKMAN" in bold black letters above "COULTER" also in bold black letters. The logo is simple and modern, with a clear emphasis on the company name.
Comparison to the Predicate
Predicate Device Name and 510k information:
Power Processor Sample Processing System (K110413) Beckman Coulter UniCel® Dxl 800 Access® Immunoassay System (K023764) Beckman Coulter Access® Ferritin assay (K926221) Beckman Coulter Access® Folate assay (K060774) Beckman Coulter Access® HYPER sensitive hTSH assay (K042281) Beckman Coulter Access® Vitamin B12 assay (K955436)
The DxA 5000 has the following similarities to the previously cleared Power Processor Sample Processing System (K110413).
| Characteristic | Power Processor | DxA 5000 |
|---|---|---|
| Intended Use | The basic Power Processor is 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 DxA 5000 is a high-speed, | |
| modular, automated sample | ||
| handling system that performs | ||
| pre-analytical and post- | ||
| analytical sample processing | ||
| and storage. The automation | ||
| system also sorts, routes, and | ||
| presents sample tubes to | ||
| analyzers for analysis. The | ||
| DxA 5000 also consolidates a | ||
| variety of analytical | ||
| instruments, such as an | ||
| Immunoassay analyzer, into a | ||
| unified workstation on a track | ||
| system. | ||
| System Design | Open LAS architecture enables | |
| multiple analyzer connections, | ||
| including 3rd party systems. | ||
| Scalable, modular configuration. | Same | |
| Fundamental | ||
| Technology | Centralized operation and | |
| monitoring of decentralized | ||
| equipment. | 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 reads
the barcode for the analyzer and
signals the analyzer's existing LAS
communications interface to
perform direct track sampling. | Same |
| Host
Communications | The ability to interface with a
Laboratory Information System (LIS)
device to receive patient
identification and test requests via
a communications protocol to
provide sample tracking via bar
code labeling. | The ability to interface with a
Laboratory Information
System (LIS) device via
Remisol to receive patient
identification and test
requests (based on bar code
labeling) and to provide
sample tracking via a
communications protocol. |
| Operating
Environment | Operating Software Microsoft
Windows XP, Computer Console
with Single User Interface. | Main Console: Microsoft
Windows embedded Standard
7 (64-Bit) with one user
interface per system.
|
| Sample
Identification | Identification of patient tubes and
sample programming using bar
codes. | Same |
| Control panel | Buttons and 2 character display | Touch screen based control on
each module console |
| Racks per Inlet | 4 racks that hold 50 tubes each | 36 tubes per rack, 4 racks per
drawer, 3 drawers |
| Immunoassay
Analyzer
Connection | Unicel Dxl 800 Access Immunoassay
System | Same |
| Assay
Performance | Access Ferritin Assay
Access Folate Assay
Access HYPERsensitive hTSH Assay
Access Vitamin B12 Assay | Same |
| Throughput | 450 tubes per hour (with 2
centrifuges). | Up 1200 tubes per hour |
| Sample
Containers | Primary and secondary Tubes | Same |
| Aliquotter | Yes | No |
| Centrifugation | Tube sizes must be all the same. | Can support multiple tube
sizes |
| De-capping | Yes | Same |
| Sample
Identification | Barcode | Same |
| Sample Storage | Yes | Same |
| Volume
Detection | Yes- (Combination of infrared
sensor and pressure sensor) | Yes- (Laser- Liquid Level
Detection) |
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Image /page/9/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the words "BECKMAN" and "COULTER" in bold, black font. The words are stacked on top of each other, with "BECKMAN" on the top line and "COULTER" on the bottom line.
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Image /page/10/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, and the words "BECKMAN COULTER" in black, with "BECKMAN" on top of "COULTER". The font is bold and sans-serif.
| Characteristic | Power Processor connected to
Beckman Coulter UniCel® Dxl 800
Access® Immunoassay System | DxA 5000 connected to
Beckman Coulter UniCel® Dxl
800 Access® Immunoassay System |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dxl 800
Indications for
Use | 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) | The UniCel Dxl 800 Access
Immunoassay System is a
microcomputer controlled,
random and continuous access
analyzer that includes an
external computer. This
computer stores the system
user interface (UI) software
and allows the operator to
interface with and direct the
instrument software. The
UniCel Dxl 800 System uses
enzyme immunoassays
(utilizing paramagnetic
particle solid phase and |
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Image /page/11/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, and the words "BECKMAN COULTER" in black, bold letters. The text is placed to the right of the red circle.
| | for determination of 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. | chemiluminescent detection)
for the quantitative, semi-
quantitative or qualitative
determination of various
analyte concentrations found
in human body fluids. The
UniCel Dxl 800 System is an in
vitro diagnostic device for use
in the clinical laboratory. |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Main
Automation
Connection
Software | Prep Link software | Remisol software |
| Sample
Identification | Barcode | Same |
| Characteristic | Power Processor connected to
Beckman Coulter UniCel® Dxl 800
Access® Immunoassay System
with Ferritin assay | DxA 5000 connected to
Beckman Coulter UniCel® Dxl
800 Access® Immunoassay
System with Ferritin assay |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Beckman Coulter
Access® Ferritin
assay Indications
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 Ferritin assay is a
paramagnetic particle,
chemiluminescent
immunoassay for the
quantitative determination of
ferritin levels in human serum
and plasma (heparin) using the
Access Immunoassay Systems. |
| Sample
Identification | Barcode | Same |
12
Image /page/12/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape on the left side, with two white curved lines running through it. To the right of the oval is the company name, "BECKMAN" in bold, black, sans-serif font, stacked on top of "COULTER", also in bold, black, sans-serif font.
| Characteristic | Power Processor connected to
Beckman Coulter UniCel® Dxl 800
Access® Immunoassay System
with Folate assay | DxA 5000 connected to
Beckman Coulter UniCel® Dxl
800 Access® Immunoassay
System with Folate assay |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Beckman Coulter
Access® Folate
assay Indications
for Use | 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 Folate assay is a
paramagnetic particle,
chemiluminescent
immunoassay for the
quantitative determination of
folic acid levels in human
serum and plasma (heparin) or
red blood cells using the
Access Immunoassay Systems.
Folate levels in serum and
plasma (heparin) or red blood
cells are used to assess folate
status. The serum folate level
is an indicator of recent folate
intake. A low RBC folate value
can indicate a prolonged
folate deficiency. |
| Sample
Identification | Barcode | Same |
| Characteristic | Power Processor connected to
Beckman Coulter UniCel® Dxl 800
Access® Immunoassay System
with hTSH assay | DxA 5000 connected to
Beckman Coulter UniCel® Dxl
800 Access® Immunoassay
System with hTSH assay |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Beckman Coulter
Access® hTSH
assay Indications
for Use | 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 Access TSH (3rd IS) assay
is a paramagnetic particle,
chemiluminescent
immunoassay for the
quantitative determination of
human thyroid-stimulating
hormone (thyrotropin, TSH,
hTSH) levels in human serum
and plasma using the Access
Immunoassay Systems. This |
13
Image /page/13/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the company name in black, bold font. The word "BECKMAN" is on the top line, and "COULTER" is on the bottom line.
| | the anterior pituitary are used in
the diagnosis of thyroid or pituitary
disorders. | assay is capable of providing
3rd generation TSH results. |
|--------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Sample
Identification | Barcode | Same |
| Characteristic | Power Processor connected to
Beckman Coulter UniCel® Dxl 800
Access® Immunoassay System
with B12 assay | DxA 5000 connected to
Beckman Coulter UniCel® Dxl
800 Access® Immunoassay
System with B12 assay |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Beckman Coulter
Access® B12
assay Indications
for Use | 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 Access Vitamin B12 assay
is a paramagnetic particle,
chemiluminescent
immunoassay for the
quantitative determination of
vitamin B12 levels in human
serum and plasma (heparin)
using the Access Immunoassay
Systems. |
| Sample
Identification | Barcode | Same |
8.0 Summary of Performance Data
The acceptance criteria were met for all method comparisons thereby demonstrating the following:
- Equivalence between the predicate lab automation system Power Processor and the candidate one, DxA 5000 in terms of the DTS barcode identification process.
- Equivalence between the predicate lab automation system Power Processor and the candidate one, DxA 5000 in terms of pre-analytical processing.
14
Image /page/14/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape with two white curved lines inside, placed to the left of the company name. The text "BECKMAN" is on the top line and "COULTER" is on the bottom line, both in a bold, sans-serif font.
A method comparison study was performed utilizing CLSI EP09 for the following assays; TSH (3rd IS) Ferritin, Folate and B12. For all method comparisons, results were within the specifications when the candidate was compared to the predicate.
The above referenced assays are representative of the assay methodologies available for use with the connected system, however performance is not limited to use with these assays.
Performance data from testing shows that all software design, development and verification activities have been completed, and supports a finding of substantial equivalency of DxA 5000 to the Power Processor Sample Processing System.