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

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

Device Facts

• Record ID: K140496
• Device Name: Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents
• Applicant: Beckman Coulter, Inc.
• Product Code: CDD · Clinical Chemistry
• Decision Date: Sep 16, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

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.

Device Story

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

Clinical Evidence

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

Technological Characteristics

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

Indications for Use

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

Regulatory Classification

Identification

A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Predicate Devices

• Power Processor Sample Processing System with Generic Connection Module V5.0 (K110413)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE
RE: DOCUMENT NUMBER K140496

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the: Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System with Generic Connection Module and Access Immunoassay System Reagents.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) Power Processor Sample Processing System With Generic Connections Module and Access Immunoassay System Reagents (K110413).

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:

A. Change name from Power Processor to Power Express
B. New process control software – from PrepLink to Cennexus
C. Improvements to hardware and software:
a. Sample Identification now performed using tube tracking performed by short range Radio Frequency Identification (RFID).
b. Increased sample tube throughput and decreased turnaround time using additional transport and sample carrier RFID tags. Power Express System performs 1200 tubes per hour (with 4 centrifuges), and addition of 2 lanes/ track to manage more carriers at same track velocity.
c. Touchscreen control on the console and each module GUI with LCD.
d. Fault tolerant capability with dual modules for the critical hardware functions.
e. Additional hardware, storage units and module capacity

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics.

5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices

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demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.