POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS

K110413 · Beckman Coulter, Inc. · CDD · May 11, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110413
• Device Name: POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
• Applicant: Beckman Coulter, Inc.
• Product Code: CDD · Clinical Chemistry
• Decision Date: May 11, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Indications 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 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 600/800 Access Immunoassay System(s) with laboratory automation connection 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 Dxl 600/800 System(s) uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent defection) 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 Dx1 600/800 System(s) 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.

Device Story

Power Processor is a scalable laboratory automation system (LAS) streamlining pre-analytical processes. Inputs: patient sample tubes. Modules: Line Control Computer, Preplink Computer, Inlet, Hematology, Centrifugation, Decapper, Outlet. Operation: sorts tubes; centrifuges; decaps; routes to Generic Connection Modules for pipetting by connected analyzers (e.g., UniCel Dxl 600/800). Connection methods: onboard (physical transfer) or outboard (point-in-space pipetting). Used in clinical labs by technicians. Output: processed samples for analysis. Benefits: increased throughput; reduced manual handling; standardized pre-analytical preparation. PrepLink V5.0 software manages routing, scheduling, and data migration.

Clinical Evidence

No clinical data. Bench testing and software validation protocols were performed to address hazards identified in the risk analysis (FMEA).

Technological Characteristics

Scalable LAS with modular track system. Components: Line Control Computer, Preplink Computer, Inlet/Outlet/Centrifugation/Decapper modules. Connectivity: Generic Connection Modules support outboard sampling via point-in-space pipetting (CSLI guidelines). Software: PrepLink V5.0 (upgraded from V3.5). Features: load balancing, data migration utility, USB backup/restore.

Indications for Use

Indicated for use in clinical laboratories for the automated processing, sorting, and preparation of clinical samples for 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, Model: 4210 (k090588)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k110413

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the Power Processor Sample Processing System with Generic Connections:

1. The name and 510(k) number of Beckman Coulter, Inc.'s previously cleared device, Power Processor Sample Processing System with Generic Connection Module, Model: 4210, cleared under k090588. (For a preamendments device, a statement to this effect has been provided.)
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.
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 to connect up to 12 generic connections (increase from current 4), plus options to increase the primary sample ID to 13 characters, plus 2 characters for the secondary sample ID, connect up to three 3K or three 5K tube stockyards, load balancing number of tubes per rack, Data Migration Utility (DMU) for V3.5/V3.6 to V5.0, route a primary tube with no assigned tests in its test order to the stockyard and the use of USB drives for data storage and retrieval.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and 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
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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 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.

Comments – Software Validation Protocols were adequate to address the identified causes of hazards identified in the Risk analysis (FMEA)