UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

K060256 · Beckman Coulter, Inc. · CFR · Feb 27, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060256
• Device Name: UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
• Applicant: Beckman Coulter, Inc.
• Product Code: CFR · Clinical Chemistry
• Decision Date: Feb 27, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The UniCel® DxC 600i System combines the UniCel® DxC 600 analyzer and the Access® 2 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a Closed Tube Aliquoter (CTA) unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or UniCel DxC 600 analyzer according to programming requirements. The UniCel DxC 600 Synchron® Clinical System is a fully automated, computercontrolled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid, (sample type is chemistry dependent). The Access 2 Immunoassay Analyzer is a microcomputer controlled, random access instrument. The analyzer performs enzyme immunoassays utilizing paramagnetic particle solid phase and chemiluminescent detection. The Access 2 Analyzer is intended for the in vitro determination of a variety of analytes of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid, (sample type is chemistry dependent).

Device Story

Unicel DxC 600i Synchron Access Clinical System; integrated clinical chemistry and immunoassay analyzer. Modification of previously cleared Synchron LXi 725 and Unicel DxC 600/800 systems. Replaces LX20 Pro analyzer component with DxC 600 analyzer; updates to Closed Tube Aliquoter (barcode reader, peri-pump, syringe drive); updates to Access 2 analyzer component; software updates across all modules; cosmetic changes. Used in clinical laboratory settings by trained laboratory personnel. System processes human clinical specimens to provide diagnostic analyte measurements. Design controls and risk analysis (FTA/FMEA) used to verify modifications; fundamental scientific technology remains unchanged from predicate systems.

Clinical Evidence

Bench testing only. Validation testing performed to support equivalency of the integrated system components and software modifications.

Technological Characteristics

Integrated clinical chemistry and immunoassay analyzer. Hardware includes DxC 600 analyzer, Access 2 analyzer, and Closed Tube Aliquoter. Features updated barcode reader, peri-pump, and syringe drive. Software-controlled modules. Compliant with 21 CFR 820.30 design control procedures.

Indications for Use

Indicated for in vitro quantitative determination of general chemistries, therapeutic drugs, and analytes in human serum, plasma, urine, or cerebrospinal fluid. Used for diagnosis and treatment of metabolic, renal, endocrine, and infectious diseases, and drug monitoring. Prescription use only.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Synchron LXi 725 (K023049)
• Unicel DxC 600 (K042291)
• Unicel DxC 800 (K042291)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER k060256

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 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM:

1. The name and 510(k) number of BECKMAN COULTER, INC.'s previously cleared devices, Synchron LXi 725 and Unicel DxC 600 and 800 clinical systems, cleared under k023049 and k042291 respectively. (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 for replacement of the LX20 Pro analyzer component with a Unicel DxC 600 analyzer with appropriate DxC modifications. Updated barcode reader, peri-pump, syringe drive and module on the Closed Tube Aliquoter. Updates for the Access 2 analyzer component based on the current stand-alone Access 2 analyzer. Software updates to all modules and general overall cosmetics.
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 – Validation Protocols were adequate to address the identified causes of hazards identified in the Risk analysis (FTA & FMEA)