SYNCHRON SYSTEMS CREATININE (CREA) REAGENT

K060935 · Beckman Coulter, Inc. · CGX · Apr 28, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060935
• Device Name: SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
• Applicant: Beckman Coulter, Inc.
• Product Code: CGX · Clinical Chemistry
• Decision Date: Apr 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Indications for Use

CREA reagent, when used in conjunction with UniCel® DxC 600/800 System(s), SYNCHRON® Systems Multi Calibrator and the CRTX Application Sheet, is intended for the quantitative determination of Creatinine concentration in human serum or plasma as a User Defined Reagent (UDR) application. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Device Story

Reagent kit for quantitative creatinine measurement in human serum/plasma/urine; used on UniCel DxC 600/800 systems. Modification introduces CRTX application using sample-blanked reaction trigger cycle to reduce bilirubin interference. System performs automated analysis; healthcare providers use results for renal disease diagnosis/monitoring. Reduced sample throughput compared to standard bar-coded assay due to blanking cycle. Benefits include improved accuracy in presence of bilirubin.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30) to assess impact of modification on assay performance and bilirubin interference mitigation.

Technological Characteristics

In vitro diagnostic reagent kit; two 300-test cartridges. Uses sample-blanked reaction trigger cycle for bilirubin interference reduction. Designed for UniCel DxC 600/800 instrument platforms. Quantitative colorimetric/enzymatic assay principle.

Indications for Use

Indicated for the measurement of creatinine in serum and plasma samples.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Predicate Devices

• SYNCHRON Systems Creatinine Reagent (K042291)

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 k060935

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):

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.) k042291
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 an alternative parameter set designed to work with the existing SYNCHRON Creatinine reagent. The creatinine triggered reagent application reduces the interference seen with bilirubin when using the creatinine assay for serum and plasma samples by using reaction trigger cycle employed for sample blanking. Use of the trigger cycle will reduce the sample throughput when compared to the creatinine assay and is therefore intended as a reflex for customers with a specific patient population with high bilirubin levels.

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