SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS

K071280 · Beckman Coulter, Inc. · CGX · Jun 1, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071280
• Device Name: SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
• Applicant: Beckman Coulter, Inc.
• Product Code: CGX · Clinical Chemistry
• Decision Date: Jun 1, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Indications for Use

CRE3 reagent, when used in conjunction with SYNCHRON CX® Delta System(s) SYNCHRON® Systems CX Calibrator 1 and 2. is intended for the quantitative determination of Creatinine (CRE3) in human serum, plasma or urine. Beckman Coulter SYNCHRON CX Calibrators 1, 2, and 3 are to be used for calibrating SYNCHRON CX Delta, CX® CE, and CX PRO Systems only.

Device Story

Clinical chemistry analyzer system; determines creatinine concentration via Jaffe rate method. Input: human serum, plasma, or urine sample injected into reaction cup with CRE3 reagent (picric acid). Operation: absorbance measured at 520 nm between 19-25 seconds post-injection. System uses aqueous-based calibrators (levels 1, 2, 3) traceable to NIST reference materials. Output: quantitative creatinine concentration. Used in clinical laboratory settings by trained personnel. Output used by clinicians to diagnose/monitor renal disease and dialysis. Modification involves updating calibrator set points in chemistry database to align with Isotope Dilution Mass Spectrometry (IDMS) values.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control procedures (21 CFR 820.30) to confirm performance following calibration traceability update.

Technological Characteristics

Jaffe rate method; absorbance measured at 520 nm. Aqueous-based calibrators traceable to NIST reference materials. System utilizes chemistry database for parameter storage. No changes to materials or hardware; software update only for calibrator value assignment.

Indications for Use

Indicated for quantitative determination of creatinine in human serum, plasma, or urine for diagnosis and treatment of renal diseases and monitoring renal dialysis.

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 CX Delta Clinical System (K950958)

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 K071280

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.) k950958
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 : The values assigned to CX Calibrator levels 1 & 2 will be modified to be traceable to Isotope Dilution Mass Spectrometry (IDMS) for creatinine recovery, instead of being traceable to NIST materials.

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.