SYNCHRON SYSTEMS CREATININE REAGENT

K071283 · Beckman Coulter, Inc. · CGX · Jun 1, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071283
• Device Name: SYNCHRON SYSTEMS CREATININE REAGENT
• 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

Intended Use

CR-S reagent, when used in conjunction with UniCel® DxC 600/800 System(s) and SYNCHRON® Systems AQUA CAL 1 and 2, is intended for the quantitative determination of Creatinine concentration in human serum, plasma or urine.

Device Story

The SYNCHRON Systems CR-S Reagent is an in vitro diagnostic reagent kit used on UniCel DxC 600/800 clinical chemistry systems. It measures creatinine concentration in human serum, plasma, or urine samples. The device functions by utilizing a two-point linear calibration method with aqueous matrix calibrators (AQUA CAL 1 and 2), which are traceable to Isotope Dilution Mass Spectrometry (IDMS). The system is operated by laboratory personnel in a clinical setting. The quantitative output provided by the system assists healthcare providers in diagnosing and treating renal diseases and monitoring patients undergoing renal dialysis.

Clinical Evidence

No clinical data provided. Performance data from validation testing supports equivalency.

Technological Characteristics

In vitro diagnostic reagent kit for creatinine measurement. Utilizes two-point linear calibration with aqueous matrix calibrators (AQUA CAL 1 and 2). Traceable to Isotope Dilution Mass Spectrometry (IDMS). Designed for use on UniCel DxC 600/800 automated clinical chemistry systems.

Indications for Use

Indicated for the quantitative determination of creatinine concentration in human serum, plasma, or urine for the diagnosis and treatment of renal diseases, monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

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

• 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 K071283

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 a modification of the calibration model from a single point linear model with a fixed intercept to a two point linear model. The two point calibrator used with the modified assay is an aqueous matrix instead of a serum matrix. The calibrator material is value assigned to be traceable to Isotope Dilution Mass Spectrometry (IDMS) for creatinine recovery.

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.