SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298

K093458 · Beckman Coulter, Inc. · JFY · Dec 4, 2009 · Clinical Chemistry

Device Facts

• Record ID: K093458
• Device Name: SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
• Applicant: Beckman Coulter, Inc.
• Product Code: JFY · Clinical Chemistry
• Decision Date: Dec 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Indications for Use

CR-E reagent, when used in conjunction with SYNCHRON® System(s), UniCel® DxC System(s) and SYNCHRON® Systems AQUA CAL 1 and 2 and SYNCHRON CX Calibrator Level 1 and 2, is intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine (urine is not available on the SYNCHRON CX® PRO Systems). 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 enzymatic creatinine measurement; utilizes multi-step photometric end-point reaction. Designed for use on SYNCHRON LX, UniCel DxC 600/800, and SYNCHRON CX PRO clinical systems. Operated by laboratory personnel in clinical settings. Input: human serum, plasma, or urine samples. Output: quantitative creatinine concentration. Modification from predicate involves extending analytical sensitivity (limit of detection) for serum samples to 0.1 mg/dL. Results assist clinicians in diagnosing/treating renal disease and monitoring dialysis.

Clinical Evidence

Bench testing only. Validation data supports the extension of the analytical sensitivity (limit of detection) for serum samples to 0.1 mg/dL.

Technological Characteristics

In vitro diagnostic device for serum and urine analysis. Modification involves adjustment of analytical range and limit of detection parameters. Design controls per 21 CFR 820.30 applied.

Indications for Use

Indicated for quantitative determination of creatinine in human serum, plasma, or urine to aid in diagnosis and treatment of renal diseases and monitoring renal dialysis. No specific age or gender restrictions provided.

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 Enzymatic Creatinine (CR-E) reagent (K091742)

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 K093458

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. K091742
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 extending the limit of detection for serum samples to 0.1 mg/dL from 0.2 mg/dL. The limit of detection for urine samples has not changed. The analytical range for serum samples is modified to 0.1 to 25 mg/dL from 0.2 to 25 mg/dL. The analytical range for urine has not changed.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance characteristics included were limit of detection, precision and linearity.

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.