MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2

K032287 · Beckman Coulter, Inc. · JIX · Aug 18, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032287
• Device Name: MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
• Applicant: Beckman Coulter, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Aug 18, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The SYNCHRON Enzyme Validator Set, in conjunction with specified enzyme assays on Beckman SYNCHRON® Systems, is intended to provide points of reference in the measurement of selected human enzymes. Use of this product will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie (DGKCh). Lipase values are specific for the LIP chemistry on SYNCHRON Systems.

Device Story

The SYNCHRON Enzyme Validator Set consists of two levels of calibrator material used to establish reference points for enzyme assays on Beckman SYNCHRON CX and LX clinical chemistry systems. The device is used by laboratory personnel in a clinical setting to ensure assay values are traceable to IFCC and DGKCh reference methods. The kit includes calibration diskettes and assigned value sheets to facilitate system calibration. By providing standardized reference values, the device enables accurate quantification of human enzymes, supporting clinical decision-making regarding patient metabolic and organ function.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures to confirm accuracy of value assignments for ALT, AMY, AST, CK, GGT, and LD using the 2002 IFCC reference method.

Technological Characteristics

Calibrator set for clinical chemistry analyzers. Traceable to 2002 IFCC reference methods. No change to chemical formula. Software/algorithm: N/A.

Indications for Use

Indicated for use as a calibrator to provide points of reference in the measurement of selected human enzymes (ALT, AMY, AST, CK, GGT, and LD) on Beckman SYNCHRON clinical chemistry systems.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device 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® Systems Validator Set (K984014)

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 K032287

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.
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 modifications, including package insert in sufficient detail to demonstrate that the fundamental scientific technology of the modified device has not changed. The modifications are the SYNCHRON Enzyme Validator Set has been value assigned for ALT, AMY, AST, CK, GGT and LD using the new 2002 IFCC reference method. Amylase (AMY) has been added to the list of analytes traceable to the IFCC reference method. There has been no change to the calibrator's formula. AMY was present in the predicate calibrator but was not value assigned until now.

4. Comparison Information similarities to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, expected values, and method.

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 and the Indications for Use Enclosure.

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.

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