MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II

K043320 · Roche Diagnostics Corp. · JJX · Dec 17, 2004 · Clinical Chemistry

Device Facts

• Record ID: K043320
• Device Name: MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
• Applicant: Roche Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

For use in the verification of the calibration established by the Elecsys Folate II reagent on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.

Device Story

Elecsys Folate II CalCheck II; calibration verification material for immunoassay analyzers. Modification of previously cleared Elecsys Folate CalCheck. Changes include: matrix shift from buffer with human albumin to human serum; removal of 0.1% azide preservative; storage form transition from liquid to lyophilized; updated target values; product name change. Used in clinical laboratory settings by laboratory technicians to verify calibration of Folate II assays. Output provides verification of assay calibration accuracy; supports clinical decision-making by ensuring reliable patient folate test results.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Calibration verification material; three-level set; human serum matrix; lyophilized form; stored at 2-8°C. Designed for use with Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.

Indications for Use

Indicated for use as a calibration verification material for the Elecsys Folate II reagent on Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. No specific patient population, age, or disease state contraindications are defined as this is an in vitro diagnostic control material.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Elecsys Folate CalCheck (K974384)

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 K043320

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.)
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 involved the buffer, preservative, storage form, target values and a product name change.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and risk analysis. The differences between the modified product and previous product are a change of the matrix type from buffer with human albumin to human serum, removal of 0.1% azide preservative, change of storage form from liquid to lyophilized, the target vales for the CalCheck levels, the name change from Elecsys Folate CalCheck to Elecsys Folate II CalCheck II

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 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.