MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)

K033501 · Roche Diagnostics Corp. · JIX · Nov 20, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033501
• Device Name: MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
• Applicant: Roche Diagnostics Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Nov 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

Calibrator for Automated Systems (C.f.a.s.) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

Device Story

Calibrator for Automated Systems (C.f.a.s.) is a lyophilized human serum-based calibrator containing chemical additives and biological materials. It is used in clinical chemistry laboratories to calibrate quantitative Roche diagnostic methods on Roche clinical chemistry analyzers. The device provides known concentrations of analytes, allowing the analyzer to establish a calibration curve. This process ensures the accuracy and reliability of patient sample measurements performed by the analyzer. Healthcare providers use the resulting quantitative data to make clinical decisions regarding patient diagnosis and monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lyophilized human serum base with chemical additives. Formulated for calibration of Roche clinical chemistry analyzers. Standalone calibrator product.

Indications for Use

Indicated for the calibration of quantitative Roche methods on Roche clinical chemistry analyzers. No specific patient population, age, or gender restrictions are defined; intended for professional use in clinical laboratory settings.

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.

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 K033501

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 MODIFICATIONS, including user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

The changes were as follows: replacing porcine lipase with recombinant human lipase for calibration of lipase assays, replacing transferrin with DTPA for calibration of unsaturated iron binding capacity assays, and reconstitution with water rather than diluent.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and stability.
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.