ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR

K050387 · Roche Diagnostics Corp. · JJY · Apr 25, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050387
• Device Name: ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 25, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Roche Diagnostics Elecsys PreciControl Tumor Marker is used for quality control of the Elecsys tumor marker immunoassays on the Elecsys immunoassay analyzers.

Device Story

PreciControl Tumor Marker is a lyophilized quality control material based on human serum. It is used in clinical laboratory settings to monitor the accuracy and precision of Elecsys immunoassay systems. The product contains analytes at two clinically relevant concentrations, including AFP, CEA, CA 15-3 II, CA 125 II, Ferritin, fPSA, tPSA, and CA 19-9. Laboratory technicians use the control by running it on the immunoassay analyzer; the resulting values are compared against expected ranges to verify system performance. This process ensures the reliability of patient test results generated by the immunoassay system.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized human serum-based control material. Analyte concentrations provided for AFP, CEA, CA 15-3 II, CA 125 II, Ferritin, fPSA, tPSA, and CA 19-9. Stability: 2-8°C unopened, 2 weeks opened; 20-25°C on-analyzer up to 5 hours; -20°C for 1 month.

Indications for Use

Indicated for quality control of Elecsys tumor marker immunoassays on Elecsys immunoassay analyzers in clinical laboratory settings.

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

• Roche Diagnostics Elecsys PreciControl Tumor Marker (K972235)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K050387 "Special"

# Roche Diagnostics Elecsys PreciControl Tumor Marker

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:

1. Roche Diagnostics Elecsys PreciControl Tumor Marker previously cleared K972235.
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 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.

The changes include:
- Addition of CA 19-9 in control reagents

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance characteristics which include the following:
- Value assignment
- Product shelf life
- Product 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 -- FMEA (Failure mode and effects analysis) see section IV, p.24
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 – Section IV, p. 24
c) A declaration of conformity with design controls (Section IV, p. 26). 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 (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.