ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC

K032089 · Roche Diagnostics Corp. · JJY · Jul 30, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032089
• Device Name: ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 30, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

PreciControl Cardiac is used for quality control of the Elecsys CK-MB, Digoxin, Myoglobin, and NT-proBNP immunoassays on the Elecsys immunoassay systems.

Device Story

Elecsys PreciControl Cardiac; quality control material for immunoassay analyzers; monitors precision/accuracy of Troponin T, CK-MB, Myoglobin, pro-BNP, Digoxin assays. Modification: deletion of Troponin T; addition of pro-BNP and Digoxin. Used in clinical laboratory settings by laboratory personnel. Output: control values compared against expected ranges to verify system performance; ensures reliability of patient diagnostic results.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized preparation of pooled human sera. Analyte concentrations are established for CK-MB, Digoxin, Myoglobin, and NT-proBNP. Designed for use on Elecsys immunoassay analyzers. Stability: 3 hours at 20-25°C, 3 days at 2-8°C, 3 months at -20°C.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision and accuracy of Elecsys immunoassay analyzers for the analytes Troponin T, CK-MB, Myoglobin, pro-BNP, and Digoxin.

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® PreciControl Cardiac (K983492)

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 K032089

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.
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 deletion of Troponin T and the addition of pro-BNP and Digoxin analyte mixture to the quality control material: Elecsys PreciControl Cardiac.

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

REVISED:3/14/95