MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER

K062751 · Quantimetrix Corp. · JJT · Oct 3, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062751
• Device Name: MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
• Applicant: Quantimetrix Corp.
• Product Code: JJT · Clinical Chemistry
• Decision Date: Oct 3, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Quantimetrix Corp. Cardiasure Cardiac Markers Control is intended as a means of monitoring serum cardiac analyte monitoring methods to validate measurement of patient serum samples. Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.

Device Story

Quantimetrix Cardiasure Cardiac Markers Control is an in vitro diagnostic quality control material. It is used by laboratory personnel to monitor the performance of serum cardiac analyte testing methods. The control is processed alongside patient serum samples to validate the accuracy and precision of the analytical system. By comparing observed control values against established intralaboratory parameters, clinicians ensure the reliability of patient test results. The device serves as an integral component of routine diagnostic quality assurance procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid-stable quality control material containing cardiac analytes. Designed for use with serum-based diagnostic assays. No specific materials of construction, energy sources, or software algorithms are applicable as this is a chemical control reagent.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory testing procedures for cardiac markers, including C-reactive protein (CRP), Homocysteine, Digoxin, NT-proBNP, and Troponin I, 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.

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 K062751

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.) k993723
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 was for addition of C-reactive protein (CRP), Homocysteine, Digoxin, and NT-proBNP to the current Cardiasure Cardiac Markers Control and the inclusion of a level 4 for Troponin I.

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

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
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.