FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM

K100917 · Biomedical Diagnostics (Bmd) SA · MOB · Nov 3, 2010 · Immunology

Device Facts

• Record ID: K100917
• Device Name: FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM
• Applicant: Biomedical Diagnostics (Bmd) SA
• Product Code: MOB · Immunology
• Decision Date: Nov 3, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The FIDIS™ VASCULITIS* kit is a semi-quantitative homogeneous fluorescent-based microparticle immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of anti-neutrophil cytoplasmic antibodies (ANCA) directed against Myeloperoxidase (MPO), Serine Proteinase 3 (PR3) and antibodies directed against glomerular basement membrane (GBM) in human serum samples. The results of the FIDIS™ VASCULITIS* test are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of various primary systemic small blood vessel vasculitides and glomerular basement membrane disease.

Device Story

Multiplex flow immunoassay for simultaneous detection of autoantibodies (MPO, PR3, GBM) in human serum. Input: patient serum samples; processed via 96-well microplate with filtering membrane. Principle: color-coded microspheres coated with specific antigens bind target antibodies; phycoerythrin anti-human IgG conjugate added for detection. Flow cytometer uses red laser to identify microsphere set and green laser to quantify fluorescence intensity. Output: titer (AU/mL) determined by interpolation. Used in clinical laboratories; operated by technicians. Results interpreted by physicians alongside clinical findings to aid diagnosis of vasculitides and Goodpasture's syndrome. Optional CARIS™ system automates sample dilution and dispensing.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30). Results demonstrated that predetermined acceptance criteria for the modified microsphere and sampling parameters were met.

Technological Characteristics

Multiplex immunoassay using color-coded microspheres. Modification: lyophilized microspheres with reconstitution buffer. Sensing principle: bead-based flow cytometry/fluorescence detection. Operational parameters: 100 beads sampled per reading; 90-second read time. Software-controlled analysis of bead signals.

Indications for Use

Indicated for the detection of antibodies in human serum or plasma, specifically for the diagnosis of vasculitis.

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Predicate Devices

• FIDIS™ VASCULITIS (K070458)

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 K100917

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. FIDIS™ VASCULITIS previously cleared k070458
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 the use of lyophilized color-coded microspheres and a reconstitution buffer. The number of beads sampled per reading is being reduced from 200 to 100 with a concomitant increase in read time from 60 to 90 seconds.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and the results provided indicate no substantial change in device performance
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 demonstrated that the predetermined acceptance criteria were met (Section 9 of the submission).
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 (documentation was provided by the Sponsor indicating that the verification and validation activities were performed by designated qualified individuals and the results demonstrated that the predetermined acceptance criteria were met (Section 9 of the submission)).
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 (this document is located in Section 9 of the submission).
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 (this document is located in Section 9 of the submission).

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.