ANA-SCREEN WITH MDSS

K113610 · Bio-Rad Laboratories · LKJ · Jul 9, 2012 · Immunology

Device Facts

• Record ID: K113610
• Device Name: ANA-SCREEN WITH MDSS
• Applicant: Bio-Rad Laboratories
• Product Code: LKJ · Immunology
• Decision Date: Jul 9, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5100
• Device Class: Class 2
• Attributes: AI/ML

AI Performance

Output	Acceptance	Observed	Dev DS	Test DS
Systemic Autoimmune Disease Association (SLE, MCTD, SS, Scleroderma, Polymyositis)	Not specified	Not specified	Pre-established database containing results for over 1,400 characterized sera/plasma.	Not specified

Indications for Use

The BioPlex® 2200 ANA Screen is intended for the qualitative screening of specific antinuclear antibodies (ANA), the quantitative detection of antibody to dsDNA, and the semi-quantitative detection of ten (10) separate antibody assays (Chromatin, Ribosomal Protein, SS-A, SS-B, Sm, SmRNP, RNP, Scl-70, Jo-1, and Centromere B) in human serum and/or EDTA or heparinized plasma. The test system is used as an aid in the diagnosis of systemic autoimmune diseases. The ANA Screen is intended for use with the Bio-Rad BioPlex 2200 System. The BioPlex 2200 Medical Decision Support Software (MDSS), used in conjunction with the ANA Screen, is an optional laboratory tool that associates patient antibody results with predefined MDSS profiles that have been correlated with the following systemic autoimmune diseases: Systemic Lupus Erythematosus (SLE), Mixed Connective Tissue Disease (MCTD), Sjögren's Syndrome (SS), Scleroderma (Systemic Sclerosis) and Polymyositis.

Device Story

Multiplex flow immunoassay system detects circulating autoantibodies in human serum or plasma. Device uses 13 populations of dyed beads coated with specific antigens (dsDNA, Chromatin, Ribosomal Protein, SS-A, SS-B, Sm, SmRNP, RNP, Scl-70, Jo-1, Centromere B). Patient sample, diluent, and beads incubated; murine monoclonal anti-human IgG-phycoerythrin conjugate added. Detector identifies beads via fluorescence and quantifies antibody binding via PE fluorescence. MDSS software uses k-nearest neighbor (kNN) algorithm to compare patient results against database of 1,400 characterized samples; identifies diagnostic patterns associated with SLE, MCTD, Sjögren's, Scleroderma, and Polymyositis. Used in clinical laboratories by trained personnel. Output aids clinicians in diagnosis and determining need for further serological testing.

Clinical Evidence

No new clinical data provided. Substantial equivalence based on design control activities, risk management, and performance verification of modified QC procedures and reagent formulations.

Technological Characteristics

Reagent-based diagnostic kit; modification involves QC frequency change (per-pack to per-day).

Indications for Use

Indicated for qualitative screening of ANA, quantitative detection of anti-dsDNA, and semi-quantitative detection of 10 specific antibodies (Chromatin, Ribosomal Protein, SS-A, SS-B, Sm, SmRNP, RNP, Scl-70, Jo-1, Centromere B) in human serum/plasma. Used as an aid in diagnosing systemic autoimmune diseases (SLE, MCTD, UCTD, Sjögren's, Scleroderma, Dermatomyositis, Polymyositis, RA, CREST, Raynaud's) in conjunction with clinical findings. For prescription use only.

Regulatory Classification

Identification

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

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 K113610

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.
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 (1) Change in the QC procedure - change the QC every pack to QC per day for each reagent lot. (2) Typographical, format and minor changes in labeling.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and (1) risk management report provided indicate the modified QC procedure is substantially equivalent to the current cleared kit.

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.