(70 days)
Not Found
No
The description focuses on the multiplex flow immunoassay technology and standard laboratory procedures for calibration and quality control. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or decision-making.
No
The device is described as an aid in diagnosis, not as a treatment or therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test system is "used as an aid in the diagnosis of anti-neutrophil cytoplasmic antibodies (ANCA)associated vasculitides" and "as an aid in the diagnosis of certain autoimmune vasculitides."
No
The device is a kit containing reagents (beads, antibodies, calibrators, controls) intended for use with a specific hardware system (Bio-Rad BioPlex 2200 System) to perform a multiplex flow immunoassay. This involves physical components and chemical reactions, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is "intended for the semi-quantitative detection of IgG autoantibodies... in human serum." It also states that the test system is used "as an aid in the diagnosis of anti-neutrophil cytoplasmic antibodies (ANCA)associated vasculitides... in conjunction with clinical findings and other laboratory tests." This clearly indicates the device is intended for use in examining specimens derived from the human body to provide information for diagnostic purposes.
- Specimen Type: The device is designed to test "human serum," which is a specimen derived from the human body.
- Purpose: The purpose is to detect specific autoantibodies that are markers for certain diseases (vasculitides and autoimmune renal disorders), which is a diagnostic purpose.
- Device Description: The description details a laboratory method (multiplex flow immunoassay) used to analyze the human serum sample.
- Performance Studies: The document includes details about performance studies (reproducibility, comparative testing, cross-reactivity) conducted to validate the device's performance for its intended diagnostic use.
- Predicate Devices: The mention of predicate devices (other commercially available tests for similar purposes) further supports its classification as an IVD.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BioPlexTM 2200 Vasculitis kit is a multiplex flow immunoassay intended for the semiquantitative detection of IgG autoantibodies to Mveloperoxidase (MPO), serine Proteinase 3 (PR3) and Glomerular Basement Membrane (GBM) in human serum.
The BioPlex 2200 Vasculitis kit is intended for use with the Bio-Rad BioPlex 2200 System.
Uses:
The test system is used to detect the presence of antibodies in serum samples, as an aid in the diagnosis of certain autoimmune vasculitides such as Microscopic Polyangiitis (MPA), Necrotising Glomerulonephritis, Churg-Strauss Syndrome, Wegener's Granulomatosis and autoimmune renal disorders, such as Goodpasture's syndrome, in conjunction with clinical findings and other laboratory tests.
BioPlexTM 2200 Vasculitis Calibrator Set
The BioPlex 2200 Vasculitis Calibrator Set is intended for the BioPlex 2200 Vasculitis Reagent Pack.
BioPlexTM 2200 Vasculitis Control Set
The BioPlex 2200 Vasculitis Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Vasculitis Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Vasculitis Control Set has not been established with any other Vasculitis assays.
Product codes
MOB, MVJ, JIX, JJY
Device Description
The Vasculitis kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EIA, but permits simultaneous detection and identification of many antibodies in a single tube. Three (3) different populations of beads are coated with antigens associated with vasculitis disease (MPO, PR3 and GBM). The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, antibody, conjugated to phycoerythin (PE), is added to the dyed beads and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data is calculated in relative fluorescence intensity (RFI),
Three additional dyed beads, an Internal Standard Bead (ISB), a Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum or plasma to the reaction vessel and the absence of significant non-specific binding in serum or plasma. Refer to the BioPlex 2200 System Operation Manual for more information.
The instrument is calibrated using a set of four (4) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. A combination of four (4) vials representing four (4) different antibody concentrations are used for semi-quantitative calibration. The result for each of these antibodies is expressed as an antibody index (Al).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A reproducibility panel, consisting of ten (10) serum panel members, was prepared by Bio-Rad Laboratories. The positive panel members were prepared by combining patient samples positive for antibodies to MPO, PR3 and GBM. Two (2) of the ten (10) had high levels of the antibodies to MPO, PR3 and GBM; two (2) members had low levels of the antibodies to MPO, PR3 and GBM; and two (2) members had antibody levels near the cutoff. There was also one (1) high negative and one (1) low negative panel member. In addition, a BioPlex 2200 Vasculitis positive control (antibody positive for MPO, PR3 and GBM) and a negative control (antibody negative for all 3 analytes) were included and tested as panel members.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Expected Values:
Expected values for the BioPlex 2200 Vasculitis kit are presented for serum samples from normal blood donors (N=293) and unselected patient samples previously tested with vasculitis tests (N=300). A total of 300 serum samples from the normal blood donor population were tested. Seven (7) samples from the normal blood donor population were excluded due to "Serum Verification Bead (SVB) signal too low" analysis error messages during BioPlex 2200 Vasculitis kit testing. For all analytes, results of
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
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).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for Bio-Rad. The logo is white text on a black rounded rectangle. The text is in all capital letters and is bolded.
BIOPLEX 2200 VASCULITIS KIT, CALIBRATORS AND CONTROLS 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510/k) Number |
CANILI
Renort Date
IImmary ! |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| A counts & com
1/070000 | 0000
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MANUFACTURER INFORMATION
| Manufacturer | |
|---|---|
| Manufacturer Address | Bio-Rad Laboratories, Inc. |
| Clinical Systems Division | |
| 4000 Alfred Nobel Drive | |
| Hercules, CA 94547 | |
| Telephone | (510) 724-7000 |
| Establishment Registration No. | 2915274 |
| Owner / Operator | Bio-Rad Laboratories, Inc. |
| 4000 Alfred Nobel Drive | |
| Hercules, CA 94547 | |
| Owner / Operator No. | 9929003 |
| Official Correspondent for the BioPlex 2200 Vasculitis | |
| Official Correspondent Address | Bio-Rad Laboratories |
| 6565 185th Ave NE | |
| Redmond, WA 98052 | |
| Telephone | 425-881-8300 |
| Establishment Registration No. | 3022521 |
| Owner / Operator | Bio-Rad Laboratories |
| 6565 185th Ave NE | |
| Redmond, WA 98052 | |
| Official Correspondent | Mr. Christopher Bentsen |
| Telephone | (425) 498-1709 |
| Fax | (425) 498-1651 |
CLASSIFICATION INFORMATION
| Classification Name | Test System, Antineutrophil Cytoplasmic Antibodies (ANCA),
Devices, Measure, Antibodies to Glomerular Basement
Membrane (GBM) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Multi-Analyte Detection System Vasculitis |
| Product Trade Name | BioPlex 2200 Vasculitis kit on the BioPlex 2200 Multi-Analyte
Detection System
BioPlex 2200 Vasculitis Calibrator Set
BioPlex 2200 Vasculitis Control Set |
| Device Class | Class II |
| Classification Panel | Immunology |
| Requlation Number | 866.5660-Multiple Autoantibodies Immunological Test System |
1
Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is black and white and features the company name in a bold, sans-serif font. The letters are slightly rounded and have a three-dimensional appearance. The logo is simple and recognizable.
LEGALLY MARKETED EQUIVALENT (SE) DEVICES
| Comparative FDA Cleared
PREDICATE DEVICE | 510(k) Number | Decision
Date |
|---------------------------------------------|---------------|------------------|
| Phadia Varelisa™ MPO EIA | K041040 | 06/16/04 |
| Phadia Varelisa™ PR3 EIA | K041043 | 07/02/04 |
| INOVA QUANTA Lite™ GBM ELISA | K984336 | 02/08/99 |
| INOVA NOVA Lite ANCA (Ethanol-fixed Slides) | K961340 | 07/10/96 |
DEVICE DESCRIPTION
The Vasculitis kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EIA, but permits simultaneous detection and identification of many antibodies in a single tube. Three (3) different populations of beads are coated with antigens associated with vasculitis disease (MPO, PR3 and GBM). The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, antibody, conjugated to phycoerythin (PE), is added to the dyed beads and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data is calculated in relative fluorescence intensity (RFI),
Three additional dyed beads, an Internal Standard Bead (ISB), a Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum or plasma to the reaction vessel and the absence of significant non-specific binding in serum or plasma. Refer to the BioPlex 2200 System Operation Manual for more information.
The instrument is calibrated using a set of four (4) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. A combination of four (4) vials representing four (4) different antibody concentrations are used for semi-quantitative calibration. The result for each of these antibodies is expressed as an antibody index (Al).
KIT COMPONENTS
BioPlex 2200 Vasculitis reagent pack (Catalog No. 665-1850). The reagent pack contains supplies sufficient for 100 tests.
| Vial | Description |
|---|---|
| Bead Set | One (1) 10 mL vial, containing dyed beads coated with Myeloperoxidase (MPO), |
| Proteinase-3 (PR3) and Glomerular Basement Membrane (GBM); an Internal | |
| Standard bead (ISB), a Serum Verification bead (SVB), and a Reagent Blank | |
| bead (RBB) in a MOPS (3-[N-Morpholino] propanesulfonic acid) buffer | |
| supplemented with Glycerol and protein stabilizers (bovine). ProClin® 300 | |
| (0.3%), sodium benzoate (0.1%) and sodium azide ( |