(456 days)
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No
The description details a traditional immunoassay method and data analysis based on fluorescence intensity and established cutoffs, with no mention of AI or ML algorithms for data processing or interpretation.
No
This device is an in vitro diagnostic (IVD) test system used to detect antibodies for diagnostic purposes, not to treat a disease or condition.
Yes
The device is intended for the semi-quantitative detection of specific antibodies in human serum and plasma, which, "in conjunction with other clinical findings, ... are used as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders." This explicitly states its purpose is to aid in diagnosis.
No
The device description clearly outlines a complex immunoassay system involving physical reagents (dyed beads, antigens, antibodies, calibrators, controls), incubation steps, wash cycles, and a detector system (Bio-Rad BioPlex 2200 System) that measures fluorescence. This is a hardware-based in vitro diagnostic device, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the kits are for the "semi-quantitative detection of IgG and IgA antibodies to Cardiolipin (CL) and Beta-2 Glycoprotein I (ß2GPI) in human serum and plasma". This involves testing samples taken from the human body.
- Purpose: The test systems are used "as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders." This is a diagnostic purpose.
- Sample Type: The device analyzes "human serum and plasma". These are biological specimens taken from a human.
- Methodology: The device uses a "multiplex flow immunoassay", which is a laboratory technique performed in vitro (outside the body).
- Clinical Laboratory Use: The intended user is the "clinical laboratory". IVDs are typically used in clinical laboratory settings.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BioPlex® 2200 APLS IgG and IgA kits are multiplex flow immunoassays intended for the semi-quantitative detection of IgG and IgA antibodies to Cardiolipin (CL) and Beta-2 Glycoprotein I (ß2GPI) in human serum and plasma (lithium heparin, sodium heparin, and sodium citrate). In conjunction with other clinical findings, the test systems are used as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders.
The BioPlex 2200 APLS IgG and IgA kits are intended for use with the Bio-Rad BioPlex 2200 System
BioPlex® 2200 APLS IgG and IgA Calibrator Sets
The BioPlex® 2200 APLS IgG and IgA Calibrator Sets are intended for the calibration of the corresponding BioPlex® 2200 APLS IgG and IgA Reagent Packs.
BioPlex® 2200 APLS IgG and IgA Control Sets
The BioPlex® 2200 APLS IgG and IgA Control Sets are intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and the corresponding BioPlex 2200 APLS IgG and IgA Reagent Packs in the clinical laboratory. The performance of the BioPlex 2200 APLS IgG and IgA Control Sets has not been established with any other anti-Cardiolipin and anti- Beta-2 Glycoprotein I IgG or IQA APS assays.
Product codes
MID, MSV, JIX, JJX
Device Description
The BioPlex® 2200 APLS IgG and IgA IgG 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. "APLS" is an acronym for Anti-Phospholipid Syndrome.
Two (2) different populations of dyed beads are coated with the antigens associated with Cardiolipin (CL) and Beta-2-Glycoprpotein I (ß2GPI), respectively. 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, anti-human IgG or IgA antibody, conjugated to phycoerythrin (PE) is added to the dyed beads and this mixture is incubated at 37℃. 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 analyte captured 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 normalize detector response, to verify the addition of serum to the reaction vessel and the absence of significant non-specific binding in serum or plasma.
The instrument is calibrated using a set of seven (7) distinct calibrator vials for APLS IgG kit and a set of three (3) distinct calibrator vials for the APLS IgA kit, all supplied separately by Bio-Rad Laboratories. For each aCL IgG and aß2GPI IgG, four (4) vials representing four (4) different antibody concentrations are used for semi-quantitative calibration. For each aCL IgA and aß2GPI IgA assay, two (2) vials representing two (2) different antibody concentrations are used for semi-quantitative calibration. The cut-off value and assignment of the calibrators are determined by performing concordance testing and Receiver Operator Characteristic (ROC) analysis, using clinical diagnosis as the standard. The results for aCL IgG and aCL IgA are expressed in GPL-U/mL and APL-U/mL units, respectively. The results for aß2GPI IgG and aß2GPI IgA are each expressed in U/mL units.
The APLS IgG and APLS IgA Control Sets are intended for use as an assayed quality control to monitor the overall performance of the BioPlex® 2200 instrument and BioPlex 2200 APLS IgG and IgA reagent packs in the clinical laboratory.
Each of the APLS IgG and APLS IgA Control Sets includes a negative control and a positive control for each aCL IgG or IgA and aß2GPI IgG or IgA in a human serum matrix made from defibrinated plasma, containing antibodies present for analytes within the APLS IgG or IgA kit. The positive controls are manufactured to give positive results with values above the cutoff for each specific bead. The negative control is manufactured to give negative results, with values below the cutoff for each specific bead. The negative control must have a negative result, and the positive control must have a positive result.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Analytical Performance
i. Precision/Reproducibility
EP15-A2 reproducibility studies were conducted to evaluate the reproducibility of the BioPlex 2200 APLS IgG and IgA kits on the BioPlex 2200 instrument. The study was performed at one clinical trial site. One lot each of BioPlex 200 APLS IgG and IgA reagent packs, Calibrator Sets and Control Sets was evaluated. Four panels were made from serum and plasma (lithium heparin, sodium heparin and sodium citrate) plus controls. Each panel of 8 samples covering the assay measuring range was tested in quadruplicate over five days (4 replicates x 1 run x 5 days x 1 testing site = 20 replicates per panel member). The data were analyzed for within-run, between-day, and total precision and the standard deviation (SD) and percent coefficient of variation (%CV) were calculated.
Within run (%CV) range: 1.3 - 8.9
Total (%CV) range: 1.7 - 9.2
ii. Linearity/Assay Reportable Ranges
Three (3) APLS anti-Cardiolipin and anti- ß2GPI IgG and IgA positive patient samples were tested to demonstrate linearity. Each sample and dilution was evaluated in replicates of four using one APLS IgG and IgA IgG lot on one instrument. Linear and polynomial regression analysis of APLS IgG and IgA IgG recovery vs. sample dilution was performed.
The BioPlex 2200 APLS IgG and IgA IgG assay demonstrated linearity from 0 to 112 GPL-U/mL for aCL IgG and, 0 to 28 APL-U/mL for aCL IgA and 0 to 112 U/mL for.aB2GPI IgG and 0 to 28 U/mL for aß2GPI IgA.
v. Analytical Specificity
Interfering Substances
An interfering substances study was conducted based on CLSI EP7-A2. No interference was observed with any of the substances tested. Maximum levels tested include: Hemoglobin ≤ 500 mg/dL, Bilirubin (Unconjugated) ≤ 20 mg/dL, Bilirubin (Conjugated) ≤ 30 mg/dL, Cholesterol ≤ 500 mg/dL, Red Blood Cells ≤ 0.4% (v/v), Gamma Globulin ≤ 6 g/dL, Triglycerides ≤ 3300 mg/dL, Protein (total) ≤ 12 g/dL, Beta-Carotene ≤ 0.6 mg/dL, Ascorbic Acid ≤ 3 mg/dL, Lithium Heparin ≤ 8000 units/dL, Sodium Heparin ≤ 8000 units/dL, Sodium Citrate ≤ 1000 mg/dL, EDTA
§ 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
510(k) Summary Report
BioPlex® 2200 Anti-Phospholipid Syndrome (APLS) IgG and IgA kits
510(k) Number: K103834
Date Prepared: March 28, 2012
Bio-Rad Laboratories hereby submits this Special 510(k) in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. This summary of 510(k) safety and effectiveness information provides detail as a basis for a determination of substantial equivalence for the BioPlex® 2200 APLS IgG and IgA.
1. Applicant/Sponsor
| Submitter | Contact Person |
|---|---|
| Bio-Rad Laboratories, Inc | Juang Wang |
| BioPlex Division | Regulatory Affairs Representative |
| 5500 E. Second Street | Phone: (510)741-4609 |
| Benicia, CA 94510 | Fax: (510)741-3941 |
2. Device Name
BioPlex® 2200 APLS IgG Kit Proprietary Name: BioPlex® 2200 APLS IgG Calibrator Set BioPlex® 2200 APLS IgG Control Set BioPlex® 2200 APLS IgA Kit BioPlex® 2200 APLS IgA Calibrator Set BioPlex® 2200 APLS IgA Control Set
Common/Usual Name: Multi-Analyte Detection System: APLS IgG and IgA IgG
Classification Name:
system, test, anticardiolipin immunological system test,antibodies,b2 - glycoprotein I (b2 - gpi) calibrator, multi-analyte mixture single-analyte controls, all kinds (assayed and unassayed)
1
3. Regulatory Information
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| system, test, | |||
| anticardiolipin | |||
| immunological | |||
| (MID) | Class II | 21 CFR § 866.5660, | |
| Multiple autoantibodies | |||
| immunological test | |||
| system. | Immunology | ||
| system, test, antibodies, b2 |
- glycoprotein I (b2 - gpi)
(MSV) | Class II | 21 CFR § 866.5660,
Multiple autoantibodies
immunological test
system. | Immunology |
| Calibrator, multi-analyte
mixture (JIX) | Class II | 21 CFR § 862.1150 -
Calibrator | Clinical Chemistry |
| single (specified) analyte
controls (assayed and
unassayed) (JJX) | Class I | 21 CFR § 862.1660 –
Quality control Material
(Assayed and Unassayed) | Clinical Chemistry |
Predicate Devices 4.
K022992 REAADS anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit (2 assays) K022990 REAADS IgA anti-Cardiolipin Semi-Quantitative Test Kit K013080 REAADS anti-Beta 2 Glycoprotein I IgG Test Kit K013079 REAADS anti-Beta 2 Glycoprotein I IgA Test Kit
5. Device Description
The BioPlex® 2200 APLS IgG and IgA IgG 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. "APLS" is an acronym for Anti-Phospholipid Syndrome.
Two (2) different populations of dyed beads are coated with the antigens associated with Cardiolipin (CL) and Beta-2-Glycoprpotein I (ß2GPI), respectively. 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, anti-human IgG or IgA antibody, conjugated to phycoerythrin (PE) is added to the dyed beads and this mixture is incubated at 37℃. 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 analyte captured is determined by the fluorescence of the attached PE. Raw data is calculated in relative fluorescence intensity (RFI).
2
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 normalize detector response, to verify the addition of serum 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 seven (7) distinct calibrator vials for APLS IgG kit and a set of three (3) distinct calibrator vials for the APLS IgA kit, all supplied separately by Bio-Rad Laboratories. For each aCL IgG and aß2GPI IgG, four (4) vials representing four (4) different antibody concentrations are used for semi-quantitative calibration. For each aCL IgA and aß2GPI IgA assay, two (2) vials representing two (2) different antibody concentrations are used for semi-quantitative calibration. The cut-off value and assignment of the calibrators are determined by performing concordance testing and Receiver Operator Characteristic (ROC) analysis, using clinical diagnosis as the standard. The results for aCL IgG and aCL IgA are expressed in GPL-U/mL and APL-U/mL units, respectively. The results for aß2GPI IgG and aß2GPI IgA are each expressed in U/mL units.
The APLS IgG and APLS IgA Control Sets are intended for use as an assayed quality control to monitor the overall performance of the BioPlex® 2200 instrument and BioPlex 2200 APLS IgG and IgA reagent packs in the clinical laboratory.
Each of the APLS IgG and APLS IgA Control Sets includes a negative control and a positive control for each aCL IgG or IgA and aß2GPI IgG or IgA in a human serum matrix made from defibrinated plasma, containing antibodies present for analytes within the APLS IgG or IgA kit. The positive controls are manufactured to give positive results. with values above the cutoff for each specific bead. The negative control is manufactured to give negative results, with values below the cutoff for each specific bead. The negative control must have a negative result, and the positive control must have a positive result.
BioPlex® 2200 APLS IgG and IgA Kit Components 6.
The BioPlex 2200® APLS IgG(665-1950) and IgA (665-2150) kit contains supplies sufficient for 100 tests.
| Vial | Description |
|---|---|
| Bead Set | One (1) 10 mL vial, containing dyed beads coated |
| with CL and β2GPI; 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 (porcine). ProClin | |
| 300 (≤0.3%), sodium benzoate (≤0.1%) and sodium | |
| azide ( BioPlex® 2200 Antiphospholipid Syndrome IgG and IgA Calibrator Sets BioPlex® 2200 Antiphospholipid Syndrome IgG and IgA Control Sets |
Indications for Use:
The BioPlex® Antiphospholipid Syndrome (APLS) IgG and IgA Kits
The BioPlex® 2200 APLS IgG and IgA kits are multiplex flow immunoassays intended for the semi-quantitative detection of IgG and IgA antibodies to Cardiolipin (CL) and Beta-2 Glycoprotein I (ß2GPI) in human serum and plasma (lithium heparin, sodium heparin, and sodium citrate). In conjunction with other clinical findings, the test systems are used as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders.
The BioPlex 2200 APLS IgG and IgA kits are intended for use with the Bio-Rad BioPlex 2200 System
BioPlex® 2200 Antiphospholipid Syndrome (APLS) IgG and IgA Calibrator Sets The BioPlex® 2200 APLS IgG and IgA Calibrator Sets are intended for the calibration of the corresponding BioPlex® 2200 APLS IgG and IgA Reagent Packs.
BioPlex® 2200 Antiphospholipid Syndrome (APLS) IgG and IgA Control Sets
The BioPlex® 2200 APLS IgG and IgA Control Sets are intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and the corresponding BioPlex 2200 APLS IgG and IgA Reagent Packs in the clinical laboratory. The performance of the BioPlex 2200 APLS IgG and IgA Control Sets has not been established with any other anti-Cardiolipin and anti- Beta-2 Glycoprotein I IgG or IgA APS assays.
Prescription Use X AND/OR Over-the-Counter Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(Please do not write below this line-Continue on another page if needed)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Marie In Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103834
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