(84 days)
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No
The document describes a multiplex flow immunoassay system and its components, focusing on the biochemical and optical detection methods. There is no mention of AI or ML in the intended use, device description, or performance studies. The data analysis described involves standard statistical calculations (agreement percentages, precision metrics, regression analysis) rather than AI/ML algorithms.
No
The device is described as a diagnostic tool for detecting antibodies to HSV, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the qualitative detection and differentiation of IgG antibodies to herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2)" and is "an aid for the presumptive diagnosis of HSV-1 or HSV-2 infection." This directly indicates its diagnostic purpose.
No
The device description clearly outlines a physical kit containing reagents (dyed beads, antigens, antibodies) and is intended for use with a specific hardware system (Bio-Rad BioPlex® 2200 System) that performs the immunoassay. This is not a software-only device.
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 qualitative detection and differentiation of IgG antibodies to herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) in human serum and EDTA or heparinized plasma." This clearly indicates that the device is used to examine specimens derived from the human body (serum and plasma) to provide information for the diagnosis of a disease (HSV infection).
- Device Description: The description details a laboratory method (multiplex flow immunoassay) used to analyze patient samples.
- Performance Studies: The document describes performance studies conducted using human samples (sexually active individuals, CDC HSV panel) to evaluate the device's accuracy in detecting HSV antibodies.
- Intended User / Care Setting: It specifies that the device is intended for use in a "clinical laboratory," which is a typical setting for IVD testing.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BioPlex® 2200 HSV-1 & HSV-2 IgG kit is a multiplex flow immunoassay intended for the qualitative detection and differentiation of IgG antibodies to herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) in human serum and EDTA or heparinized plasma. The test is indicated for sexually active individuals and expectant mothers as an aid for the presumptive diagnosis of HSV-1 or HSV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-1 and HSV-2. The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients or for use at point of care facilities.
The BioPlex® 2200 HSV-1 & HSV-2 IgG kit is intended for use with the Bio-Rad BioPlex® 2200 System.
The BioPlex® 2200 HSV-1 & HSV-2 IgG Calibrator Set is intended for the calibration of the BioPlex® 2200 HSV-1 & HSV-2 IgG Reagent Pack.
The BioPlex® 2200 HSV-1 & HSV-2 IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex® 2200 Instrument and BioPlex® HSV-1 & HSV-2 IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex® 2200 HSV-1 & HSV-2 IgG Control Set has not been established with any other HSV-1 and HSV-2 antibody assays.
Product codes (comma separated list FDA assigned to the subject device)
MXJ, MYF, JIX, JJY
Device Description
The BioPlex® 2200 HSV-1 & HSV-2 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. Two (2) different populations of dyed beads are each coated with antigens associated with herpes simplex virus, types 1 and 2.
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, antihuman IgG 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 antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data are 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. The four (4) vials representing four (4) different antibody concentrations are used for calibration. The result for each of these antibodies is expressed as an antibody index (AI).
The BioPlex® 2200 HSV-1 & HSV-2 IgG Control Set includes a negative control as well as multi-analyte positive control. The Positive Control is manufactured to give positive results, with values above the cut-off for each specific analyte. The Negative Control is manufactured to give negative results, with values below the cut-off for each specific analyte.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients.
Intended User / Care Setting
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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. Expected Values
Prevalence study with serum samples from sexually active individuals where an HSV-1 (N=200) and HSV-2 (N=200) tests were ordered.
- Sexually Active Individuals with an HSV-1 Test Ordered (N=200): Modified BioPlex® 2200 HSV-1 IgG; 144 (72.0%) positive, 1 (0.5%) equivocal, 55 (27.5%) negative.
- Sexually Active Individuals with an HSV-2 Test Ordered (N=200): Modified BioPlex® 2200 HSV-2 IgG; 78 (39.0%) positive, 0 (0.0%) equivocal, 122 (61.0%) negative.
B. Comparative Testing
- Comparative study against the predicate method for sexually active individuals where HSV-1 (N=200) and HSV-2 (N=200) tests were ordered.
- Sexually Active Individuals With an HSV-1 Test Ordered: Modified BioPlex® 2200 HSV-1 IgG vs. Predicate (N=399)
- % Positive Agreement (95% CI): 100% (280/280) (98.6-100%)
- % Negative Agreement (95% CI): 98.3% (116/118) (94.0-99.5%)
- % Total Agreement (95% CI): 99.5% (396/398) (98.2-99.9%)
- Sexually Active Individuals With an HSV-2 Test Ordered: Modified BioPlex® 2200 HSV-2 IgG vs. Predicate (N=399)
- % Positive Agreement (95% CI): 99.4% (166/167) (96.7-99.9%)
- % Negative Agreement (95% CI): 100% (232/232) (98.4-100%)
- % Total Agreement (95% CI): 99.7% (398/394) (98.6-100%)
- Sexually Active Individuals With an HSV-1 Test Ordered: Modified BioPlex® 2200 HSV-1 IgG vs. Predicate (N=399)
- Comparative study using a CDC HSV panel (N=80).
- CDC HSV Panel: Modified BioPlex® 2200 HSV-1 IgG vs. CDC (N=80)
- % Positive Agreement (95% CI): 100.0% (42/42) (91.6-100%)
- % Negative Agreement (95% CI): 97.4% (37/38) (86.5-99.5%)
- % Total Agreement (95% CI): 98.8% (79/80) (93.3-99.8%)
- CDC HSV Panel: Modified BioPlex® 2200 HSV-2 IgG vs. CDC (N=80)
- % Positive Agreement (95% CI): 100.0% (40/40) (91.2-100%)
- % Negative Agreement (95% CI): 100.0% (40/40) (91.2-100%)
- % Total Agreement (95% CI): 100.0% (80/80) (95.4-100%)
- CDC HSV Panel: Modified BioPlex® 2200 HSV-1 IgG vs. CDC (N=80)
- Linear regression analysis:
- HSV-1: Slope = 0.9977, Intercept = -0.002, Correlation (R2) = 0.9879
- HSV-2: Slope = 1.0352, Intercept = -0.0514, Correlation (R2) = 0.9866
C. Precision Studies
Precision testing performed at Bio-Rad Laboratories on one lot of the modified BioPlex® 2200 HSV-1 & HSV-2 IgG kit. Each of the 8 panel members was tested in duplicate on 2 runs per day for 5 days, total 20 replicates per panel member. Data analyzed for intra-assay and inter-assay precision.
- HSV-1 IgG: Total %CV ranged from 4.5% to 10.3%.
- HSV-2 IgG: Total %CV ranged from 4.1% to 7.4%.
D. Interference
Testing for interfering substances according to CLSI EP7-A2. Samples were prepared by blending negative human serum with HSV-1 and HSV-2 IgG positive samples to achieve values of 2.0 to 3.0 AI and interferent or solvent (negative control) was added exogenously. Test and control samples evaluated in replicates of ten. Substances tested: Hemoglobin, Bilirubin (unconjugated/conjugated), Cholesterol, Red Blood Cells, Gamma-Globulin, Triglycerides, Total Protein (albumin), Beta-Carotene, Ascorbic Acid, Lithium Heparin, Sodium Heparin, EDTA, Sodium Citrate.
E. Matrix Comparison
Matched serum and plasma (EDTA and heparin sodium) samples (N>40 for each assay) from the same donor were acquired from commercial sources. Samples were assayed in replicates of two using the modified BioPlex® 2200 HSV-1 & HSV-2 IgG kits. Mean plasma AI values compared to matched mean serum AI values.
- HSV-1:
- EDTA vs. Serum: Slope = 1.0023, Intercept = -0.0358, Correlation (r) = 0.9902
- Heparin vs. Serum: Slope = 0.9988, Intercept = -0.0069, Correlation (r) = 0.9946
- HSV-2:
- EDTA vs. Serum: Slope = 0.9945, Intercept = -0.0737, Correlation (r) = 0.9945
- Heparin vs. Serum: Slope = 0.9523, Intercept = 0.0649, Correlation (r) = 0.9946
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for agreement percentages (% Positive Agreement, % Negative Agreement, % Total Agreement). Sensitivity, Specificity, PPV, NPV are not explicitly reported in the text with these terms.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BioPlex® 2200 HSV-1 & HSV-2 IgG Kit, K090409
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.3305 Herpes simplex virus serological assays.
(a)
Identification. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.(b)
Classification. Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
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JUN 2 2 2012
BioPlex® 2200 HSV-1 & HSV-2 IgG 510(k) Summary
510(k) Number K120959
Date Prepared: June 22, 2012
Introduction
Bio-Rad Laboratories hereby submits this 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 HSV-1 & HSV-2 IgG kit.
Submitter name, address and contact
| 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 |
Device name
Product Trade Name: BioPlex® HSV-1 & HSV-2 IgG on the BioPlex® 2200 Multi-Analyte Detection System
Proprietary Name: BioPlex® 2200 HSV-1 & HSV-2 IgG
Classification Name:
enzyme linked immunosorbent assay, herpes simplex virus, hsv-1 enzyme linked immunosorbent assay, herpes simplex virus, hsv-2 calibrator, multi-analyte mixture multi-analyte controls, all kinds (assayed)
1
Regulation Information
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| Enzyme linked | |||
| immunosorbent assay, | |||
| Herpes Simplex Virus, | |||
| HSV-1 | |||
| (MXJ) | Class II | 21 CFR § 866.3305, | |
| Herpes simplex virus | |||
| serological assays. | Microbiology | ||
| Enzyme linked | |||
| immunosorbent assay, | |||
| Herpes Simplex Virus, | |||
| HSV-2 | |||
| (MYF) | Class II | 21 CFR § 866.3305, | |
| Herpes simplex virus | |||
| serological assays. | Microbiology | ||
| Calibrator, multi-analyte | |||
| mixture | |||
| (JIX) | Class II | 21 CFR § 862.1150 - | |
| Calibrator | Clinical Chemistry | ||
| Multi-Analyte Controls | |||
| All kinds(assayed) | |||
| (JJY) | Class I | 21 CFR § 862.1660 - | |
| Quality control Material | |||
| (Assayed and Unassayed) | Clinical Chemistry |
Legally Marketed Predicate Device
BioPlex® 2200 HSV-1 & HSV-2 IgG Kit, K090409
INTENDED USE / INDICATIONS FOR USE
BioPlex® 2200 HSV-1 & HSV-2 IgG Kit
The BioPlex® 2200 HSV-1 & HSV-2 IgG kit is a multiplex flow immunoassay intended for the qualitative detection and differentiation of IgG antibodies to herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) in human serum and EDTA or heparinized plasma. The test is indicated for sexually active individuals and expectant mothers as an aid for the presumptive diagnosis of HSV-1 or HSV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-1 and HSV-2. The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients or for use at point of care facilities.
The BioPlex® 2200 HSV-1 & HSV-2 IgG kit is intended for use with the Bio-Rad BioPlex® 2200 System.
2
BioPlex® 2200 HSV-1 & HSV-2 IgG Calibrator Set
The BioPlex® 2200 HSV-1 & HSV-2 IgG Calibrator Set is intended for the calibration of the BioPlex® 2200 HSV-1 & HSV-2 IgG Reagent Pack.
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BioPlex® 2200 HSV-1 & HSV-2 IgG Control Set
The BioPlex® 2200 HSV-1 & HSV-2 IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex® 2200 Instrument and BioPlex® HSV-1 & HSV-2 IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex® 2200 HSV-1 & HSV-2 IgG Control Set has not been established with any other HSV-1 and HSV-2 antibody assays.
Kit Components :
The BioPlex® 2200 HSV-1 & HSV-2 IgG Reagent Pack (665-3350). The reagent pack contains supplies sufficient for 100 tests. .
| Vial | Description |
|---|---|
| Bead Set | One (1) 10 mL vial, containing dyed beads coated with |
| HSV-1 and HSV-2 antigen, an Internal Standard bead | |
| (ISB), a Serum Verification bead (SVB), and a Reagent | |
| Blank bead (RBB) in buffer with glycerol and protein | |
| stabilizers (bovine). ProClin 300 (≤0.3%), sodium | |
| benzoate (≤0.1%) and sodium azide ( |