(129 days)
946157, 862008
Not Found
No
The description details a multiplex flow immunoassay and its components, focusing on the chemical and physical processes of the assay and the instrument's detection method. There is no mention of AI, ML, or any algorithms that learn from data to improve performance or make predictions. The analysis relies on established thresholds (antibody index) for interpretation.
No
The device is an in vitro diagnostic (IVD) test for detecting antibodies to aid in the diagnosis of infectious mononucleosis, not for direct therapeutic treatment.
Yes
This device is intended for the qualitative detection of antibodies as an aid in the laboratory diagnosis of infectious mononucleosis (IM), which is a diagnostic purpose.
No
The device description clearly outlines a physical kit with reagents (dyed beads, proteins, antibodies) and is intended for use with a specific hardware system (Bio-Rad BioPlex 2200 System). 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 of two (2) separate analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum." This indicates that the device is used to examine specimens derived from the human body (serum) to provide information for diagnostic purposes (aiding in the laboratory diagnosis of infectious mononucleosis).
- Device Description: The description details a laboratory test methodology (multiplex flow immunoassay) that analyzes components of a human sample (serum) to detect specific antibodies.
- Performance Studies: The document describes various performance studies conducted in clinical laboratory settings using human serum samples to evaluate the device's accuracy and reliability for its intended diagnostic purpose.
- Intended User / Care Setting: The intended user is specified as the "clinical laboratory," which is a typical setting for IVD use.
- Predicate Device(s): The mention of predicate devices (K946157 Diasorin EBV VCA IgM Capture EIA; K862008 Wampole Monolatex) which are also IVDs, further supports the classification of this device as an IVD.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions.
N/A
Intended Use / Indications for Use
The BioPlex 2200 EBV IgM kit is a multiplex flow immunoassay intended for the qualitative detection of two (2) separate analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum. The test system can be used in conjunction with the BioPlex 2200 EBV IgG kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM).
The EBV IgM kit is intended for use with the Bio-Rad BioPlex 2200 System.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas.
BioPlex 2200 EBV IgM Calibrator Set
The BioPlex 2200 EBV IgM Calibrator Set is intended for the calibration of the BioPlex 2200 EBV IgM Reagent Pack.
BioPlex 2200 EBV IgM Control Set
The BioPlex 2200 EBV IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 EBV IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 EBV IgM Control Set has not been established with any other EBV assays.
Product codes (comma separated list FDA assigned to the subject device)
LSE, KTN
Device Description
The BioPlex 2200 EBV IgM kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional ElA, but permits simultaneous detection and identification of many antibodies in a single tube. Two (2) different populations of dyed beads are coated with proteins associated with infectious mononucleosis. One (1) is coated with an E. coli derived recombinant fusion protein, EBV VCA p18 (40kD), and the other is coated with horse erythrocyte stromal extract (heterophile antigen). The BioPlex 2200 System combines an aliquot of patient sample, sample diluent containing goat anti-human IgG, and bead reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, anti-human IgM antibody, conjugated to phycoerythrin (PE), is added to the dyed beads and this mixture is incubated at 37°C. The excess coniugate 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.
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 respectively. The instrument is calibrated using a set of two (2) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. A combination of two (2) vials representing two (2) different antibody concentrations is used for calibration. The result for each of these antibodies is expressed as an antibody index (AI).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum
Indicated Patient Age Range
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants.
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Expected Values
Expected values for the EBV IgM kit are presented by age and gender in the following tables for serum samples from unselected hospitalized pediatric and adult patients (N=302) and patients for which an EBV test was ordered (N=619). A total of 303 serum samples from unselected hospitalized pediatric and adult patients and a total of 621 serum samples from patients for which an EBV test was ordered were tested. One (1) sample from the unselected hospitalized population, and two (2) samples from the patients for which an EBV test was ordered population were excluded due to RBB analysis error messages during BioPlex 2200 EBV IgM testing. For all analytes, results of ≤0.8 Al are negative, 0.9 and 1.0 Al are equivocal, and ≥1.1 Al are reported as positive.
B. Reproducibility Studies
A reproducibility panel, consisting of six (6) panel members was prepared by Bio-Rad Laboratories. Two (2) of the six (6) panel members had high levels of the antibodies contained in the BioPlex 2200 EBV IgM kit (EBV VCA IgM and Heterophile) and two (2) of the six (6) panel members had antibody levels near the cutoff, both prepared from positive patient samples. Two (2) of the six (6) panel members were negative (one high negative and one low negative) for both of the analytes. In addition, a positive control (antibody positive for both analytes) and a negative control (antibody negative for both analytes) were also tested. Reproducibility testing was performed at each of three (3) US testing facilities on a total of three (3) lots of the EBV IgM kit, three (3) lots of the EBV IgM Calibrator Set and three (3) lots of the EBV IgM Control Set. The panels were provided to each of the testing sites. Each of the six (6) panel members and positive and negative controls was tested in quadruple (x4) on each day for three (3) days at each of three (3) US testing facilities using one (1) lot of EBV IgM kit, one (1) lot of EBV IgM Calibrator Set and one (1) lot of EBV IgM Control Set (4 times x 3 days x 3 sites = 36 replicates per panel member and controls). The data were analyzed for intra-assay and inter-assay reproducibility according to the principles described in the Clinical Laboratory Standards Institute guidance EP5-A2, revised November 2004 and ISO/TR 22971:2205. The standard deviation (SD) and percent coefficient of variation (%CV) were calculated.
C. Precision Studies
A precision panel, consisting of six (6) panel members was prepared by Bio-Rad Laboratories. Two (2) of the six (6) panel members had high levels of the antibodies contained in the BioPlex 2200 EBV IgG kit EBV IgM kit (EBV VCA IgM and Heterophile) and two (2) of the six (6) panel members had antibody levels near the cutoff, both prepared from positive patient samples. Two (2) of the six (6) panel members were negative (one high negative and one low negative) for both of the analytes.
Precision testing was performed at Bio-Rad Laboratories on one lot of the EBV IgM kit, one lot of the EBV IgM Calibrator Set and one lot of the EBV IgM Control Set. Each of the six (6) panel members was tested in duplicate (x2) on two (2) runs per day for ten (10) days using one (1) lot of EBV IgM kit, one (1) lot of EBV IgM Calibrator Set and one (1) lot of EBV IgM Control Set (2 times x 2 runs x 10 days = 40 replicates per panel member). The data were analyzed for intraassay and inter-assay precision according to the principles described in the Clinical Laboratory Standards Institute guidance EP5-A2, revised November 2004 and ISO/TR 22971:2205. The standard deviation (SD) and percent coefficient of variation (%CV) were calculated.
D. Comparative Testing
Comparison of BioPlex 2200 EBV IgM kit and Microplate EIA/Agglutination Tests Performance of the EBV IgM kit was tested against corresponding commercially available microplate EIA/agglutination tests. A total of 621 banked serum samples from patients for which an EBV test was ordered were tested at 3 U.S. clinical testing sites. The EBV IgG kit was run in conjunction with the EBV IgM kit to allow for a complete antibody response profile. The characterization by antibody response was not compared with clinical data regarding presence, absence or status of disease. Two (2) samples were excluded due to RBB analysis error messages during BioPlex 2200 EBV IgM testing, One (1) sample was excluded due to RBB analysis error messages during BioPlex 2200 EBV IgG testing. Using Table 16 as a guideline, results were analyzed by BioPlex 2200 EBV IgM analytes and corresponding EBV IgM reference assays according to serological characterization based on reference assay results. For the purpose of percent agreement calculations, BioPlex 2200 EBV IgM equivocal results were assigned to the opposite clinical interpretation than that of the corresponding reference assay result.
Comparison of BioPlex 2200 EBV IgM kit and Microplate EIA (known VCA IgM positive samples) Performance of the EBV IgM kit was further tested with serum samples that were previously characterized as EBV VCA IgM positive samples by another commercially available IgM EIA. A total of 100 purchased EBV VCA IgM positive samples were tested with the EBV IgM kit against corresponding commercially available microplate EIA/agglutination tests at a U.S. clinical testing site. The EBV IgG kit was run in conjunction with the EBV IgM kit to allow for a complete antibody response profile. The characterization by antibody response was not compared with clinical data regarding presence, absence or status of disease. Using Table 16 as a guideline, results were analyzed by BioPlex 2200 EBV IgM analytes and corresponding EBV IgM reference assays according to serological characterization based on reference assay results. For the purpose of percent agreement calculations, BioPlex 2200 EBV IgM equivocal results were assigned to the opposite clinical interpretation than that of the corresponding reference assay result.
Comparison of EBV Serological Status
Using Table 16 as a guideline, samples characterized into serological status associated with EBV disease, using the commercially available microplate EIA and agglutination tests, were compared with characterizations using BioPlex 2200 EBV IgG and IgM kits. The BioPlex 2200 EBV IgM kit was run in conjunction with the BioPlex 2200 EBV IgG kit to allow for a complete antibody response profile. The characterization by antibody response was not compared with clinical data regarding presence, absence or status of disease. Results from 618 serum samples tested at 3 U.S. clinical testing sites are shown in Table 25.
Comparison of Acute and Non-acute EBV Serological Status
The results obtained from the summarized information provided in Table 26 were further classified into Acute Infection. Acute Infection includes Primary Acute and Late Acute. Non-Acute Infection includes Susceptible, Recovering and Previous Infection as defined in Table 16. Inconclusive includes any samples reactivity are not consistent with any category listed in Table 16. Results are summarized in Table 26.
Comparison of EBV Serological Status (known IgM positive samples)
Using Table 16 as a quideline, samples characterized into serological status associated with EBV disease, using the commercially available microplate EIA and agglutination tests, were compared with characterizations using BioPlex 2200 EBV IgG and IgM kits. The BioPlex 2200 EBV IgM kit was run in conjunction with the BioPlex 2200 EBV IgG kit to allow for a complete antibody response profile. The characterization by antibody response was not compared with clinical data regarding presence, absence or status of disease. A total of 100 purchased EBV VCA IgM positive samples were tested at a U.S. clinical testing site.
Cross-Reactivity
A cross-reactivity study was performed to determine if samples from various disease states and other potentially interfering factors interfere with test results when tested with the BioPlex 2200 EBV IqM kit. A panel of at least ten (10) specimens* positive for each cross reactant were evaluated for possible cross reactivity with the BioPlex 2200 EBV IgM kit for both EBV IgM antibody assays. The test specimens were also evaluated on corresponding commercially available microplate EIA and latex agglutination tests. Due to the number of VCA IgM positive results obtained with the initial 10 Toxoplasmosis and CMV samples, an additional 33 toxoplasmosis and 42 CMV positive samples were tested with the BioPlex 2200 EBV IqM kit. This study was performed to demonstrate that the BioPlex 2200 VCA 1gM assay does not exhibit cross reactivity with Toxoplasmosis or CMV IdM samples. For these additional samples, only those that exhibited positive reactivity were tested on corresponding commercially available microplate EIA and latex agglutination tests. Most of the samples evaluated were high positive for each disease state. The majority of all samples that elicited a positive result were also confirmed positive by the corresponding commercially available test, indicating reactivity to EBV IgM antibodies rather than cross reactivity with a potentially interfering factor. Results can be found in Table 30.
*Due to limited availability of samples, only four E. coli specimens were evaluated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Table 18: BioPlex 2200 EBV VCA IgM vs. EIA: Percent Agreement & Confidence Intervals by Serological Pattern Characterization
Overall Positive Agreement: (65/83) 78.3% [68.3 - 85.8%]
Overall Negative Agreement: (507/535) 94.8% [92.5 - 96.4%]
Table 20: BioPlex 2200 Heterophile vs. Agglutination Test: Percent & Confidence Intervals by Serological Pattern Characterization
Overall Positive Agreement: (23/50) 46.0% [33.0 - 59.6%]
Overall Negative Agreement: (561/568) 98.8% [97.5 - 99.4%]
Table 22: BioPlex 2200 EBV VCA IgM vs. EIA: Percent Agreement & Confidence Intervals by Serological Pattern Characterization (known VCA IgM positive samples)
Late acute Positive Agreement: (100/100) 100% [96.3 - 100%]
Late acute Negative Agreement: (0/0) NA*
Table 24: BioPlex 2200 Heterophile vs. Agglutination Test: Percent & Confidence Intervals by Serological Pattern Characterization (known VCA IgM positive samples)
Late acute Positive Agreement: (100/100) 100% [96.3 - 100%]
Late acute Negative Agreement: (0/0) NA*
Table 25: Comparison of EBV Serological Status
Overall % Serological Agreement: 83.3% [80.2 - 86.1%]
Table 26: Acute vs. Non-acute
Overall % Serological Agreement: 85.1% [82.1 - 87.7%]
Table 27: Comparison of EBV Serological Status (known VCA IgM positive samples)
Overall % Serological Agreement: 100% [96.3-100%]
Table 28: Acute vs. Non-acute (known VCA IgM positive samples)
Overall % Serological Agreement: 100% [96.3-100%]
Table 29: Primary Acute Serological Status by Age
Total EBV VCA IgM Positive: 30 (97%) [83.8 - 99.4%]
Total Heterophile Positive: 18 (58%) [40.8 - 73.6%]
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.
946157, 862008
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.
Not Found
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).
Not Found
§ 866.3235 Epstein-Barr virus serological reagents.
(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).
0
Image /page/0/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 in white text on a black background. The text is in a bold, sans-serif font.
KOC2213
DEC - 8 2006
BIOPLEX 2200 EBV IgM 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 | 510(k) Summary Report Date |
|---|---|
| K062213 | December 7, 2006 |
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 EBV IgM | |
| 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 | Epstein Barr Virus, Other (LSE) | |
|---|---|---|
| Common Name: | Multi-Analyte Detection System EBV IgM | |
| Product Trade Name | BioPlex 2200 EBV IgM on the BioPlex 2200 Multi-Analyte | |
| Detection System | ||
| BioPlex 2200 EBV IgG Control Set | ||
| BioPlex 2200 EBV IgG Calibrator Set | ||
| Device Class | Class I | |
| Classification Panel | Microbiology | |
| Regulation Number | 866.3235 |
1
Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The logo is in a rounded rectangle shape. The text "BIO-RAD" is in white and the background is black.
| | BioPlex2200 EBV
IgG Analyte | Comparative FDA Cleared
PREDICATE DEVICE | 510(k)
Number | Decision
Date |
|----|--------------------------------|---------------------------------------------|------------------|------------------|
| 1. | EBV VCA | Diasorin EBV VCA IgM Capture EIA | 946157 | 6/7/95 |
| 2. | Heterophile | Wampole Monolatex | 862008 | 7/03/86 |
LEGALLY MARKETED EQUIVALENT (SE) DEVICES
DEVICE DESCRIPTION
The BioPlex 2200 EBV IgM kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional ElA, but permits simultaneous detection and identification of many antibodies in a single tube. Two (2) different populations of dyed beads are coated with proteins associated with infectious mononucleosis. One (1) is coated with an E. coli derived recombinant fusion protein, EBV VCA p18 (40kD), and the other is coated with horse erythrocyte stromal extract (heterophile antigen). The BioPlex 2200 System combines an aliquot of patient sample, sample diluent containing goat anti-human IgG, and bead reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, anti-human IgM antibody, conjugated to phycoerythrin (PE), is added to the dyed beads and this mixture is incubated at 37°C. The excess coniugate 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.
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 respectively. The instrument is calibrated using a set of two (2) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. A combination of two (2) vials representing two (2) different antibody concentrations is used for calibration. The result for each of these antibodies is expressed as an antibody index (AI).
KIT COMPONENTS
EBV IgM Reagent Pack (Catalog No. 665-1350). The reagent pack contains supplies sufficient for 100 tests.
| Vial | Description |
|---|---|
| Bead Set | One (1) 10 mL vial, containing 2 different populations of dyed beads coated |
| with affinity-purified E. coli derived recombinant protein to EBV VCA p18 | |
| (40kD), and Heterophile antigen (horse erythrocyte stromal extract); an | |
| Internal Standard (ISB), a Serum Verification (SVB), and a Reagent Blank | |
| (RBB); with Glycerol and protein stabilizers (bovine) in a MOPS (3-[N- | |
| Morpholino] propanesulfonic acid) buffer. ProClin® 300 (0.3%) and sodium | |
| azide (E. Coli | 4* |
| women | 10 |
| Toxo IgM | |
Table 30: Cross-Reactivity
*Commercially available assay data was not obtained, due to low sample volume.
+Commercially available assay testing was performed on BioPlex 2200 positive samples only. tt Commercially available assay testing was performed on the initial ten samples evaluated.
19
Image /page/19/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. David Bhend Regulatory Affairs Associate Bio-Rad Laboratories, Inc. Diagnostics Group 6565 18510 Ave, N.E. Redmond, WA 98052
DEC - 8 2006
K062213 Re:
Trade/Device Name: BioPlex 2200 EBV IgM Panel on the BioPlex 2200 Multi-Analyte Detection System BioPlex 2200 EBV IgM Control Set BioPlex 2200 EBV IgM Calibrator Set Regulation Number: 21 CFR 866.5640 Regulation Name: Infectious mononucleosis immunological test system. Regulatory Class: Class II Product Code: LSE, KTN Dated: November 13, 2006 Received: November 14, 2006
Dear Mr. Bhend:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
20
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sala Hans
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
21
INDICATIONS FOR USE STATEMENT
510(k) Number: K062213
BioPlex 2200 EBV IqM Kit on the BioPlex 2200 Multi-Analyte Device Name: Detection System BioPlex 2200 EBV IgM Control Set BioPlex 2200 EBV IgM Calibrator Set
Indications for Use:
BioPlex 2200 EBV IqM Kit
The BioPlex 2200 EBV IgM kit is a multiplex flow immunoassay intended for the qualitative detection of two (2) separate analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum. The test system can be used in conjunction with the BioPlex 2200 EBV IgG kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM).
The EBV IgM kit is intended for use with the Bio-Rad BioPlex 2200 System.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas.
BioPlex 2200 EBV IgM Calibrator Set
The BioPlex 2200 EBV IgM Calibrator Set is intended for the calibration of the BioPlex 2200 EBV IgM Reagent Pack.
BioPlex 2200 EBV IgM Control Set
The BioPlex 2200 EBV IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 EBV IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 EBV IgM Control Set has not been established with any other EBV assays.
X ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prescription Use: (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use: (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Office of Device Evaluation (ODE) Concur Division Siein-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510/k) 1206221