(30 days)
Not Found
No
The device description details a multiplex flow immunoassay system with standard laboratory procedures and data processing (relative fluorescence intensity, antibody index). There is no mention of AI, ML, or any learning algorithms used for data analysis, interpretation, or decision-making. The analysis is based on comparing results to established cut-offs and calibrators.
No
This device is an in vitro diagnostic (IVD) device intended for the qualitative detection of antibodies, not for therapeutic purposes.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the qualitative detection of IgG antibodies" and "can be used in conjunction...as an aid in the laboratory diagnosis of infectious mononucleosis (IM)" and "provides serological evidence of infection with T. pallidum," all of which are diagnostic purposes.
No
The device description clearly outlines a physical kit containing beads coated with antigens and reagents, 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 solely software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The text explicitly states the kits are "intended for the qualitative detection of IgG antibodies" in "human serum." This is a classic description of an in vitro diagnostic test, as it analyzes biological samples outside of the body to provide information about a patient's health status (in this case, exposure to EBV or Syphilis).
- Device Description: The description details a laboratory-based assay using reagents, beads, and a system to analyze patient samples. This is consistent with the nature of an IVD.
- Predicate Devices: The mention of predicate devices with K numbers (K062211 and K063866) strongly indicates that these devices have gone through the regulatory process for IVDs, which involves demonstrating substantial equivalence to previously cleared devices.
Therefore, the BioPlex® 2200 EBV IgG kit and the BioPlex® 2200 Syphilis IgG kit, as described, are IVDs.
N/A
Intended Use / Indications for Use
The BioPlex® 2200 EBV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of IgG antibodies to three (3) separate EBV antigens; Epstein-Barr Virus Nuclear Antigen-1 (EBV NA-1), Viral Capsid Antigen (EBV VCA), and Early . Antigen diffuse (EBV EA-D) in human serum. The test system can be used in conjunction with the BioPlex 2200 EBV IgM kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM).
The EBV IgG 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.
The BioPlex® 2200 Syphilis IgG kit is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidum IgG antibodies in human serum. The test system, when used in conjunction with non-treponemal based assays, provides serological evidence of infection with T. pallidum. This test system also confirms reactive test results form non-treponemal based screening assays.
The Syphilis IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
The BioPlex 2200 Syphilis IgG kit is not intended for use in screening blood or plasma donors
Warning: A positive result is not useful for establishing a diagnosis of Syphilis. In most situations, such a result may reflect prior treated infection; a negative result can exclude a diagnosis of syphilis except for incubating or early primary disease.
Product codes (comma separated list FDA assigned to the subject device)
LSE, JIX, JJY, LIP
Device Description
The EBV IgG 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. Three (3) different populations of beads are coated with E. coli derived recombinant proteins, EBV NA-1 (28kD and 45kD), EBV VCA p18 (40kD), and EBV EA-D (28kD) associated with infectious mononucleosis. 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 antibody, conjugated to phycoerythrin (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 seven (7) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. A combination of four (4) vials representing four (4) different antibody concentrations are used for semiquantitative calibration. The result for each of these antibodies is expressed as an antibody index (AI).
The Syphilis IgG 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. Three (3) different populations of beads are coated with recombinant proteins associated with T. pallidum (15kD. 17kD. and 47kD). The BioPlex 2200 System combines an aliquot of patient sample diluent, and bead reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, anti-human IgG antibody, conjugated to phycoerythrin (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 system is calibrated using a set of four (4) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. Four (4) vials representing two (2) or three (3) different antibody concentrations are used for calibration. Results are calculated for each of the three (3) antibodies and are compared against their own respective cut-off and are expressed as an antibody index (AI). A single result is reported after completing a composite analysis of all the antibodies (the highest AI value is reported).
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).
0
Bio-Rad Laboratories, Inc Special 510(k): Device Modification BioPlex 2200 EBV IgG
MAR 1 4 2012
Confidential
BioPlex® 2200 EBV IgG 510(k) Summary
510(k) Number: K120439
Date Prepared: February 29, 2012
Introduction
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 EBV IgG Panel.
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 and Classification
BioPlex 2200 EBV IgG `
| Classification Name | Epstein Barr Virus, Other |
|---|---|
| Common Name: | Multi-Analyte Detection System EBV IgG |
| Product Trade Name | BioPlex 2200 EBV IgG on the BioPlex 2200 Multi- |
| Analyte Detection System | |
| Device Class | Class I |
| Classification Panel | Microbiology |
| Regulation Number | 866.3235 |
| Product Code | LSE, JIX, JJY |
Legally Marketed Predicate Device
BioPlex® 2200 EBV IgG Panel, K062211
INTENDED USE / INDICATIONS FOR USE
The BioPlex® 2200 EBV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of IgG antibodies to three (3) separate EBV antigens; Epstein-Barr Virus Nuclear Antigen-1 (EBV NA-1), Viral Capsid Antigen (EBV VCA), and Early . Antigen diffuse (EBV EA-D) in human serum. The test system can be used in
1
Bio-Rad Laboratories, Inc Special 510(k): Device Modification BioPlex 2200 EBV IgG
Confidential
conjunction with the BioPlex 2200 EBV IgM kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM).
The EBV IgG 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.
Device Description
The EBV IgG 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. Three (3) different populations of beads are coated with E. coli derived recombinant proteins, EBV NA-1 (28kD and 45kD), EBV VCA p18 (40kD), and EBV EA-D (28kD) associated with infectious mononucleosis.12-13 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°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 seven (7) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. A combination of four (4) vials representing four (4) different antibody concentrations are used for semiquantitative calibration. The result for each of these antibodies is expressed as an antibody index (AI).
2
Confidential
Similarities and Differences
Similarities
| Feature | Modified Device |
|---|---|
| Intended Use/Indications For Use | No Change |
| Kit components | No Change |
| Technical Specifications | No Change |
| Fundamental Scientific Technology | No Change |
Differences
The differences are to modify QC testing from each reagent pack to once per day as stated in the Instructions For Use (IFU) of the BioPlex® 2200 EBV IgG and to add protein stabilizer and protease inhibitor in the particle (bead) diluent.
| Feature | Modified | Predicate |
|---|---|---|
| Frequency of | ||
| Reagent Pack QC | ||
| Testing | QC once per day or per new | |
| reagent pack lot | QC once per pack and per | |
| day | ||
| Microbial | ||
| Contamination | ||
| Prevention | Addition of protein stabilizer | |
| and protease inhibitors in the | ||
| particle (bead) diluent | None |
Summary of Design Control Activities
A Failure Mode and Effect Analysis (FMEA) was used to facilitate, capture, and quantify potential impacts of false positive or negative patient results. The Risk Priority Number (RPN) is a quantitative measure of the combined effects of severity, occurrence, and detection of potential risks. Specific mitigations are recommended that may include changes to the design or formulation if the RPN score exceeds a chosen threshold.
The Design Control Activities include Risk Analysis method to identify the verification and validation activities required, test used and acceptance criteria.
Based on the conclusion of the risk management report, the modified QC procedure fulfills the requirements of the specifications of the design control process. Therefore, the performance of the modified QC test frequency is substantially equivalent to the current cleared kit.
3
Confidential
BioPlex® 2200 Syphilis IgG 510(k) Summary
510(k) Number: K120439
Date Prepared: March 14, 2012
Introduction
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 Syphilis IgG Panel.
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 and Classification
BioPlex 2200 Syphilis IgG
【
| Classification Name | Treponema pallidum treponemal test reagents |
|---|---|
| Common Name: | Multi-Analyte Detection System Syphilis IgG |
| Product Trade Name | BioPlex 2200 Syphilis IgG on the BioPlex 2200 Multi- |
| Analyte Detection System | |
| Device Class | Class II |
| Classification Panel | Microbiology |
| Regulation Number | 866.3830 |
| Product Code | LIP, JIX, JJY |
Legally Marketed Predicate Device
BioPlex® 2200 Syphilis IgG Panel, K063866
INTENDED USE / INDICATIONS FOR USE
The BioPlex® 2200 Syphilis IgG kit is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidum IgG antibodies in human serum. The test system, when used in conjunction with non-treponemal based assays, provides
4
Confidential
serological evidence of infection with T. pallidum. This test system also confirms reactive test results form non-treponemal based screening assays.
The Syphilis IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
The BioPlex 2200 Syphilis IgG kit is not intended for use in screening blood or plasma donors
Warning: A positive result is not useful for establishing a diagnosis of Syphilis. In most situations, such a result may reflect prior treated infection; a negative result can exclude a diagnosis of syphilis except for incubating or early primary disease.
Device Description
The Syphilis IgG 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. Three (3) different populations of beads are coated with recombinant proteins associated with T. pallidum (15kD. 17kD. and 47kD). The BioPlex 2200 System combines an aliquot of patient sample diluent, and bead reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, anti-human IgG antibody, conjugated to phycoerythrin (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 system is calibrated using a set of four (4) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. Four (4) vials representing two (2) or three (3) different antibody concentrations are used for calibration. Results are calculated for each of the three (3) antibodies and are compared against their own respective cut-off and are expressed as an antibody index (AI). A single result is reported after completing a composite analysis of all the antibodies (the highest AI value is reported).
5
Similarities and Differences
Similarities
| Feature | Modified Device |
|---|---|
| Intended Use/Indications For Use | No Change |
| Kit components | No Change |
| Technical Specifications | No Change |
| Fundamental Scientific Technology | No Change |
Differences
The differences are to modify QC testing from each reagent pack to once per day as stated in the Instructions For Use (IFU) of the BioPlex® 2200 Syphilis IgG and to add protein stabilizer and protease inhibitor in the particle (bead) diluent.
| Feature | Modified | Predicate |
|---|---|---|
| Frequency of | ||
| Reagent Pack QC | ||
| Testing | QC once per day or per new | |
| reagent pack lot | QC once per pack and per | |
| day | ||
| Microbial | ||
| Contamination | ||
| Prevention | Addition of protein stabilizer | |
| and protease inhibitors in the | ||
| particle (bead) diluent | None |
Summary of Design Control Activities
A Failure Mode and Effect Analysis (FMEA) was used to facilitate, capture, and quantify potential impacts of false positive or negative patient results. The Risk Priority Number (RPN) is a quantitative measure of the combined effects of severity, occurrence, and detection of potential risks. Specific mitigations are recommended that may include changes to the design or formulation if the RPN score exceeds a chosen threshold.
The Design Control Activities include Risk Analysis method to identify the verification and validation activities required, test used and acceptance criteria.
Based on the conclusion of the risk management report, the modified QC procedure fulfills the requirements of the specifications of the design control process. Therefore, the performance of the modified QC test frequency is substantially equivalent to the current cleared kit.
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, positioned to the right of a circular inscription. The inscription reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters, arranged around the circle's perimeter. The eagle is rendered in black, while the text is also in black against a white background.
10903 New Hampshire Avenue Silver Spring, MD 20993
Bio-Rad Laboratories, Inc. c/o Mr. Juang Wang Regulatory Affairs Representative BioPlex Division 5500 E. Second Street Benicia, CA 94510
MAR 1 4 2012
Re: K120439
Trade Device Name: BioPlex 2200 EBV IgG and Syphilis on the BioPlex 2200 Multi-Analyte Detection System Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LIP, LSE, JIX, JJY Dated: February 9, 2012 Received: February 13, 2012
Dear Mr. Wang:
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 class II (Special Controls), 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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the
7
Page 2 Mr. Juang Wang
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Ube Sif for
Sally A. Hoivat. 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
8
Indication(s) For Use Statement
510(k) Number (if known): KI2 0439
BioPlex 2200 EBV IgG kit on the Device Name: BioPlex 2200 Multi-Analyte Detection System
Indications for Use:
The BioPlex® 2200 EBV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of IgG antibodies to three (3) separate EBV antigens; Epstein-Barr Virus Nuclear Antigen-1 (EBV NA-1), Viral Capsid Antigen (EBV VCA), and Early Antigen diffuse (EBV EA-D) in human serum. The test system can be used in conjunction with the BioPlex 2200 EBV IgM kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM).
The EBV IgG 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.
AND/OR Over-the-Counter Use Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(Please do not write below this line-Continue on another page of needed)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Tomaa Fldol
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K 120439
Page 1 of 1
9
Indication(s) For Use Statement
510(k) Number (if known): K120439
BioPlex® 2200 Syphilis IgG kit on the Device Name: BioPlex® 2200 Multi-Analyte Detection System
Indications for Use:
The BioPlex® 2200 Syphilis IgG kit is a multiplex flow immunoassay intended for the qualitative detection Treponema pallidum in human serum. The test system, when used in conjunction with non-treponemal based assays, provides serological evidence of infection with T. pallidum. This test system also confirms reactive test results form non-treponemal based screening assays.
The Syphilis IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
The BioPlex 2200 Syphilis IgG kit is not intended for use in screening blood or plasma donors
Warning: A positive result is not useful for establishing a diagnosis of Syphilis. In most situations, such a result may reflect prior treated infection; a negative result can exclude a diagnosis of syphilis except for incubating or early primary disease.
Prescription Use _ x Over-the-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(Please do not write below this line-Continue on another page if needed)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Tausa Feldblo
Director, Siting Office
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120439
Page 1 of 1