(28 days)
Not Found
No
The description details a standard multiplex flow immunoassay system and its components, calibration, and controls. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or decision-making. The results are based on relative fluorescence intensity and predefined cut-off values.
No.
The device is an in vitro diagnostic test kit designed to detect antibodies for diagnostic purposes, not to provide therapy or treatment.
Yes
Explanation: The device is intended for the "quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella" and "qualitative detection of IgG antibodies to Cytomegalovirus (CMV)," and is an "aid in the determination of serological status." These are all diagnostic functions.
No
The device description clearly outlines a kit containing physical components like dyed beads coated with antigens, calibrator vials, and control sets, which are used in conjunction with the Bio-Rad BioPlex 2200 System (a hardware instrument) to perform a multiplex flow 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 "quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella. and the qualitative detection of IgG antibodies to Cytomegalovirus (CMV) 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 diagnostic purposes (determining serological status).
- Device Description: The description details a laboratory method (multiplex flow immunoassay) used to analyze human samples.
- Clinical Context: The intended use mentions aiding in the "determination of serological status" and the device is used in a "clinical laboratory" setting.
- Regulatory Information: The presence of a "Predicate Device(s)" section with a K number (K080008) strongly suggests that this device has gone through a regulatory process for medical devices, specifically IVDs, in the past.
Therefore, based on the provided text, the BioPlex 2200 ToRC IgG kit fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BioPlex 2200 ToRC IgG kit is a multiplex flow immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella. and the qualitative detection of IgG antibodies to Cytomegalovirus (CMV) in human serum and EDTA or heparinized plasma.
The ToRC IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
This kit is intended as an aid in the determination of serological status to.T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors.
Performance characteristics for T. gondii and Rubella have not been evaluated in immunocompromised or immunosuppressed individuals. Performance characteristics for CMV have not been evaluated in immunosuppressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at a point of care.
The BioPlex 2200 ToRC IgG Calibrator Set is intended for the calibration of the BioPlex 2200 ToRC IgG Reagent Pack.
The BioPlex 2200 ToRC IgG Control Set is intended for use as an assaved quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex ToRC IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 ToRC IgG Control Set has not been established with any other Toxoplasma gondii, Rubella or Cytomegalovirus (CMV) IgG antibody assays.
Product codes (comma separated list FDA assigned to the subject device)
OMI, JIX, JJY
Device Description
The BioPlex® 2200 ToRC 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. "ToRC" is an acronym for individual tests to detect antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV). Three (3) different populations of dyed beads are coated with cell lysates bearing T. gondii, Rubella, or CMV antigens.
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 are calculated in relative fluorescence intensity (RFI).
Three additional dyed beads, Internal Standard Bead (ISB), 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.
The instrument is calibrated using a set of six (6) distinct calibrator vials. the BioPlex 2200 ToRC IgG Calibrator Set. For T. gondii and Rubella, six (6) vials, representing six (6) different levels of antibody concentrations, are used for quantitative calibration, and results for patient samples are expressed in IU/mL. For T. gondii, results of ≤ 9 IU/mL are negative, 10 and 11 IU/mL are equivocal, and results of > 12 IU/mL are reported as positive. For Rubella, results of ≤ 7 IU/mL are reported as negative, 8 and 9 IU/mL are equivocal, and ≥ 10 IU/mL are reported as positive. For CMV, four (4) vials, representing four (4) different antibody concentrations, are used for qualitative calibration. CMV results are expressed as an antibody index (AI) and results of ≤ 0.8 AI are negative, 0.9 and 1.0 AI are equivocal, and results of ≥ 1.1 AI are reported as positive.
The BioPlex 2200 ToRC IgG Control Set includes a negative control as well as two (2) multi-analyte positive controls. The BioPlex ToRC IgG Low Positive Control contains antibodies for T. gondii, Rubella and CMV and the BioPlex ToRC IgG High Positive Control contains antibodies for T. gondii and Rubella. The BioPlex ToRC IgG Positive Controls are manufactured to give positive results, with values above the cut-off for each specific analyte. The BioPlex ToRC IgG Negative Control is manufactured to give negative results, with values below the cut-off for each specific analyte. The recommended frequency for performing quality control is once every 24-hour testing period. Performing quality control is also necessary after each new assay calibration and certain service procedures.
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
§ 866.3510 Rubella virus serological reagents.
(a)
Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).(b)
Classification. Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards':
(i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,”
(ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,”
(iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,”
(iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and
(v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,”
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.
0
Bio-Rad Laboratories, Inc Special 510(k): Device Modification BioPlex 2200 ToRC IgG
Confidential
BioPlex® 2200 ToRC IgG 510(k) Summary
510(k) Number K120572
Date Prepared: March 26, 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 ToRC 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 ToRC IgG
| Classification Name | multiplex flow immunoassay, T. gondii, rubella and
CMV - Rubella virus serological reagents |
|----------------------|-----------------------------------------------------------------------------------------------------------|
| Common Name | Multi-Analyte Detection System for Toxoplasma
gondii IgG, Rubella IgG and Cytomegalovirus (CMV)
lgG |
| Product Trade Name | BioPlex 2200 ToRC IgG on the BioPlex 2200 Muli-
Analyte Detection System |
| Device Class | Class II |
| Classification Panel | Microbiology |
| Regulation Number | 866.3510 |
| Product Code | OMI, JIX, JJY |
Legally Marketed Predicate Device
BioPlex® 2200 ToRC IgG Kit, K080008
1
Bio-Rad Laboratories, Inc Special 510(k): Device Modification BioPlex 2200 ToRC IgG
Confidential
INTENDED USE / INDICATIONS FOR USE
BioPlex® 2200 ToRC IgG Kit
The BioPlex 2200 ToRC IgG kit is a multiplex flow immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella. and the qualitative detection of IgG antibodies to Cytomegalovirus (CMV) in human serum and EDTA or heparinized plasma.
The ToRC IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
This kit is intended as an aid in the determination of serological status to.T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors.
Performance characteristics for T. gondii and Rubella have not been evaluated in immunocompromised or immunosuppressed individuals. Performance characteristics for CMV have not been evaluated in immunosuppressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at a point of care.
BioPlex® 2200 ToRC IgG Calibrator Set
The BioPlex 2200 ToRC IgG Calibrator Set is intended for the calibration of the BioPlex 2200 ToRC IgG Reagent Pack.
BioPlex® 2200 ToRC IgG Control Set
The BioPlex 2200 ToRC IgG Control Set is intended for use as an assaved quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex ToRC IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 ToRC IgG Control Set has not been established with any other Toxoplasma gondii, Rubella or Cytomegalovirus (CMV) IgG antibody assays.
Device Description
The BioPlex® 2200 ToRC 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. "ToRC" is an acronym for individual tests to detect antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV). Three (3) different populations of dyed beads are coated with cell lysates bearing T. gondii, Rubella, or CMV antigens.
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, 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 are calculated in relative fluorescence intensity (RFI).
Three additional dyed beads, Internal Standard Bead (ISB), 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.
The instrument is calibrated using a set of six (6) distinct calibrator vials. the BioPlex 2200 ToRC IgG Calibrator Set. For T. gondii and Rubella, six (6) vials, representing six (6) different levels of antibody concentrations, are used for quantitative calibration, and results for patient samples are expressed in IU/mL. For T. gondii, results of ≤ 9 IU/mL are negative, 10 and 11 IU/mL are equivocal, and results of > 12 IU/mL are reported as positive. For Rubella, results of ≤ 7 IU/mL are reported as negative, 8 and 9 IU/mL are equivocal, and ≥ 10 IU/mL are reported as positive. For CMV, four (4) vials, representing four (4) different antibody concentrations, are used for qualitative calibration. CMV results are expressed as an antibody index (AI) and results of ≤ 0.8 AI are negative, 0.9 and 1.0 AI are equivocal, and results of ≥ 1.1 AI are reported as positive.
The BioPlex 2200 ToRC IgG Control Set includes a negative control as well as two (2) multi-analyte positive controls. The BioPlex ToRC IgG Low Positive Control contains antibodies for T. gondii, Rubella and CMV and the BioPlex ToRC IgG High Positive Control contains antibodies for T. gondii and Rubella. The BioPlex ToRC IgG Positive Controls are manufactured to give positive results, with values above the cut-off for each specific analyte. The BioPlex ToRC IgG Negative Control is manufactured to give negative results, with values below the cut-off for each specific analyte. The recommended frequency for performing quality control is once every 24-hour testing period. Performing quality control is also necessary after each new assay calibration and certain service procedures.
3
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 |
*Note: No reagent formulation change since clearance
Differences
The only difference of the BioPlex® 2200 ToRC IgG is to modify QC testing from each reagent pack to once per day as stated in the Instructions For Use (IFU) of the BioPlex® 2200 ToRC IgG.
| Feature | Modified | Predicate |
|---|---|---|
| Frequency of | ||
| Reagent Pack QC | ||
| Testing | QC once per day and per | |
| new reagent pack lot | QC once per pack and per | |
| day |
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.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration
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 2 6 2012
Re: K120572
Trade/Device Name: BioPlex 2200 ToRC IgG on the BioPlex 2200 Multi-Analyte Detection System
Regulation Number: 21 CFR 866.3510
Regulation Name: Rubella Virus Serological Reagents Regulatory Class: Class II Product Code: OMI, JIX, JJY Dated: February 24, 2012 Received: February 27, 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 (reporting of
5
Page 2 - Mr. Juang Wang
medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device related acreted ovelity systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quarty "Jour device as described in your Section 510(k) premarket will anow you to begin maline.org of substantial equivalence of your device to a legally marketed nonification. The I Dri Imazing of Eastion 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 If you desire specific ad not to your viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5 150. This , process 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/ReportaProblem/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 r ou may ovain 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,
Uve Scif Ro
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
6
Indication(s) For Use Statement
510(k) Number (if known):
Device Name: BioPlex® 2200 ToRC IgG Kit BioPlex® 2200 ToRC IgG Calibrator Set BioPlex® 2200 ToRC IgG Control Set
Indications for Use:
BioPlex® 2200 ToRC IgG Kit
The BioPlex™ 2200 ToRC IgG kit is a multiplex flow immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella, and the qualitative detection of IgG antibodies to Cytomegalovirus (CMV) in human serum and EDTA or heparinized plasma.
The ToRC IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
This kit is intended as an aid in the determination of serological status to T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors.
Performance characteristics for T. gondii and Rubella have not been evaluated in immunocompromised or immunosuppressed individuals. Performance characteristics for CMV have not been evaluated in immunosuppressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at a point of care.
BioPlex® 2200 ToRC IgG Calibrator Set
The BioPlex 2200 ToRC IgG Calibrator Set is intended for the calibration of the BioPlex 2200 ToRC IgG Reagent Pack.
BioPlex® 2200 ToRC IgG Control Set
The BioPlex 2200 ToRC IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex ToRC IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 ToRC IgG Control Set has not been established with any other Toxoplasma gondii, Rubella or Cytomegalovirus (CMV) IgG antibody assays.
AND/OR Over-the-Counter Use Prescription Use X (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)
Tamara Feldblum
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120572
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