(29 days)
Not Found
No
The description details a multiplex flow immunoassay system and its components, focusing on chemical reactions and fluorescence detection. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or decision-making within the device's operation.
No.
The device is clearly indicated as a diagnostic aid ("an aid in the diagnosis of rheumatoid arthritis"), not a therapeutic device. It detects antibodies, which is a diagnostic function, not a treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the kit is "intended for the semiquantitative detection of IgG antibodies to Cyclic Citrullinated Peptide (CCP) in human serum or plasma... Detection of CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis". This clearly indicates its role in aiding diagnosis.
No
The device is a kit containing reagents and beads for a multiplex flow immunoassay, which are physical components, not software. It is intended for use with a specific hardware system (Bio-Rad BioPlex® 2200 System).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "semiquantitative detection of IgG antibodies to Cyclic Citrullinated Peptide (CCP) in human serum or plasma". This involves testing a sample taken from the human body in vitro (outside the body).
- Diagnosis: The intended use also states that the detection of CCP antibodies is used "as an aid in the diagnosis of rheumatoid arthritis". This directly links the test results to a diagnostic purpose.
- Sample Type: The device analyzes "human serum or plasma", which are biological samples taken from a patient.
- Methodology: The description details a "multiplex flow immunoassay", which is a laboratory testing method performed on biological samples.
- Clinical Setting: The intended user is a "clinical laboratory", which is where IVD tests are typically performed.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BioPlex® 2200 Anti-CCP kit is a multiplex flow immunoassay intended for the semiquantitative detection of IgG antibodies to Cyclic Citrullinated Peptide (CCP) in human serum or plasma (EDTA and sodium heparin). Detection of CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis and should be used in conjunction with other clinical findings and laboratory results.
The BioPlex® 2200 Anti-CCP kit is intended for use with the Bio-Rad BioPlex® 2200 System.
The BioPlex 2200 Anti-CCP Calibrator Set is intended for the calibration of the BioPlex 2200 Anti-CCP Reagent Pack.
The BioPlex 2200 Anti-CCP Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and BioPlex 2200 Anti-CCP Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Anti-CCP Control Set has not been established with any other Anti-CCP assay.
Product codes (comma separated list FDA assigned to the subject device)
NHX
Device Description
The BioPlex® 2200 Anti-CCP kit uses multiplex flow immunoassay, a methodology that permits simultaneous detection and identification of antibodies in a single tube. "CCP IgG" is an acronym for the detection of IgG antibodies to Cyclic Citrullinated Peptide.
One (1) population of fluorescent beads is coated with antigens associated with cyclic citrullinated peptide (CCP). The BioPlex® 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel and incubates the mixture sample. After a wash cycle to remove unbound antibody, anti-human IgG conjugated to phycoerythrin is added and the mixture is incubated at 37°C. Excess conjugate is proved in another wash cycle and the washed beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the assay and control beads is determined by the fluorescence embedded in the surface of the bead and the amount of immobilized antibody is determined by the fluorescence of the anti-IgG reporter conjugate. Raw data are calculated in relative fluorescence intensity (RFI).
Three additional dyed beads, Internal Standard Bead (ISB), Serum Verification Bead (SVB) and Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum or plasma to the reaction and the absence of significant non-specific binding. Refer to the BioPlex® 2200 System Operation Manual for more information.
The instrument is calibrated using a set of six (6) distinct calibrator vials, supplied separately by Bio-Rad Laboratories.
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)
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.
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
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).
0
Bio-Rad Laboratories, Inc Special 510(k): Device Modification BioPlex 2200 Anti-CCP Kit
Confidential
BioPlex® 2200 Anti-CCP Kit 510(k) Summary
510(k) Number_K112810
Date Prepared: September 19, 2011
Introduction
Bio-Rad Laboratories hereby submits this Special 510(k) in accordance with the Dio-Rud Laboratories neroof backers of 807.92. This summary of 510(k) safety and requirements of STAD i on provides detail as a basis for a determination of substantial equivalence for the BioPlex® 2200 Anti-CCP 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)741-4650 |
Device name and Classification
| Product Trade Name | BioPlex® 2200 Anti-CCP Kit |
|---|---|
| Common Name | Multi-Analyte Detection System --Anti-CCP IgG |
| Classification name | Antibodies, anti-Cyclic Citrullinated Peptide (CCP) |
| Device Class | Class II |
| Classification Panel | Immunology |
| Regulation Number | 21 CFR 866.5775 |
| Product Code | NHX |
Legally Marketed Predicate Device
BioPlex® 2200 Anti-CCP Kit, K093954
Intended Use/Indications For Use
The BioPlex® 2200 Anti-CCP kit is a multiplex flow immunoassay intended for the semiquantitative detection of IgG antibodies to Cyclic Citrullinated Peptide (CCP) in human serum or plasma (EDTA and sodium heparin). Detection of CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis and should be used in conjunction with other clinical findings and laboratory results.
1
Bio-Rad Laboratories, Inc Special 510(k): Device Modification BioPlex 2200 Anti-CCP Kit
Confidential
The BioPlex® 2200 Anti-CCP kit is intended for use with the Bio-Rad BioPlex® 2200 System.
Device Description
The BioPlex® 2200 Anti-CCP kit uses multiplex flow immunoassay, a methodology that I ne DIOT for " Les be a resembly but permits simultaneous detection and identification groat. y reseilbodies in a single tube. "CCP IgG" is an acronym for the detection of lgG antibodies to Cyclic Citrullinated Peptide.
One (1) population of fluorescent beads is coated with antigens associated with cyclic citrullinated peptide (CCP). The BioPlex® 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel and incubates the mixture sample, After a wash cycle to remove unbound antibody, anti-human IgG conjugated to phycoerythrin is added and the mixture is incubated at 37°C. Excess conjugate is proved in another wash cycle and the washed beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the assay and control beads is determined by the fluorescence embedded in the surface of the bead and the amount of immobilized antibody is determined by the fluorescence of the anti-lgG reporter conjugate. Raw data are calculated in relative fluorescence intensity (RFI).
Three additional dyed beads, Internal Standard Bead (ISB), Serum Verification Bead (SVB) and Reagent Blank Bead (RBB) are present in each reaction mixture to verify , detector response, the addition of serum or plasma to the reaction and the absence of significant non-specific binding. Refer to the BioPlex® 2200 System Operation Manual for more information.
The instrument is calibrated using a set of six (6) distinct calibrator vials, supplied separately by Bio-Rad Laboratories.
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 |
2
Bio-Rad Laboratories, Inc Special 510(k): Device Modification BioPlex 2200 Anti-CCP Kit
Confidential
Differences
The only difference of the BioPlex® 2200 Anti-CCP kit 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 Anti-CCP reagent kit.
| 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 |
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Bio-Rad Laboratories c/o Mr. Juang Wang Regulatory Affairs Representative BioPlex 2200 Division 5500 E. Second Street Benicia, CA 94510
OCT 2 6 2011
Re: K112810
Trade/Device Name: Bio-Plex® 2200 Anti-CCP Kit Regulation Number: 21 CFR § 866.5775 Regulation Name: Rheumatoid factor immunological test system Regulatory Class: Class II Product Code: NHX Dated: September 26, 2011 Received: September 27, 2011
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 medical device-related adverse events) (21 CFR 803); and good manufacturing practice
4
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/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 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,
Maria M. Chan, Ph.D.
Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indication(s) for use
510(k) Number (if known): _ K 112810
Device Name: BioPlex® 2200 Anti-CCP Kit
Indications for Use:
The BioPlex® 2200 Anti-CCP kit is a multiplex flow immunoassay intended for the semi-quantitative detection of IgG antibodies to Cyclic Citrullinated Peptide (CCP) in human serum or plasma (EDTA and sodium heparin). Detection of CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis and should be used in conjunction with other clinical findings and laboratory results.
The BioPlex 2200 Anti-CCP kit is intended for use with the Bio-Rad BioPlex 2200 system. .
The BioPlex 2200 Anti-CCP Calibrator Set is intended for the calibration of the BioPlex 2200 Anti-CCP Reagent Pack.
The BioPlex 2200 Anti-CCP Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and BioPlex 2200 Anti-CCP Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Anti-CCP Control Set has not been established with any other Anti-CCP assay.
| Prescription Use | x |
|---|---|
| ------------------ | --- |
AND/OR
| Over-the-Counter Use | |
|---|---|
| ---------------------- | -- |
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)(Please do not write below this line-Continue on another page of needed)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off( Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112810