(134 days)
Not Found
No
The device description details a standard immunoassay technology (MEIA) and does not mention any computational methods that would suggest the use of AI or ML. The performance studies focus on method comparison and ROC analysis, which are standard statistical methods, not indicative of AI/ML.
No
The device is an in vitro diagnostic (IVD) device used to aid in the diagnosis of Rheumatoid Arthritis by detecting anti-CCP antibodies, not for therapeutic intervention.
No
The device is an immunoassay (MEIA) used to detect anti-CCP antibodies, which serves as an aid in diagnosing Rheumatoid Arthritis. It determines the presence of specific autoantibodies and is explicitly stated "for in vitro diagnostic use," meaning it is a laboratory test performed outside the body to assist in diagnosis, rather than being a diagnostic device itself in the sense of directly performing a diagnosis or providing an immediate diagnostic output. The diagnostic part is done by a clinician combining the output of this test with other clinical information.
No
The device description clearly outlines a Microparticle Enzyme Immunoassay (MEIA) technology involving physical reagents, pipetting steps, reaction vessels, and a processing center with a matrix cell and optical assembly. This indicates a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states "For in vitro diagnostic use."
- Intended Use: The intended use is the "semiquantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma." This involves testing biological samples (serum and plasma) outside of the body to provide information for diagnosis.
- Diagnostic Aid: The intended use also states that the detection of anti-CCP antibodies is used "as an aid in the diagnosis of Rheumatoid Arthritis (RA)." This clearly indicates a diagnostic purpose.
- Sample Type: The device analyzes human serum and plasma, which are biological specimens.
- Methodology: The device uses a Microparticle Enzyme Immunoassay (MEIA), a common laboratory technique for analyzing biological samples.
- Components: The description includes reagents, calibrators, and controls, which are typical components of an IVD assay system.
N/A
Intended Use / Indications for Use
AxSYM® Anti-CCP is a Microparticle Enzyme Immunoassay (MEIA) for the semiquantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma on the AxSYM System. Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multicriterion diagnostic process, encompassing both clinical and laboratory-based assessments.
The AxSYM® Anti-CCP Standard Calibrators are for the standard calibration of the AxSYM System when used for the semi-quantitative determination the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma.
The AxSYM® Anti-CCP Controls are for the use in quality control to monitor the accuracy and precision of the AxSYM Anti-CCP assay when used for the semiquantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma on the AxSYM System.
For in vitro diagnostic use.
Product codes
NHX, JIT, JJX, JJY
Device Description
AxSYM Anti-CCP is based on Microparticle Enzyme Immunoassay (MEIA) technology. The AxSYM Anti-CCP reagents and sample are pipetted in the following sequence:
SAMPLING CENTER
-. Sample and all AxSYM Anti-CCP reagents required for one test are pipetted by the Sampling Probe into various wells of a Reaction Vessel (RV),
- AxSYM Line Diluent and sample are pipetted into the Incubation Well of the . RV.
-. The AxSYM Anti-CCP Sample Diluent and diluted sample are pipetted into the Sample Well of the RV.
-. The AxSYM Anti-CCP Matrix Cell Blocker is pipetted into the Buffer Well of the RV.
-. The AxSYM Anti-CCP Mouse Anti-Human IgG:Alkaline Phosphatase Conjugate is pipetted into Reagent Well 3 of the RV.
-. AxSYM Line Diluent and CCP-Coated Microparticles are pipetted into Reagent Well 2 of the RV.
-. A reaction mixture is formed by combining diluted sample and diluted microparticles coated with CCP in Reagent Well 1 of the RV.
-. When anti-CCP antibody is present in the sample, it binds to the CCP-Coated Microparticles, forming antigen-antibody complexes on the microparticles.
The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe.
PROCESSING CENTER
-. An aliquot of Matrix Cell Blocker is transferred to the Matrix Cell.
-. An aliquot of the reaction mixture, containing microparticles and bound antigen-antibody complex, is transferred to the Matrix Cell. The microparticles bind irreversibly to the glass fiber matrix.
- The Matrix Cell is washed to remove materials not bound to the . microparticles.
- The AxSYM Anti-CCP Mouse Anti-Human IgG:Alkaline Phosphatase . Conjugate is dispensed onto the Matrix Cell and it binds with the antigenantibody complexes.
-. The Matrix Cell is washed to remove conjugate not bound to the microparticles.
-. The substrate, 4-Methylumbelliferyl Phosphate, is added to the Matrix Cell. The alkaline phosphatase-labeled conjugate catalyzes the removal of a phosphate group from the substrate, yielding the fluorescent product, 4-Methylumbelliferone. This fluorescent product is measured by the MEIA optical assembly.
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
Prescription Use
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)
The AxSYM® Anti-CCP assay is substantially equivalent to the DIASTAT™ Anti-CCP assay in terms of precision, linearity, interferences and stability as demonstrated in non-clinical performance data in this 510(k) submission.
The AxSYM® Anti-CCP assay demonstrated substantially equivalent performance to the DIASTAT™ Anti-CCP indicated by a method comparison with 97.3 % concordance for all samples tested. A Receiver Operator Characteristic (ROC) curve analysis determined that the DIASTAT Anti-CCP and the AxSYM Anti-CCP assays' Area Under the Curve are 0.870 and 0.875, respectively. This analysis indicates that the two assays are comparable with respect to cut-off and specimen values.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
ADMIN 3.0 AxSYM® Anti-CCP 510(K) SUMMARY MAR 2 0 2007 (Summary of Safety and Effectiveness)
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of CFR.
Submission Date: 03 Nov 2006
Dr Erica Conway Regulatory Affairs Manager
Axis-Shield Diagnostics, Ltd.
The Technology Park
Dundee DD2 1XA, Scotland, UK
Device Name: AxSYM® Anti-CCP
Reagents:
Classification Name: Antibodies, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) Trade Name: AxSYM® Anti-Cyclic Citrullinated Peptide (Anti-CCP) Common Name: Anti-CCP test Governing Regulation: 866.5775 Device Classification: Class II Classification Panel: Immunology Product Code: NHX
Calibrators:
Classification Name: Calibrator, Secondary Trade Name: AxSYM® Anti-CCP Standard Calibrators
AxSYM Anti-CCP 510(k) Premarket notification submission ADMIN 4.0 510(k) Summary 03 Nov 2006 FINAL
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Common Name: Calibrator Governing Regulation: 862.1150 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: JIT
Controls:
Classification Name: Single (specified) analyte controls (assayed and unassayed) Trade Name: AxSYM® Anti-CCP Control Common Name: Control Governing Regulation: 862.1660 Device Classification: Class I Classification Panel: Clinical Chemistry Product Code: JJX
Legally marketed device to which equivalency is claimed:
DIASTAT™ Anti-CCP Assay (K023285)
Intended Use of Device:
AxSYM® Anti-CCP is a Microparticle Enzyme Immunoassay (MEIA) for the semiquantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma on the AxSYM System. Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multicriterion diagnostic process, encompassing both clinical and laboratory-based assessments.
2
The AxSYM® Anti-CCP Standard Calibrators are for the standard calibration of the AxSYM System when used for the semi-quantitative determination the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma.
The AxSYM® Anti-CCP Controls are for the use in quality control to monitor the accuracy and precision of the AxSYM Anti-CCP assay when used for the semiquantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma on the AxSYM System.
Description of Device:
AxSYM Anti-CCP is based on Microparticle Enzyme Immunoassay (MEIA) technology. The AxSYM Anti-CCP reagents and sample are pipetted in the following sequence:
SAMPLING CENTER
- . Sample and all AxSYM Anti-CCP reagents required for one test are pipetted by the Sampling Probe into various wells of a Reaction Vessel (RV),
- AxSYM Line Diluent and sample are pipetted into the Incubation Well of the . RV.
- . The AxSYM Anti-CCP Sample Diluent and diluted sample are pipetted into the Sample Well of the RV.
- . The AxSYM Anti-CCP Matrix Cell Blocker is pipetted into the Buffer Well of the RV.
- . The AxSYM Anti-CCP Mouse Anti-Human IgG:Alkaline Phosphatase Conjugate is pipetted into Reagent Well 3 of the RV.
- . AxSYM Line Diluent and CCP-Coated Microparticles are pipetted into Reagent Well 2 of the RV.
3
- . A reaction mixture is formed by combining diluted sample and diluted microparticles coated with CCP in Reagent Well 1 of the RV.
- . When anti-CCP antibody is present in the sample, it binds to the CCP-Coated Microparticles, forming antigen-antibody complexes on the microparticles.
The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe.
PROCESSING CENTER
- . An aliquot of Matrix Cell Blocker is transferred to the Matrix Cell.
- . An aliquot of the reaction mixture, containing microparticles and bound antigen-antibody complex, is transferred to the Matrix Cell. The microparticles bind irreversibly to the glass fiber matrix.
- The Matrix Cell is washed to remove materials not bound to the . microparticles.
- The AxSYM Anti-CCP Mouse Anti-Human IgG:Alkaline Phosphatase . Conjugate is dispensed onto the Matrix Cell and it binds with the antigenantibody complexes.
- . The Matrix Cell is washed to remove conjugate not bound to the microparticles.
- . The substrate, 4-Methylumbelliferyl Phosphate, is added to the Matrix Cell. The alkaline phosphatase-labeled conjugate catalyzes the removal of a phosphate group from the substrate, yielding the fluorescent product, 4-Methylumbelliferone. This fluorescent product is measured by the MEIA optical assembly.
4
Comparison of Technological Characteristics:
AxSYM Anti-CCP is based on Microparticle Enzyme Immunoassay (MEIA) technology.
DIASTAT™ Anti-CCP is an enzyme-linked immunosorbent assay (ELISA).
Summary of Non-Clinical Performance:
The AxSYM® Anti-CCP assay is substantially equivalent to the DIASTAT™ Anti-CCP assay in terms of precision, linearity, interferences and stability as demonstrated in non-clinical performance data in this 510(k) submission.
Summary of Clinical Performance:
The AxSYM® Anti-CCP assay demonstrated substantially equivalent performance to the DIASTAT™ Anti-CCP indicated by a method comparison with 97.3 % concordance for all samples tested. A Receiver Operator Characteristic (ROC) curve analysis determined that the DIASTAT Anti-CCP and the AxSYM Anti-CCP assays' Area Under the Curve are 0.870 and 0.875, respectively. This analysis indicates that the two assays are comparable with respect to cut-off and specimen values.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Axis-Shield Diagnostics Ltd c/o Ms. Erica Conway Regulatory Affairs Manager The Technology Park Dundee, Scotland DD2 1XA United Kingdom
MAR 2 0 2007
Re: K063347
Trade/Device Name: AxSYM® Anti-CCP Reagent Kit, AxSYM® Anti-CCP Standard Calibrator Kit and AxSYM® Anti-CCP Control Kit Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid factor immunological test system Regulatory Class: Class II Product Code: NHX, JIX, JJX, JJY Dated: February 23, 2007 Received: February 26, 2007
Dear Ms. Conway:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to
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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) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html.
Sincerely vours.
Robert A. Becker f
Robert L. Becker, Jr., M.D., 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
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ADMIN 5.0 Product Classification - Indications for Use
Statement
510(k) Number (if known): K 063347
Device Name: AxSYM® Anti-CCP Reagents, AxSYM® Anti-CCP Standard Calibrators (A-F) and AxSYM® Anti-CCP Controls (Positive and Negative)
Indications for Use:
Reagents
AxSYM® Anti-CCP is a Microparticle Enzyme Immunoassay (MEIA) for the semiquantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma on the AxSYM System. Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multicriterion diagnostic process, encompassing both clinical and laboratory-based assessments.
Calibrators
The AxSYM® Anti-CCP Standard Calibrators are for the standard calibration of the AxSYM System when used for the semi-quantitative determination the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma.
Controls
The AxSYM® Anti-CCP Controls are for the use in quality control to monitor the accuracy and precision of the AxSYM Anti-CCP assay when used for the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma on the AxSYM System.
For in vitro diagnostic use.
Prescription Use
OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 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)
Marie Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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AxSYM Anti-CCP 510(k) Premarket notification submission ADMIN 5.0 Indications for Use 02 Nov 2006 FINAL
510(k) Kol3347