(237 days)
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No
The document describes a standard immunoassay for detecting antibodies and does not mention any AI or ML components in its description, performance studies, or intended use.
No
This device is an in vitro diagnostic (IVD) assay designed to aid in the diagnosis of Rheumatoid Arthritis by detecting specific autoantibodies, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "is for in vitro diagnostic use" and "is used as an aid in the diagnosis of Rheumatoid Arthritis (RA)".
No
The device description clearly states it is a "fully automated, two-step immunoassay using chemiluminescent technology" and describes physical components like "acridinium ester-labeled anti-human lgG as the Lite Reagent" and "biotinylated CCP coupled to streptavidin which is then coated onto magnetic latex microparticles." 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:
- Intended Use/Indications for Use: The document explicitly states "for in vitro diagnostic use" multiple times when describing the assay, the quality control material, and the master curve material.
- Device Description: The description details an immunoassay that analyzes human serum or plasma samples, which is a characteristic of an in vitro diagnostic test.
- Purpose: The assay is used to detect anti-CCP antibodies in human samples as an aid in the diagnosis of Rheumatoid Arthritis. This is a diagnostic purpose performed outside of the body.
N/A
Intended Use / Indications for Use
The ADVIA Centaur® anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma (K2-EDTA and lithium heparin) using the ADVIA Centaur XP 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 multi-criteria diagnostic process, encompassing both clinical and laboratory-based assessments.
Quality Control:
The ADVIA Centaur® Anti-CCP IgG (aCCP) quality control material is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur aCCP assay using the ADVIA Centaur systems.
Master Curve Material (MCM):
The ADVIA Centaur® Anti-CCP IgG (aCCP) Master Curve Material (MCM) is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur aCCP assay.
Product codes (comma separated list FDA assigned to the subject device)
NHX, JJX
Device Description
The ADVIA Centaur aCCP assay is a fully automated, two-step immunoassay using chemiluminescent technology. The assay utilizes an acridinium ester-labeled anti-human lgG as the Lite Reagent. The Solid Phase consists of biotinylated CCP coupled to streptavidin which is then coated onto magnetic latex microparticles.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Performance:
The ADVIA Centaur aCCP assay demonstrated substantially equivalent performance to the ARCHITECT Anti-CCP assay. A summary of the non-clinical performance data included in this 510(k) submission has been presented.
Linearity: Linearity was evaluated according to the CLSI protocol EP6-A. Three samples containing high levels of anti-CCP IgG were mixed with a pool of negative serum. The resulting sample mixtures were assayed for anti-CCP IgG. The ADVIA Centaur aCCP assay is linear from 0.40-200.00 U/mL.
Dilution Linearity: Two samples containing high levels of anti-CCP IgG (140.63 and 180.08 U/mL) were diluted 1:10 (1 part sample plus 9 parts diluent) with Multi-Diluent 1 and assayed for recovery and parallelism.
Recovery % for sample 1 (1:10 dilution): 107.87
Recovery % for sample 2 (1:10 dilution): 105.62
Measuring Interval: The ADVIA Centaur aCCP assay measures anti-CCP IgG concentrations from 0.40-200.0 U/mL.
Detection Capability: The ADVIA Centaur aCCP assay is designed to have a Limit of Detection (LoD) of less than 1.50 U/mL. The LoD was determined to be 0.40 U/mL.
High Dose Hook: Patient samples with anti-CCP IgG levels as high as 3000.00 U/mL will assay greater than 200.00 U/mL.
Cross-reactivity: Cross-reactivity was tested in the presence and absence of anti-CCP IgG according to CLSI EP7-A2 using the ADVIA Centaur aCCP assay. Populations evaluated included Sm, RNP, SSB, Scl-70, Jo-1, Ribosomal P, M2, TPO, ds-DNA, SSA and Chromatin. The study showed no clinically significant cross-reactivity.
Interference: Interfering substances at the levels indicated in the table were tested as described in CLSI Document EP7-A2. Potential interference in the ADVIA Centaur aCCP assay is designed to be less than or equal to 10%.
No significant interference was observed from hemolyzed (1000 mg/dL of hemoglobin), icteric (40 mg/dL of unconjugated bilirubin, 40 mg/dL of conjugated bilirubin), lipemic (1500 mg/dL of lipemia (Intralipid), 2450 mg/dL of triglycerides) specimens.
No significant interference was observed from Biotin (500 ng/dL), Caprine IgG (6 g/dL), Total Protein (12 g/dL), Rheumatoid Factor (200 IU/mL).
Precision: Precision was evaluated according to the CLSI protocol EP5-A2. Six serum precision panels were prepared with anti-CCP IgG concentrations spanning the measuring interval. Each sample was tested in replicates of 2 in two runs per day over 20 days. One ADVIA Centaur system was used and one reagent lot giving a total of 80 observations per sample.
Within-Laboratory %CV ranged from 3.3% to 4.3% in the tested samples.
Specimen Collection Comparison: A clinical specimen collection study was performed. Any negative anti-CCP IgG values were excluded. The specimen anti-CCP IgG values ranged from 0.41-180.82 U/mL. Linear regression analysis was performed and no significant difference between tube types was observed.
Serum Vs. Serum Separator Tube (n=50): Slope=1.01, Intercept=0.05, r=1.00
Serum Vs. K2-EDTA (n=51): Slope=0.98, Intercept=0.03, r=1.00
Serum Vs. Lithium heparin (n=49): Slope=1.00, Intercept=0.11, r=0.98
Summary of Clinical Performance:
The ADVIA Centaur anti-CCP IgG assay demonstrated substantially equivalent performance to the ARCHITECT Anti-CCP assay as indicated by a clinical concordance and method comparison study.
Method Comparison: 253 samples (143 samples confirmed positive for RA, and 110 samples where other auto-antibodies may be present) were tested.
Overall % Agreement (95% Confidence Interval (CI)) 96.84% (93.89-98.39%).
Positive % Agreement (95% Confidence Interval (CI)) 96.80% (92.06-98.75%).
Negative % Agreement (95% Confidence Interval (CI)) 96.88% (92.24-98.78%).
Clinical Sensitivity and Specificity: Clinical sensitivity and specificity were determined using 767 patients samples.
The sensitivity assessment was conducted on 307 confirmed-positive RA subjects.
The specificity assessment was conducted on 22 subgroups of non-RA subjects (n=460) with potentially cross-reacting conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Sensitivity (Exact 95% Confidence Interval (CI)) 68.08% (62.5-73.3%).
Clinical Specificity (Exact 95% Confidence Interval (CI)) 97.17% (95.22-98.49%).
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.
ARCHITECT Anti-CCP Assay (K083868)
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.
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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).
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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures facing to the right. The figures are connected and appear to be in motion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2016
Axis-Shield Diagnostics Ltd Dr. Claire L. Dora Regulatory Affairs Manager The Technology Park, Luna Place Dundee, DD2 1XA, UK
Re: K153551
Trade/Device Name: ADVIA Centaur® Anti-CCP IgG (aCCP) Assay ADVIA Centaur® Anti-CCP IgG (aCCP) Quality Controls ADVIA Centaur® Anti-CCP IgG (aCCP) Master Curve Materials Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid Factor Immunological Test System Regulatory Class: II Product Code: NHX, JJX Dated: July 18, 2016 Received: July 19, 2016
Dear Dr. Dora:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
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as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kelly Oliner -S
FOR
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153551
Device Name
ADVIA Centaur® anti-CCP IgG (aCCP) Assay ADVIA Centaur® anti-CCP IgG (aCCP) Quality Control ADVIA Centaur® anti-CCP IgG (aCCP) Master Curve Material (MCM)
Indications for Use (Describe)
The ADVIA Centaur® anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma (K2-EDTA and lithium heparin) using the ADVIA Centaur XP 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 multi-criteria diagnostic process, encompassing both clinical and laboratory-based assessments.
Quality Control:
The ADVIA Centaur® Anti-CCP IgG (aCCP) quality control material is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur aCCP assay using the ADVIA Centaur systems.
Master Curve Material (MCM):
The ADVIA Centaur® Anti-CCP IgG (aCCP) Master Curve Material (MCM) is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur aCCP assay.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
The assigned 510(k) number is: K1535551.
Submission correspondent:
Dr Claire Dora Regulatory Affairs Manager Axis-Shield Diagnostics Ltd. The Technology Park Dundee DD2 1XA, Scotland, UK
Device Name:
ADVIA Centaur® anti-CCP IgG (aCCP) assay ADVIA Centaur® anti-CCP IgG (aCCP) Quality Control ADVIA Centaur® anti-CCP IgG (aCCP) Master Curve Material (MCM)
Reagents:
Classification Name: Antibodies, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) Trade Name: ADVIA Centaur® anti-CCP IgG (aCCP) assay Common Name: Anti-CCP test Governing Regulation: 866.5775 Device Classification: Class II Classification Panel: Immunology Product Code: NHX
Quality Control:
Classification Name: Single (Specified) Analyte Control Trade Name: ADVIA Centaur® anti-CCP IgG (aCCP) quality control material Common Name: Control Governing Regulation: 862.1660 Device Classification: Class I Classification Panel: Clinical Chemistry Product Code: JJX
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Master Curve Materials:
Classification Name: Single (Specified) Analyte Control Trade Name: ADVIA Centaur® anti-CCP IgG (aCCP) Master Curve Material (MCM) 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:
ARCHITECT Anti-CCP Assay (K083868)
Intended Use of Device:
The ADVIA Centaur® anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semiquantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma (K2-EDTA and lithium heparin) using the ADVIA Centaur XP 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 multi-criteria diagnostic process, encompassing both clinical and laboratory-based assessments.
Quality Control:
The ADVIA Centaur® Anti-CCP IgG (aCCP) quality control material is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur aCCP assay using the ADVIA Centaur systems.
Master Curve Material (MCM):
The ADVIA Centaur® Anti-CCP IgG (aCCP) Master Curve Material (MCM) is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur aCCP assay.
Description of Device:
The ADVIA Centaur aCCP assay is a fully automated, two-step immunoassay using chemiluminescent technology. The assay utilizes an acridinium ester-labeled anti-human lgG as the Lite Reagent. The Solid Phase consists of biotinylated CCP coupled to streptavidin which is then coated onto magnetic latex microparticles.
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Comparison of Technological Characteristics:
The ADVIA Centaur aCCP assay and the ARCHITECT Anti-CCP are both automated immunoassays for the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma. The ADVIA Centaur System and ARCHITECT i System share similar detection methods both utilizing chemiluminescent microparticle immunoassay (CMIA) technology. Both assays also demonstrated substantial equivalence in terms antibodies employed and units of measure.
| Similarities | ||
|---|---|---|
| Parameter | Submission device | |
| ADVIA Centaur® aCCP | Predicate device | |
| ARCHITECT Anti-CCP | ||
| Intended use | Intended for the semi-quantitative | |
| determination of the IgG class of | ||
| autoantibodies specific to cyclic | ||
| citrullinated peptide (CCP) in human serum | ||
| or plasma using the ADVIA Centaur XP | ||
| 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 multi-criteria diagnostic | ||
| process, encompassing both clinical and | ||
| laboratory-based assessments. | Intended for the semi-quantitative | |
| determination of the IgG class of | ||
| autoantibodies specific to cyclic citrullinated | ||
| peptide (CCP) in human serum or plasma on | ||
| the ARCHITECT i 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. | ||
| Assay Technology | Automated. | |
| Chemiluminescent Microparticle | ||
| Immunoassay (CMIA) | Automated. | |
| Chemiluminescent Microparticle | ||
| Immunoassay (CMIA) | ||
| Substrate / Signal | ||
| Generation | Acridinium Tracer | Acridinium Tracer |
| Specimen type | Human serum and serum separator tubes. | |
| Human plasma collected in lithium heparin | ||
| and potassium EDTA tubes | Human serum and serum separator tubes. | |
| Human plasma collected in lithium heparin | ||
| and potassium EDTA tubes | ||
| Capture antibody | Cyclic citrullinated peptide (CCP), second | |
| generation. | Cyclic citrullinated peptide (CCP), second | |
| generation. | ||
| Conjugate antibody | Mouse anti-human IgG: acridinium-labeled. | Mouse anti-human IgG: acridinium-labeled. |
| Storage conditions | Intended Storage of 2-8 °C. | Intended Storage of 2-8 °C. |
| Calibrator Range | 0.0-200.0 U/mL | 0.0-200.0 U/mL |
| Suggested Cut-Off | 5.0 U/mL | 5.0 U/mL |
| Interference | No interference from | |
| Total Protein (12 g/dL) | ||
| Rheumatoid Factor (200 IU/mL) | No interference from | |
| Total Protein (12 g/dL) | ||
| Rheumatoid Factor (200 IU/mL) | ||
| Cross- Reactivity | No significant cross-reactivity of the CCP | |
| antigen with any of these other | ||
| autoantibodies (SSA, SSB, Sm, RNP, Scl-70, | ||
| TPO, Jo-1, ds-DNA, and Ribosomal P). | No significant cross-reactivity of the CCP | |
| antigen with any of these other | ||
| autoantibodies (SSA, SSB, Sm, RNP, Scl-70, | ||
| TPO, Jo-1, ds-DNA, and Ribosomal P). | ||
| Similarities | ||
| Parameter | Submission device | |
| ADVIA Centaur® aCCP | Predicate device | |
| ARCHITECT Anti-CCP | ||
| Sample Stability | Separated specimens are stable for up to | |
| 22 hours at room temperature or up to 7 | ||
| days at 2-8 ºC. | ||
| Avoid more than 2 freeze-thaw cycles. | Specimens may be stored for up to 7 days at | |
| 2-8ºC or 22 hours at 30ºC after the date of | ||
| collection. For longer storage, store | ||
| specimens at -20ºC or colder. | ||
| Avoid more than three freeze/thaw cycles. |
Comparison of the subject device with the predicate device:
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| Differences | ||
|---|---|---|
| Parameter | Submission device | |
| ADVIA Centaur® Anti-CCP | Predicate device | |
| ARCHITECT Anti-CCP | ||
| Calibration | Semi-quantitative assay. | |
| 10-point master calibration curve (4PL, Y-weighted) generated and stored on the lot-specific aCCP master curve card. | ||
| The ADVIA Centaur aCCP assay utilises a 2-point operator-initiated calibration. The assay calibration covers 0 to 200 U/mL | Semi-quantitative assay. 6-point calibration curve (4PLC, Y-weighted) generated and stored on the instrument. The ARCHITECT Anti-CCP Standard Calibrators A-F (0.0, 5.0, 25.0, 50.0, 100.0, 200.0 U/mL) | |
| Expected Values in | ||
| Asymptomatic Population | The median was established at 0.74 U/mL. | |
| (Mean 95% Confidence Limits of 0.25 -1.87 U/mL) in a representative study | Specimen values ranged from |