(244 days)
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No
The description details a standard multiplex flow immunoassay with automated sample handling and detection. There is no mention of AI or ML in the device description, intended use, or performance studies. The data analysis described is based on established statistical methods (concordance, ROC analysis) and not AI/ML algorithms.
No
The device is described as a multiplex flow immunoassay kit intended for the semi-quantitative detection of IgG antibodies to Cyclic Citrullinated Peptide (CCP) for diagnostic aid in rheumatoid arthritis. It is an in-vitro diagnostic device used for diagnosis, not for therapy or treatment.
Yes
The BioPlex™ 2200 Anti-CCP Kit is intended for the detection of IgG antibodies to Cyclic Citrullinated Peptide (CCP), and its detection of CCP antibodies "may be used as an aid in the diagnosis of rheumatoid arthritis." This directly classifies it as a diagnostic device.
No
The device description clearly outlines a physical kit with reagents (fluorescent beads, anti-human IgG conjugate), calibrators, and controls used with a specific hardware system (Bio-Rad BioPlex 2200 system) to perform a multiplex flow immunoassay. This involves physical components and processes, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "semi-quantitative detection of IgG antibodies to Cyclic Citrullinated Peptide (CCP) in human serum and EDTA or heparinized plasma." This indicates it is used to test samples taken from the human body.
- Purpose: The detection of CCP antibodies is used "as an aid in the diagnosis of rheumatoid arthritis." This is a diagnostic purpose.
- Sample Type: It uses "human serum and EDTA or heparinized plasma," which are biological specimens.
- Device Description: The description details a laboratory assay using patient samples and reagents to measure a specific analyte (CCP antibodies).
- Performance Studies: The document describes performance studies conducted using patient samples to evaluate the device's accuracy and reliability for its intended diagnostic use.
- Intended User/Care Setting: It is intended for use in a "clinical laboratory," which is a typical setting for IVD testing.
- Predicate Device: A predicate device (K023285 DIASTAT™ Anti-CCP) is listed, which is also an IVD.
All of these factors align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / 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 or 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 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 or 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.
BioPlex™ 2200 Anti-CCP Calibrator Set
The BioPlex 2200 Anti-CCP Calibrator Set is intended for calibration of the BioPlex 2200 Anti-CCP Reagent Pack.
BioPlex™ 2200 Anti-CCP Control Set
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 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 immunoassays.
Product codes (comma separated list FDA assigned to the subject device)
NHX, JIX, JJX
Device Description
The BioPlex™ 2200 Anti-CCP 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. "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). Three populations of fluorescent beads function as assay controls (see below). The BioPlex™ 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel and incubates the mixture at 37°C. 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 removed 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 distinct calibrator vials, supplied separately by Bio-Rad Laboratories. The six vials representing six different analyte concentrations are used for calibration. The cut-off value and assignment of the calibrators are determined by performing concordance and Receiver Operator Characteristic (ROC) analysis using Axis-Shield DIAStat Anti-CCP predicate results as the reference. The result for anti-CCP is expressed as arbitrary units (U/mL). Results of 3 U/mL as positive.
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 Control Set includes a negative and a positive control. The BioPlex Anti-CCP Positive Control is manufactured to give positive results, with values above the cut-off for the analyte. The BioPlex Anti-CCP Negative Control is manufactured to give negative results, with values below the cut-off for the 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
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Anatomical Site
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Indicated Patient Age Range
The intended use does not specify a patient age range. However, samples from clinical studies ranged from 4 to 93 years.
Intended User / Care Setting
Clinical laboratory
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
A total of 1394 patient samples including 177 normal patients, 504 patients with either Rheumatoid Factor (RF) tested or positive, 82 older patients (age >70), 287 Rheumatoid Arthritis (RA) diagnosed patients and 344 non-RA patients were evaluated to determine the anti-CCP IgG assay cutoff. All samples were confirmed positive or negative by the Axis-Shield DIASTAT anti-CCP predicate assay.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of studies was conducted to evaluate the performance of the BioPlex™ 2200 Anti-CCP kit. The studies included reproducibility, linearity, limits of detection, interfering substances, cross-reactivity, assay cut-off, expected values and method comparison. The results of all studies demonstrated that the BioPlex 2200 Anti-CCP kit performed according to its specifications.
A. Analytical Performance
i. Precision/Reproducibility
- CLSI EP5-A2 Reproducibility Study:
- Study design: Three (3) panels made from serum and plasma (EDTA and heparinized), each composed of 10 samples covering the measuring range of the device, were assayed two times in two separate daily runs over 20 days (n=80 replicates per sample) plus one negative and one positive control.
- Key results: Precision results for serum, EDTA plasma, and heparin plasma panels were provided, showing within-run, between-run, between-day, and total precision (SD and %CV). Total %CV for most samples was below 10%, with some higher values for very low concentration negative samples or controls.
- CLSI EP15-A2 Reproducibility Study:
- Study design: Conducted at one clinical trial site. Three panels were made from serum and plasma (EDTA and heparinized) plus two controls (one negative and one positive). Each panel of 10 samples was tested in quadruplicate over five days (20 replicates per panel member).
- Key results: The within-run precision (%CV) for positive samples near the cut-off (3 U/mL) in all sample matrices ranged from 3.5% to 5.3%. The total precision (%CV) for positive samples near the cut-off (3 U/mL) ranged from 4.0% to 5.3%.
ii. Linearity/Assay Reportable Ranges
- Study design: Three high anti-CCP IgG positive patient samples (241 to 270 U/mL) were diluted with immunodepleted serum. Each sample and dilution was evaluated in replicates of four using one anti-CCP IgG lot on one instrument. Linear and polynomial regression analysis was performed.
- Key results: The BioPlex 2200 Anti-CCP IgG assay demonstrated linearity from 0 to 300 U/mL. Regression parameters (slope, intercept, r²) for the three samples were 0.9999-1.0002 for slope and 0.9978-0.9990 for r².
- On-board Dilution:
- Study design: Evaluated on-board dilution features (1:4, 1:10, 1:100) using three different high positive anti-CCP samples. Samples were assayed in replicates of ten. Recovery of on-board diluted samples compared to manual dilutions, and precision were assessed.
- Key results: Onboard values for 1:100, 1:10, and 1:4 dilutions had recoveries ranging from 87% to 104% compared to manual dilution, meeting the ±20% criterion. Onboard CVs were all ≤ 10%.
iii. Traceability of Calibrators/Controls
- No international or certified reference material for anti-CCP IgG is available. Calibrators are assigned relative units from predicate Axis-Shield DIASTAT Anti-CCP Calibrators.
iv. Limit of Detection
- Study design: Determined by assaying low positive, high negative and blank samples in replicates of fifty (50), according to CLSI EP17-A.
- Key results: The calculated LoD for the anti-CCP IgG assay is 0.2 U/mL.
v. Analytical Specificity
- Interfering Substances:
- Study design: Evaluated potential interference of specific endogenous and exogenous substances according to CLSI EP7-A2.
- Key results: No interference was observed with any of the substances tested (Hemoglobin, Bilirubin, Cholesterol, Red Blood Cells, Gamma Globulin, Triglycerides, Protein, Rheumatoid Factor, Ascorbic Acid, Lithium Heparin, Sodium Heparin, EDTA).
- Cross-Reactivity:
- Study design: 163 ANA samples and 72 other samples known to be positive for potential cross reactants were evaluated.
- Key results: Possible cross reactivity at 11% was observed with ANA samples (inclusive of all analytes). Centromere B (23%) and SS-A (12%) showed highest potential cross reactivity. Samples containing Myeloma IgG also showed cross reactivity (30%).
vi. Assay Cut-off
- Study design: A total of 1394 patient samples (177 normal, 504 RF tested/positive, 82 older patients, 287 RA diagnosed, 344 non-RA) were evaluated. All samples were confirmed by the Axis-Shield DIASTAT anti-CCP predicate assay.
- Key results: A cutoff of 3.0 U/mL was obtained to achieve percent positive and negative agreement at 92.9% and 98.2%, respectively, with the predicate.
B. Comparative Performance
i. Comparative Testing - Method Comparison
- Study design: Performance evaluated against predicate device, Axis-Shield DIASTAT Anti-CCP immunoassay, using 997 specimens (300 healthy blood donors, 496 RA patients, 201 other rheumatic disease patients). 822 samples within the detection range were evaluated.
- Key results:
- Positive Agreement (95% CI) = 97.5% (358/367) (95.4 - 98.7%)
- Negative Agreement (95% CI) = 91.4% (416/455) (88.5 - 93.7%)
Matrix Comparison
- Study design: 41 matched sets of serum and plasma (EDTA and heparin) samples from the same donor were spiked with high positive anti-CCP IgG serum. Samples were evaluated in replicates of two. Scatter plots with regression and correlation coefficients were generated.
- Key results:
- EDTA vs. Serum: Slope = 0.9636, Intercept = 2.5368, Correlation (r) = 0.9824
- Heparin vs. Serum: Slope = 0.9642, Intercept = 2.5264, Correlation (r) = 0.9852
ii. Clinical Sensitivity and Specificity
- Study design: Clinical studies involved testing 997 specimens (300 healthy blood donors, 496 diagnosed RA patients, 201 other rheumatic disease patients).
- Key results:
- Clinical Sensitivity (for Previously Diagnosed Rheumatoid Arthritis): 83.1% (412/496) with 95% CI 79.5 – 86.1%
- Clinical Specificity (for Healthy Blood Donors and Patients with Other Rheumatic Diseases): 97.8% (490/501) with 95% CI 96.1 – 98.8%
iii. Expected Values
- Expected Values/Reference Range: 300 samples from apparently healthy donors (114 males, 186 females) were tested. Results ranged from 3.0 U/mL as positive.
- Prevalence:
- In Apparently Healthy Blood Donors (N=300): 0/300 (0%) positive.
- In Samples sent to the lab with RF or CCP Test Ordered (N=300): 4/300 (1.3%) positive.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Agreement (95% CI) = 97.5% (358/367) (95.4 - 98.7%)
Negative Agreement (95% Cl) = 91.4% (416/455) (88.5 - 93.7%)
Clinical Sensitivity: 83.1%(412/496)
Clinical Specificity: 97.8% (490/501)
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.
DIASTAT™ Anti-CCP K023285
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
510(k) Summary Report BioPlex™ 2200 Anti-CCP Bio-Rad Laboratories, Inc.
AUG 2 4 2010
Bio-Rad Laboratories, Inc. BioPlex Division 5500 East Second Street Benicia, CA 94510 Contact Person: Telephone: Date Prepared:
- Applicant/Sponsor
Juang Wang 510-741-4609 August 19, 2010
- Device Name 2.
- Proprietary Name: BioPlex™ 2200 Anti-CCP Kit BioPlex™ 2200 Anti-CCP Calibrator Set BioPlex™ 2200 Anti-CCP Control Set
Multi-Analyte Detection System: Anti-CCP IgG Common/Usual Name:
| Classification Name: | Antibodies, Anti-Cyclic Citrullinated Peptide (CCP) |
|---|---|
| Calibrator, multi-analyte mixture | |
| Single-analyte controls, all kinds (assayed and unassayed) |
1
3. Regulatory Information
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| Antibodies, Anti-Cyclic | |||
| Citrullinated Peptide | |||
| (CCP) | |||
| (NHX) | Class II | 21 CFR § 866.5775, | |
| Rheumatoid factor | |||
| immunological test system | Immunology | ||
| Calibrator, multi-analyte | |||
| mixture (JIX) | Class II | 21 CFR § 862.1150 - | |
| Calibrator | Clinical Chemistry | ||
| single (specified) | |||
| analyte controls | |||
| (assayed and | |||
| unassayed) (JJX) | Class I | 21 CFR § 862.1660 – | |
| Quality control Material | |||
| (Assayed and Unassayed) | Clinical Chemistry |
Predicate Devices 4.
DIASTAT™ Anti-CCP K023285
Device Description ട.
The BioPlex™ 2200 Anti-CCP 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. "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). Three populations of fluorescent beads function as assay controls (see below). The BioPlex™ 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel and incubates the mixture at 37°C. 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 removed 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.
Bio-Rad Laboratories, Inc. BioPlex™ 2200 Anti-CCP 510(k) Summary August 19, 2010 Page 2 of 22
2
The instrument is calibrated using a set of six distinct calibrator vials, supplied separately by Bio-Rad Laboratories. The six vials representing six different analyte concentrations are used for calibration. The cut-off value and assignment of the calibrators are determined by performing concordance and Receiver Operator Characteristic (ROC) analysis using Axis-Shield DIAStat Anti-CCP predicate results as the reference. The result for anti-CCP is expressed as arbitrary units (U/mL). Results of 3 U/mL as positive.
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 Control Set includes a negative and a positive control. The BioPlex Anti-CCP Positive Control is manufactured to give positive results, with values above the cut-off for the analyte. The BioPlex Anti-CCP Negative Control is manufactured to give negative results, with values below the cut-off for the 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.
BioPlex™ 2200 Anti-CCP Kit Components 6.
| Vial | Description |
|---|---|
| Bead Set | One (1) 10 mL vial, containing dyed beads coated with |
| Cyclic Citrullinated Peptide, plus Internal Standard beads | |
| (ISB), Serum Verification beads (SVB), and Reagent | |
| Blank beads (RBB) in buffer with glycerol and protein | |
| stabilizers (bovine). ProClin 300 (0.3%), sodium benzoate | |
| (0.1%) and sodium azide (70), 287 Rheumatoid Arthritis (RA) diagnosed patients and 344 non-RA patients were evaluated to determine the anti-CCP IgG assay cutoff. All samples were confirmed positive or negative by the Axis-Shield DIASTAT anti-CCP predicate assay. A cutoff of 3.0 U/mL was obtained to achieve the percent positive and negative agreement at 92.9% and 98.2%, respectively. |
B. Comparative Performance
i. Comparative Testing
Method Comparison
Performance of the BioPlex 2200 Anti-CCP kit was evaluated against predicate device, Axis-Shield DIASTAT Anti-CCP immunoassay.
The performance of the BioPlex 2200 Anti-CCP was evaluated using a total of 997 specimens: 300 apparently healthy blood donors, 496 patients previously diagnosed with Rheumatoid Arthritis (RA), and 201 patients with other rheumatic diseases were tested at one clinical site. Patient specimens were purchased from commercial suppliers and were frozen serum. Each sample was unique and was unlinked to patient identity and not individual identifiable. Eight hundred twenty-two (822) samples within the detection range were evaluated.
Patients previously diagnosed with RA were selected by either physicians' diagnosis or an ICD-9 code 714.0.
Patients diagnosed with other rheumatic or inflammatory diseases include 3 Atherosclerotic disease, 2 CREST Syndrome, 18 Crohn's disease, 15 Fibromyalgia, 19 Gout, 16 Inflammatory Arthritis, 8 Osteoarthritis, 18 Scleroderma, 21 Sjögren's Syndrome, 31 Systemic Lupus Erythematosus, 17 Ulcerative Colitis and 2 Wegener's Granulomatosis.
BioPlex 2200 Anti-CCP
The results are presented in the table below.
Bio-Rad Laboratories, Inc. BioPlex™ 2200 Anti-CCP 510(k) Summary
16
| | | Positive | Negative | Total | % Positive
Agreement
(95% CI) | % Negative
Agreement
(95% CI) |
|--------------------------|----------|----------|----------|-------|-------------------------------------|-------------------------------------|
| Predicate
Immunoassay | Positive | 358 | 9 | 367 | 97.5% (358/367) | 91.4% (416/455) |
| | Negative | 39 | 416 | 455 | 95% CI
95.4 - 98.7% | 95% CI
88.5 - 93.7% |
| | Total | 397 | 425 | 822 | | |
Positive Agreement (95% CI) = 97.5% (358/367) (95.4 - 98.7%)
Negative Agreement (95% Cl) = 91.4% (416/455) (88.5 - 93.7%)
Matrix Comparison
Testing for matrix effects was conducted in accordance with CLSI EP9-A2 (Vol. 22, No. 19). Forty-one matched sets of serum and plasma (EDTA and heparin) samples drawn from the same donor were acquired from commercial sources. The matched sets were spiked with high positive anti-CCP IgG serum in order to cover the measuring range of the assay from 0.5 to 300 U/mL. All samples were evaluated in replicates of two. Plasma U/mL values were compared to matched serum U/mL values. Scatter plots using the first replicate results to compare the performance of EDTA and heparin plasma samples against serum samples along with the corresponding slopes of regression and correlation coefficient (r) are shown below.
| Matrix Comparison | N | Slope
(95% CI) | Intercept
(95% CI) | Correlation ( r )
(95% CI) |
|-------------------|----|----------------------------|-----------------------------|-------------------------------|
| EDTA vs. Serum | 41 | 0.9636
(0.8753, 1.0519) | 2.5368
(-2.5799, 7.6536) | 0.9824
(0.9670, 0.9906) |
| Heparin vs. Serum | 41 | 0.9642
(0.8995, 1.0289) | 2.5264
(-1.4891, 6.5419) | 0.9852
(0.9723, 0.9921) |
17
Image /page/17/Figure/0 description: The image contains two scatter plots comparing plasma and serum measurements. The left plot compares Heparin Plasma (U/mL) to Serum (U/mL), with a regression equation of y = 0.9642x + 2.5264 and a correlation coefficient of r = 0.9852. The right plot compares EDTA Plasma (U/mL) to Serum (U/mL), with a regression equation of y = 0.9636x + 2.5368 and a correlation coefficient of r = 0.9824. Both plots show a strong positive correlation between plasma and serum measurements, with data points clustered closely around the regression line.
Bio-Rad Laboratories, Inc. BioPlex™ 2200 Anti-CCP 510(k) Summary August 19, 2010 Page 18 of 22
18
ii. Clinical Sensitivity and Specificity
The clinical studies involved testing 997 specimens including 300 apparently healthy blood donors, 496 diagnosed RA patients, and 201 other rheumatic disease patients. The BioPlex 2200 Anti-CCP Sensitivity and Specificity are shown below.
| Anti-CCP Clinical
Sensitivity and
Specificity | Positive | Negative | Total | BioPlex 2200 Anti-CCP
% Sensitivity
(95% CI) | % Specificity
(95% CI) |
|--------------------------------------------------------------------------|----------|----------|-------|----------------------------------------------------|---------------------------|
| Previously
Diagnosed
Rheumatoid
Arthritis | 412 | 84 | 496 | 83.1%(412/496) | 97.8% (490/501) |
| Healthy Blood
Donors and
Patients with Other
Rheumatic Diseases | 11 | 490 | 501 | 95% CI
79.5 – 86.1% | 95% CI
96.1 – 98.8% |
| Total | 423 | 574 | 997 | | |
iii. Expected Values
Expected Values/Reference Range:
300 samples from apparently healthy donors including 114 males ranging in age from 4 to 84 and 186 females ranging in age from 4 to 88 were tested with BioPlex 2200 Anti-CCP assay. The Anti-CCP results range from 3.0 U/mL are reported as positive.
| BioPlex 2200
Anti-CCP
| (U/mL) | Gender | Minimum | Maximum | N |
|---|---|---|---|---|
| Apparently | ||||
| healthy donors | Male |