(138 days)
The EDIA™ anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera and plasma. The assay is used to detect antibodies in a single specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals.
The EDIA™ anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera and plasma. The assay is used to detect antibodies in a single specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. Trained laboratory professionals should perform the analysis. "For in vitro diagnostic use".
The wells are coated with Cyclic Citrullinated Peptides. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating.
The wells are then washed to remove unbound antibodies and other components. A conjugate of alkaline phosphatase labelled antibodies to human IgG binds to the antibodies in the wells in this second incubation.
After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the colour intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated against a calibrator curve and the results are given in arbitrary units.
Here's a breakdown of the acceptance criteria and study details for the EDIA™ anti-CCP kit, based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly stated as strict pass/fail thresholds in the provided document. Instead, the study aims to demonstrate substantial equivalence to a predicate device and establish clinical performance characteristics. The reported device performance is as follows:
| Performance Metric | Acceptance Criteria (Implied / Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Predicate Device Comparison | ||
| Positive Percent Agreement | Substantial equivalence to Immunoscan RA anti-CCP (e.g., high agreement). | 98.4% (95% CI: 96.4 - 99.5%) |
| Negative Percent Agreement | Substantial equivalence to Immunoscan RA anti-CCP (e.g., high agreement). | 99.4% (95% CI: 98.0 - 99.9%) |
| Overall Percent Agreement | Substantial equivalence to Immunoscan RA anti-CCP (e.g., high agreement). | 99.0% (95% CI: 97.9 - 99.6%) |
| Linear Correlation (EDIA vs. Immunoscan RA) | Strong positive linear correlation expected. | R-squared = 0.8886 |
| Clinical Performance | ||
| Clinical Sensitivity (RA patients) | Adequate sensitivity for aiding in RA diagnosis (no explicit numerical target, but typically >70% for such markers). | 76.2% (95% CI: 72.1-80.3) |
| Clinical Specificity (Healthy Blood Donors) | High specificity to differentiate from healthy individuals and other diseases (no explicit numerical target, but typically >90%). | 99.2% (95% CI: 97.3 - 99.9%) |
| Clinical Specificity (Non-RA Diseased) | High specificity to differentiate from various non-RA conditions (no explicit numerical target, but ideally >90% for most). | Ranged from 80% (Chlamydia) to 100% (many conditions) |
| Total Clinical Specificity (Non-RA) | Overall high specificity across non-RA conditions. | 98.6% |
| Analytical Performance | ||
| Intra-assay Precision (% CV) | Low variability (e.g., <10-15% for immunoassays). | Ranged from 1.9% to 7.9% |
| Inter-assay Precision (% CV) | Low variability (e.g., <10-15% for immunoassays). | Ranged from 6.3% to 10.6% |
| Batch to Batch Variation (% CV) | Low variability (e.g., <15-20% for immunoassays). | Ranged from 8.3% to 13.3% |
| Dilution Recovery | Recoveries generally within 80-120% of expected values. | Ranged from 84% to 116% |
| Limit of Detection | Low enough to detect clinically relevant levels (no explicit numerical target, but lower is better). | 0.5 U/mL |
| Interference | No significant interference from common interfering substances. | Indicated no interference from tested substances. |
2. Sample Sizes and Data Provenance
- Test Set for Predicate Device Comparison: 678 frozen retrospective sera
- 416 from RA patients
- 262 from apparently healthy blood donors
- Data provenance: Not explicitly stated, but given the manufacturer is Euro-Diagnostica AB in Sweden, it is likely European. The data is retrospective.
- Test Set for Clinical Sensitivity and Specificity: 1209 frozen retrospective sera with clinical characterization.
- 416 from established RA patients
- 793 from non-RA diseased patients and asymptomatic individuals (healthy blood donors)
- Data provenance: Not explicitly stated, but likely European. The data is retrospective.
- Test Set for Linear Correlation: 174 sera from RA patients.
- Data provenance: Not explicitly stated, but likely European. Retrospective.
- Test Sets for Analytical Performance (Precision, Dilution Recovery, Limit of Detection, Interference): Small numbers of pooled or individual samples (e.g., six different samples for precision, three different patient samples for dilution recovery, zero calibrator for LOD, three low positive samples for interference).
- Data provenance: Not explicitly stated. Likely performed in the manufacturer's lab.
3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications for establishing the ground truth.
4. Adjudication Method
The document does not describe any adjudication method for establishing the ground truth. It states "Patients with clinically defined RA" and "frozen retrospective sera with clinical characterisation," suggesting the clinical status was pre-determined based on existing medical records/diagnoses prior to the study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This study is for an in-vitro diagnostic (IVD) kit that measures a biomarker. MRMC studies are typically performed for imaging devices or other diagnostic tools where human interpretation is a primary component of the diagnostic process. This kit's output is a quantitative measure (U/mL) and a positive/negative result, which does not involve human readers in the same way.
6. Standalone Performance
Yes, this study primarily focuses on the standalone performance of the EDIA™ anti-CCP kit. The clinical sensitivity and specificity results in Tables 2 and 3 represent the algorithm's (the assay's) performance independent of human interpretation (beyond laboratory technicians performing the assay). The comparison to the predicate device also evaluates the standalone performance of the new device against an existing standalone device.
7. Type of Ground Truth Used
The ground truth for the clinical performance studies was based on:
- Clinical Characterization/Clinically Defined RA: This implies a diagnosis made by physicians based on established diagnostic criteria for Rheumatoid Arthritis, likely involving clinical signs, symptoms, imaging, and other laboratory tests.
- Healthy Blood Donors and Non-RA Diseased Patients: These classifications serve as controls or negative ground truths, indicating the absence of RA or the presence of other specific conditions.
For the predicate device comparison, the ground truth was the result obtained from the Immunoscan RA anti-CCP test kit.
For analytical studies (precision, detection limit, dilution recovery, interference), the ground truth is predefined theoretical values or established experimental protocols to assess the assay's fundamental performance characteristics.
8. Sample Size for the Training Set
The document does not explicitly describe a separate "training set" for the EDIA™ anti-CCP kit. ELISA-based assays are developed using established biochemical principles and reagents, and their "training" typically involves optimizing the assay components and parameters during the development phase, rather than statistical machine learning training on a distinct data set. The provided data represents evaluation or validation sets.
9. How the Ground Truth for the Training Set was Established
As no explicit training set for an algorithm is described, this question is not directly applicable. The "ground truth" during the development and optimization of such an assay would involve known concentrations of antibodies, reference standards, and samples with confirmed clinical status to fine-tune the assay's performance characteristics.
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JEL - 3 2006
K06204-5
Revised Summary of Safety and Effectiveness Information EDIA™ anti-CCP kit
- Euro-Diagnostica AB, Medeon, SE-205 12 Malmo, Sweden Contact person: Ms. Annika Andersson Telephone: +46 40 32 11 55 Fax: +46 40 92 31 50 Date of preparation: October 16, 2006
II. Description of Device: The EDIA™ anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera and plasma. The assay is used to detect antibodies in a single specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. Trained laboratory professionals should perform the analysis. "For in vitro diagnostic use".
The wells are coated with Cyclic Citrullinated Peptides. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating.
The wells are then washed to remove unbound antibodies and other components. A conjugate of alkaline phosphatase labelled antibodies to human IgG binds to the antibodies in the wells in this second incubation.
After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the colour intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated against a calibrator curve and the results are given in arbitrary units.
III. Predicate Device: The EDIA™ anti-CCP test is substantially equivalent to the. Immunoscan RA anti-CCP test kit. Equivalence is demonstrated by the following comparative results:
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Table 1. Percent agreement of the EDIA™ anti-CCP compared to the Immunoscan RA anti-CCP test kit. A total of 678 frozen retrospective sera were assayed. 416 from RA patients and 262 samples were apparently healthy blood donors.
| Predicate device(Immunoscan RA anti-CCP) | |||
|---|---|---|---|
| New device | N = 678 | Positive | Negative |
| EDIA™ anti-CCP | Positive | 317 | 2 |
| Negative | 5 | 354 |
| Positive Percent Agreement: 317/322 = 98.4% | 95% CI = 96.4 - 99.5% |
|---|---|
| Negative Percent Agreement: 354/356 = 99.4% | 95% CI = 98.0 - 99.9% |
| Overall Percent Agreement: 671/678 = 99.0% | 95% CI = 97.9 - 99.6% |
The 95% confidence interval (CI) was calculated using the exact method.
Figure 1 Linear correlation between anti-CCP titres of 174 sera from RA patients with values <50 U/mL for the EDIA anti-CCP and <250 U/mL for the Immunoscan RA anti-CCP.
Image /page/1/Figure/5 description: This image is a scatter plot titled "Correlation Immunoscan RA anti-CCP and EDIA anti-CCP". The x-axis is labeled "EDIA anti-CCP (U/mL)" and ranges from 0 to 60. The y-axis is labeled "Immunoscan RA anti-CCP (U/mL)" and ranges from 0 to 350. A regression line is plotted with the equation y = 6.27x + 4.389 and an R-squared value of 0.8886.
Table 2. Clinical sensitivity and specificity. A total of 1209 frozen retrospective sera with clinical characterisation were assayed. The following table summarises the results.
| Sensitivity of EDIA™ anti-CCP for 416 sera from established RA patients | ||
|---|---|---|
| ------------------------------------------------------------------------- | -- | -- |
| n | negative | positive | Sensitivity | |
|---|---|---|---|---|
| Patients with clinicallydefined RA | 416 | 99 | 317 | 76% |
Clinical Sensitivity: RA 317/416 = 76.2% 95% Cl = 72.1-80.3
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Clinical specificity for the EDIA™ anti-CCP for non-RA diseased patients and
asymptomatic individuals (healthy blood donors).
| n | negative | positive | Specificity | |
|---|---|---|---|---|
| Healthy blood donors | 262 | 260 | 2 | 99% |
| Crohn's disease | 10 | 10 | 0 | 100% |
| Colitis ulcerosa | 10 | 10 | 0 | 100% |
| Systemic lupus erythematosus | 30 | 30 | 0 | 100% |
| Sjögren's syndrome | 17 | 16 | 1 | 94% |
| EBV | 5 | 5 | 0 | 100% |
| Parvo | 5 | 5 | 0 | 100% |
| Mycoplasma | 9 | 9 | 0 | 100% |
| Toxoplasma | 6 | 6 | 0 | 100% |
| Yersinia | 8 | 8 | 0 | 100% |
| Chlamydia | 5 | 4 | 1 | 80% |
| Malaria | 4 | 4 | 0 | 100% |
| Borrelia | 9 | 9 | 0 | 100% |
| Lues | 5 | 5 | 0 | 100% |
| Rubella | 5 | 5 | 0 | 100% |
| TPO-AB (anti-thyroid peroxidase ab) | 20 | 20 | 0 | 100% |
| Osteoarthritis | 21 | 21 | 0 | 100% |
| Endocarditis | 3 | 3 | 0 | 100% |
| Tuberculosis | 5 | 5 | 0 | 100% |
| Legionella | 4 | 4 | 0 | 100% |
| Salmonella | 3 | 3 | 0 | 100% |
| AST/ASH (anti-streptococcal ab) | 3 | 3 | 0 | 100% |
| Schistosomiasis | 4 | 4 | 0 | 100% |
| Chaga's disease | 3 | 3 | 0 | 100% |
| Scleroderma | 17 | 16 | 1 | 94% |
| Multiple sclerosis | 20 | 20 | 0 | 100% |
| Insulin dependent diabetes mellitus | 20 | 20 | 0 | 100% |
| Polymyositis / Dermatomysositis | 20 | 20 | 0 | 100% |
| Mixed connective tissue disease | 20 | 19 | 1 | 95% |
| MPO-ANCA positive. MP | 20 | 20 | 0 | 100% |
| PR3-ANCA positive. WG | 20 | 20 | 0 | 100% |
| Ds-DNA positive | 40 | 38 | 2 | 95% |
| Inflammatory bowel disease | 80 | 79 | 1 | 99% |
| nonRA autoimmune patients | 80 | 78 | 2 | 98% |
| TOTAL | 793 | 782 | 11 | 98.6% |
MP = Microscopic polyangiitis
:
WG = Wegener's granulomatosis
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Clinical specificity
| Blood donors | 260/262 = 99.2% | 95% CI = 97.3 - 99.9% |
|---|---|---|
| Crohn's disease | 10/10 = 100% | 95% CI = 69.2 - 100% |
| Colitis ulcerosa | 10/10 = 100% | 95% CI = 69.2 - 100% |
| SLE | 30/30 = 100% | 95% CI = 88.4 - 100% |
| Sjorgen's syndrome | 16/17 = 94.1% | 95% CI = 71.3 - 99.8% |
| EBV | 5/5 = 100% | 95% CI = 47.8 - 100% |
| Parvo | 5/5 = 100% | 95% CI = 47.8 - 100% |
| Mycoplasma | 9/9 = 100% | 95% CI = 66.4 - 100% |
| Toxoplasma | 6/6 = 100% | 95% CI = 54.1 - 100% |
| Yersinia | 8/8 = 100% | 95% CI = 63.1 - 100% |
| Chlamydia | 4/5 = 80% | 95% CI = 28.4 - 99.5% |
| Malaria | 4/4 = 100% | 95% CI = 39.8 - 100% |
| Borrelia | 9/9 = 100% | 95% CI = 66.4 - 100% |
| Lues | 5/5 = 100% | 95% CI = 47.8 - 100% |
| Rubella | 5/5 = 100% | 95% CI = 47.8 - 100% |
| TPO-AB | 20/20 = 100% | 95% CI = 83.2 - 100% |
| Osteoarthritis | 21/21 = 100% | 95% CI = 83.9 - 100% |
| Endocarditis | 3/3 = 100% | 95% CI = 29.2 - 100% |
| Tuberculosis | 5/5 = 100% | 95% CI = 47.8 - 100% |
| Legionella | 4/4 = 100% | 95% CI = 39.8 - 100% |
| Salmonella | 3/3 = 100% | 95% CI = 29.2 - 100% |
| AST/ASH | 3/3 = 100% | 95% CI = 29.2 - 100% |
| Schistosomiasis | 4/4 = 100% | 95% CI = 39.8 - 100% |
| Chaga's disease | 3/3 = 100% | 95% CI = 29.2 - 100% |
| Scleroderma | 16/17 = 94.1% | 95% CI = 71.3 - 99.8% |
| Multiple Sclreosis | 20/20 = 100% | 95% CI = 83.2 - 100% |
| IDDM | 20/20 = 100% | 95% CI = 83.2 - 100% |
| PM/DM | 20/20 = 100% | 95% CI = 83.2 - 100% |
| MCTD | 19/20 = 95% | 95% CI = 75.1 - 99.9% |
| MP | 20/20 = 100% | 95% CI = 83.2 - 100% |
| WG | 20/20 = 100% | 95% CI = 83.2 - 100% |
| ds-DNA positive | 38/40 = 95% | 95% CI = 83.1 - 99.4% |
| IBD | 79/80 = 98.6% | 95% CI = 93.2 - 100% |
| nonRA autoimmune | 78/80 = 97.5% | 95% CI = 91.3 - 99.7% |
The 95% confidence interval (CI) was calculated using the exact method.
·
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| High(U/mL) | Medium(U/mL) | Low(U/mL) | |
|---|---|---|---|
| Mean | 173.9 | 34.0 | 9.9 |
| S.D. | 13.8 | 0.6 | 0.2 |
| % C.V. | 7.9 | 1.9 | 2.1 |
| Low(U/mL) | Low(U/mL) | Low(U/mL) | |
| Mean | 11.8 | 7.8 | 9.7 |
| S.D. | 0.5 | 0.1 | 0.4 |
| %C.V. | 4.0 | 1.9 | 4.4 |
- Table 3. Intra-assay precision was determined by testing six different samples eight times each.
- Table 4. Inter-assay precision was determined by testing six different samples eight times each. Results were obtained for three different runs.
| High(U/mL) | Medium(U/mL) | Low(U/mL) | |
|---|---|---|---|
| Mean. | 183.8 | 36.6 | 9.3 |
| S.D. | 19.5 | 3.0 | 0.9 |
| % C.V. | 10.6 | 8.2 | 9.8 |
| Low(U/mL) | Low(U/mL) | Low(U/mL) | |
| Mean | 11.9 | 7.8 | 10.6 |
| S.D. | 0.8 | 0.7 | 0.9 |
| %C.V. | 6.3 | 9.5 | 8.9 |
Table 5. Batch to batch variation was determined by testing six different samples eight times each. Results were obtained for three different batches.
| High(U/mL) | Medium(U/mL) | Low(U/mL) | |
|---|---|---|---|
| Mean | 232.5 | 41.6 | 11.5 |
| S.D. | 30.9 | 4.5 | 1.3 |
| % C.V. | 13.3 | 10.8 | 11.2 |
| Low(U/mL) | Low(U/mL) | Low(U/mL) | |
| Mean | 14.1 | 9.8 | 13.0 |
| S.D. | 1.2 | 1.0 | 1.2 |
| %C.V. | 8.3 | 10.4 | 9.3 |
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| Sample | Dilution | MeanMeasuredConcentration(U/mL) | CalculatedConcentration(U/mL) | DilutionCorrected %Recovery |
|---|---|---|---|---|
| 1 | 1/100 | 205.0 | 205.0 | 100 |
| 1/200 | 110.5 | 102.5 | 108 | |
| 1/400 | 47.3 | 51.3 | 92 | |
| 1/800 | 24.8 | 25.6 | 97 | |
| 1/1600 | 10.8 | 12.8 | 84 | |
| Sample | Dilution | MeanMeasuredConcentration(U/mL) | CalculatedConcentration(U/mL) | DilutionCorrected %Recovery |
| 2 | 1/100 | 138.9 | 138.9 | 100 |
| 1/200 | 70.3 | 69.5 | 101 | |
| 1/400 | 40.4 | 34.7 | 116 | |
| 1/800 | 18.3 | 17.4 | 105 | |
| 1/1600 | 8.7 | 8.7 | 100 | |
| Sample | Dilution | MeanMeasuredConcentration(U/mL) | CalculatedConcentration(U/mL) | DilutionCorrected %Recovery |
| 3 | 1/100 | 47.3 | 47.3 | 100 |
| 1/200 | 26.7 | 23.6 | 113 | |
| 1/400 | 13.0 | 11.8 | 110 | |
| 1/800 | 6.3 | 5.9 | 107 | |
| 1/1600 | 3.0 | 3.0 | 103 |
Table 6. Dilution recovery was determined by testing five serial dilutions of three different patient samples.
Limit of detection
The detection limit of the assay was determined by running the zero calibrator 12 times on three different lots. The detection limit of 0.5 U/mL was calculated by finding the mean plus two standard deviations.
Interference study
Three low positive samples were spiked to the following concentrations in diluted serum samples; Billrubin F at 0.188 mg/dL, Bilirubin C at 0.2 mg/dL, Haemoglobin at 453 mg/dL, Chyle at 0.24 U/dL and Rheumatoid Factor at 200 IU/mL. The data indicates that the assayed concentrations do not interfere with the anti-CCP results.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, and it is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The figure is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Euro-Diagnostica AB c/o Ms. Annika Andersson Regulatory Affairs Specialist Medeon SE-205 12 Malmő Sweden
DEC - 4 2006
Re: K062045
Trade/Device Name: EDIA™ Anti-CCP Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid Factor Immunological Test System Regulatory Class: Class II Product Code: NHX Dated: July 14, 2006 Received: July 19, 2006
Dear Ms. Andersson:
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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
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 Part 801), please contact the Office of Compliance at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert W. Beckerf
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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Indications for Use
510(k) Number (if known):
Device Name: EDIA™ anti-CCP
Indications For Use: The EDIA™ anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera and plasma. The assay is used to detect antibodies in a single specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals.
Prescription Use × (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Mana M Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of 1
510(k) K062045
§ 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).