(138 days)
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No
The description details a standard ELISA assay process, which involves chemical reactions and optical density measurements, not AI/ML algorithms for data analysis or interpretation. There are no mentions of AI, ML, or related concepts in the document.
No
The device is an in vitro diagnostic test used to aid in the diagnosis of Rheumatoid Arthritis by detecting antibodies; it does not provide therapy or treatment.
Yes
The intended use explicitly states that the results of the assay are to be used "as an aid to the diagnosis of Rheumatoid Arthritis (RA)." Additionally, the device description includes the phrase "For in vitro diagnostic use," which directly indicates its purpose as a diagnostic tool.
No
The device is an enzyme-linked immunosorbent assay (ELISA) test kit, which is a laboratory-based in vitro diagnostic device that involves physical reagents and procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera and plasma." This involves testing biological samples in vitro (outside the body).
- Purpose: The assay is used "as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings." This clearly indicates a diagnostic purpose.
- Device Description: The description details an "enzyme-linked immunosorbent assay (ELISA)," which is a common in vitro laboratory technique. It also explicitly states "For in vitro diagnostic use".
- Performance Studies: The document includes performance studies like comparative results to a predicate device and clinical sensitivity and specificity, which are standard requirements for demonstrating the performance of an IVD.
- Predicate Device: The mention of a "Predicate Device(s)" (Immunoscan RA anti-CCP test kit) further confirms its classification as an IVD, as predicate devices are used for comparison in regulatory submissions for new IVDs.
N/A
Intended Use / 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.
Product codes
NHX
Device Description
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.
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
Trained laboratory professionals / Not Found
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)
Comparative Study (Substantial Equivalence)
- Sample Size: A total of 678 frozen retrospective sera were assayed: 416 from RA patients and 262 samples were apparently healthy blood donors.
- Key Results:
- 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%)
- Linear correlation (R-squared) between anti-CCP titres of 174 sera from RA patients with values
§ 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
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:
1
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