(163 days)
No
The description details a standard ELISA assay with optical density measurement and calculation against a calibrator curve, which does not involve AI/ML.
No
The device is an in vitro diagnostic (IVD) test kit used to aid in the diagnosis of Rheumatoid Arthritis by detecting antibodies, not to treat or therapeutically manage a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA)".
No
The device is an in vitro diagnostic (IVD) test kit, which is a physical product containing reagents and components for performing an ELISA assay. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative and semi-quantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera." This involves testing a sample taken from the human body (serum) outside of the body (in vitro).
- Indications for Use: It's used as an "aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings." This is a diagnostic purpose.
- Device Description: The description details an "enzyme-linked immunosorbent assay (ELISA)" which is a common in vitro diagnostic technique. It also explicitly states "For in vitro diagnostic use".
- Performance Studies: The document includes performance studies like sensitivity, specificity, and agreement, which are standard for evaluating the performance of IVD devices.
- Predicate Device: The mention of a predicate device (K052133) indicates that this device is being compared to a previously cleared IVD.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Immunoscan CCPlus® test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semi-quantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. The assay is used to detect antibodies in a single serum 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. "For in vitro diagnostic use".
Product codes (comma separated list FDA assigned to the subject device)
NHX
Device Description
The Immunoscan CCPlus® test kit is a modification of the Immunoscan RA anti-CCP Test kit, K052133. It is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semi-quantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. The assay is used to detect antibodies in a single serum 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. "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
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained laboratory professionals.
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 628 frozen retrospective sera were assayed for percent agreement of the Immunoscan CCPlus® compared to the Immunoscan RA anti-CCP Test kit. 368 were obtained from RA patients and 260 samples were from apparently healthy blood donors.
A total of 1180 frozen retrospective sera with clinical characterisation were assayed for clinical sensitivity and specificity.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative Study (Percent Agreement):
Sample Size: 628 frozen retrospective sera (368 from RA patients, 260 from healthy blood donors).
Key Results:
Positive Percent Agreement: 275/277 = 99.3% (95% CI = 97.4 - 99.9%)
Negative Percent Agreement: 346/351 = 98.6% (95% CI = 96.7 - 99.5%)
Overall Percent Agreement: 621/628 = 98.9% (95% CI = 97.7 - 99.6%)
Clinical Sensitivity and Specificity Study:
Sample Size: 1180 frozen retrospective sera with clinical characterisation.
Key Results:
Clinical sensitivity for patients with clinically defined RA: 309/399 = 77.4% (95% CI = 73.3 - 81.5%)
Clinical specificity for non-RA diseased patients and asymptomatic individuals (healthy blood donors):
Blood donors: 257/260 = 98.8% (95% CI = 96.7 - 99.8%)
Wegener's granulomatosis (WG): 18/20 = 90.0% (95% CI = 68.3 - 98.8%)
Microscopic polyangiitis (MP): 20/20 = 100% (95% CI = 83.2 - 100%)
Systemic lupus erythematosus (SLE): 64/66 = 97.0 % (95% CI = 89.5 - 99.6%)
Sjögren's syndrome: 13/13 = 100 % (95% CI = 75.3 - 100%)
Inflammatory bowel disease (IBD): 95/98 = 96.9% (95% CI = 91.3 - 99.4%)
Osteoarthritis: 21/21 = 100% (95% CI = 83.9 - 100%)
Thyroiditis: 20/20 = 100% (95% CI = 83.2 - 100%)
Infectious Disease: 85/86 = 98.8% (95% CI = 93.7 - 100%)
Scleroderma: 16/17 = 94.1% (95% CI = 71.3 - 99.8%)
Multiple Sclerosis: 20/20 = 100% (95% CI = 83.2 - 100%)
Insulin dependent diabetes mellitus (IDDM): 20/20 = 100% (95% CI = 83.2 - 100%)
Polymyositis/Dermatomyositis (PM/DM): 20/20 = 100% (95% CI = 83.2 - 100%)
Mixed connective tissue disease (MCTD): 19/20 = 95.0% (95% CI = 75.1 - 99.9%)
Routine samples: 78/80 = 97.5 % (95% CI = 91.3 - 99.7 %)
Precision studies:
Intra-assay precision: Six different samples tested eight times each. Anti-CCP: 28 - 2685 U/mL %C.V.: 1.0-7.6
Inter-assay precision: Six different samples tested eight times each in three different runs. Anti-CCP: 28 - 2696 U/mL %C.V.: 2.1-12.2
Lot to lot variation: Six different samples tested eight times each in three different lots. Anti-CCP: 60 - 2896 U/mL %C.V.: 6.9-17.0
Detection Limit Study:
Determined by running the zero standard 14 times on three different lots.
Detection limit: 1.6 U/mL (mean plus two standard deviations).
Interference Study:
Three low positive samples spiked with bilirubin (0.2 mg/mL), haemoglobin (400 mg/dl), lipid (15 mg/mL), and rheumatoid factor (200 IU/mL).
Conclusion: Assayed concentrations do not interfere with anti-CCP results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement: 99.3%
Negative Percent Agreement: 98.6%
Overall Percent Agreement: 98.9%
Clinical sensitivity: 77.4%
Clinical specificity: Between 94.1% - 100%
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.
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
NOV 1 9 2009
- Euro-Diagnostica AB, " 1. Lundavägen 151, SE-212 24 Malmo, Sweden Contact person: Ms. Annika Andersson Telephone: +46 40 53 76 04 Fax: +46 40 43 22 88 Date of preparation: June 5, 2009 Revised: November 5, 2009
- II. Device/Trade name: Immunoscan CCPIus® Common name: Anti-CCP test Governing regulation: 21 CFR 866.5775 Device classification: Class II Classification panel: Immunology Product code: NHX
- III. Description of Device: The Immunoscan CCPlus® test kit is a modification of the Immunoscan RA anti-CCP Test kit, K052133. It is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semi-quantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. The assay is used to detect antibodies in a single serum 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. "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.
- IV. Legally marketed device to which equivalence is claimed: Immunoscan RA anti-CCP Test kit, K052133.
1
- V. Intended use of the device: The intended use of the modified device has not changed. The Immunoscan CCPlus® test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semi-quantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. The assay is used to detect antibodies in a single serum 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. "For in vitro diagnostic use".
- VI. Comparison of technological characteristics:
Table 1. Similarities and differences between Immunoscan CCPlus® and Predicate Device, Immunoscan RA anti CCP Test kit, K052133
| Item | Modified Device Immunoscan CCPlus® | Predicate Device Immunoscan RA anti-CCP |
|---|---|---|
| Intended use | 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 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. |
| Intended user | For use by health care professionals | For use by health care professionals |
| Method | ELISA | ELISA |
| Type of test | Qualitative and semi-quantitative | Qualitative and semi-quantitative |
| Analyte measured | Anti-CCP | Anti-CCP |
| Coated antigen | Synthetic CCP | Synthetic CCP |
| Conjugate | Anti-human IgG | Anti-human IgG |
| Substrate | TMB (3, 3', 5, 5'-tetramethylbenzidin) | TMB (3, 3', 5, 5'-tetramethylbenzidin) |
| Wavelength | 450 nm | 450 nm |
| Incubation time | 60 min + 30 min + 30 min | 60 min + 30 min + 30 min |
| Cut-off | ≥25 U/mL | ≥25 U/mL |
| Sample | Serum | Serum |
| Sample preparation | Dilute 1:50 | Dilute 1:50 |
| Microtitre plate | Material: Polystyrene | |
| Surface: MaxiSorp | Material: Polystyrene | |
| Surface: MaxiSorp |
Similarities
2
Differences
| Item | Modified Device
Immunoscan CCPlus® | Predicate Device
Immunoscan RA
anti-CCP |
|------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Microtiter plate | 96 individual wells plate | 8 strips x 12 wells plate |
| | Note: The material and
surface of the microtitre
plate are the same | Note: The material and
surface of the microtitre
plate are the same |
| | | |
| Calibrator curve | | 25 U/mL, 50 U/mL,
200 U/mL, 800 U/mL,
3200 U/mL |
| | Note: The same material is
used to produce the
calibrator | Note: The same material is
used to produce the
calibrator |
- VII. Summary of performance: The modified device, Immunoscan CCPlus®, is substantially equivalent to the Immunoscan RA anti-CCP Test kit. Equivalence is demonstrated by the following comparative results.
Table 2. Percent agreement of the Immunoscan CCPlus® compared to the Immunoscan RA anti-CCP Test kit. A total of 628 frozen retrospective sera were assayed. 368 were obtained from RA patients and 260 samples were from apparently healthy blood donors.
| | | Predicate device
Immunoscan RA anti-CCP | |
|-----------------------|----------|--------------------------------------------|----------|
| Immunoscan
CCPlus® | N = 628 | Positive | Negative |
| | Positive | 275 | 5 |
| Negative | 2 | 346 | |
| Positive Percent Agreement: | 275/277 = 99.3% 95% CI = 97.4 - 99.9% |
|---|---|
| Negative Percent Agreement: | 346/351 = 98.6% 95% CI = 96.7 - 99.5% |
| Overall Percent Agreement: | 621/628 = 98.9% 95% CI = 97.7 - 99.6% |
The 95% confidence interval (CI) was calculated using the exact method.
Table 3. Clinical sensitivity and specificity. A total of 1180 frozen retrospective sera with clinical characterisation were assayed. The following table summarizes the results.
| n | negative | positive | Sensitivity | |
|---|---|---|---|---|
| Patients with clinically | ||||
| defined RA | 399 | 90 | 309 | 77.4% |
Clinical sensitivity
95% Cl = 73.3 - 81.5% RA 309/399 = 77.4%
3
Clinical specificity for the Immunoscan CCPlus® for non-RA diseased patients and asymptomatic individuals (healthy blood donors).
| Control and | Total | Negative | Positive |
|---|---|---|---|
| Disease groups | number |