(37 days)
K 954105, K 954062
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No
The device description and performance studies describe a standard ELISA assay, which is a biochemical test. There is no mention of AI, ML, or any computational analysis beyond reading the color change in an EIA plate reader.
No.
This device is an in-vitro diagnostic (IVD) test intended for the detection of specific autoantibodies to aid in the diagnosis of certain conditions, not to treat them.
Yes
The intended use explicitly states that the device "can aid in the diagnosis of Wegener's granulomatosis (WG), polyarteritis, necrotizing glomerulonephritis and other conditions". This directly indicates a diagnostic purpose.
No
The device is an enzyme-linked immunosorbent assay (ELISA), which is a laboratory test involving physical reagents and a microwell plate, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "indicated for the detection of autoantibodies... in human serum." This is a classic characteristic of an in vitro diagnostic device, as it is used to examine a sample taken from the human body (serum) outside of the body (in vitro) to provide information for diagnosis.
- Device Description: The description details an "enzyme-linked immunosorbent assay (ELISA)" which is a common laboratory technique used for in vitro diagnostic testing. It describes the process of using patient serum and reagents to detect specific antibodies.
- Performance Studies: The document includes performance studies such as precision and comparison testing using serum specimens, which are standard evaluations for IVD devices to demonstrate their accuracy and reliability.
- Predicate Devices: The mention of predicate devices (K954105 and K954062) which are also described as "EIA Kit For the Detection of Anti-PR3 Antibodies" and "EIA Kit For the Detection of Anti-MPO Antibodies" further confirms that this device falls within the category of in vitro diagnostics.
The purpose of the device is to provide information about a patient's health status (presence of specific autoantibodies) by analyzing a biological sample (serum) in a laboratory setting, which aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
An enzyme-linked immunosorbent assay (ELISA) intended to determine an individual's serologic status with respect to autoantibodies to the antigens Proteinase 3 and myeloperoxidase in human serum.
This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection of autoantibodies to the antigens Proteinase 3 (PR-3) and myeloperoxidase (MPA) in human serum. The presence of these antibodies, In combination with clinical observations and other serological tests, can aid in the diagnosis of Wegener's granulomatosis (WG), polyarteritis, necrotizing glomerulonephritis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (ANCA). Since a positive test result with this assay does not indicate which ANCA is (are) present, all positives should be confirmed using assays designed for particular ANCA specificities.
Product codes
мов
Device Description
An enzyme-linked immunosorbent assay (ELISA) designed for the detection of autoantibodies to the antigens Proteinase 3 and mveloperoxidase in human serum.
The ELISA methodology is commonly used for serum antibody evaluations. Purified PR3 and Myeloperoxidase antigens have been attached to the inner surfaces of the microwell plate. During the initial incubation step, antibodies in patient serum bind specifically to the immobilized antigens and remain in place after a wash step.
A second antibody which is conjucated to horseradish peroxidase (HRP) is used to recognize the "heavy + light" chain regions of the patient's antibodies remaining after the wash step. In the wells where the second antibody remains bound, the conjugated HRP catalyzes a color change in the substrate, tetramethyl benzidine (TMB). After the reaction is stopped, the color is read in an EIA Plate reader.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
human serum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Comparison Testing: A total of 109 serum specimens (17 from individuals with Wegners Granulomatosis, 19 pANCA A would or 100 bornh op of our the United States, and 73 from normal apparently positive specificals taken from ally assayed by both the predicate device and the proposed device.
Key Metrics
Relative Sensitivity = 100.0 % {35/35}, "gs confidence interval = 90.1 % to 100 %
Relative Specificity = 100.0 % {66/66}, o.ss confidence interval = 94.5 % to 100 %
Predicate Device(s)
K 954105, K 954062
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).
0
K973822
510(k) Summary
- Submitter's Name/Contact Person 1.
Joseph M. Califano Manager, Regulatory Affairs
Address
Hemagen Diagnostics, Inc. 34-40 Bear Hill Road Waltham, MA, 02154
| Phone: | (781) 890-3766 |
|---|---|
| Fax: | (781) 890-3748 |
| email: | jcalifano@hemagen.com |
Date Prepared
30 September 1997
2. Device Name
| Trade Name: | VIRGO® ANCA SCREEN (EIA method) |
|---|---|
| Common Name: | PR3 and MPO Antibody Kit |
| Classification Name: | Antineutrophil Cytoplasmic Antibodies test system |
3. Predicate Devices
- Scimedx EIA Kit For the Detection of Anti-PR3 Antibodies a. {510 (k) Docket No. K 954105}
- Scimedx EIA Kit For the Detection of Anti-MPO Antibodies b. {510 (k) Docket No. K 954062}
NOV 1 3 1997
1
Description of Device 3.
An enzyme-linked immunosorbent assay (ELISA) designed for the detection of autoantibodies to the antigens Proteinase 3 and mveloperoxidase in human serum.
The ELISA methodology is commonly used for serum antibody evaluations. Purified PR3 and Myeloperoxidase antigens have been attached to the inner surfaces of the microwell plate. During the initial incubation step, antibodies in patient serum bind specifically to the immobilized antigens and remain in place after a wash step.
A second antibody which is conjucated to horseradish peroxidase (HRP) is used to recognize the "heavy + light" chain regions of the patient's antibodies remaining after the wash step. In the wells where the second antibody remains bound, the conjugated HRP catalyzes a color change in the substrate, tetramethyl benzidine (TMB). After the reaction is stopped, the color is read in an EIA Plate reader.
4. Intended Use of Device
An enzvme-linked immunosorbent assay (ELISA) intended to determine an individual's serologic status with respect to autoantibodies to the antigens Proteinase 3 and myeloperoxidase in human serum.
5.(A) Technological Characteristics
Proposed Device
The VIRGO ® ANCA SCREEN Kit is an enzyme-linked immunosorbent assay. The device utilizes optical density as a measure of antibody presence, with an established cutoff between a positive and a negative reaction.
Predicate Devices
The Scimedx ANTI-PR3 ANTIBODY EIA and the Scimedx ANTI-MPO ANTIBODY EIA are also an enzyme-linked immunosorbent assays. Both of the devices utilize optical density as a measure of antibody presence, with an established cutoff between a positive and a negative reaction.
2
5.(B) Performance Data
Precision
To evaluate precision, both inter-assay and intra-assay studies were conducted. The results are summarized below:
A. Inter-assay
Eight samples were assayed twice a day for five different days.
| Sample | Mean OD | Std. Dev. | % CV |
|---|---|---|---|
| 1 | 1.622 | 0.151 | 9.3 |
| 2 | 0.731 | 0.093 | 12.7 |
| 3 | 0.532 | 0.057 | 10.7 |
| 4 | 0.787 | 0.096 | 12.2 |
| 5 | 0.777 | 0.093 | 12.0 |
| 6 | 1.375 | 0.152 | 11.1 |
| 7 | 0.071 | 0.007 | N/A |
| 8 | 0.040 | 0.007 | N/A |
The assay controls {Positive, Negative, and Cutoff Serum} were assayed concurrently twice a day for each of the five days.
| Sample | Mean OD | Std. Dev. | % CV |
|---|---|---|---|
| Negative Control | 0.009 | 0.003 | N/A |
| cANCA Positive Control | 1.538 | 0.115 | 7.5 |
| pANCA Positive Control | 0.973 | 0.145 | 14.9 |
| Cutoff Serum | 0.224 | 0.019 | 8.5 |
B. Intra-assay
The eight serum samples were assayed 20 consecutive times in a single run.
| Sample | Mean OD | Std. Dev. | % CV |
|---|---|---|---|
| 1 | 1.563 | 0.072 | 4.6 |
| 2 | 0.763 | 0.072 | 9.4 |
| 3 | 0.557 | 0.052 | 9.3 |
| 4 | 0.916 | 0.103 | 11.2 |
| 5 | 0.777 | 0.057 | 7.3 |
| 6 | 1.233 | 0.173 | 14.0 |
| 7 | 0.083 | 0.006 | 7.2 |
| 8 | 0.046 | 0.003 | 6.5 |
3
Comparison Testing
A total of 109 serum specimens (17 from individuals with Wegners Granulomatosis, 19 pANCA A would or 100 bornh op of our the United States, and 73 from normal apparently positive specificals taken from ally assayed by both the predicate device and the proposed device. The results are summarized in the tables that follow:
| Table 1.1 Positive Panels, n = 36} | |||
|---|---|---|---|
| Predicate Device | |||
| Positive | Negative | Total | |
| Proposed Device | |||
| Positive | 35 | 0 | 35 |
| Negative | 0 | 1 | 1 |
| Total | 35 | 1 | 36 |
Relative Sensitivity = 100.0 % {35/35}, "gs confidence interval = 90.1 % to 100 %
| Table 1.2 Normals, n = 73 | |||
|---|---|---|---|
| Predicate Device | |||
| Proposed Device | Positive | Negative | Total |
| Positive | 1 | 0 | 1 |
| Negative | 61 | 66 | 72 |
| Total | 7 | 66 | 73 |
Relative Specificity = 100.0 % {66/66}, o.ss confidence interval = 94.5 % to 100 %
- The six discrepants were evaluated by a third party IFA assay. All six of the samples were reported to be negative.
4
Interfering Substances
Lipemic, icteric, and hemolytic samples were evaluated with the assay following NCCLS Document EP7-P Proposed Guideline, Interference Testing in Clinical Chemistry. The results indicate that there is no significant effect (