(37 days)
K 954062
Not Found
No
The device description and performance studies detail a standard ELISA assay, which is a biochemical method for detecting antibodies. There is no mention of AI or ML in the methodology, data analysis, or performance evaluation.
No.
This device is an in vitro diagnostic (IVD) test designed to detect MPO antibodies in human serum to aid in diagnosis, not to treat or alleviate a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can aid in the diagnosis of polyarteritis, necrotizing glomerulonephritis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (ANCA)." This indicates its role in identifying or confirming a disease state.
No
The device is an enzyme-linked immunosorbent assay (ELISA) kit, which is a laboratory test involving physical reagents and a microwell plate, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "detection of autoantibodies to the antigen Myeloperoxidase (MPO) in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information for diagnosis.
- Device Description: The description details an "enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of autoantibodies to the antigen myeloperoxidase in human serum." This further confirms the in vitro nature of the test.
- Sample Type: The device uses "human serum" as the sample, which is a biological specimen taken from a human.
- Diagnostic Purpose: The intended use states that the results "can aid in the diagnosis of polyarteritis, necrotizing glomerulonephritis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (ANCA)." This clearly indicates a diagnostic purpose.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of autoantibodies to the antigen myeloperoxidase in human serum. The test is intended as an aid in the diagnosis of current or past autoimmune mediated vasculitides.
This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection of altoantilian to the antigen Myeloperoxidase (MPO) in human serum. The presence of MPO antibodies, in combination with dinical observations and other serological tests, can aid in the dlagnosis of polyarterits, necrotizing glomerulonephritis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (ANCA).
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of autoantibodies to the antigen myeloperoxidase in human serum.
The ELISA methodology is commonly used for serum antibody evaluations. Purified MPO antigen has been attached to the inner surfaces of the microwell plate. During the initial incubation step, antibodies in patient serum bind specifically to the immobilized antigen and remain in place after a wash step.
A second antibody which is conjugated 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
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
Inter-assay precision was evaluated using seven samples assayed in duplicate twice a day for five different days. For sample 1, Mean OD was 3.338 with a Std. Dev. of 0.142 and % CV of 4.2. Mean Units were 12.6 with a Std. Dev. of 0.828 and % CV of 6.6. Similar data were provided for six other samples, as well as for Cutoff Serum and Positive Control.
Intra-assay precision was evaluated by assaying the same seven serum samples 20 consecutive times in a single run. For sample 1, Mean OD was 3.274 with a Std. Dev. of 0.131 and % CV of 4.0. Similar data were provided for six other samples, as well as for Cutoff Serum and Positive Control.
Comparison Testing:
A total of 132 serum specimens (22 pANCA positive specimens from throughout the United States, 40 specimens from individuals demonstrating pauci-immune necrotizing and/or crescentic glomerulonephritis, and 70 specimens from normal apparently healthy donors) were concurrently assayed by both the predicate device and the proposed device.
- For pANCA Panel 1 (n=22): Relative Sensitivity = 100.0 % (21/21), 0.85 confidence interval = 84.5 % to 100 %.
- For pANCA Panel 2 (n=40): Relative Sensitivity = 100.0 % (40/40), 0.88 confidence interval = 91.2 % to 100 %.
- For Normals (n=70): Relative Specificity = 100 % (62/62), 4.8 confidence interval = 94.2 % to 100 %.
The eight discrepant samples from the Normals panel (where the Proposed Device was negative but Predicate Device was positive in Table 1.3, likely a typo in the table as the counts are 8 and 62 totaling 70) were assayed with a third party IFA kit and found to be negative.
The range of AU values for the positive specimens was 1.2 to 18. The average AU value for the normal specimens was 0.3 with a range of 0.1 to 0.8.
Interfering Substances:
Libemic, icteric, and hemolytic samples were evaluated. Results indicate no significant effect (
§ 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
510(k) Summary
NOV 1 3 1997
Submitter's Name/Contact Person 1.
Joseph M. Califano Manager, Regulatory Affairs
Address
Hemagen Diagnostics, Inc. 34-40 Bear Hill Road Waltham, MA, 02154
(781) 890-3766 Phone: (781) 890-3748 Fax: jcalifano@hemagen.com email:
Date Prepared
30 September 1997
2. Device Name
| Trade Name: | VIRGO ® pANCA Kit (EIA method) |
|---|---|
| Common Name: | MPO Antibody Kit |
| Classification Name: | Antineutrophil Cytoplasmic Antibodies test system |
3. Predicate Device
Scimedx MPO Antibody EIA Kit {510 (k) Docket No. K 954062}
1
Description of Device 3.
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of autoantibodies to the antigen myeloperoxidase in human serum.
The ELISA methodology is commonly used for serum antibody evaluations. Purified MPO antigen has been attached to the inner surfaces of the microwell plate. During the initial incubation step, antibodies in patient serum bind specifically to the immobilized antigen and remain in place after a wash step.
A second antibody which is conjugated 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 enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of autoantibodies to the antigen myeloperoxidase in human serum. The test is intended as an aid in the diagnosis of current or past autoimmune mediated vasculitides.
5.(A) Technological Characteristics
Proposed Device
The VIRGO ® pANCA 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 Device
The Scimedx MPO ANTIBODY EIA is also 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.
2
5.(B) Performance Data
Precision
To evaluate precision, inter-assay and intra-assay studies were conducted.
A. Inter-assay
Seven samples were assayed in duplicate twice a day for five different days.
| Sample | Mean OD | Std. Dev. | % CV | Mean Units | Std. Dev | % CV |
|---|---|---|---|---|---|---|
| 1 | 3.338 | 0.142 | 4.2 | 12.6 | 0.828 | 6.6 |
| 2 | 2.333 | 0.142 | 6.1 | 8.6 | 0.542 | 6.3 |
| 3 | 1.376 | 0.111 | 8.1 | 5.1 | 0.370 | 7.3 |
| 4 | 0.712 | 0.071 | 10.0 | 2.6 | 0.221 | 8.4 |
| 5 | 0.362 | 0.040 | 11.0 | 1.4 | 0.162 | 11.7 |
| 6 | 0.047 | 0.005 | N/A | 0.2 | 0.015 | N/A |
| 7 | 0.038 | 0.006 | N/A | 0.1 | 0.023 | N/A |
The assay Cutoff Serum, and Positive Control were assayed concurrently twice a day for each of the five days.
| Mean OD | Std. Dev. | % CV | |
|---|---|---|---|
| Cutoff Serum | 0.271 | 0.027 | 10.1 |
| Positive Control | 4.027 | 0.096 | 2.4 |
B. Intra-assay
The same seven serum samples were assayed 20 consecutive times in a single run.
| Sample | Mean OD | Std. Dev. | % CV |
|---|---|---|---|
| 1 | 3.274 | 0.131 | 4.0 |
| 2 | 2.239 | 0.121 | 5.4 |
| 3 | 1.315 | 0.112 | 8.5 |
| 4 | 0.570 | 0.034 | 5.9 |
| 5 | 0.374 | 0.024 | 6.5 |
| 6 | 0.066 | 0.003 | 4.3 |
| 7 | 0.058 | 0.004 | 7.1 |
The assay Cutoff Serum, and Positive Control were assayed concurrently 20 consecutive times in a single run
| Mean OD | Std. Dev. | % CV | |
|---|---|---|---|
| Cutoff Serum | 0.264 | 0.017 | 6.4 |
| Positive Control | 3.895 | 0.166 | 4.3 |
.
3
Comparison Testing
A total of 132 serum specimens (22 pANCA positive specimens taken from throughout the United States, 40 specimens from individuals demonstrating pauci-immune necrotizing and/or crescentic glomerulonephritis, and, 70 specimens from normal apparently healthy donors} were concurrently assayed by both the predicate device and the proposed device. The results are presented in the tables that follow:
| Table 1.1 pANCA Panel 1. n = 22
| Predicate Device | |||
|---|---|---|---|
| Proposed Device | Positive | Negative | Total |
| Positive | 21 | 0 | 21 |
| Negative | 0 | 1 | 1 |
| Total | 21 | 1 | 22 |
Relative Sensitivity = 100.0 % {21/21}, 0.85 confidence interval = 84.5 % to 100 %
| Table 1.2 pANCA Panel 2. n = 40
| Predicate Device | |||
|---|---|---|---|
| Proposed Device | Positive | Negative | Total |
| Positive | 40 | 0 | 40 |
| Negative | 0 | 0 | 0 |
| Total | 40 | 0 | 40 |
Relative Sensitivity = 100.0 % {40/40}. 0.88 confidence interval = 91.2 % to 100 %
| Table 1.3 Normals, n = 70
| Predicate Device | |||
|---|---|---|---|
| Proposed Device | Positive | Negative | Total |
| Positive | 0 | 0 | 0 |
| Negative | 81 | 62 | 70 |
| Total | 8 | 62 | 70 |
Relative Specificity = 100 % {62/62}, 4.8 confidence interval = 94.2 % to 100 %
- The eight discrepant samples were assayed with a third party IFA kit and were found to be negative.
The range of AU values for the positive specimens was 1.2 to 18. The average AU value for the normal specimens was 0.3 with a range of 0.1 to 0.8
4
Interfering Substances
Libemic, 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 (