(37 days)
K 954105
No
The device description and performance studies detail a standard ELISA assay, which is a biochemical test and does not involve AI or ML for its operation or interpretation. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
This device is an in vitro diagnostic test designed to detect autoantibodies in human serum, which aids in diagnosis rather than providing therapy or treatment.
Yes
This device is an enzyme-linked immunosorbent assay (ELISA) designed to detect autoantibodies that "can aid in the diagnosis of Wegener's granulomatosis (WG) and other conditions." This directly implies its use in diagnosing health conditions.
No
The device is an in vitro diagnostic (IVD) test that utilizes an ELISA methodology, which is a laboratory-based assay involving physical reagents and a plate reader, 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 to the antigen Proteinase 3 in human serum." This is a classic description of an in vitro diagnostic test, as it analyzes a biological sample (human serum) outside of the body to provide information for diagnosis.
- Device Description: The description details an ELISA methodology, which is a common technique used in IVD tests to detect and measure substances in biological samples.
- Sample Type: The device uses "human serum" as the sample, which is a biological specimen.
- Purpose: The purpose is to "aid in the diagnosis of Wegener's granulomatosis (WG) and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (ANCA)." This directly relates to providing diagnostic information.
- Performance Studies: The inclusion of performance studies like precision, comparison testing, interfering substances, and prozone testing are standard for demonstrating the analytical performance of an IVD device.
- Key Metrics: The reporting of sensitivity and specificity are key metrics used to evaluate the clinical performance of IVD tests.
- Predicate Device: The mention of a predicate device (K954105; Scimedx EIA Kit For the Detection of Anti-PR3 Antibodies) which is also an EIA kit for detecting anti-PR3 antibodies further confirms that this device falls within the category of IVDs.
All of these factors align with the definition and characteristics 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 Proteinase 3 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 autoantibodies to the antigen Proteinase 3 in human serum. The presence of PR-3 antibodies, in combination with clinical observations and other serological tests, can aid in the diagnosis of Wegener's granulomatosis (WG) and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (ANCA)
Product codes
MOB
Device Description
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of autoantibodies to the antigen Proteinase 3 in human serum.
The ELISA methodology is commonly used for serum antibody evaluations. Purified PR3 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
Inter-assay precision evaluated using eight serum samples assayed in duplicate twice a day for five different days. Intra-assay precision evaluated using eight serum samples assayed 20 consecutive times in a single run.
Comparison Testing:
A total of 108 serum specimens (28 from individuals with Wegners Granulomatosis and 80 from apparently normal donors) were concurrently assayed by both the proposed device and the predicate device.
Table 1.1 Panel 1, n = 28 (Positive Panel):
Proposed Device Positive: 28, Negative: 0
Predicate Device Positive: 28, Negative: 0
Relative Sensitivity = 100.0 % (28/28), confidence interval = 87.9 % to 100 % = 100.0
Table 1.2 Normals, n = 80:
Proposed Device Positive: 0, Negative: 80
Predicate Device Positive: 0, Negative: 80
Relative Specificity = 100.0 % (80/80), confidence interval = 95.4 % to 100 %
Interfering Substances:
Evaluated interfering substances including hemoglobin (
§ 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
K973823
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
(617) 890-3766 Phone: (617) 890-3748 Fax: jcalifano@hemagen.com email:
Date Prepared
26 September 1997
Device Name 2.
| Trade Name: | VIRGO® cANCA Kit (EIA method) |
|---|---|
| Common Name: | PR3 Antibody Kit |
| Classification Name: | Antineutrophil Cytoplasmic Antibodies test system |
Predicate Device 3.
Scimedx EIA Kit For the Detection of Anti-PR3 Antibodies
Scimedx Election AN - 16 051105) {510 (k) Docket No. K 954105}
1
Description of Device 3.
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of autoantibodies to the antigen Proteinase 3 in human serum.
The ELISA methodology is commonly used for serum antibody evaluations. Purified PR3 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 enzvme-linked immunosorbent assay (ELISA) designed for the detection and measurement of autoantibodies to the antigen Proteinase 3 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 ® cANCA 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 ANTI-PR3 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, both inter-assay and intra-assay studies were conducted. The results are summarized below:
Eight serum samples were assayed in duplicate twice a day for five different days.
| Sample | Mean OD | Std. Dev. | % CV | Mean Units | Std. Dev | % CV |
|---|---|---|---|---|---|---|
| 1 | 1.444 | 0.112 | 7.8 | 7.3 | 0.6 | 7.9 |
| 2 | 1.060 | 0.070 | 6.6 | 5.3 | 0.4 | 8.0 |
| 3 | 0.128 | 0.020 | N/A | 0.6 | 0.1 | N/A |
| 4 | 0.037 | 0.009 | N/A | 0.2 | 0.04 | N/A |
| 5 | 0.770 | 0.075 | 9.7 | 3.7 | 0.5 | 12.3 |
| 6 | 0.586 | 0.059 | 10.1 | 3.0 | 0.3 | 11.1 |
| 7 | 0.515 | 0.039 | 7.5 | 2.6 | 0.2 | 8.2 |
| 8 | 0.351 | 0.040 | 11.5 | 1.8 | 0.2 | 11.7 |
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 | 0.011 | 0.004 | N/A |
| Positive Control | 0.863 | 0.068 | 7.8 |
| Cutoff Serum | 0.197 | 0.012 | 6.2 |
B. Intra-assay
Eight serum samples were assayed 20 consecutive times in a single run.
| Sample | Mean OD | Std. Dev. | % CV | Mean Units | Std. Dev. | % CV |
|---|---|---|---|---|---|---|
| 1 | 1.197 | 0.073 | 6.1 | 6.1 | 0.4 | 6.7 |
| 2 | 0.818 | 0.045 | 5.6 | 4.1 | 0.2 | 5.7 |
| 3 | 0.131 | 0.005 | 3.7 | 0.7 | 0.02 | 3.7 |
| 4 | 0.057 | 0.003 | 4.4 | 0.3 | 0.01 | 4.4 |
| 5 | 0.563 | 0.034 | 6.1 | 3.0 | 0.2 | 6.4 |
| 6 | 0.460 | 0.032 | 6.9 | 2.4 | 0.1 | 6.1 |
| 7 | 0.407 | 0.020 | 4.9 | 2.2 | 0.1 | 4.9 |
| 8 | 0.269 | 0.018 | 6.8 | 1.5 | 0.1 | 6.7 |
3
Comparison Testing
A total of 108 serum specimens (28 from individuals with Wegners Granulomatosis, and 80 includes that follow: Computers.
A total of 108 serum specimens (28 from individuals with Wegners).
from normal apparently donors) were concurrently assayed by both the predice. A total of 108 serum specifieds (2011-11-11).
from normal apparently healthy donors) were concurrently assayed by bom the posses
from normal apparently healthy donors) were p
| Table 1.1 Panel 1, n = 28 { Positive Panel} | Predicate Device |
|---|---|
| --------------------------------------------- | ------------------ |
| Positive | Negative | l olai | |
|---|---|---|---|
| Proposed Device | |||
| Positive | 28 | ||
| O | 0 | ||
| O | 28 | ||
| O | |||
| Negative | 28 | O | 28 |
| Relative Sensitivity = 100.0 % {28/28}, oss confidence interval = 87.9 % to 100 % = 100.0 | |||
| Table 1.2 Normals, n = 80 | Predicate Device | ||
| Positive | Negative | Total | |
| Proposed Device | |||
| Positive | 0 | ||
| 0 | 0 | ||
| 80 | 0 | ||
| 80 | |||
| Negative | 0 | 80 | 80 |
| Total | . | --- confidence interval = 95.4 % to 100 % |
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