(60 days)
K 932373
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No
The device description details a standard ELISA assay, and there is no mention of AI, ML, or related technologies in any section of the summary.
No
The device aids in diagnosis by detecting antibodies, but it does not treat or prevent disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can aid in the diagnosis of Primary and Secondary Antiphospholipid Syndrome."
No
The device description clearly outlines a physical ELISA kit with microwell plates, reagents, and a requirement for an EIA plate reader, indicating it is a hardware-based diagnostic test, not software only.
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 and measurement of circulating IgG antibodies to ß2 Glycoprotein in human serum." It also states that the results, in combination with other information, "can aid in the diagnosis of Primary and Secondary Antiphospholipid Syndrome." This clearly indicates that the device is intended to be used in vitro (outside the body) to examine specimens (human serum) to provide information for diagnostic purposes.
- 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 and measure antibodies.
- Performance Studies: The document includes performance data based on testing "clinically characterized serum samples," further supporting its use for diagnostic purposes.
- Key Metrics: The inclusion of metrics like Relative Sensitivity, Relative Specificity, and Relative Agreement are standard performance indicators for IVD devices.
- Predicate Device: The mention of a "Predicate Device" (K932373; Hemagen ® Cardiolipin Antibody Kit) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This enzyme-linked immunosorbent assay (ELISA) is intended for the detection and measurement of IgG antibodies to ß, Glycoprotein I in human serum.
This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection and measurement of circulating IgG antibodies to ß2 Glycoprotein in human serum. The presence of these antibodies, in combination with clinical observations and other serological tests, can aid in the diagnosis of Primary and Secondary Antiphospholipid Syndrome.
Product codes (comma separated list FDA assigned to the subject device)
MSV
Device Description
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of IgG antibodies to ß, Glycoprotein I in human serum.
The ELISA methodology is commonly used for serum antibody evaluations. Purified human B, glycoprotein has been attached to the inner surfaces of the microwell plate. During the initial incubation step, specific antibodies in patient serum will bind to the antigen and are immobilized on the surface. After incubation and a wash step, a peroxidase labeled anti human IgG (gamma chain specific) second antibody is added to the wells to react with the immobilized anti beta 2 GP1 antibodies. After incubation and another wash step, the substrate is added. In the wells where the specific antigenantibody-HRP complex remains bound, the peroxidase enzyme catalyzes a color change in the substrate. After the enzymatic reaction is stopped, the colored product is read in an EIA plate reader at a specified wavelength.
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
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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
To demonstrate the effectiveness of the device, a number of clinically characterized serum samples were tested.
Comparison with aCL IgG: 37 of the clinically characterized serum samples and 23 serum samples from apparently healthy donors were evaluated with the VIRGO® ß2Glycoprotein I IgG Antibody Kit, and a commercially available anti-cardiolipin IgG EIA assay.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data
Precision
To estimate the overall precision of the VIRGO ® βչ Glycoprotein I lgG Antibody Kit, inter, and intra assay studies were conducted.
Inter Assay: Three serum samples, the Negative, and Positive Controls, and the Calibrator were assayed five times each, twice a day, on five different days.
Intra Assay: The same three serum samples were assayed ten consecutive times in duplicate.
Performance Testing
A number of clinically characterized serum samples were tested.
| Patient Group | Number | Number Positive (%) |
|---|---|---|
| APS1 | 43 | 32 (74.4) |
| SLE + APS | 7 | 6 (85.7) |
| TOTAL | 50 | 38 (76.0) |
| Rheumatoid Arthritis | 40 | 1 (2.5) |
| SLE (No APS) | 20 | 2 (10.0) |
| Scl-70 (No APS) | 20 | 0 (0) |
| Infectious2 | 40 | 2 (5.0) |
| Normals | 120 | 1 (0.8) |
Comparison with aCL IgG
37 of the clinically characterized serum samples and 23 serum samples from apparently healthy donors were evaluated with the VIRGO® ß2Glycoprotein I IgG Antibody Kit, and a commercially available anti-cardiolipin IgG EIA assay.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity: 72.7 %: {60.3 to 82.3 %; ₀.₉₅ Confidence Interval}
Relative Specificity: 92.6 %: {83.1 to 97.0 %; ₀.₉₅ Confidence Interval}
Relative Agreement: 81.7 %: { 70.2 to 89.5 %; 0.95 Confidence Interval}
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.
K 932373
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
§ 866.5660 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
1. Submitter's Name/Contact Person
loseph M. Califano Director, Regulatory Affairs
Address
Hemagen Diagnostics, Inc. 34-40 Bear Hill Road Waltham, MA, 02154
(781) 890-3766 x 257 Phone: (781) 890-3748 Fax: email: jcalifano@hemagen.com
Date Prepared
14 June 1999
Date Revised
25 August 1999
2. Device Name
| Trade Name: | VIRGO® β₂ Glycoprotein I IgG Antibody Kit |
|---|---|
| Common Name: | β₂ Glycoprotein I Antibodies Test System |
| Classification Name: | Multiple Autoantibodies Immunological Test System |
3. Predicate
Hemagen ® Cardiolipin Antibody Kit Trade Name: 510 (k) Docket No. K 932373, SE Date; 16 July 1993
The performance of the VIRGO® ® ß, Glycoprotein I IgC Antibody Kit was evaluated
with a panel of characterized serum specimens from individuals diagnosed with Primary APS and other diseases.
510(k) Summary Page 1
1
Description of Device 3.
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of IgG antibodies to ß, Glycoprotein I in human serum.
The ELISA methodology is commonly used for serum antibody evaluations. Purified human B, glycoprotein has been attached to the inner surfaces of the microwell plate. During the initial incubation step, specific antibodies in patient serum will bind to the antigen and are immobilized on the surface. After incubation and a wash step, a peroxidase labeled anti human IgG (gamma chain specific) second antibody is added to the wells to react with the immobilized anti beta 2 GP1 antibodies. After incubation and another wash step, the substrate is added. In the wells where the specific antigenantibody-HRP complex remains bound, the peroxidase enzyme catalyzes a color change in the substrate. After the enzymatic reaction is stopped, the colored product is read in an EIA plate reader at a specified wavelength.
4. Intended Use of Device
This enzyme-linked immunosorbent assay (ELISA) is intended for the detection and measurement of IgG antibodies to ß, Glycoprotein I in human serum.
5. Technological Characteristics
Proposed Device
The VIRGO ® ß, Glycoprotein I IgG Antibody 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. The device also contains a IgG Calibrator to enable the assignment of arbitrary IgG antibody values to patient samples.
Predicate Device
The Hemagen ® Cardiolipin IgG/IgM Antibody 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. The device also contains both an IgM Calibrator, and an IgG Calibrator to enable the assignment of MPL or GPL unit values to patient samples. The calibrators have been standardized to the IgG standards obtained from Louisville APL Diagnostics, Inc.
000002
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5. Performance Data
Precision
To estimate the overall precision of the VIRGO ® βչ Glycoprotein I lgG Antibody Kit,
inter, and intra assay studies were conducted. The results of these studies is summarize in the tables below
Inter Assay
Three serum samples, the Negative, and Positive Controls, and the Calibrator were assayed five times each, twice a day, on five different days :
| Mean RGU | Std. Deviation | % C.V. | |
|---|---|---|---|
| Sample 1 | 95.7 | 11.2 | 11.7 |
| Sample 2 | 47.5 | 6.9 | 14.6 |
| Sample 3 | 12.1 | 1.7 | 13.9 |
| Neg. Control |