(60 days)
K 932373
Not Found
No
The device description details a standard ELISA methodology, which is a biochemical assay and does not inherently involve AI or ML for data processing or interpretation. The performance studies describe standard statistical analysis of assay results.
No
This device is an in vitro diagnostic (IVD) test intended for the detection and measurement of antibodies, which aids in diagnosis. It does not directly treat or prevent a disease or condition.
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 laboratory-based ELISA kit, which is a physical product involving reagents, microwell plates, and requires an EIA plate reader for analysis. This is a hardware-dependent diagnostic test, 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 "detection and measurement of circulating IgM antibodies to ß2 Glycoprotein in human serum." This is a test performed in vitro (outside the body) on a biological sample (serum) 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 and measure specific antibodies.
- Performance Studies and Key Metrics: The document includes information on performance studies using clinically characterized serum samples and provides key metrics like Relative Sensitivity, Relative Specificity, and Relative Agreement. These are standard measures used to evaluate the performance of in vitro diagnostic devices.
- Predicate Device: The mention of a "Predicate Device" (K 932373, Hemagen ® Cardiolipin Antibody Kit) is common in regulatory submissions for IVDs, indicating a comparison to a previously cleared device of a similar type.
All of these elements strongly indicate that this device is intended for use in a laboratory setting to perform diagnostic testing on human samples, which is the definition 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 IgM antibodies to B, Glycoprotein I in human serum.
This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection and measurement of circulating IgM 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 IgM antibodies to ß, Glycoprotein I in human serum.
The ELISA methodology is commonly used for serum antibody evaluations. Purified human ß, 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 IgM (u 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
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
To demonstrate the effectiveness of the device, a number of clinically characterized serum samples were tested.
A panel of characterized serum specimens from individuals diagnosed with Primary APS and other diseases.
The 50 clinically characterized APS serum samples, and 40 serum samples from apparently healthy donors were evaluated with the VIRGO® B, Glycoprotein I IgM Antibody Kit, and a commercially available anti-cardiolipin IgM EIA.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
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.
Sample 1: Mean RMU 131.5, Std. Deviation 16.2, % C.V. 12.3
Sample 2: Mean RMU 57.7, Std. Deviation 8.0, % C.V. 13.9
Sample 3: Mean RMU 11.4, Std. Deviation 1.2, % C.V. 10.7
Neg. Control: Mean RMU
§ 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
K992243
Submitter's Name/Contact Person 1.
Joseph 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: jcalifano@hemagen.com email:
Date Prepared
14 June 1999
Date Revised
25 August 1999
2. Device Name
| Trade Name: | VIRGO® β₂ Glycoprotein I IgM Antibody Kit |
|---|---|
| Common Name: | β₂ Glycoprotein I Antibodies Test System |
| Classification Name: | Multiple Autoantibodies Immunological Test System |
3. Predicate
Trade Name: 510 (k) Docket No. Hemagen ® Cardiolipin Antibody Kit Hemagen ® Cardiolipin Antibody Kit
K 932373, SE Date; 16 July 1993,
The performance of the VIRGO® B, Glycoprotein I Igg Antibody Kit was also evaluated with a panel of characterized serum specimens from individuals diagnosed with Primary APS and other diseases.
510 (k) Summary Page 1
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3. Description of Device
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of IgM antibodies to ß, Glycoprotein I in human serum.
The ELISA methodology is commonly used for serum antibody evaluations. Purified human ß, 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 IgM (u 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 IgM antibodies to B, Glycoprotein I in human serum.
5. Technological Characteristics
Proposed Device
The VIRGO® ® ß, Glycoprotein I 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 a IgM Calibrator to enable the assignment of arbitrary IgM 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 IgM and 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 ® ß, Glycoprotein I IgM Antibody Kit, inter, and intra assay studies were conducted. The results of these studies is summarized 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 RMU | Std. Deviation | % C.V. | |
|---|---|---|---|
| Sample 1 | 131.5 | 16.2 | 12.3 |
| Sample 2 | 57.7 | 8.0 | 13.9 |
| Sample 3 | 11.4 | 1.2 | 10.7 |
| Neg. Control | Trade Name: VIRGO® ß, Glycoprotein I IgM Antibody Kit Regulatory Class: II Product Code: MSV Dated: June 14, 1999 Received: July 1, 1999 |
Dear Mr. Califano:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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VIRGO ® ß2 Glycoprotein I IgM Antibody Kit Device Name:
Indication(s) For Use
This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection and measurement of circulating IgM 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.
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lester E. Mdress
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K99224
Prescription Use
(Per 21 CFR 801.109)
✓
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OR
Over-The-Counter-Use