(67 days)
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None
No
The summary describes a standard ELISA assay, which is a laboratory technique and does not mention any AI or ML components.
No
This device is an in vitro diagnostic test designed to detect autoantibodies for diagnosis, not to provide therapy or treatment.
Yes
The 'Intended Use / Indications for Use' states, "This test is an aid in the diagnosis of autoimmune renal disorders such as Goodpasture's syndrome."
No
The device is described as a semiquantitative enzyme linked immunosorbant assay (ELISA), which is a laboratory test involving physical reagents and equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "semiquantitative enzyme linked immunosorbant assay (ELISA) detecting IgG class autoantibody to glomerular basement membrane (GBM) in human serum." This describes a test performed on a biological sample (human serum) outside of the body.
- Purpose: The purpose is to "aid in the diagnosis of autoimmune renal disorders such as Goodpastre's syndrome." This indicates the test is used to provide information for medical diagnosis.
These are key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A semiquantitative enzyme linked immunosorbant assay (ELISA) detecting IgG class autoantibody to glomerular basement membrane (GBM) in human serum. This test is an aid in the diagnosis of autoimmune renal disorders such as Goodpasture's syndrome.
Product codes
MVJ
Device Description
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. The text is arranged so that "DEPARTMENT OF HEALTH & HUMAN SERVICES" is on the left side of the circle, and "USA" is on the right side.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
8 1999 FEB
Mr. Brys C. Myers Regulatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, California 92131-1234
Re: K984336 Trade Name: QUANTA Lite™ GBM ELISA Regulatory Class: II Product Code: MVJ Dated: December 2, 1998 Received: December 3, 1998
Dear Mr. Myers:
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/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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510(k) Number (if known): 长984336
Device Name: QUANTA Lite™ GBM ELISA
Indications For Use:
A semiquantitative enzyme linked immunosorbant assay (ELISA) detecting IgG class autoantibody to glomerular basement membrane (GBM) in human serum. This test is an aid in the diagnosis of autoimmune renal disorders such as Goodpasture's syndrome.
Peter E. Malcom
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use