(67 days)
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No
The summary describes a standard ELISA assay, which is a biochemical test and does not typically involve AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
This device is an in vitro diagnostic (IVD) test used to detect IgG autoantibodies. It aids in the assessment of autoimmune conditions but does not directly treat or provide therapy to a patient.
Yes
The device is described as an "enzyme linked immunosorbant assay (ELISA) for the semi-quantitative detection of IgG autoantibodies to serine protease 3 (PR3)" which is "to be used in conjunction with other clinical findings to aid in the assessment of certain autoimmune vasculitides." This clearly indicates its use in identifying and assessing a medical condition, which is the definition of a diagnostic device.
No
The device description clearly states it is an enzyme linked immunosorbant assay (ELISA), which is a laboratory test involving physical reagents and equipment, 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 an "enzyme linked immunosorbant assay (ELISA) for the semi-quantitative detection of IgG autoantibodies to serine protease 3 (PR3)." This describes a test performed on biological samples (likely blood or serum) outside of the body to provide information about a patient's health status.
- Device Description: The device description confirms it's an ELISA, which is a common type of in vitro diagnostic test.
- Purpose: The test is used "in conjunction with other clinical findings to aid in the assessment of certain autoimmune vasculitides." This indicates it's used to diagnose or monitor a disease, which is a key characteristic of an IVD.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits that description.
N/A
Intended Use / Indications for Use
An enzyme linked immunosorbant assay (ELISA) for the semi-quantitative detection of IgG autoantibodies to serine protease 3 (PR3). This test is to be used in conjunction with other clinical findings to aid in assessment of certain autoimmune vasculitides such as Wegener's granulomatosis.
Product codes
MOB
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.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 9 1998
Mr. Brys Myers Regulatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, California 92131-1234
K981328 Re : Trade Name: QUANTA Lite™ PR3 IgG Requlatory Class: II Product Code: MOB Dated: April 9, 1998 Received: April 13, 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 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 requirement, 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
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 ……………………
2
510(lk) Number (if known): 1981329
QUANTA Lite™ PR3 IgG Device Name:
Indications For Use:
An enzyme linked immunosorbant assay (ELISA) for the semi-quantitative detection of IgG autoantibodies to serine protease 3 (PR3). This test is to be used in conjunction with other clinical findings to aid in Wegener's certain autoimmune vasculitides such as assessment of granulomatosis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tete E. Medison
(Division Sign-Off) Division of Clinical Laboratory D
. escription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)