(83 days)
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No
The summary describes a standard ELISA kit for detecting antibodies, with no mention of AI, ML, or related technologies.
No.
The device is an in vitro diagnostic (IVD) test intended to aid in the diagnosis of autoimmune hepatitis (AIH) by detecting specific antibodies; it does not directly treat or alleviate a medical condition.
Yes
The product's intended use explicitly states, "This test is intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis (AIH)." This directly indicates a diagnostic purpose.
No
The device description clearly states it is an "enzyme-linked immunosorbent assay (ELISA) kit," which is a laboratory test involving physical reagents and procedures, 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 "semi-quantitative detection of anti-SLA (soluble liver antigen) antibody of the IgG class in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body).
- Purpose: The test is intended to "aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis (AIH)." This is a diagnostic purpose, which is a key characteristic of IVDs.
- Device Description: The device is described as an "enzyme-linked immunosorbent assay (ELISA)," which is a common type of laboratory test performed in vitro.
Therefore, based on the provided information, the QUANTA Lite™ SLA kit fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QUANTA Lite™ SLA (soluble liver antigen) kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-SLA (soluble liver antigen) antibody of the IgG class in human serum. This test is intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis (AIH).
Product codes
NIY
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
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Key Metrics
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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 consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting hair or movement. The logo is presented in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Brys C. Myers Manager, Regulatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, California 92131-1234
Re: K021482
Trade/Device Name: OUANTA Lite SLA ELISA Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: NIY Dated: July 24, 2002 Received: July 25, 2002
JUL 3 0 2002
Dear Mr. Myers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.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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Page | of |
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: QUANTA Lite™ SLA (Soluble Liver Antigen ) ELISA
Indications For Use:
The QUANTA Lite™ SLA (soluble liver antigen) kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-SLA (soluble liver antigen) antibody of the IgG class in human serum. This test is intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis (AIH).
FBA/CDRH/ODE/DMC
May 8 10 22 AM '02
RECEIVED
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
J.P. Reeves for S. Altaie
sion of Clinical 510(k) Number _
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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I
II