(63 days)
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No
The summary describes an ELISA assay, which is a laboratory test based on biochemical reactions, not AI/ML. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is an in vitro diagnostic (IVD) assay designed to detect antibodies for diagnostic purposes, not to treat or therapeutically intervene in a disease.
Yes
The "Intended Use / Indications for Use" explicitly states that the device is to "aid in the diagnosis of autoimmune thyroid diseases."
No
The device is an 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:
- "In Vitro": The assay is performed on a sample taken from the human body (human serum), outside of the body.
- "Diagnostic": The intended use is to "aid in the diagnosis of autoimmune thyroid diseases". This clearly indicates a diagnostic purpose.
The description explicitly states it's an "enzyme linked immunosorbant assay (ELISA) for the semiquantitative detection of antibodies... in human serum to aid in the diagnosis". This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
An enzyme linked immunosorbant assay (ELISA) for the semienzyme quantitative detection of antibodies to thyroid peroxidase (TPO) in human serum to aid in the diagnosis of autoimmune thyroid diseases such as Hashimoto's Thyroiditis and Graves Disease.
Product codes
LLL
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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§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol resembles a bird in flight, with three curved lines representing the wings and body. The overall design is simple and recognizable, representing the department's mission and values.
JUL 29 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Brys C. Myers Manager, Requlatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, California 92131
Re: K981857 Quanta Lite TPO ELISA Trade Name: Regulatory Class: II Product Code: LLL Dated: May 26, 1998 Received: May 27, 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 Requlations, 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 Requlation (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 requlatory 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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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 Gutman
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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t
99185 510(k) Number (if known):
QUANTA Lite™ TPO ELISA Device Name:
Indications For Use:
immunosorbant assay (ELISA) for the semienzyme linked An quantitative detection of antibodies to thyroid peroxidase (TPO) in human serum to aid in the diagnosis of autoimmune thyroid diseases such as Hashimoto's Thyroiditis and Graves Disease.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Madeni
(Division Sign-Off) Division of Clinical Laborat 5 1 (4x, : vuinber
Image /page/2/Picture/9 description: The image shows the text ": rescription Use" with a check mark next to it. The text "(Per 21 CFR 801.109)" is located below the first line of text. The text is in bold font.
OR
Over-The-Counter Use
(Optional Format 1-2-96)