(141 days)
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No
The summary describes a standard ELISA kit, which is a laboratory assay and does not mention any AI or ML components.
No
Explanation: The device is an ELISA kit used for the qualitative detection of IgG antibodies for diagnostic purposes (initial detection of Lyme disease), not for treatment or therapy.
Yes
The device is an ELISA kit for the qualitative detection of IgG antibodies to B. burgdorferi (Lyme disease), providing presumptive evidence of antibodies and supporting a clinical diagnosis when combined with other data. This directly relates to diagnosing a medical condition.
No
The device description explicitly states it is an "enzyme-linked immunosorbent 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:
- It is an assay: The description explicitly states it is an "enzyme-linked immunosorbent assay (ELISA)". Assays are laboratory tests used to measure the presence or amount of a substance.
- It is used on human specimens: The intended use specifies it detects antibodies "in human serum".
- It is used for diagnostic purposes: The intended use states it is for the "qualitative detection of IgG antibodies to B. burgdorferi, the agent of Lyme disease" and is intended to "provide presumptive evidence of the presence of antibodies to B. burgdorferi". This indicates it is used to aid in the diagnosis of a disease.
- It is performed in vitro: The term "in vitro" means "in glass" or "in the laboratory," referring to tests performed outside of a living organism. An ELISA performed on a serum sample is an in vitro procedure.
The definition of an IVD is a medical device that is used to examine specimens taken from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that definition.
N/A
Intended Use / Indications for Use
The QUANTA Lite™ Lyme B. burgdorferi IgG ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the initial (first-step) qualitative detection of IgG antibodies to B. burgdorferi, the agent of Lyme disease (Lyme borreliosis), in human serum. This ELISA is intended to provide presumptive evidence of the presence of antibodies to B. burgdorferi. Equivocal or positive results should be followed by a standardized second-step supplemental procedure such as Western blot assays. Positive results on a second-step assay can support a clinical diagnosis of Lyme disease. Diagnosis of Lyme disease should be based on history, physical findings, and other laboratory data in addition to anti-B. burgdorferi results. Negative results should not be the sole basis for exclusion of B. burgdorferi infection.
Product codes
LSR
Device Description
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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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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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§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).
0
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a caduceus, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 15 1999
Brys C. Myers Manager, Regulatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, CA 92131-1234
Re: K984222 Trade Name: QUANTA Lite™ Lyme B. burgdorferi IgG ELISA Regulatory Class: II Product Code: LSR Dated: February 5, 1999 Received: February 9, 1999
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 OS 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 Autman
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(k) Number (if known): K984222
Device Name: QUANTA Lite™ Lyme B. burgdorferi IgG ELISA
Indications For Use:
The QUANTA Lite™ Lyme B. burgdorferi IgG ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the initial (first-step) qualitative detection of IgG antibodies to B. burgdorferi, the agent of Lyme disease (Lyme borreliosis), in human serum. This ELISA is intended to provide presumptive evidence of the presence of antibodies to B. burgdorferi. Equivocal or positive results should be followed by a standardized second-step supplemental procedure such as Western blot assays. Positive results on a second-step assay can support a clinical diagnosis of Lyme disease. Diagnosis of Lyme disease should be based on history, physical findings, and other laboratory data in addition to anti-B. burgdorferi results. Negative results should not be the sole basis for exclusion of B. burgdorferi infection.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K984222
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)