(228 days)
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No
The summary describes an ELISA system for detecting antibodies, which is a standard laboratory technique and does not mention any AI or ML components.
No.
This device is an in vitro diagnostic (IVD) system used to detect antibodies in human serum, which is for diagnostic purposes, not for treating a disease or condition.
Yes
The device is designed for the "determination of IgG antibodies to Toxoplasma gondii," which is a diagnostic purpose to evaluate serologic evidence for T. gondii infection.
No
The device is an ELISA system, which is a laboratory-based assay involving physical reagents and equipment, not solely software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The text explicitly states "for in vitro diagnostic use."
- Intended User / Care Setting: The text also mentions "in vitro diagnostic use."
These statements clearly indicate that the device is intended to be used outside of the body to examine specimens for diagnostic purposes, which is the definition of an IVD.
N/A
Intended Use / Indications for Use
The QUANTA Lite ™ Toxoplasma IgG ELISA System is designed for the semi-quantitative determination of IgG antibodies to Toxoplasma gondii in human Sera. The assay is for in vitro diagnostic use. It can be used to evaluate serologic evidence and for prenatal screening for T. gondii IgG.
Product codes
LGD
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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§ 866.3780
Toxoplasma gondii serological reagents.(a)
Identification. Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toToxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyToxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoanToxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.(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 and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that suggest the shape of a bird in flight. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health and Human Services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 2 1997
Brys C. Myers Manager, Regulatory Affairs INOVA Diagnostics 10451 Roselle Street San Diego, CA 92121
K971441 Re:
Trade Name: Quanta Lite™ Toxoplasma IgG ELISA Regulatory Class: II Product Code: LGD Dated: September 9, 1997 Received: September 10, 1997
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
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K971441 510(k) Number (if known): __
QUANTA Lite™ Toxoplasma IgG ELISA Test Kit Device Name:
Indications For Use:
The QUANTA Lite ™ Toxoplasma IgG ELISA System is designed for the semiine Quantitative determination of IgG antibodies to Toxoplasma gondii in human qualiticative accemination on as a be used to evaluate serologic evidence Serma. The esse off our and for in vitro diagnostic use. It can be used for prenatal screening for T. gondii IgG.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
- John Tichurst MD, medical officer
Division of Medical Official
(Division Sign-Off) Division of Clinical Laboratory Devices Micros 77 144 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)