(109 days)
Meridian Premier Giardia lamblia
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No
The device description and performance studies focus on a traditional ELISA assay using antibodies and reagents, with no mention of AI or ML.
No
This device is an in vitro diagnostic test designed to detect Giardia cysts, not to treat a condition or disease.
Yes
The device detects Giardia cysts in fecal specimens from persons suspected of having giardiasis, which is a diagnostic purpose.
No
The device description clearly indicates it is a kit containing physical reagents, microtiter wells, and antibodies, which are hardware components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "detect Giardia cysts in fecal specimens from persons suspected of having giardiasis." This involves testing a sample taken from the human body (fecal specimen) to provide information about a person's health status (presence of Giardia, indicating giardiasis). This aligns directly with the definition of an in vitro diagnostic device.
- Device Description: The description details a kit with reagents and components designed to perform a laboratory test on a biological sample (fecal specimen). This is characteristic of an IVD.
- Performance Studies: The performance studies compare the device's results with other methods for detecting Giardia in fecal specimens, further confirming its use in a diagnostic context.
N/A
Intended Use / Indications for Use
The Giardia CELISA can be used to detect Giardia cysts in fecal specimens from persons suspected of having giardiasis.
Product codes
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Device Description
The kit, which includes ready-to-use reagents, contains microtiter wells coated with monoclonal antibody, positive control reagent, detecting antibody (polyclonal antibody), conjugate (anti-rabbit IgG-peroxidase), substrate, wash solution, and intensifier. The microtiter wells coated with monoclonal antibody "capture" the antigen and the polyclonal antibody serves as the "detecting" antibody. The polyclonal antibody used as the detecting antibody is prepared from hyperimmune antiserum developed in rabbits. The monoclonal antibody used to coat microtiter wells is prepared from mouse ascites fluid.
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
fecal specimens
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)
The Giardia CELISA was compared with the detection of the organism in fecal specimens by microscopy with conventional staining. In addition, the test was compared with the Meridian Premier Giardia lamblia for the detection of Giardia antigen in fecal specimens. The results of our clinical evaluations show that the Giardia CELISA exhibits a correlation of >95% when compared with these other methods for detecting Giardia in fecal specimens. These results show that the Giardia CELISA is useful for the detection of Giardia in fecal specimens.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation of >95%
Predicate Device(s)
Meridian Premier Giardia lamblia
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3220
Entamoeba histolytica serological reagents.(a)
Identification. Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toEntamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyEntamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasiteEntamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
VENESS
K963135-
- Name of Manufacturer
NOV 2 9 1996
TechLab, Inc. 1861 Pratt Drive Corporate Research Center Blacksburg, VA 24060
- Establishment Registration
Federal ID # 54-1527427 Initial Registration of Medical Device Establishment, #1122855
- Trade Name
Giardia CELISA
- Common Name
Giardia enzyme immunoassay
- Class of Device
This device is classified in Class I.
- Performance Standards
No performance standards have been developed for this device under 514 of the Food, Drug, and Cosmetic Act.
7. Safety and Effectiveness
The Giardia CELISA can be used to detect Giardia cysts in fecal specimens from persons suspected of having giardiasis. The kit, which includes ready-to-use reagents, contains microtiter wells coated with monoclonal antibody, positive control reagent, detecting antibody (polyclonal antibody), conjugate (anti-rabbit IgG-peroxidase), substrate, wash solution, and intensifier. The microtiter wells coated with monoclonal antibody "capture" the antigen and the polyclonal antibody serves as the "detecting" antibody. The polyclonal antibody used as the detecting antibody is prepared from hyperimmune antiserum developed in rabbits. The monoclonal antibody used to coat microtiter wells is prepared from mouse ascites fluid.
1
The Giardia CELISA is to be used in an enzyme immunoassay format and is substantially equivalent to microscopy (conventional staining methods) used in some clinical laboratories as diagnostic aids for giardiasis. In addition, the Giardia CELISA is substantially equivalent to the Meridian Premier Giardia lamblia which has been approved for in vitro diagnostic use. These tests all serve as diagnostic aids for Giardia-associated disease by detecting the organism or its antigens.
The Giardia CELISA was compared with the detection of the organism in fecal specimens by microscopy with conventional staining. In addition, the test was compared with the Meridian Premier Giardia lamblia for the detection of Giardia antigen in fecal specimens. The results of our clinical evaluations show that the Giardia CELISA exhibits a correlation of >95% when compared with these other methods for detecting Giardia in fecal specimens. These results show that the Giardia CELISA is useful for the detection of Giardia in fecal specimens.