(248 days)
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No
The description details an ELISA-based immunoassay for detecting a specific protein, with no mention of AI or ML technologies.
No
This device is an in vitro diagnostic test designed to detect a specific antigen (adhesin) in fecal specimens for the diagnosis of amebiasis. It does not provide any treatment or therapeutic benefit to a patient.
Yes
The device is described as a test that can be used to detect adhesin in fecal specimens from persons suspected of having amebiasis, and its clinical evaluations show it is useful for the detection of pathogenic E. histolytica in stool specimens. This functionality directly supports the diagnosis of a disease.
No
The device description clearly outlines a physical kit with reagents, microtiter wells, antibodies, and other chemical components, indicating it is a hardware-based diagnostic test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to detect a specific substance (adhesin) in a biological specimen (fecal specimens) from a person suspected of having a disease (amebiasis). This is a classic definition of an in vitro diagnostic test.
- Device Description: The description details a kit with reagents and a microtiter plate designed to perform an ELISA (Enzyme-Linked Immunosorbent Assay) on a biological sample. This is a common format for IVD tests.
- Anatomical Site: The test is performed on fecal specimens, which are biological samples taken from the human body.
- Intended User / Care Setting: The intended users are clinical laboratories, which are the typical settings where IVD tests are performed.
- Performance Studies: The document describes clinical evaluations comparing the test results to a "gold standard" (zymodeme analysis) using biological specimens. This is a standard practice for validating the performance of IVD tests.
- Key Metrics: The document provides a performance metric (correlation) based on the analysis of biological samples.
- Reference Device(s): The mention of reference devices (TechLab's Entamoeba Test and Alexon ProSpecT Entamoeba histolytica Test) further indicates that this device is intended to be used in a clinical diagnostic context, similar to existing IVD tests.
All of these factors strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The E. histolytica Test can be used to detect adhesin (also referred to as galactose-inhibitable lectin) produced by strains of E. histolytica. It does not cross-react with the adhesin from E. dispar (formerly known as nonpathogenic E. histolytica). The test can be used to detect the adhesin in fecal specimens from persons suspected of having amebiasis.
Product codes
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Device Description
The kit, which includes ready-to-use reagents, contains microtiter wells coated with polyclonal antibody, positive control reagent, monoclonal-antibody conjugate, diluent, two component substrate, wash solution, and intensifier. The microtiter wells coated with polyclonal antibody "capture" the adhesin and the monoclonal antibodyconjugate serves as the "detecting" antibody. The polyclonal antibody used to coat the wells is prepared from hyperimmune antiserum developed in rabbits. The monoclonal antibody used to prepare the conjugate 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
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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
The E. histolytica Test was used to analyze stool specimens in areas where amebiasis is endemic, and the results were compared with zymodeme analysis of Entamoeba isolates cultured from these specimens. For the purpose of our studies, zymodeme analysis represents the "gold standard". The results of our clinical evaluations show that the E. histolytica Test exhibits a correlation of >93% when compared with zymodeme analysis, and demonstrate that the test is useful for the detection of pathogenic E. histolytica in stool specimens.
Key Metrics
correlation of >93%
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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§ 866.3220
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.
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SUMMARY OF SAFETY AND EFFECTIVENESS
1. Name of Manufacturer
TechLab, Inc. Corporate Research Center 1861 Pratt Drive Blacksburg, VA 24060
AUG 30 1996
2. Establishment Registration
Federal ID # 54-1527427 Initial Registration of Medical Device Establishment, #1122855
3. Trade Name
E. histolytica Test
4. Common Name
E. histolytica ELISA
5. Class of Device
This device is classified in Class I.
6. 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 E. histolytica Test can be used to detect adhesin (also referred to as galactose-inhibitable lectin) produced by strains of E. histolytica. It does not cross-react with the adhesin from E. dispar (formerly known as nonpathogenic E. histolytica). The test can be used to detect the adhesin in fecal specimens from persons suspected of having amebiasis. The kit, which includes ready-to-use reagents, contains microtiter wells coated with polyclonal antibody, positive control reagent, monoclonal-antibody conjugate, diluent, two component substrate, wash solution, and intensifier. The microtiter wells coated with polyclonal antibody "capture" the adhesin and the monoclonal antibodyconjugate serves as the "detecting" antibody. The polyclonal antibody used to coat the wells is prepared from hyperimmune antiserum developed in rabbits. The monoclonal antibody used to prepare the conjugate is prepared from mouse ascites fluid.
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The E. histolytica Test is to be used in an ELISA format and is substantially equivalent to culturing and zymodeme analysis that are used in some clinical laboratories as diagnostic aids. Culturing is used to obtain the isolate and zymodeme analysis is used to examine the enzyme profile of the isolate. Zymodeme analysis must be used to determine if the isolated Entamoeba strain is pathogenic. The major disadvantages are that culturing and zymodeme are time-consuming and laborintensive. Only a few clinical laboratories around the world are capable of performing this type of analysis. The E. histolytica Test offers a major advantage to clinical laboratories because it is rapid. easy-to-perform, and it is the first test to offer clinical labs a simpler and easier alternative format for the specific detection of pathogenic E. histolytica.
The E. histolytica Test is different from two other ELISAs currently on the market in the U.S. These other ELISAs, TechLab's Entamoeba Test and the Alexon ProSpecT Entamoeba histolytica Test, detect both E. histolytica (formerly referred to as pathogenic E. histolytica) and E. dispar (formerly referred to as nonpathogenic E. histolytica). They do not distinguish between E. histolytica and E. dispar. The E. histolytica Test is specific for the adhesin of E. histolytica and it does not cross-react with the adhesin of E. dispar. Although all of these tests serve as diagnostic aids for amebiasis, the E. histolytica Test offers the advantage of being specific for pathogenic strains.
The E. histolytica Test was used to analyze stool specimens in areas where amebiasis is endemic, and the results were compared with zymodeme analysis of Entamoeba isolates cultured from these specimens. It is important to remember, however, that culture, without the aid of zymodeme analysis, does not distinguish between E. histolytica and E. dispar. Zymodeme analysis, which is available only in a select number of clinical laboratories around the world, is the only method that distinguishes these species. For the purpose of our studies, zymodeme analysis represents the "gold standard". The results of our clinical evaluations show that the E. histolytica Test exhibits a correlation of >93% when compared with zymodeme analysis, and demonstrate that the test is useful for the detection of pathogenic E. histolytica in stool specimens.