← Product Code [KHW](/submissions/MI/subpart-d%E2%80%94serological-reagents/KHW) · K955895 # E. HISTOLYTICA TEST (K955895) _Techlab, Inc. · KHW · Aug 30, 1996 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/KHW/K955895 ## Device Facts - **Applicant:** Techlab, Inc. - **Product Code:** [KHW](/submissions/MI/subpart-d%E2%80%94serological-reagents/KHW.md) - **Decision Date:** Aug 30, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.3220 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## 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. ## Device Story ELISA-based diagnostic test for detection of E. histolytica adhesin (galactose-inhibitable lectin) in human fecal specimens. Principle: microtiter wells coated with rabbit-derived polyclonal antibody capture adhesin; mouse-derived monoclonal antibody-conjugate detects captured adhesin. Kit includes reagents, substrate, and intensifier. Used in clinical laboratories as a rapid, simplified alternative to culture and zymodeme analysis for identifying pathogenic E. histolytica. Provides specific detection of pathogenic strains without cross-reactivity to E. dispar. Results assist clinicians in diagnosing amebiasis. ## Clinical Evidence Clinical evaluation compared test results against zymodeme analysis of cultured Entamoeba isolates in endemic areas. Study demonstrated >93% correlation with zymodeme analysis, confirming utility for detecting pathogenic E. histolytica. ## Technological Characteristics ELISA format; microtiter wells coated with rabbit polyclonal antibody; mouse monoclonal antibody-conjugate; colorimetric detection using two-component substrate and intensifier. Manual assay. ## Regulatory Identification Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Entamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Entamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasite Entamoeba 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. ## Special Controls *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. ## Reference Devices - TechLab Entamoeba Test - Alexon ProSpecT Entamoeba histolytica Test ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} TECHLAB 510(k) E. histolytica Test # SUMMARY OF SAFETY AND EFFECTIVENESS ## 1. Name of Manufacturer TechLab, Inc. Corporate Research Center 1861 Pratt Drive Blacksburg, VA 24060 $k955895$ 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 antibody-conjugate 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. {1} TECHLAB 510(k) E. histolytica Test 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 labor-intensive. 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. --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/KHW/K955895](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/KHW/K955895) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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