← Product Code [MHI](/submissions/MI/subpart-d%E2%80%94serological-reagents/MHI) · K963135 # GIARDIA CELISA (K963135) _Techlab, Inc. · MHI · Nov 29, 1996 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MHI/K963135 ## Device Facts - **Applicant:** Techlab, Inc. - **Product Code:** [MHI](/submissions/MI/subpart-d%E2%80%94serological-reagents/MHI.md) - **Decision Date:** Nov 29, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.3220 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Indications for Use The Giardia CELISA can be used to detect Giardia cysts in fecal specimens from persons suspected of having giardiasis. ## Device Story Giardia CELISA is an enzyme immunoassay (EIA) for detecting Giardia antigens in fecal specimens. Device utilizes microtiter wells coated with mouse-derived monoclonal antibodies to capture Giardia antigen; rabbit-derived polyclonal antibodies serve as detecting agents. Conjugate (anti-rabbit IgG-peroxidase) and substrate are added to produce colorimetric signal. Performed in clinical laboratories by trained personnel. Output is qualitative or semi-quantitative detection of Giardia cysts; aids clinicians in diagnosing giardiasis. Benefits include improved diagnostic sensitivity compared to traditional microscopy. ## Clinical Evidence Clinical evaluation compared Giardia CELISA against microscopy with conventional staining and Meridian Premier Giardia lamblia. Study demonstrated >95% correlation with comparator methods for detecting Giardia antigen in fecal specimens. ## Technological Characteristics Enzyme immunoassay (EIA) format. Components: microtiter wells coated with monoclonal antibody (mouse ascites), polyclonal detecting antibody (rabbit hyperimmune antiserum), anti-rabbit IgG-peroxidase conjugate, substrate, wash solution, intensifier. Manual or semi-automated plate-based detection. ## 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. ## Predicate Devices - Meridian Premier Giardia lamblia ## Reference Devices - Microscopy (conventional staining methods) ## 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) Giardia CELISA # SUMMARY OF SAFETY AND EFFECTIVENESS K963135 1. Name of Manufacturer TechLab, Inc. 1861 Pratt Drive Corporate Research Center Blacksburg, VA 24060 NOV 29 1996 2. Establishment Registration Federal ID # 54-1527427 Initial Registration of Medical Device Establishment, #1122855 3. Trade Name Giardia CELISA 4. Common Name Giardia enzyme immunoassay 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 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} TECHLAB 510(k) Giardia CELISA 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. 5 --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MHI/K963135](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MHI/K963135) **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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