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K Number
K033274
Device Name
GIARDIA II
Manufacturer
TECHLAB, INC.
Date Cleared
2003-11-04

(25 days)

Product Code
MHI
Regulation Number
866.3220
Type
Special
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cyst antigen in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of G. lamblia gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children. FOR IN VITRO DIAGNOSTIC USE.

Device Description

The GIARDIA II test is an enzyme immunoassay.

AI/ML Overview

This document does not contain the detailed study information, acceptance criteria, or performance data for the GIARDIA II device. The provided text is an FDA 510(k) clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device. It states the intended use and regulatory classification but does not include the specifics of the performance study that would demonstrate it meets acceptance criteria.

Therefore, I cannot fulfill the request for:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes for the test set or data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study details or effect size.
  6. Standalone performance details.
  7. Type of ground truth used for the test set.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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.