CRYPTO/GIARDIA-CEL IF TEST

K955897 · Techlab, Inc. · MHI · Aug 5, 1996 · Microbiology

Device Facts

• Record ID: K955897
• Device Name: CRYPTO/GIARDIA-CEL IF TEST
• Applicant: Techlab, Inc.
• Product Code: MHI · Microbiology
• Decision Date: Aug 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3220
• Device Class: Class 2

Indications for Use

The TechLab Crypto/Giardia-Cel IF Test can be used to detect Cryptosporidium oocysts and Giardia cysts in fecal specimens from persons suspected of having intestinal disease due to these pathogens.

Device Story

In vitro diagnostic immunofluorescent assay; detects Cryptosporidium oocysts and Giardia cysts in fecal specimens. Kit contains FITC-labeled anti-Cryptosporidium and anti-Giardia monoclonal antibodies derived from mouse ascites fluid. Used in clinical laboratory settings by trained personnel. Provides visual identification of pathogens via fluorescence microscopy; aids diagnosis of cryptosporidiosis and giardiasis. Results assist clinicians in identifying intestinal parasitic infections.

Clinical Evidence

Two clinical studies compared the device against the Merifluor Cryptosporidium/Giardia Direct Immunofluorescent Detection Procedure. One study also included comparisons with Giardia-Cel IF and Crypto-Cel IF tests. Results showed 100% correlation across all comparative evaluations.

Technological Characteristics

Immunofluorescent assay; utilizes FITC-labeled monoclonal antibodies (mouse ascites origin) for detection. Reagents provided ready-to-use. Requires fluorescence microscopy for visualization.

Indications for Use

Indicated for detection of Cryptosporidium oocysts and Giardia cysts in fecal specimens from patients suspected of having intestinal disease caused by these pathogens.

Regulatory Classification

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

• Merifluor Cryptosporidium/Giardia Direct Immunofluorescent Detection Procedure (Meridian Diagnostics, Inc.)

Reference Devices

• Giardia-Cel IF Test (K912152)
• Crypto-Cel IF Test

Submission Summary (Full Text)

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TECHLAB 510(k)
Crypto/Giardia-Cel IF Test

# SUMMARY OF SAFETY AND EFFECTIVENESS

1. Name of Manufacturer
TechLab, Inc.
Corporate Research Center
1861 Pratt Drive
Blacksburg, VA 24060

K 955897
AUG - 5 1996

2. Establishment Registration
Federal ID # 54-1527427
Initial Registration of Medical Device Establishment, #1122855

3. Trade Name
Crypto/Giardia-Cel IF Test

4. Common Name
Cryptosporidium and Giardia Immunofluorescent Test

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 TechLab Crypto/Giardia-Cel IF Test can be used to detect Cryptosporidium oocysts and Giardia cysts in fecal specimens from persons suspected of having intestinal disease due to these pathogens. The kit, which includes ready-to-use reagents, contains an antibody reagent consisting of a mixture of FITC-labeled anti-Cryptosporidium monoclonal antibody and FITC-labeled anti-Giardia monoclonal antibody. These antibodies function as the detecting antibodies. The monoclonal antibodies are prepared from mouse ascites fluid. The antibodies against Giardia are the same as those used in the Giardia-Cel IF Test (K912152), which has been cleared for in vitro diagnostic use.

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TECHLAB 510(k)
Crypto/Giardia-Cel IF Test

The Crypto/Giardia-Cel IF Test is to be used in an immunofluorescent assay and is substantially equivalent to an approved immunofluorescent test that also is specific for Cryptosporidium and Giardia. Both of these tests serve as diagnostic aids for cryptosporidiosis and giardiasis by detecting the organism or its antigens.

The TechLab Crypto/Giardia-Cel IF Test was compared in two studies with the Merifluor Cryptosporidium/Giardia Direct Immunofluorescent Detection Procedure (Meridian Diagnostics, Inc., Cincinnati, OH) for the detection of these organisms in fecal specimens. In addition, the TechLab test was compared in one of the studies with the Giardia-Cel IF Test, which has been approved for in vitro diagnostic use, and with the Crypto-Cel IF Test, for which we have submitted a 510(k) application. The results of our clinical evaluations show that the TechLab Crypto/Giardia-Cel IF Test exhibits a correlation of 100% when compared with these tests. These results show that the TechLab Crypto/Giardia-Cel IF Test is useful for the detection of these pathogens in fecal specimens.