CRYPTO-CEL IF TEST

K955852 · Techlab, Inc. · MHJ · Aug 5, 1996 · Microbiology

Device Facts

• Record ID: K955852
• Device Name: CRYPTO-CEL IF TEST
• Applicant: Techlab, Inc.
• Product Code: MHJ · 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-Cel IF Test can be used to detect Cryptosporidium oocysts in fecal specimens from persons suspected of having intestinal disease due to this pathogen.

Device Story

Immunofluorescent assay kit; detects Cryptosporidium oocysts in fecal specimens. Input: fecal samples; reagent: FITC-labeled anti-Cryptosporidium monoclonal antibody derived from mouse ascites fluid. Operation: immunofluorescent staining of specimens; visualization via fluorescence microscopy. Output: visual detection of fluorescent oocysts. Used in clinical laboratories by trained personnel. Results serve as diagnostic aid for cryptosporidiosis; informs clinical management of intestinal disease.

Clinical Evidence

Two clinical studies compared TechLab Crypto-Cel IF Test against Merifluor Cryptosporidium/Giardia Direct Immunofluorescent Detection Procedure and Crypto/Giardia-Cel IF Test. Results showed 100% correlation across all compared tests for detection of Cryptosporidium in fecal specimens.

Technological Characteristics

Immunofluorescent assay; utilizes FITC-labeled anti-Cryptosporidium monoclonal antibody (mouse ascites origin). Manual diagnostic test kit.

Indications for Use

Indicated for detection of Cryptosporidium oocysts in fecal specimens from patients suspected of intestinal cryptosporidiosis.

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.

Reference Devices

• Merifluor Cryptosporidium/Giardia Direct Immunofluorescent Detection Procedure (Meridian Diagnostics, Inc.)
• Crypto/Giardia-Cel IF Test

Submission Summary (Full Text)

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TECHLAB 510(k)
Crypto-Cel IF Test

# SUMMARY OF SAFETY AND EFFECTIVENESS

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

K955852
AUG - 5 1996

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

3. Trade Name
Crypto-Cel IF Test

4. Common Name
Cryptosporidium 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-Cel IF Test can be used to detect Cryptosporidium oocysts in fecal specimens from persons suspected of having intestinal disease due to this pathogen. The kit, which includes ready-to-use reagents, contains an antibody reagent consisting of FITC-labeled anti-Cryptosporidium monoclonal antibody. This antibody functions as the detecting antibodies. The monoclonal antibody is prepared from mouse ascites fluid.

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TECHLAB 510(k)
Crypto-Cel IF Test

The Crypto-Cel IF Test is to be used in an immunofluorescent assay and is substantially equivalent to an approved immunofluorescent test that can be used for the detection of Cryptosporidium and Giardia in stool specimens. These tests serve as diagnostic aids for cryptosporidiosis by detecting the organism or its antigens.

The TechLab Crypto-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 Cryptosporidium in fecal specimens. In addition, the TechLab test was compared with the Crypto/Giardia-Cel IF Test, for which we have submitted a 510(k) application. The results of our clinical evaluations show that the TechLab Crypto-Cel IF Test exhibits a correlation of 100% when compared with these tests. These results show that the TechLab Crypto-Cel IF Test is useful for the detection of these pathogens in fecal specimens.