CRYPTOSPORIDIUM TEST

K980354 · Techlab, Inc. · MHJ · May 18, 1998 · Microbiology

Device Facts

• Record ID: K980354
• Device Name: CRYPTOSPORIDIUM TEST
• Applicant: Techlab, Inc.
• Product Code: MHJ · Microbiology
• Decision Date: May 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3220
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Cryptosporidium TEST is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of Cryptosporidium 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 Story

Cryptosporidium TEST is an enzyme immunoassay (EIA) for detecting Cryptosporidium parvum oocyst antigen in human fecal specimens. The device utilizes microtiter wells coated with monoclonal antibodies to capture the antigen, followed by a polyclonal detecting antibody and an anti-rabbit IgG-peroxidase conjugate. The test is performed in a clinical laboratory setting. The healthcare provider processes the fecal sample, performs the immunoassay, and interprets the results to aid in the diagnosis of cryptosporidiosis. The test provides a qualitative result, assisting clinicians in identifying Cryptosporidium-associated disease, thereby guiding appropriate patient management and treatment.

Clinical Evidence

Clinical evaluation compared the Cryptosporidium TEST against conventional microscopy (staining and immunofluorescence) and the Alexon ProSpecT Cryptosporidium Microplate Assay. Results demonstrated a correlation of >95% across these methods for detecting Cryptosporidium antigen in fecal specimens.

Technological Characteristics

Enzyme immunoassay (EIA) format. Components include microtiter wells coated with mouse monoclonal antibody, rabbit polyclonal detecting antibody, anti-rabbit IgG-peroxidase conjugate, substrates, wash solution, and stop solution. Manual diagnostic test.

Indications for Use

Indicated for qualitative detection of Cryptosporidium oocyst antigen in fecal specimens from adults and children with diarrhea to determine presence of gastrointestinal infection.

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

• Alexon ProSpecT Cryptosporidium Microplate Assay

Submission Summary (Full Text)

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## TECHLAB 510(k) Cryptosporidium TEST

480335

## 1 8 1998 MAY SUMMARY OF SAFETY AND EFFECTIVENESS

1. Name of Manufacturer

TechLab, Inc. 1861 Pratt Drive, Ste. 1030 Corporate Research Center Blacksburg, VA 24060-6364

2. Establishment Registration

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

3. Trade Name

Cryptosporidium TEST

4. Common Name

Cryptosporidium 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 Cryptosporidium TEST can be used to detect Cryptosporidium parvum oocyst antigen in fecal specimens from persons suspected of having cryptosporidiosis. 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), substrates, wash solution, and stop solution. 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.

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The Cryptosporidium TEST 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 cryptosporidiosis. In addition, the Cryptosporidium TEST is substantially equivalent to the Alexon ProSpecT Cryptosporidium Microplate Assay which has been approved for in vitro diagnostic use. These tests all serve as diagnostic aids for Cryptosporidium-associated disease by detecting the organism or its antigens.

The Cryptosporidium TEST was compared with the detection of the organism in fecal specimens by microscopy with conventional staining and immunofluorescence. In addition, the test was compared with the Alexon ProSpecT Cryptosporidium Microplate Assay for the detection of Cryptosporidium antigen in fecal specimens. The results of our clinical evaluations show that the Cryptosporidium TEST exhibits a correlation of >95% when compared with these other methods for detecting Cryptosporidium in fecal specimens. These results show that the Cryptosporidium TEST is useful for the detection of Cryptosporidium in fecal specimens.

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MAY 1 8 1998

Vice President TechLab. Inc.

David M. Lyerly, Ph.D.

1861 Pratt Drive, Suite 1030 Corporate Research Center Blacksburg, VA 24060-6364 Food and Drug Administration 2098 Gaither Road Rockville MD 20850

K980354 Re: Trade Name: Cryptosporidium Test Regulatory Class: II Product Code: MHJ Dated: April 20, 1998 Received: April 24, 1998

Dear Dr. Lyerly:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Cryptosporidium TEST

Indications For Use:

ﺴﺴ

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Woodley Dubois

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_K 980 354

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)