(109 days)
No
The description details a standard enzyme immunoassay kit with chemical reagents and antibodies. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of such technologies.
No
This device is an in vitro diagnostic test used to detect an antigen, not to treat a condition.
Yes
The intended use explicitly states "FOR IN VITRO DIAGNOSTIC USE" and indicates it's used to "determine the presence of Cryptosporidium gastrointestinal infection" in patients with diarrhea, which directly aligns with the purpose of a diagnostic device.
No
The device description clearly outlines a physical kit containing reagents, microtiter wells, and other chemical components, indicating it is an in vitro diagnostic (IVD) test kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "FOR IN VITRO DIAGNOSTIC USE."
- Nature of the Test: The device is an enzyme immunoassay designed to detect a specific antigen (Cryptosporidium oocyst antigen) in a biological sample (fecal specimens) to diagnose a condition (Cryptosporidium gastrointestinal infection). This is the core function of an in vitro diagnostic device.
- Intended Use: The intended use is to provide information for the diagnosis of a disease, which is a key characteristic of an IVD.
- Sample Type: It uses a biological sample (fecal specimens) taken from the human body.
- Testing Location: The intended user is clinical laboratories, which is a typical setting for IVD testing.
N/A
Intended Use / 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.
Product codes
MHJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults or children
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation of >95%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
TECHLAB 510(k) Cryptosporidium TEST
480335
1 8 1998 MAY SUMMARY OF SAFETY AND EFFECTIVENESS
- Name of Manufacturer
TechLab, Inc. 1861 Pratt Drive, Ste. 1030 Corporate Research Center Blacksburg, VA 24060-6364
- Establishment Registration
Federal ID # 54-1527427 Initial Registration of Medical Device Establishment, #1122855
- Trade Name
Cryptosporidium TEST
- Common Name
Cryptosporidium enzyme immunoassay
- Class of Device
This device is classified in Class I.
- 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.
1
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.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its head turned to the right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the eagle.
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.
3
Page 2
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 (770)488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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
4
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)