(109 days)
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.
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. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation with conventional staining methods (microscopy) for detecting Cryptosporidium in fecal specimens | >95% correlation |
| Correlation with immunofluorescence for detecting Cryptosporidium in fecal specimens | >95% correlation |
| Correlation with the Alexon ProSpecT Cryptosporidium Microplate Assay for detecting Cryptosporidium antigen in fecal specimens | >95% correlation |
2. Sample Size and Data Provenance:
The document does not specify the exact sample size used for the test set. It only mentions "clinical evaluations" and comparison with other methods. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth:
The document does not specify the number of experts or their qualifications used to establish the ground truth. It refers to "microscopy with conventional staining and immunofluorescence" as methods for detection, implying expert interpretation, but offers no details about the experts themselves.
4. Adjudication Method:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. The study focuses on the standalone performance of the device compared to other detection methods.
6. Standalone Performance Study:
Yes, a standalone performance study was conducted. The Cryptosporidium TEST was directly compared against established methods (microscopy with conventional staining, immunofluorescence, and the Alexon ProSpecT Cryptosporidium Microplate Assay) to evaluate its effectiveness in detecting Cryptosporidium in fecal specimens.
7. Type of Ground Truth Used:
The ground truth used was based on established laboratory diagnostic methods:
- Detection of the organism in fecal specimens by microscopy with conventional staining.
- Detection of the organism in fecal specimens by immunofluorescence.
- Detection of Cryptosporidium antigen in fecal specimens using the Alexon ProSpecT Cryptosporidium Microplate Assay (a predicate device).
8. Sample Size for the Training Set:
The document does not specify the sample size for the training set.
9. How Ground Truth for the Training Set Was Established:
The document does not provide information on how the ground truth for any training set was established. The focus of this submission is on the clinical evaluation of the device's performance against existing methods for substantial equivalence. It's common for 510(k) submissions, especially older ones, not to detail training data if the device's development wasn't explicitly machine learning-driven in a way that requires extensive training set documentation.
§ 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.