(119 days)
The Premier Cryptosporidium enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Cryptosporidium antigens in stool. Test results are intended to aid in the diagnosis of Cryptosporidium infection.
The assay is a conventional microwell sandwich enzyme immunoassay, utilizing polyclonal capture and monoclonal detection antibodies.
Here's a breakdown of the acceptance criteria and study information for the Premier Cryptosporidium device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a separate section with predefined thresholds. However, it provides performance metrics for the Premier Cryptosporidium and compares them to a predicate device. We can infer the "acceptance criteria" were implicitly met if the Premier Cryptosporidium's performance was considered substantially equivalent to or better than the predicate.
| Performance Metric | Acceptance Criteria (Inferred from Predicate Performance or clinical utility) | Reported Device Performance (Premier Cryptosporidium) |
|---|---|---|
| Sensitivity | At least comparable to the predicate (97%) | 100% |
| Specificity | At least comparable to the predicate (98%) | 99% |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only provides the summarized performance metrics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not provided in the document. This type of study is more common for diagnostic imaging devices where human interpretation is a primary component. For an immunoassay like this, the focus is typically on the standalone performance of the assay.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The reported sensitivity of 100% and specificity of 99% for the Premier Cryptosporidium are results of its standalone performance. The document explicitly states "Performance vs. Reference Methods," indicating that the device was evaluated on its own against established reference methods (which serve as the ground truth).
7. Type of Ground Truth Used:
The document states "Performance vs. Reference Methods." While the specific reference methods are not detailed, in the context of diagnostic assays for infections, this typically implies:
- Culture: Growing the Cryptosporidium parasite in a laboratory setting.
- Microscopy: Direct observation of Cryptosporidium oocysts in stool samples by trained personnel using specific staining techniques (e.g., acid-fast stain).
- PCR (Polymerase Chain Reaction): Molecular detection of Cryptosporidium DNA.
Without more detail, it's most likely a combination of these, with microscopy and potentially culture being the gold standards at the time for direct detection of the parasite.
8. Sample Size for the Training Set:
This information is not provided in the document. Given that this is an immunoassay, the "training set" concept (as used in machine learning) may not directly apply in the same way. Immunoassays are typically developed and validated through a series of experiments to optimize reagents and conditions, rather than being "trained" on a data set.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the document. As mentioned above, the concept of a "training set" with ground truth in the machine learning sense is unlikely to be directly applicable to this type of device. The development process would involve extensive analytical sensitivity and specificity testing, cross-reactivity studies, and optimization of assay components and protocols against known positive and negative samples.
§ 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.