(113 days)
The Premier Giardia enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Giardia antigens in human stool. Test results are intended to aid in the diagnosis of Giardia infection (giardiasis).
The Premier Giardia test utilizes polyclonal anti-Giardia capture antibody adsorbed to microwells.
Here's a breakdown of the acceptance criteria and study information for the Premier Giardia device, based on the provided text:
Acceptance Criteria and Device Performance
The core acceptance criteria for the Premier Giardia device, as presented in comparison to its predicate device, are focused on its diagnostic performance metrics:
1. Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Premier Giardia) |
|---|---|---|
| Sensitivity | 98% | 98% |
| Specificity | 98% | 98% |
Note: The document explicitly states that the Premier Giardia performed at 98% sensitivity and 98% specificity, directly matching the performance of the predicate device, the Alexon ProspecT Giardia Microplate Assay. This direct match implies that these performance metrics of the predicate device serve as the acceptance criteria for the new device.
2. Sample Size and Data Provenance for the Test Set
The provided 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number and Qualifications of Experts for Ground Truth
The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. For an in vitro diagnostic device like this, ground truth would typically be established by culture, microscopy, or other established reference methods interpreted by qualified laboratory personnel.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this 510(k) summary. This type of study is more common for imaging devices where human interpretation is a critical component influencing diagnostic accuracy. The Premier Giardia is an in vitro diagnostic assay with a qualitative (positive/negative) output.
6. Standalone (Algorithm Only) Performance
The information provided describes the performance of the Premier Giardia as a standalone device. It's an enzyme immunoassay (EIA) that directly detects Giardia antigens. There is no indication of a human-in-the-loop component or an "algorithm only" performance separate from the assay itself. The "Level of Skill Required" is stated as a "Laboratory Technician," meaning technicians perform the assay according to the specified steps and interpret the results.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the performance evaluation (e.g., expert consensus, pathology, other reference methods, or outcomes data). However, for an in vitro diagnostic for infectious disease, the ground truth is typically established by:
- Microscopy: Direct observation of Giardia cysts or trophozoites in stool samples by a trained microbiologist.
- Culture: Growing the Giardia parasite in a laboratory setting (though this can be challenging for Giardia).
- Reference molecular tests: PCR or other nucleic acid-based tests could also be used as a gold standard.
Given the context of a 510(k) for an EIA, it is highly probable that the reference "Performance vs. Reference Methods" implies comparison against microscopy or another established laboratory method for Giardia detection.
8. Sample Size for the Training Set
The provided 510(k) summary does not mention a training set sample size. For an immunoassay like the Premier Giardia, there isn't typically a "training set" in the machine learning sense. The assay itself is developed and optimized, not "trained" on data. The figures for sensitivity and specificity reflect the performance after development and optimization, assessed against a "test set" (though its size is not specified).
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of this immunoassay, the question of how its ground truth was established is not applicable. The development of the assay likely involved internal validation and optimization against known positive and negative samples, but these are part of the assay's development, not a separate "training set" with ground truth in the way a machine learning algorithm would have.
§ 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.