(229 days)
The ADVIA Centaur Toxoplasma IgG assay is an IgG antibody capture microparticle direct in vitro diagnostic immunoassay intended for the quantitative and qualitative detection of IgG antibodies to the Toxoplasma gondii parasite in human serum or plasma (EDTA, heparin) using the ADVIA Centaur systems. The measurement of Toxoplasma IgG may be used to aid in the assessment of a patient's immunological response from individuals including women of childbearing age. This assay may be utilized with an IgM Toxoplasma result to determine recent serological response to Toxoplasma.
The modified ADVIA Centaur Toxo G Assay is comprised of the following:
ADVIA Centaur Toxo G ReadyPack® Primary Reagent Pack, including:
ADVIA Centaur Toxo G Lite Reagent (10.0 mL/reagent pack)
purified T. gondii p30 antigen (~0.75 µg/mL) complexed with mouse antip30 monoclonal antibody (F(ab)2 fragment) labeled with acridinium ester in protein buffer with surfactant and preservatives
ADVIA Centaur Toxo G Solid Phase (25.0 mL/reagent pack)
mouse anti-human IgGE monoclonal antibody (~0.3 mg/mL) covalently coupled to paramagnetic particles in protein buffer with surfactant and preservatives
ADVIA Centaur Toxo G Calibrators (1.0 mL/vial)
processed defibrinated human plasma positive for toxoplasma IgG antibodies with preservatives
ADVIA Centaur Toxo G Quality Control Material (2.7 mL/vial)
processed defibrinated human plasma negative and positive for toxoplasma igG antibodies with preservatives
The provided text describes a 510(k) premarket notification for a modified immunoassay, the ADVIA Centaur® Toxoplasma IgG (Toxo G) Assay. The purpose of the submission is to demonstrate substantial equivalence to a predicate device, not to present a new study with specific acceptance criteria and performance metrics for regulatory approval of a novel device.
Therefore, the document does not contain the information requested in points 1-7, and 9 about acceptance criteria, device performance, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance, nor does it specify details for the training set (point 8 and 9).
The core of this submission is to show that the modified device is substantially equivalent to the predicate device, meaning its safety and effectiveness are not adversely impacted by minor changes in reagent composition.
Here's what can be extracted from the provided text relevant to the request, focusing on the comparison between the modified and predicate device:
1. A table of acceptance criteria and the reported device performance:
The document does not specify formal acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity thresholds) for the modified device against a ground truth. Instead, the "acceptance" is based on demonstrating that the performance claims are unchanged compared to the predicate device, despite the modifications.
| Feature | Predicate (Unmodified) ToxoG Assay (K012183) | Modified ToxoG Assay | Reported Performance (Claim) |
|---|---|---|---|
| Intended Use | See Section 5 | Same - See Section 6 | Unchanged |
| Sample Type | Serum, Heparinized Plasma, EDTA Plasma | Serum, Heparinized Plasma, EDTA Plasma | Unchanged |
| Sample Volume | 10 µL | 10 µL | Unchanged |
| Assay Range | 0.5-700 IU/mL | 0.5-700 IU/mL | Unchanged |
| Performance Claims | See Instructions for Use | Unchanged | "Unchanged" indicating equivalence to predicate device |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not detail specific sample sizes for a "test set" in the context of a new efficacy study. It only mentions "performance testing, and verification and validation activities" were conducted to demonstrate substantial equivalence, but without providing details on these studies, their sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This type of information is generally found in studies establishing the diagnostic accuracy of a new device against a clinical reference standard, not in a 510(k) submission for a modified device seeking substantial equivalence based on unchanged performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for the same reasons as point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is an immunoassay and does not involve human readers interpreting results in the way an AI-assisted diagnostic imaging device would.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This phrase is typically used for AI/algorithm-driven diagnostics. This is an in vitro diagnostic immunoassay. While its performance is "standalone" in the sense of the instrument reading and quantifying results, the concept of a "human-in-the-loop" performance as distinct from "standalone" is not applicable here. The device itself performs the measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The document does not specify a "ground truth" in the context of a new diagnostic accuracy study. For initial approval of the predicate device, a ground truth for Toxoplasma IgG (e.g., highly characterized clinical samples, possibly confirmed by other reference methods or clinical diagnosis) would have been used. For this 510(k) of a modified device, the "ground truth" for demonstrating substantial equivalence is effectively the performance of the predicate device.
8. The sample size for the training set:
Not applicable. This is an immunoassay, not a machine learning or AI-driven device that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established:
Not applicable for the same reason as point 8.
§ 866.3780
Toxoplasma gondii serological reagents.(a)
Identification. Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toToxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyToxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoanToxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.(b)
Classification. Class II (performance standards).