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IMMULITE® Rubella IgM - For in vitro diagnostic use with the IMMULITE Analyzer - for the qualitative detection of IgM antibodies to rubella virus in human serum or plasma (EDTA or heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.

IMMULITE 2000® Rubella IgM - For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the qualitative detection of IgM antibodies to rubella virus in human serum or plasma (EDTA or heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.

IMMULITE Rubella IgM and IMMULITE 2000 Rubella IgM are clinical devices for use with their respective IMMULITE and I IMMULITE 2000 Automated Immunoassay Analyzers.

IMMULITE Rubella IgM is a solid-phase, two-step chemiluminescent enzyme immunoassay. The solid phase, a polystyrene bead enclosed within an IMMULITE Test Unit, is coated with partially purified rubella antigen.

Prediluted patient sample (1-in-21 dilution) and a protein-based buffer are simultaneously introduced into the Test Unit, and incubated for approximately 30 minutes at 37°C with intermittent agitation. During this time, rubella-specific IgM in the sample binds to the rubella antigen-coated bead. Unbound serum is then removed by a centrifugal wash.

An alkaline phosphatase-labeled anti-human IgM antibody is introduced, and the Test Unit is incubated for approximately another 30-minute cycle. The unbound enzyme conjugate is removed by a centrifugal wash. Substrate is then added, and the Test Unit is incubated for a further 10 minutes.

The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex -- and thus also the photon output, as measured by the luminometer -- is related to the presence of rubella IgM in the sample. A qualitative result is then obtained by comparing the patient result to an established Cutoff.

IMMULITE 2000 Rubella IgM is a solid-phase, two-step chemiluminescent enzyme immunoassay. The solid phase, a polystyrene bead added to an IMMULITE 2000 Reaction Tube, is coated with partially purified rubella antigen.

Prediluted patient sample (1-in-20 dilution) and a protein-based buffer are simultaneously introduced into the Reaction Tube, and incubated for approximately 30 minutes at 37℃ with intermittent agitation. During this time, rubella-specific IgM in the sample binds to the rubella antigen-coated bead. Unbound serum is then removed by a centrifugal wash.

An alkaline phosphatase-labeled anti-human IgM antibody is introduced, and the Reaction Tube is incubated for approximately another 30-minute cycle. The unbound enzyme conjugate is removed by a centrifugal wash. Substrate is then added, and the Reaction Tube is incubated for a further 5 minutes.

The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex -- and thus also the photon output, as measured by the luminometer -- is related to the presence of rubella IgM in the sample. A qualitative result is then obtained by comparing the patient result to an established Cutoff.

The provided text describes the 510(k) summary for IMMULITE and IMMULITE 2000 Rubella IgM devices, focusing on their performance equivalence to a predicate device. The information presented is primarily a comparison study between the new devices and an existing one (Trinity Biotech CAPTIA Rubella-M), rather than a standalone study with pre-defined acceptance criteria tested against a ground truth.

Here's an attempt to extract the requested information, acknowledging that some specific aspects (like explicit acceptance criteria for the new devices, a training set, or traditional ground truth in an AI/ML context) are not directly applicable or stated for this type of immunoassay device submission:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state pre-defined acceptance criteria for the IMMULITE and IMMULITE 2000 Rubella IgM devices in terms of specific performance metrics (e.g., sensitivity, specificity thresholds) that they needed to meet. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Trinity Biotech CAPTIA Rubella-M). The performance is reported in terms of agreement with this predicate device.

Reported Device Performance (Agreement with Predicate Device: Trinity Biotech CAPTIA Rubella-M)

Note: Indeterminate results were excluded from agreement calculations.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• IMMULITE Rubella IgM:
  • Southern US study: 236 specimens (92 pregnant women, 144 individuals with various conditions). Data provenance: Southern United States. The time frame (retrospective/prospective) is not explicitly stated, but the mention of "frozen samples" often implies retrospective analysis.
  • Northeastern US study: 233 specimens (60 pregnant women, 173 individuals with various conditions). Data provenance: Northeastern United States. Same as above regarding retrospective/prospective.
• IMMULITE 2000 Rubella IgM:
  • Southern US study (vs. Kit A): 236 specimens (same set as IMMULITE Rubella IgM Southern US study).
  • DPC study (vs. IMMULITE Rubella IgM): 223 samples. Data provenance: DPC (in-house study).

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)

The ground truth is established by the predicate device, Trinity Biotech CAPTIA Rubella-M (Kit A), and in one case, by the IMMULITE Rubella IgM itself when comparing IMMULITE 2000. For this type of immunoassay, the "ground truth" is typically defined by the performance of an established, cleared device or by reference methods, not by human expert opinion as would be the case for image interpretation. No human experts are mentioned for establishing the "ground truth" in the context of this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The "ground truth" is based on the results of the predicate device, not on human adjudication.

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 submission is for an immunoassay device, not an AI/ML-driven diagnostic or an imaging study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is a standalone immunoassay device (a "reagent system" for qualitative detection). The device performs the detection and provides a qualitative result (Positive, Negative, Indeterminate) without direct "human-in-the-loop" interpretation beyond reading the instrument's output. Its performance is compared to another standalone immunoassay device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in these studies is the result obtained from the predicate device, Trinity Biotech CAPTIA Rubella-M (Kit A). For the comparison between IMMULITE 2000 and IMMULITE, the latter serves as the reference. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic (IVD) devices where an established, legally marketed device serves as the benchmark.

8. The sample size for the training set

This document does not describe a "training set" in the context of machine learning. The studies described are performance evaluations for an immunoassay, involving testing clinical samples against a predicate device. Immunoassay development typically involves optimization and validation steps, but these are not explicitly presented as "training" in the AI sense.

9. How the ground truth for the training set was established

Not applicable, as no training set (in the AI/ML sense) is described.

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