(29 days)
The ADVIA Centaur HAV IgM assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human serum or plasma (EDTA, lithium heparinized, or sodium heparinized) using the ADVIA Centaur® System. This assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis A virus. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, infants, or children. WARNING: This assay has not been FDA cleared or approved for the screening of blood or plasma donors. United States federal law restricts this device to sale by or on the order of a physician.
The modified ADVIA Centaur® HAV IgM Assay is comprised of the following:
- ADVIA Centaur HAV IgM ReadyPack primary reagent pack is composed of three components:
Lite Reagent - Mouse anti-HAV human IgM monoclonal antibody labeled with acridinium ester in . buffer with bovine serum albumin and preservatives. The modified device uses the fab2 fragment of the monoclonal antibody
- Solid Phase Streptavidin coated paramagnetic microparticles with bovine serum albumin and . preservatives
- Ancillary Well Reagent Inactivated purified hepatitis A virus (
This looks like a 510(k) premarket notification for an in vitro diagnostic immunoassay, not an AI/ML medical device. Therefore, many of the requested fields related to AI/ML device studies (e.g., MRMC studies, number of experts for ground truth, training set information) are not applicable.
Here's the information as best as can be extracted from the provided text, focusing on the device's performance and the study details that are relevant to this type of diagnostic assay:
Acceptance Criteria and Device Performance for ADVIA Centaur® HAVM Assay
The provided text does not explicitly state "acceptance criteria" in a table format with specific quantifiable thresholds for this 510(k) submission. However, for diagnostic assays, acceptance criteria are generally established during internal validation and analytical performance studies to demonstrate that the assay consistently meets performance specifications (e.g., sensitivity, specificity, precision, accuracy). The 510(k) summary typically includes a comparison to a predicate device and demonstrates that the new device is "substantially equivalent" in performance.
The provided document focuses on describing the device, its intended use, and affirming its substantial equivalence to a predicate device without listing detailed performance metrics or the specific studies used to demonstrate those metrics for the modified device. The document explicitly states:
"The modified ADVIA Centaur HAV IgM assay has the same operating principles, design, method of manufacture, assay performance characteristics and intended use as the predicate device. The modified ADVIA Centaur HAV IgM assay is substantially equivalent to the predicate ADVIA Centaur HAV IgM assay."
This statement implies that the "acceptance criteria" are effectively met by demonstrating performance equivalent to the predicate device. Without further documentation (e.g., a detailed performance study report), specific numerical acceptance criteria and reported device performance cannot be extracted from the provided text.
Therefore, a table of acceptance criteria and reported device performance cannot be formulated from the given text.
Here's an attempt to answer the other questions based on the available information:
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. For an in vitro diagnostic, this would typically involve human serum or plasma samples. The country of origin and whether data was retrospective or prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Specified: For an immunoassay like this, ground truth is typically established by established diagnostic methods (e.g., other validated assays, clinical diagnosis based on a combination of tests and patient history) rather than expert consensus on image interpretation. The document does not provide details on how the ground truth for any validation samples was established.
4. Adjudication method for the test set:
- Not Applicable / Not Specified: Adjudication methods are more relevant for subjective interpretations (e.g., radiology reads). For a quantitative or qualitative immunoassay result, the "adjudication" is typically the result of the reference method used to establish ground truth.
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 in vitro diagnostic immunoassay, not an AI-assisted device that involves human readers interpreting cases. Therefore, an MRMC study and AI assistance effect size are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes (Implied): The ADVIA Centaur® HAVM Assay is an automated immunoassay system. Its performance characteristics (like sensitivity and specificity) are inherently "standalone" in the sense that the assay itself generates the result without human intervention in the result determination beyond running the sample on the instrument. No "human-in-the-loop" is involved in interpreting the assay's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Specified: The document does not detail how the ground truth for establishing assay performance (e.g., sensitivity, specificity) was determined. For diagnostic assays, it is typically established using a highly accurate reference method or a composite reference standard (e.g., a combination of other serological tests, clinical diagnosis, and follow-up).
8. The sample size for the training set:
- Not Applicable / Not Specified: For an immunoassay, there isn't a "training set" in the sense of AI/ML models. Assay development involves optimizing reagents and conditions, and then validating performance with a series of characterized clinical samples. The document does not provide details on sample sizes used during assay development or validation.
9. How the ground truth for the training set was established:
- Not Applicable / Not Specified: As there isn't a "training set" in the AI/ML context, this question is not directly applicable. If referring to samples used during assay development and optimization, their "ground truth" would likely be established through reference methods.
§ 866.3310 Hepatitis A virus (HAV) serological assays.
(a)
Identification. HAV serological assays are devices that consist of antigens and antisera for the detection of hepatitis A virus-specific IgM, IgG, or total antibodies (IgM and IgG), in human serum or plasma. These devices are used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis to determine if an individual has been previously infected with HAV, or as an aid to identify HAV-susceptible individuals. The detection of these antibodies aids in the clinical laboratory diagnosis of an acute or past infection by HAV in conjunction with other clinical laboratory findings. These devices are not intended for screening blood or solid or soft tissue donors.(b)
Classification. Class II (special controls). The special control is “Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays.” See § 866.1(e) for the availability of this guidance document.