(164 days)
The ARCHITECT HAVAB-M assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HA V) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum. A test for IgM anti-HAV is indicated for testing of specimens from individuals who have signs and symptoms consistent with acute hepatitis. Test results are used in conjunction with other laboratory results and clinical information as an aid in the diagnosis of acute or recent hepatitis A viral infection.
Warning: Not intended for use in screening blood, plasma, or tissue donors. The effectiveness of ARCHITECT HAVAB-M for use in screening blood, plasma, or tissue donors has not been established.
Assay performance characteristics have not been established when the ARCHITECT HAVAB-M assay is used in conjunction with other manufacturers' assays for specific hepatitis markers. Users are responsible for establishing their own performance characteristics.
The ARCHITECT HAVAB-M assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma and neonatal serum. The ARCHITECT HAVAB-M assay is calibrated with ARCHITECT HAVAB-M Calibrator. ARCHITECT HAVAB-M Controls are used for monitoring the performance of the Abbott ARCHITECT i System.
Here's a breakdown of the acceptance criteria and study information for the Abbott ARCHITECT® HAVAB®-M device, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for the ARCHITECT HAVAB-M assay are based on its agreement with a comparator assay (the predicate device, Abbott AxSYM® HAVAB®-M 2.0 assay). The study established various percent agreements for different populations.
| Acceptance Criteria Category | Reported Device Performance (Percent Agreement) | 95% Confidence Interval |
|---|---|---|
| Instrument Negative Percent Agreement | 100.0% | 96.38% to 100.00% |
| Instrument Positive Percent Agreement | 100.0% | 94.64% to 100.00% |
| Prospective Population Positive Agreement | 98.10% | 93.29% to 99.77% |
| Prospective Population Negative Agreement | 100.00% | 99.34% to 100.00% |
| Acute HAV Population Positive Agreement | 98.10% | 93.29% to 99.77% |
| Pediatric Low Risk Negative Agreement | 100.00% | 96.38% to 100.00% |
| Prospective Pediatric Positive Agreement | 98.88% | 93.90% to 99.97% |
| Prospective Pediatric Negative Agreement | 100.00% | 75.29% to 100.00% |
Study Details
This submission describes a comparison study between the ARCHITECT HAVAB-M assay and its predicate device, the Abbott AxSYM® HAVAB®-M 2.0 assay, to demonstrate substantial equivalence.
1. Sample sizes used for the test set and data provenance:
- Instrument Comparison Study:
- 100 IgM anti-HAV negative specimens
- 67 IgM anti-HAV positive specimens
- Comparison of Results and Percent Agreement (General Population): The specific numbers for the "prospectively collected population" are not explicitly stated, but the percentages are based on a comparison to the comparator assay.
- Acute HAV Population: Not specified, but the positive percent agreement is reported.
- Pediatric Low-Risk Population: Not specified, but the negative percent agreement is reported.
- Prospective Pediatric Population: Not specified, but positive and negative percent agreements are reported.
- Data Provenance: The text states "prospectively collected population" for some of the comparisons, indicating prospective data collection. The geographic origin of the data is not specified.
2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- This device is an in vitro diagnostic (IVD) assay for detecting IgM antibodies, not an imaging device or one that typically involves human expert interpretation of raw data for ground truth establishment in the same way as, for example, a radiology AI.
- The ground truth for the test set is established by the results from the comparator assay (Abbott AxSYM® HAVAB®-M 2.0 assay), which is itself a legally marketed and presumably validated device. There is no mention of independent human experts establishing ground truth for individual samples beyond what the predicate assay determines.
3. Adjudication method for the test set:
- Not applicable in the conventional sense. The "adjudication" is essentially the result provided by the predicate device. The study design is a comparison of the new device's results against those of the predicate. Discordant results are not explicitly mentioned as undergoing a separate adjudication process by additional experts.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this is an in vitro diagnostic (IVD) assay, not an AI-powered image analysis tool or a device designed to assist human readers in interpretation. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not applicable and was not conducted.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance presented for the ARCHITECT HAVAB-M assay is its standalone performance (referred to as "algorithm only" in the context of an IVD) compared to the predicate assay. There isn't a human-in-the-loop component for the interpretation of the ARCHITECT HAVAB-M assay's results; it provides a qualitative "positive" or "negative" result.
6. The type of ground truth used:
- The ground truth is established by the results of the predicate device, the Abbott AxSYM® HAVAB®-M 2.0 assay. This is a common approach for demonstrating substantial equivalence for new IVD assays. While not explicitly stated, the predicate assay itself would have been validated against clinical diagnosis or other accepted methods to determine acute Hepatitis A infection.
7. The sample size for the training set:
- The document does not specify a separate "training set" for the ARCHITECT HAVAB-M assay. For IVDs, the development process typically involves internal validation and optimization using various sample panels during development, but these are rarely presented as distinct "training sets" in 510(k) summaries in the same way an AI/ML device would. The data presented here is for the test set used to demonstrate performance against the predicate.
8. How the ground truth for the training set was established:
- Since a distinct training set and its ground truth establishment are not described, this information is not available from the provided text. For IVD development, samples used for optimization (analogous to a training set) would typically have their status (positive/negative for the analyte) determined by reference methods or clinical diagnosis.
§ 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.