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510(k) Data Aggregation
(71 days)
ADVIA Centaur HAV total assay
ADVIA Centaur and ADVIA Centaur XP systems:
The ADVIA Centaur HAV Total (HAVT) assay is an in vitro diagnostic immunoassay for the qualitative deternination of total antibodies to hepatitis A virus (anti-HAV) in human neonatal, pediatric, and adult serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur XP systems. This anti-HAV assay is indicated as an aid in the diagnosis of previous or ongoing hepatitis A viral infection or HAVsusceptible individuals for vaccination.
Assay performance characteristics have not been established for immunosompromised or immunosuppressed patients.
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.
ADVIA Centaur CP system:
The ADVIA Centaur HAV Total (HAVT) assay is an in vitro diagnostic immunoassay for the qualitative deternination of total antibodies to hepatitis A virus (anti-HAV) in human neonatal, pediatric, and adult serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur CP system. This anti-HAV assay is indicated as an aid in the diagnosis of previous or ongoing hepatitis A viral infection of HAV-susceptible individuals for vaccination.
Assay performance characteristics have not been established for immunosuppressed patients.
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 ADVIA Centaur HAVT reagent kit contains the following:
- ReadyPack primary reagent pack containing ADVIA Centaur HAVT Lite Reagent, Solid Phase Reagent, and Antigen Reagent
- ReadyPack ancillary pack containing ADVIA Centaur HAVT Ancillary Reagent
- ADVIA Centaur HAVT Low Calibrator
- ADVIA Centaur HAVT High Calibrator
- ADVIA Centaur systems HAVT Master Curve card
- ADVIA Centaur systems HAVT Calibrator Assigned Value Card
The HAVT ReadyPack consists of the following:
Primary reagent pack
- The Lite Reagent is an anti-human HAV monoclonal antibody (~1.0 ug/mL) labeled with acridinium ester and biotinylated monoclonal mouse anti-HAV Fab fragment (~0.08 µg/mL) in phosphate buffer with bovine serum albumin, sodium azide (
This document describes the request to add neonate and pediatric populations to the intended use statement of the ADVIA® Centaur HAV Total Assay. The submission focuses on demonstrating that the assay's performance remains acceptable for these new populations without requiring a full re-evaluation of all analytical performance characteristics.
Here's the breakdown of the acceptance criteria and study information provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it presents study results and implies that "substantially equivalent in principle and performance" to the predicate device (VITROS Immunodiagnostic Products Anti-HAV Total Reagent Pack) for these new populations is the underlying acceptance criterion. The performance data focuses on demonstrating comparable results between adult, neonate, and pediatric samples, and concordance with an existing cleared assay.
Here's a table summarizing the reported device performance for the introduced data:
| Study/Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Spike/Recovery - Neonatal Cord Blood vs. Adult Serum | Bias distribution demonstrating acceptable similarity. | Negative (0.6 Index): 0.0% ≤ 10% bias, 33.3% > 10% to ≤ 20%, 33.3% > 20% to ≤ 30%, 33.3% > 30% |
| Cut-off (1.0 Index): 16.7% ≤ 10% bias, 33.3% > 10% to ≤ 20%, 50.0% > 20% to ≤ 30%, 0.0% > 30% | ||
| Low Pos. (1.7 Index): 83.3% ≤ 10% bias, 16.7% > 10% to ≤ 20%, 0.0% > 20% to ≤ 30%, 0.0% > 30% | ||
| High Pos. (5.8 Index): 83.3% ≤ 10% bias, 16.7% > 10% to ≤ 20%, 0.0% > 20% to ≤ 30%, 0.0% > 30% | ||
| Total: 53.33% ≤ 10% bias, 23.33% > 10% to ≤ 20%, 16.67% > 20% to ≤ 30%, 6.67% > 30% | ||
| Spike/Recovery - Pediatric vs. Adult Serum | Bias distribution demonstrating acceptable similarity. | Negative (0.6 Index): 0.0% ≤ 10% bias, 0.0% > 10% to ≤ 20%, 0.0% > 20% to ≤ 30%, 100.0% > 30% |
| Cut-off (1.0 Index): 66.7% ≤ 10% bias, 16.7% > 10% to ≤ 20%, 16.7% > 20% to ≤ 30%, 0.0% > 30% | ||
| Low Pos. (1.7 Index): 50.0% ≤ 10% bias, 41.7% > 10% to ≤ 20%, 0.0% > 20% to ≤ 30%, 8.3% > 30% | ||
| High Pos. (5.8 Index): 83.3% ≤ 10% bias, 16.7% > 10% to ≤ 20%, 0.0% > 20% to ≤ 30%, 0.0% > 30% | ||
| Total: 50% ≤ 10% bias, 23.33% > 10% to ≤ 20%, 3.33% > 20% to ≤ 30%, 23.33% > 30% | ||
| Concordance Study - Pediatric Samples | High positive and negative agreement with comparative assay. | % Positive Agreement: 84.62% (11/13*) |
| 95% Confidence Interval: 54.55 to 98.08% | ||
| % Negative Agreement: 97.62% (41/42) | ||
| 95% Confidence Interval: 87.43 to 99.94% | ||
| *Note: The 2 borderline results from the comparative assay are scored as discordant results in the %Positive Agreement calculation. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Spike/Recovery studies (Neonatal and Pediatric):
- Test Set Sample Size: 30 neonatal cord blood samples and 30 pediatric serum samples. In both studies, these were compared against 30 adult serum samples.
- Data Provenance: Not specified (e.g., country of origin). The data appears to be prospective in nature, as samples were "spiked with anti-HAV positive stock to yield samples at different analyte levels."
- Concordance Study (Pediatric):
- Test Set Sample Size: 55 pediatric serum samples (male and female, age range from 2 to 21 years), including samples from a high-risk population.
- Data Provenance: Not specified (e.g., country of origin). The study "evaluated...samples with the ADVIA Centaur HAVT assay and another commercially available assay," suggesting a retrospective evaluation of collected samples.
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 studies described in the document do not rely on expert-established ground truth in the traditional sense.
- For the spike/recovery studies, the "ground truth" is based on the known spiking concentrations of anti-HAV antibodies and comparison to adult serum samples.
- For the concordance study, the "ground truth" is established by a "commercially available assay" which serves as the comparator. No information is provided about experts involved in establishing the results of this comparative assay.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The studies are based on quantitative (spike/recovery) or comparative (concordance with another assay) measurements, rather than subjective expert interpretations requiring 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 is an in-vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic device that involves human readers interpreting cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented represent the standalone performance of the ADVIA Centaur HAV Total Assay. It's an automated immunoassay, and its output is a direct measurement (index value) or a qualitative result (Reactive/Nonreactive). There is no human interpretation integrated into the assay's performance evaluation as described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Spike/Recovery studies: The ground truth is effectively the known concentration of spiked analyte and the comparison against a referencable population (adult serum).
- Concordance study: The ground truth is established by a comparative commercially available assay.
8. The sample size for the training set
The document does not detail specific "training set" information for the submitted studies. The original ADVIA Centaur HAVT assay was approved under PMA P040017, and the current submission is an amendment. The original PMA would have involved extensive studies using a large number of samples for assay development, optimization, and establishment of performance characteristics (which could be considered analogous to a training phase in machine learning, though it's not explicitly called that here). The current submission leverages that prior approval and focuses on bridging data for new populations.
9. How the ground truth for the training set was established
As above, explicit "training set" and its ground truth establishment are not detailed in this specific document. For an IVD assay like this, the "ground truth" for the original PMA approval would typically involve:
- Reference materials: Use of well-characterized positive and negative samples, often with known HAV infection status confirmed by other methods (e.g., PCR for viral load, clinical diagnosis, seroconversion panels).
- Clinical correlation: Samples from patients with confirmed HAV infections (acute, past) and uninfected individuals.
- Comparison to established gold standards: Benchmarking against widely recognized and validated assays.
The goal is to ensure the assay accurately detects the presence or absence of anti-HAV antibodies.
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