(177 days)
AQT90 FLEX analyzer is for in vitro diagnostic use. The instrument is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings.
AQT90 FLEX Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin in EDTA or lithium-heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is indicated for use as an aid in the rapid diagnosis of heart disease, e.g. acute myocardial infarction.
AOT90 FLEX Myo CAL cartridge is for in vitro diagnostic use. For calibration adjustment of the Myo Test, as indicated on the cartridge, on the AQT90 FLEX analyzer.
AQT90 FLEX LQC Multi-CHECK, Levels 1-3, is for in vitro diagnostic use. For use with the AQT90 FLEX analyzer as a liquid quality control serum (LQC) to monitor the precision of laboratory testing procedures for the analytes listed on the specification insert.
The AOT90 FLEX is a cartridge-based immunoassay, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are 300 µL test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting; this measurement cycle is repeated up to 3,300 times. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample.
This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups - no liquids other than the sample itself together with the assay buffer are required. Total assay time is less than 20 minutes.
Here's an analysis of the provided text regarding the AQT90 FLEX Myo Test, Myo CAL cartridge, and LQC Multi-CHECK, detailing the acceptance criteria and study information:
Acceptance Criteria and Device Performance
The provided document describes the AQT90 FLEX Myo Test being compared to a predicate device, the ARCHITECT STAT Myoglobin. The acceptance criteria are implicitly based on demonstrating substantial equivalence to the predicate device, particularly in terms of analytical performance.
A key performance metric presented is the correlation between the new device and the predicate device for Myoglobin measurements.
Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (AQT90 FLEX Myo Test) |
|---|---|---|
| Correlation with Predicate Device (Myoglobin) | High correlation (e.g., r² approaching 1.0) with the ARCHITECT STAT Myoglobin assay. | Whole Blood: y = 1.07 x ARCHITECT + 15, r² = 0.99 |
| Plasma: y = 1.02 x ARCHITECT + 13, r² = 0.99 | ||
| Reportable Range | Comparable to predicate device (ARCHITECT STAT Myoglobin: 0.0-1,200.0 ng/mL) | 20-900 ng/mL (µg/L) |
| Analytical Sensitivity | Comparable to predicate device (ARCHITECT STAT Myoglobin: ≤ 1.0 ng/mL at 95% CI) | Limit of quantitation 1 ng/mL (µg/L) |
| Imprecision (CV%) | Comparable to predicate device (ARCHITECT STAT Myoglobin: ≤ 10% for concentrations ≥ 40 ng/mL, 3.2-5.4% for controls) | Plasma: Within-run CV ≤ 2.5%, Total CV ≤ 5.2% |
| Whole Blood: Within-run CV ≤ 3.7%, Total CV ≤ 3.7% | ||
| Interference | No significant interferences (same as predicate) | No significant interferences |
Study Details
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Sample sizes used for the test set and the data provenance:
- Whole Blood Samples: 157 samples
- Plasma Samples: 165 samples
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective, using existing samples to compare performance against a predicate device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This study is a comparative method study for an in vitro diagnostic device, comparing its quantitative measurements against a previously cleared predicate device. "Ground truth" in this context is the quantitative measurement provided by the predicate device, not expert interpretation of images or clinical outcomes.
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Adjudication method for the test set:
- Not Applicable. As mentioned above, this is a quantitative comparison, not a study requiring adjudication of expert interpretations.
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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 document describes an in vitro diagnostic device for quantitative measurement of myoglobin, not an AI-assisted diagnostic imaging device that involves human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes. The study presents the performance of the AQT90 FLEX Myo assay (the algorithm/device only) in measuring myoglobin concentrations and comparing these measurements directly to those obtained from the predicate device. There is no human-in-the-loop component in the measurement process itself.
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The type of ground truth used:
- The "ground truth" for comparison was the measurements obtained from the predicate device: ARCHITECT STAT Myoglobin assay. This is considered a "reference standard" or "comparator method" for demonstrating substantial equivalence.
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The sample size for the training set:
- Not explicitly stated in the provided text. The document describes a "comparison" study. For quantitative IVD devices, a "training set" in the machine learning sense is not typically discussed in 510(k) summaries as the device calibration and analytical method development process usually involves proprietary internal development and validation, separate from the clinical performance comparison against a predicate.
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How the ground truth for the training set was established:
- Not explicitly stated. As noted above, typical IVD development involves extensive analytical validation. The "ground truth" for establishing the device's accuracy and precision during its development (analogous to a training phase) would involve reference materials, spiked samples, and potentially calibrators whose concentrations are established using highly accurate reference methods or certified reference materials. The provided document focuses on the comparison to the predicate device for regulatory submission.
§ 862.2560 Fluorometer for clinical use.
(a)
Identification. A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes. Fluorescence is the property of certain substances of radiating, when illuminated, a light of a different wavelength. This device is used in conjunction with certain materials to measure a variety of analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.