(293 days)
AQT90 FLEX CKMB Test is an in vitro diagnostic assay for the quantitative determination of creatine kinase isoform MB in EDTA or lithium-heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the diagnosis of myocardial infarction.
AQT90 FLEX CKMB CAL cartridge is for in vitro diagnostic use for the calibration of the CKMB Test on the AQT90 FLEX analyzer by establishing points of reference to estimate CKMB values.
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 a breakdown of the acceptance criteria and study information for the AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge, and LQC Multi-CHECK, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate) | Reported Device Performance (AQT90 FLEX CKMB Test - in context of substantial equivalence to predicate) |
|---|---|---|
| Reportable/Calibration Range | 0.8-300 ng/mL (VIDAS CKMB Assay) | 1.5-300 ng/mL (µg/L) |
| Analytical Sensitivity | Limit of Detection is 0.8 ng/mL at the 95% level of confidence (VIDAS CKMB Assay) | Limit of Quantitation 1 ng/mL (µg/L) |
| Reference Range | 99th percentile is 6.8 ng/mL (VIDAS CKMB Assay) | 97.5th percentile for females is 6.9 ng/mL (µg/L), for males 11 ng/mL (µg/L). (Note: This is a direct comparison of reference ranges, not typically an acceptance criterion in the same way as analytical performance, but presented as a characteristic comparison) |
| Imprecision | CV(%) intraassay range is ≤ 6.2%; CV(%) interassay is ≤ 7.2%; CV(%) total is ≤ 16.7% (VIDAS CKMB Assay) | Across the reportable range, CV(%) within-run is ≤ 6.5% for plasma and ≤ 6.0% for whole blood; CV(%) total is ≤ 8.2% for plasma and ≤ 6.0% for whole blood. |
| Interference | No interference with CKBB and CKMM; no interference with hemoglobin, triglycerides and bilirubin (VIDAS CKMB Assay) | No interference with CKBB, CKMM, hemoglobin, triglycerides, bilirubin and other endogenous blood components. No interference with any of 52 drugs and solvents tested. |
| Comparison (Correlation with Predicate) | N/A (The predicate itself showed a comparison with Ciba-Corning Magic Lite CK-MB assay: y = 0.83x - 0.66, r = 0.97 for 175 samples in the range 0.8-300 ng/mL) | Whole blood vs VIDAS: POC Site 1 = 0.93x - 0.2; n = 43; r² = 0.99; POC Site 2 = 0.93x + 0.0; n = 46; r² = 0.98; POC Site 3 = 0.96x - 0.5; n = 48; r² = 0.95. Plasma vs VIDAS: POC Site 1 = 0.94x - 0.3; n = 44; r² = 0.99; POC Site 2 = 0.96x + 0.0; n = 46; r² = 0.99; POC Site 3 = 0.93x - 0.4; n = 48; r² = 0.95. |
Study Proving Acceptance Criteria:
The study proving the device meets its acceptance criteria is a comparison study against a legally marketed predicate device, the VIDAS Creatine Kinase MB (CKMB) Assay (K962549). This is a common approach for 510(k) submissions to demonstrate substantial equivalence.
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Whole blood samples: n = 43 (POC Site 1), n = 46 (POC Site 2), n = 48 (POC Site 3). Total = 137 samples.
- Plasma samples: n = 44 (POC Site 1), n = 46 (POC Site 2), n = 48 (POC Site 3). Total = 138 samples.
- Overall total for the comparison study seems to be around 275 samples.
- The samples used in the comparison study were in the range of 2.1 - 217 ng/mL (µg/L) for plasma and 1.5 - 277 ng/mL (µg/L) for whole blood.
- Data Provenance: Not explicitly stated regarding the country of origin. The study was performed at "POC Sites" (Point of Care Sites), suggesting it was conducted in a clinical or laboratory setting. It is a prospective study in the sense that samples were collected and tested on both the new device and the predicate for comparison.
3. Number of Experts and Qualifications for Ground Truth
This type of diagnostic test (quantitative immunoassay) relies on analytical performance rather than expert interpretation of images or clinical data for its primary ground truth establishment. Therefore, there were no "experts" in the traditional sense (e.g., radiologists) establishing ground truth for the test set. The ground truth for the comparison study is the result obtained from the predicate device (VIDAS Creatine Kinase MB (CKMB) Assay).
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is an analytical comparison with a predicate device, not a human interpretation study requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for imaging devices or devices where human interpretation directly influences the outcome and is being assisted by AI. This submission is for an in vitro diagnostic assay.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, the primary performance data presented is for the standalone algorithm/device performance in comparison to a predicate device. The results (concentration values) are generated directly by the AQT90 FLEX analyzer. There is no "human-in-the-loop" aspect to the CKMB measurement itself, and the study focuses on the analytical agreement between the new device and the predicate.
7. Type of Ground Truth Used
The ground truth used for the comparison study is the results obtained from the predicate device (VIDAS Creatine Kinase MB (CKMB) Assay). For analytical sensitivity and imprecision, the "ground truth" refers to established analytical methods and reference materials, often traceable to international standards (e.g., ERM-AD455/IFCC mentioned for traceability).
8. Sample Size for the Training Set
The provided document does not specify the sample size for a training set. This is typical for a 510(k) submission for a traditional in vitro diagnostic device, which usually involves development, verification, and validation studies but might not explicitly refer to "training sets" in the context of machine learning algorithms. The development of the assay reagents and calibration curve would have involved extensive testing, but not typically referred to as a "training set" as understood in AI/ML.
9. How the Ground Truth for the Training Set Was Established
Since no specific "training set" is mentioned in the context of AI/ML, this question is not directly applicable. For a traditional diagnostic assay, the "ground truth" for developing the assay's performance characteristics (e.g., calibration curve, analytical sensitivity, reference ranges) is established through:
- Reference materials (e.g., ERM-AD455/IFCC mentioned for traceability).
- Known concentrations of analyte in control samples.
- Extensive laboratory testing using established analytical methods to define assay parameters.
- Clinical studies to determine reference ranges in a healthy population.
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.