(64 days)
This reagent is intended for the in vitro quantitative determination of Alkaline Phosphatase in human serum and plasma. Measurements of Alkaline Phosphatase or its isoenzymes are used as in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases.
TRACE Scientifics' alkaline phosphatase reagents are intended for the in vitro quantitative determination of alkaline phosphatase in human serum and plasma. The TRACE ALP - AMP (IFCC) method is based on the recommendations of the International Federation of Clinical Chemistry (IFCC). This method utilizes 4-nitrophenylphosphate (4-NPP) as the substrate. Under the optimized conditions ALP present in the sample catalyses the following transphosphorylation reaction. At the pH of the reaction 4-NPP has an intense yellow color. The reagent also contains a metal ion buffer system to ensure that optimal concentrations of metal ions are maintained. The metal ion buffer can also chelate other potentially inhibitory ions, which may be present. The reaction is monitored by measuring the increase in absorbance at 405 nm, which is proportional to the activity of ALP in the serum.
This document describes the acceptance criteria and the study conducted to demonstrate that the TRACE Scientific Alkaline Phosphatase, Two-Part Liquid Assay meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Method Comparison | Strong correlation with predicate device (Roche Diagnostics Alkaline Phosphatase). | Correlation Coefficient: 0.9997 |
| Slope: 1.03 | ||
| Intercept: -0.33 | ||
| Mean (TRACE Scientific): 105 U/L | ||
| Mean (Roche): 100 U/L | ||
| Precision (Within Run) | Low variability (CV%) | Level 1: CV 0.9% |
| Level 2: CV 0.6% | ||
| Precision (Total) | Low variability (CV%) | Level 1: CV 3.5% |
| Level 2: CV 2.9% | ||
| Sensitivity | Adequate detection capability | 0.4 AmAbs/min per U/L |
| Reportable Range | Linear performance across clinically relevant range | Linear up to 2000 U/L |
| Specificity (Interference) | Minimal interference from common substances | Bilirubin (conjugated): No interference up to 16.3 mg/dL |
| Bilirubin (unconjugated): No interference up to 17.1 mg/dL | ||
| Hemoglobin: No interference up to 790 mg/dL | ||
| Lipemia: No interference up to 2000 mg/dL (measured as triglycerides, bichromatically) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Method Comparison): 60 sample pairs.
- Sample Size (Precision): 40 data points per level for both "Within Run" and "Total" precision.
- Data Provenance: Not explicitly stated, but implies human serum and plasma samples based on the intended use. The study was carried out by Thermo DMA, Inc., which is based in Arlington, TX, USA. It is a retrospective study since it involved already collected serum/plasma samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This device is an in vitro diagnostic (IVD) assay for quantitative determination of a chemical marker (Alkaline Phosphatase) in biological samples, not an imaging or diagnostic AI requiring expert human interpretation for ground truth. The predicate device (Roche Diagnostics Alkaline Phosphatase) serves as the reference for comparative analysis.
4. Adjudication Method for the Test Set
- Not applicable. The study involves direct quantitative comparison of measurements between the TRACE Scientific device and a predicate device, not qualitative assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging AI where human readers interpret cases. This document describes an in vitro diagnostic assay.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, this document primarily describes standalone performance of the TRACE Scientific Alkaline Phosphatase assay. The method comparison was done by directly comparing results from the TRACE Scientific device with those from the Roche Diagnostics Alkaline Phosphatase assay on an automated clinical chemistry analyzer (Hitachi 911), without human intervention in result generation for the comparison. The other studies (precision, sensitivity, linearity, specificity) also describe the standalone performance of the assay.
7. The Type of Ground Truth Used
- For the method comparison study, the "ground truth" was established by the predicate device measurement (Roche Diagnostics Alkaline Phosphatase assay), considered a legally marketed and accepted method for Alkaline Phosphatase determination.
- For other performance characteristics like linearity and specificity, the "ground truth" was established through controlled experiments using known concentrations of analytes or interfering substances.
8. The Sample Size for the Training Set
- Not applicable. This is an in vitro diagnostic assay based on a chemical reaction methodology (IFCC method), not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this type of device.
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.