(28 days)
Elan ALP Reagent is intended for the quantitative determination of alkalinc phosphatasc in serum and plasma for the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
This reagent is intended to be used on a Beckman® SYNCHRON CX ® autoanalyzer in a professional setting or by trained personnel, and is not intended for home use.
Elan ALP Reagent is intended for the quantitative determination of alkaline phosphatasc in serum and plasma nd plant of the same of any the wide with and interlinal diverder Flan ALP Reagent is intended for the qualificantes news.id, and intestinal disorders.
The Elan ALP Reagent determines alkaline phosphatase by catalyzing the hydrolysis of p-nitrohenythosphate to The Elan ALP Reagent determines alkaline phosphalase of catalyzhig in 1970 - 1991 - 1991
p-nitrophenol. The resulting increase in absorbance at approximately 410 nm is propo phosphatase activity in the sample.
The Elan AIJP Reagent is an adaptation of the AACC and IFCC methods, and is intended for use with the Beckman The Elan ALP Reagent is an adaptation of the AACC and ICC negired manipulations To support this Synchron CX-5 Autoanalyzer, or with analyzers willen ear attemate at other of those instruments.
Iatter use, procedure supplication sheets) will be supplied to the users of t
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The Elan ALP Reagent is intended for the quantitative determination of alkaline phosphatase. The reported device performance is compared to the Beckman® SYNCHRON® Systems ALP Reagent.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Linearity Range | Recoveries of alkaline phosphatase show a linearity range from 5 U/L to 1000 U/L. |
| Regression equation: (Elan Recoveries) = 2.788 U/L + 0.990 x (Standard Factors), r² = 1.000, Sys = 1.148, df = 10. (Standard factors ranging from 0 to 1251 U/L) | |
| Precision (within-run SD and total SD) | Low Specimen (37.5 U/L): within-run SD = 1.34, total SD = 1.36 |
| Medium Specimen (251.4 U/L): within-run SD = 1.38, total SD = 3.70 | |
| High Specimen (740.6 U/L): within-run SD = 4.13, total SD = 15.38 | |
| Method Comparison (Patient Samples) | Serum and Plasma Specimens: (Elan Results) = - 0.451 U/L + 0.9986 x (Beckman® Results), r² = 0.9964, S(x) = 3.059. |
| Interference (Anticoagulants) | The addition of anticoagulants (heparin and lithium iodoacetate) resulted in changes of less than 1.5 U/L alkaline phosphatase, and this was statistically insignificant. This indicates acceptable performance in the presence of these additives. |
| Detection Limit | Claimed: 5 U/L |
| Observed: 1.845 U/L (calculated as three standard deviations of a 30 replicate within-run precision study). This is below the claimed limit. | |
| On-board Reagent Stability | 10 days on-board stability. |
| Changes in alkaline phosphatase recoveries over the test periods were less than 3 U/L or 6%. |
Study Details
-
Sample sizes used for the test set and the data provenance:
- Linearity/Precision:
- Precision: 60 replicates for each of the low, medium, and high control specimens.
- Linearity: Not explicitly stated as a separate sample size for a "test set" but implied by the recovery of linearity standards.
- Method Comparison: 80 serum specimens and 78 plasma specimens (total 158 specimens).
- Detection Limit: 30 replicate assays of an alkaline phosphatase standard.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be retrospective as they are described as evaluations of the reagent's performance.
- Linearity/Precision:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a diagnostic reagent for quantitative measurement. The "ground truth" is established by the performance of the predicate device (Beckman® SYNCHRON® Systems ALP Reagent) and established laboratory reference methods/standards. No human experts are directly used to establish "ground truth" for individual cases in this context.
-
Adjudication method for the test set:
- Not applicable. This is a quantitative assay comparison against a predicate device and established analytical performance specifications. No adjudication method involving multiple readers/experts for case interpretation is mentioned or relevant.
-
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 a submission for a diagnostic reagent, not an AI or imaging device that involves human interpretation.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a laboratory reagent. The performance described is inherently "standalone" in the sense that it refers to the reagent's analytical performance on an autoanalyzer, without direct human cognitive interpretation of results as a primary outcome.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Linearity and Precision: Established laboratory standards and commercially available control sera with known concentrations.
- For Method Comparison: The results obtained from the predicate device (Beckman® SYNCHRON® Systems ALP Reagent) on the same specimens.
- For Detection Limit: An alkaline phosphatase standard.
- For Anticoagulant Interference: Spiked and unspiked serum pools.
- For On-board Stability: Serum controls.
-
The sample size for the training set:
- Not applicable for a reagent submission. There is no "training set" in the context of machine learning. The "development" or "optimization" of the reagent would involve calibrants and controls, but these are not referred to as a "training set."
-
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the machine learning sense. The methodological basis for the Elan ALP Reagent is an adaptation of the AACC and IFCC methods, which are widely accepted and standardized chemical assays.
§ 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.