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510(k) Data Aggregation
(27 days)
HiChem ALP/AMP Reagent (product no. 70001) is intended for the quantitative determination of alkaline phosphatase in serum and plasma. The principal diagnostic indications of elevated serum alkaline phosphatase are diseases of the liver, bone, parathyroid and intestine.
The HiChem ALP/AMP Reagent determines alkaline phosphatase by enzymatic hydrolysis of p-nitrophenylphosphate to p-nitrophenoxide at alkaline pH. The HiChem ALP/AMP Reagent is intended to be used either as a manual procedure or on clinical analyzers which can automate the required manipulations. The reagent is supplied as two liquid-stable components which are combined, either before or during use, in the approximate ratio of 1 part ALP/AMP Substrate and 5 parts ALP/AMP Reagent Buffer. The ALP/AMP Substrate can also be used as a start reagent and combined with the Reagent Buffer following sample addition.
Here's a breakdown of the acceptance criteria and study information for the HiChem ALP/AMP Reagent, based on the provided text:
Important Note: The provided document is a 510(k) summary for a diagnostic reagent, not a medical device in the typical sense of AI-powered imaging or diagnostic software. Therefore, many of the requested categories (e.g., number of experts, adjudication methods, MRMC studies, standalone performance for AI, training set details) are not applicable to this type of submission. This document focuses on demonstrating substantial equivalence to existing, legally marketed devices through analytical performance characteristics.
Acceptance Criteria and Reported Device Performance
Device: HiChem ALP/AMP Reagent (product no. 70001)
Intended Use: Quantitative determination of alkaline phosphatase (ALP) in serum and plasma.
| Acceptance Criteria Category | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Manual Procedure | ||
| Linearity (30°C) | Linear to at least 900 U/L | Linear to at least 900 U/L (Recoveries at 30°C) = -1.7 U/L + 1.005 x (Standard Activity), r² = 0.9998, sy.x = 6.5 U/L |
| Linearity (37°C) | Linear to at least 900 U/L | Linear to at least 900 U/L (Recoveries at 37°C) = 2.9 U/L + 0.969 x (Standard Activity), r² = 0.9998, sy.x = 8.0 U/L |
| Precision (37°C) | Replicate assay with acceptable within-run and total SD values (implied by tabulated results) | See table below for detailed precision results at 37°C (n=30 for each control). |
| Comparison to MAS ALP Reagent | Acceptable correlation and agreement (implied by regression statistics) | r² = 0.9986, (HiChem Results) = -0.2 U/L + 1.058 x (MAS Results), sy.x = 5.5 U/L |
| Anticoagulant Interference | Bias < 2% and statistically insignificant at 95% confidence level for heparin and lithium iodoacetate | Bias < 2% and statistically insignificant at 95% confidence level for heparin and lithium iodoacetate |
| Combined Reagent Stability (2-8°C) | Shifts in recovery < 3 U/L or 5% (whichever is greater) over 1 month | Shifts in recovery < 3 U/L or 5% (whichever is greater) over 1 month |
| Combined Reagent Stability (18-25°C) | Shifts in recovery < 3 U/L or 5% (whichever is greater) over 3 days | Shifts in recovery < 3 U/L or 5% (whichever is greater) over 3 days |
| Automated Procedure (Hitachi 704) | ||
| Linearity | Linear to at least 1,200 U/L | Linear to at least 1,200 U/L (Recoveries) = 3.6 U/L + 0.981 x (Standard Activity), r² = 1.000, sy.x = 3.6 U/L |
| Precision | Replicate assay with acceptable within-run and total SD values (implied by tabulated results) | See table below for detailed precision results (n=60 for each control). |
| Comparison to BMD ALP/AMP Reagent | Acceptable correlation and agreement (implied by regression statistics) | r² = 1.000, (HiChem Results) = 1.2 U/L + 1.974 x (BMD Results), sy.x = 1.4 U/L |
| Calibration Stability (24 hours) | Observed shifts in recoveries < 0.25% | Observed shifts in recoveries < 0.25% over 24 hours without calibration |
| On-board Stability (2 weeks) | Largest observed control shift < 2% over 15 days | Largest observed control shift was 2% over 15 days |
Precision Results - Manual Procedure (37°C):
| Specimen | n | mean | within-run SD | total SD |
|---|---|---|---|---|
| Serum control 1 | 30 | 55 U/L | 2.1 U/L | 2.2 U/L |
| Serum control 2 | 30 | 225 U/L | 3.7 U/L | 3.9 U/L |
| Serum control 3 | 30 | 765 U/L | 6.6 U/L | 9.0 U/L |
Precision Results - Automated Procedure:
| Specimen | n | mean | within-run SD | total SD |
|---|---|---|---|---|
| Serum control 1 | 60 | 49 U/L | 0.4 U/L | 0.6 U/L |
| Serum control 2 | 60 | 196 U/L | 0.8 U/L | 1.1 U/L |
| Serum control 3 | 60 | 692 U/L | 2.5 U/L | 3.0 U/L |
Study Details
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Sample size used for the test set and the data provenance:
- Manual Procedure:
- Linearity: Standards ranging from 0 to over 1,350 U/L (number of individual standards not specified, but usually involves multiple levels).
- Precision: 30 replicates for each of 3 control sera.
- Method Comparison (vs. MAS Reagent): 83 mixed serum and plasma specimens.
- Anticoagulant Interference: "spiked serum pools" (specific number not given, but plural implies more than one).
- Stability: Serum controls (ranging from approx. 50 to 750 U/L ALP) tested over 1 month and 3 days.
- Automated Procedure (Hitachi 704):
- Linearity: Ten linearity standards spanning the claimed linear range.
- Precision: 60 replicates for each of 3 commercially available control sera.
- Method Comparison (vs. BMD Reagent): 178 mixed serum and plasma specimens.
- Calibration Stability: Serum controls (ranging from approx. 50 to 750 U/L ALP).
- On-board Stability: Serum controls using the same reagent tested over 15 days.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective analytical performance studies designed to test the reagent's characteristics. The "mixed serum and plasma specimens" for method comparison suggest real-world patient samples.
- Manual Procedure:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is an in-vitro diagnostic reagent. Ground truth is established through the measurement of analyte concentrations using the stated methods and comparisons to established, legally marketed predicate devices, not through expert human interpretation.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are relevant for subjective interpretations (e.g., medical imaging reads), not for quantitative chemical measurements.
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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:
- N/A. This applies to AI-assisted diagnostic tools, not chemical reagents.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This applies to AI algorithms, not chemical reagents. The performance described is the "standalone" performance of the reagent, either manually or on an automated analyzer.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Analytical Measurement (Reference Methods/Predicate Devices): The "ground truth" for the linearity studies were known concentrations of alkaline phosphatase in standards. For method comparison studies, the "ground truth" was established by measurements performed using the legally marketed predicate devices (MAS ALP Reagent and BMD Alkaline Phosphatase/AMP Reagent), which are accepted reference points for determining substantial equivalence.
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The sample size for the training set:
- N/A. This reagent is not an AI algorithm requiring a training set in the conventional sense. The "training" of the reagent would involve its formulation and optimization during development, which is not detailed here.
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How the ground truth for the training set was established:
- N/A. See point 7.
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