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The S-Test Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Amylase Reagent is intended for the quantitative determination of amylase activity in serum or heparin plasma using the S40 Clinical Analyzer. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Aspartate Aminotransferase Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum or heparin plasma using the S40 Clinical Analyzer. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test alkaline phosphatase (ALP) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of ALP activity in serum or heparin plasma based on an enzymatic photometric test using p -nitrophenyl phosphate as a substrate.

The S-Test amylase (AMY) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of amylase activity in serum or heparin plasma based on an enzymatic photometric test using 2-chloro-4-nitrophenyl-alpha-galactopyranosyl maltoside (Gal-G2-CNP) as a substrate.

The S-Test aspartate aminotransferase (AST) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of AST in serum or heparin plasma based on an enzymatic photometric test using L-aspartate and alpha-ketoglutarate as substrates.

Here's a summary of the acceptance criteria and study details for the S-Test ALP, AMY, and AST reagent cartridges, extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the reported performance, which demonstrates substantial equivalence to predicate devices. The study compares the performance of the S-Test reagents on the S40 Clinical Analyzer against comparison methods.

2. Sample Sizes Used for the Test Set and Data Provenance

• S-Test ALP:
  • Accuracy (Correlation Study): 180 samples.
  • Accuracy (Patient Correlation Studies): Not explicitly stated, but conducted at four separate POL sites, implying a collection of patient samples.
• S-Test AMY:
  • Accuracy (Correlation Study): 196 samples.
  • Accuracy (Patient Correlation Studies): Not explicitly stated, but conducted at four separate POL sites.
• S-Test AST:
  • Accuracy (Correlation Study): 177 samples.
  • Accuracy (Patient Correlation Studies): Not explicitly stated, but conducted at four separate POL sites.

Data Provenance: The studies were conducted "in-house" and at "three/four separate Physician Office Laboratories (POL) sites." This suggests a mix of laboratory and real-world clinical settings, likely within the US given the submission to the FDA. The data is presented as if it's from prospective collection for the study, as it involved assaying samples on the new device and a comparison method.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the summary. The study relies on "comparison methods" to establish the reference values for the samples, rather than human expert interpretation of raw data. The performance is assessed by comparing the S-Test results to these established comparison methods.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth is established by "comparison methods" (presumably other validated IVD assays), not by human interpretation requiring adjudication.

5. 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

An MRMC comparative effectiveness study was not performed. This submission is for an in vitro diagnostic (IVD) reagent cartridge for quantitative determination of analytes, not a device requiring human interpretation of images or other qualitative data that would benefit from an MRMC study with human readers (or AI assistance).

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This study is inherently a standalone performance evaluation of the reagent cartridges used with the S40 Clinical Analyzer. The "algorithm" here is the enzymatic photometric test and the analyzer's processing of the photometric data to produce a quantitative result. The performance data presented (precision, accuracy, sensitivity) directly reflects the standalone capabilities of the device without human intervention in the result generation process itself.

7. The type of ground truth used

The ground truth was established by "comparison methods." This refers to existing, legally marketed, and presumably validated IVD assays for ALP, AMY, and AST. The performance of the S-Test reagents was compared directly to the results obtained from these comparison methods on the same samples.

8. The Sample Size for the Training Set

This information is not provided. As these are chemical reagents and an analyzer system, there isn't a "training set" in the sense of machine learning algorithms that learn from data. The reagents and analyzer system are developed and validated through chemical and engineering principles.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no mention of a "training set" in the context of this IVD device. The development and validation of such a system would involve extensive analytical characterization (e.g., linearity, interference, stability) and verification against known standards and reference materials, rather than a data-driven "ground truth" for training.

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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.

Precision Results - Manual Procedure (37°C):

Precision Results - Automated Procedure:

Study Details

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. How the ground truth for the training set was established:

   • N/A. See point 7.

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