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510(k) Data Aggregation
(329 days)
CKF
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.
| Metric | Acceptance Criteria (Implied) | Reported Performance (S-Test ALP) | Reported Performance (S-Test AMY) | Reported Performance (S-Test AST) |
|---|---|---|---|---|
| Precision | Comparable to predicate devices and acceptable for intended use. | In-house (22 days, 3 ALP levels): Within-run CV: 2.2-3.5%; Total CV: 5.4-5.7%. POL sites (5 days, 3 ALP levels): Within-run CV: 1.5-4.4%; Total CV: 1.5-4.9%. | In-house (22 days, 3 AMY levels): Within-run CV: 1.7-2.4%; Total CV: 6.4-8.2%. POL sites (5 days, 3 AMY levels): Within-run CV: 1.0-6.4%; Total CV: 1.0-6.6%. | In-house (22 days, 3 AST levels): Within-run CV: 0.8-2.5%; Total CV: 4.4-4.9%. POL sites (5 days, 3 AST levels): Within-run CV: 0.8-4.8%; Total CV: 0.9-7.0%. |
| Accuracy | High correlation with comparison methods. | Correlation Study (180 samples, 28-733 U/L): Correlation coefficient: 0.997; Standard error estimate: 10.9; CI slope: 0.929-1.009; CI intercept: -4.43-2.02. POL sites (patient correlation): Correlation coefficients: 0.996-0.998; Standard error estimates: 10.4-14.3; CI slopes: 0.963-1.011; CI intercepts: -2.5-15.6. | Correlation Study (196 samples, 9-1461 U/L): Correlation coefficient: 0.997; Standard error estimate: 21.0; CI slope: 0.932-1.005; CI intercept: 0.56-5.81. POL sites (patient correlation): Correlation coefficients: 0.997; Standard error estimates: 35.6-37.0; CI slopes: 0.914-0.960; CI intercepts: -7.4-21.6. | Correlation Study (177 samples, 10-333 U/L): Correlation coefficient: 0.998; Standard error estimate: 4.5; CI slope: 0.986-1.042; CI intercept: -1.75-0.09. POL sites (patient correlation): Correlation coefficients: 0.998; Standard error estimates: 6.3-6.7; CI slopes: 1.041-1.110; CI intercepts: -7.7-4.9. |
| Sensitivity | Detection limits suitable for clinical use. | Detection limit: 20 U/L. | Detection limit: 8 U/L. | Detection limit: 8 U/L. |
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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(27 days)
CKF
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 |
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