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HemosIL Homocysteine is an automated latex enhanced immunoassay for the quantitative determination of total L-homocysteine in human citrated plasma on IL Coagulation Systems. Homocysteine (Hcy) values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia or homocystinuria.

HemosIL Homocysteine Controls are assayed quality controls intended to monitor the accuracy and precision of HemosIL Homocysteine on IL Coagulation Systems.

For in vitro diagnostic use.

Device Description

HemosIL Homocysteine Controls are assayed quality controls intended to monitor the accuracy and precision of HemosIL Homocysteine on IL Coagulation Systems.

Hey levels in patient plasma are measured automatically on IL Coagulation Systems in three stages:

Reduction of mixed disulfides and protein-bound forms of Hcy present in the plasma samples to free Hcy.
Enzymatic conversion of free Hcy to S-adenosyl-L-homocysteine (SAH) by the SAH hydrolase (SAHH) in the presence of an excess of adenosine.
Competitive agglutination reaction between anti-SAH and SAH / conjugate.

The degree of agglutination is inversely proportional to the concentration of total Hev in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the HemosIL Homocysteine and HemosIL Homocysteine Controls, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric (Implicit)	Acceptance Criteria (Implicit)	Reported Device Performance
Method Comparison	Correlation with predicate device (Abbott IMx Homocysteine)	Strong correlation (e.g., r > 0.95 or similar range)	ACL Advance: Slope: 0.8292, Intercept: 0.3503, r: 0.9915 (for 76 paired samples with Hcy levels 4.2 to 56.7 umol/L)
Precision	Within-run Coefficient of Variation (CV%)	Low CV% (typically < 10% for clinical assays, often < 5% for high precision)	ACL TOP: Hcy Control Level 1: 2.0%, Hcy Control Level 2: 1.5%, Hcy Plasma Sample: 2.9% ACL ELITE/ELITE PRO/8/9/10000: Hcy Control Level 1: 2.3%, Hcy Control Level 2: 4.3%, Hcy Plasma Sample: 2.6% ACL Futura/ACL Advance: Hcy Control Level 1: 3.5%, Hcy Control Level 2: 2.6%, Hcy Plasma Sample: 3.5%
Precision	Total Coefficient of Variation (CV%)	Low CV% (typically < 10% for clinical assays, often < 5% for high precision)	ACL TOP: Hcy Control Level 1: 4.8%, Hcy Control Level 2: 3.5%, Hcy Plasma Sample: 5.5% ACL ELITE/ELITE PRO/8/9/10000: Hcy Control Level 1: 5.1%, Hcy Control Level 2: 6.2%, Hcy Plasma Sample: 5.9% ACL Futura/ACL Advance: Hcy Control Level 1: 6.0%, Hcy Control Level 2: 3.5%, Hcy Plasma Sample: 5.6%
Substantial Equivalence	Equivalence in performance and intended use to predicate device	Demonstrated (via method comparison and precision data)	Stated: "HemosIL Homocysteine is substantially equivalent to the commercially available predicate device (Abbott IMx Homocysteine) in performance and intended use."

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

Sample Size for Test Set (Method Comparison): 76 paired sodium citrate and EDTA patient plasma samples.
Data Provenance: Not explicitly stated regarding country of origin. The samples are patient plasma samples, implying a clinical setting. It is a retrospective study as it's a "method comparison study evaluating 76 paired... samples," suggesting pre-collected samples.

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

This information is not provided in the document. For in vitro diagnostic assays like this, the "ground truth" is typically the result from a recognized reference method or a legally marketed predicate device, rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the study describes a quantitative laboratory assay comparison, not a diagnostic imaging or subjective interpretation task requiring adjudication. The comparison is directly between numerical results from two different assay methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic interpretation tasks (e.g., radiology reads) where different readers evaluate cases. The HemosIL Homocysteine assay is an automated, quantitative lab test, not subject to individual "reader" variability in the same way.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this entire study represents standalone performance. The HemosIL Homocysteine is an automated device designed to quantify homocysteine levels directly. The performance metrics (method comparison and precision) are inherent to the device's ability to produce accurate and precise measurements autonomously. There is no human-in-the-loop component for the measurement itself.

7. The Type of Ground Truth Used

The "ground truth" for the method comparison study was the results obtained from the predicate device, Abbott IMx Homocysteine. This is a common approach for demonstrating substantial equivalence for new IVD devices. The precision studies use defined control levels and patient plasma samples, with the mean values serving as a reference for assessing reproducibility.

8. The Sample Size for the Training Set

This information is not applicable/provided. The HemosIL Homocysteine is an immunoassay, not a machine learning or AI-driven device in the sense that it requires a "training set" to learn. Its performance is based on the chemical and enzymatic reactions described.

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

This information is not applicable as there is no "training set" in the context of this immunoassay device.

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