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The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

The Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Test System includes two reagents and two calibrators.

The first reagent (Reag 1) includes Lactate dehydrogenase (LDH), Serine, nicotinamide adenine dinucleotide reduced di-sodium salt (NADH), tris [2-carboxyethyl] phosphine (TCEP) reductant, with buffers and stabilizers (Trizma Base and Trizma Hydrochloride), and preservative (Sodium Azide).

The second reagent (Reag2) includes Cystathionine beta-Synthase (CBS) and Cystathionine beta-Lvase (CBL) cvcling enzymes with preservative (sodium azide).

The Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent kit will also include two calibrators; Calibrator "0" (0 µmol/L) and Calibrator "28" (28 µmol/L).

Here's a breakdown of the acceptance criteria and the study details for the Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

• Intercept: 0.3165 (95% Confidence interval 0.031 to 0.290)
• r-value: 1.00 (95% Confidence interval 1.00 to 1.00)
• Average Percent Bias: 0.01% (95% Confidence interval -0.10 to 0.07%) |

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 94 plasma specimens.
   • Data Provenance: Not explicitly stated, but the submission is from Axis-Shield Diagnostics, Ltd. in the UK, suggesting potential European origin. It is a retrospective comparison study against an existing, legally marketed device.

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

   • This is a quantitative diagnostic assay. The "ground truth" for the test set is established by the predicate device (CATCH Incorporated Liquid Stable (LS) 2-Part Homocysteine Reagent assay) measurements rather than expert consensus on images or clinical diagnoses. Therefore, expert involvement for ground truth establishment as in image interpretation studies is not applicable here.

3. Adjudication Method for the Test Set:

   • Not applicable. The comparison is between two quantitative assays, not subjective interpretations requiring adjudication.

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:

   • No. This is a study comparing the performance of a new quantitative laboratory assay against a predicate assay, not an AI-assisted diagnostic tool for human readers.

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

   • Yes, this is a standalone performance study. The Axis-Shield device is a reagent system for automated laboratory analysis, and its performance is evaluated directly without human interpretation in the loop impacting the result.

6. The Type of Ground Truth Used:

   • The "ground truth" in this context is the quantitative results obtained from the legally marketed predicate device, the CATCH Incorporated Liquid Stable (LS) 2-Part Homocysteine Reagent assay. The study aims to demonstrate that the new device produces results that are substantially equivalent to this established method.

7. The Sample Size for the Training Set:

   • Not applicable. This device is a biochemical reagent system, not a machine learning model that requires a dedicated "training set" in the computational sense. The "development" and "optimization" of the reagent would involve internal testing and validation, but not a formally segregated "training set" like in AI/ML contexts.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no "training set" in the conventional AI/ML sense for this type of device.

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