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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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Intended for the in vitro quantitative determination of total Homocysteine in serum and plasma to assist in the diagnosis and treatment of patients suspected in having homocystinuria and hyperhomocysteinemia.

The Liquid Stable (LS) 2-Part Homocysteine Reagent will consist of two (2) reagents plus calibrators. The first reagent (LS-R1) will include Lactic Acid Dehydrogenase (LDH), Serine, and ß-Nicotinamide Adenine Di-Nucleotide reduced Di-Sodium Salt (NADH) with buffers and stabilizers. The fill volume will be 30 to 50 mL, depending on the kit configuration. The second reagent (LS-R2) will include Cystathionine B-Synthase (CBS) and Cystathionine B-Lyase (CBL) enzymes with buffers and stabilizers. The fill volume will be 7 mL for all kit configurations. The calibrators will include two (2) bottles; Calibrator "A" will be 0 µmoles/L and Calibrator "D" will be 25-30 umoles/L. The fill volume for the calibrators will be 3 mL.

This document is a 510(k) Special Premarket Notification for the Liquid Stable (LS) 2-Part Homocysteine Reagent. It details the device's characteristics and compares it to a legally marketed predicate device to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device, K011689 Homocysteine Enzymic Homocysteine Reagent. The new device is considered to meet acceptance criteria if its performance is "Same" or comparable to the predicate device, especially for the "Correlation coefficient" and "Precision".

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It refers to performance data obtained when compared to other reagents, but the details of the samples used for these comparisons are not provided.

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 document. The study focuses on comparing the new reagent's analytical performance against a predicate device, not on diagnostic interpretations requiring expert ground truth in the typical clinical sense.

4. Adjudication method for the test set

This information is not applicable and therefore not provided, as the study is an analytical performance comparison of a diagnostic reagent, not a clinical study involving human readers or interpretations.

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 done. This document describes an analytical performance evaluation of an in vitro diagnostic reagent, not an AI-assisted diagnostic tool involving human readers.

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

This concept is not directly applicable to the described device. The device is a chemical reagent, not an algorithm. The "standalone" performance is effectively the reported correlation coefficient and precision data, which are laboratory measurements of the reagent's analytical accuracy and reproducibility.

7. The type of ground truth used

The "ground truth" for this type of analytical validation is implicitly the performance of the established comparison methods:

• The "current Homocysteine Enzymic Homocysteine Reagent" for the correlation study.
• The Abbott FPIA assay (for the predicate device's correlation, which the new device aims to match or exceed).
  The measurements obtained from these established methods are considered the reference or "ground truth" against which the new reagent's performance is assessed.

8. The sample size for the training set

This information is not applicable. The device is a chemical reagent, which does not involve a "training set" in the context of machine learning or AI algorithms.

9. How the ground truth for the training set was established

This information is not applicable, as there is no "training set" for this type of device.

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