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The Randox Ammonia Ethanol Control Levels 1, 2 & 3 are intended for in vitro diagnostic use in the quality control of Ammonia and Alcohol Assays to monitor precision and to detect systematic analytical deviations on clinical chemistry systems. This device is for prescription use only.

The Randox Ammonia Ethanol Controls are liquid and supplied at levels 1, 2 and level 3. The base matrix used for the manufacture of Randox Ammonia Ethanol Controls Levels 1, 2 & 3 is saturated benzoic acid with added chemicals. Each level of control is supplied in liquid form in 6 x 2ml vials and is ready for use. Only the required amount of product should be removed from the vial. After use, any residual product should not be returned to the original vial.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

Device Type: Randox Ammonia Ethanol Control Levels 1, 2 & 3 (Multi-analyte Controls, Assayed)

Study Focus: Open Vial Stability and Real-Time Shelf-Life Stability

• Level 1: 0.7%
• Level 2: -0.9%
• Level 3: -2.0%
  Ethanol (RX Daytona):
• Level 1: 4.7%
• Level 2: 1.2%
• Level 3: 1.3% | Not explicitly given for individual analytes at specific time points, but states "Current Real Time studies support an 18 month shelf life." |
  | Real Time Shelf-Life (Percentage Deviation to routine temp. controls) | ≤ 5% | N/A (Applies to comparison against routine temp. controls, not open vial test) | "Current Real Time studies support an 18 month shelf life." |
  | Value Assignment Precision (CV) | ≤ 10% for Control Level 1
  ≤ 7.5% for Control Levels 2 and 3 | Not explicitly stated in the results section, only the criteria. | N/A |
  | Value Assignment Recovery Error (Master Lot) | ≤ 7.5% for all control levels | Not explicitly stated in the results section, only the criteria. | N/A |

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

• Sample Size: The text does not explicitly state the number of vials or how many test runs were conducted for the open vial stability study. It mentions testing "a set of Randox Ammonia Ethanol Control levels 1, 2 & 3." For real-time testing, it mentions "the controls were then tested." The exact number of replicates or distinct samples per time point is not provided.
• Data Provenance: The study was conducted by Randox Laboratories Limited, located in Crumlin, County Antrim, BT29 4QY, United Kingdom. The data is prospective as it involves testing materials over time under specific conditions to assess stability.

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

This information is not applicable to this device and study. The "device" is a quality control material, not a diagnostic tool that provides a result that requires human interpretation or expert ground truth. The "ground truth" in this context is the measured concentration of Ammonia and Ethanol by the specified analytical instruments (ADVIA 1650 for Ammonia and RX Daytona for Ethanol) and comparison to a fresh control or a defined target value.

4. Adjudication Method for the Test Set

This information is not applicable as the study does not involve subjective human interpretation that would require adjudication. The results are quantitative measurements from analytical instruments.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where reader performance is a key metric. This submission is for a quality control material where the performance is assessed through analytical precision and stability.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone study was done. The device itself is a control material, and its performance (stability, value assignment) is evaluated independently using established laboratory methods and instruments (ADVIA 1650 and RX Daytona). There is no "human-in-the-loop" interaction for the functioning or assessment of the control material itself in these studies.

7. The Type of Ground Truth Used

The ground truth used for this study is based on:

• Analytical Measurement: The measured concentrations of ammonia and ethanol obtained from established and calibrated clinical chemistry systems (ADVIA 1650 for Ammonia, RX Daytona for Ethanol).
• Comparison to Fresh Material: For open vial stability, the "fresh result" serves as the reference point (ground truth) for calculating percentage difference.
• Comparison to Routine Temperature Controls: For real-time testing, the "control material stored unopened at the routine storage temperature of +2 to +8°C" serves as the reference.
• Master Lot Concept: For value assignment, a "master lot" is used as a reference to assign values to new lots.

Essentially, the ground truth is derived from objective analytical measurements and comparisons to reference materials/conditions rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable/Not provided. The concept of a "training set" is generally associated with machine learning or artificial intelligence models. This submission is for a quality control material, which does not involve such a training process.

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

Not applicable. As the device is a quality control material and not an AI/ML diagnostic model, there is no "training set" or "ground truth for the training set" in the context typically described for such technologies.

Ask a specific question about this device

The Randox Laboratories Limited Ammonia Test Kit is an in vitro diagnostic assay for the quantitative determination of ammonia in plasma. During the assay ammonia combines with α-ketoglutarate and NADPH in the presence of qlutamate dehydrogenase (GLDH) to vield glutamate and NADP*. The corresponding decrease in absorbance at 340mm is proportional to the concentration of ammonia in the plasma. Ammonia measurememts are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis and Reye's Syndrome. This application sheet has been developed for the Advia 1650 analyser and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

The Randox Laboratories Limited Ammonia Test Kit is an in vitro diagnostic assay for the quantitative determination of ammonia in plasma. During the assay ammonia combines with α-ketoglutarate and NADPH in the presence of qlutamate dehydrogenase (GLDH) to vield glutamate and NADP*. The corresponding decrease in absorbance at 340mm is proportional to the concentration of ammonia in the plasma.

I am sorry, but the provided text from the FDA 510(k) approval letter for the "Randox Ammonia" device does not contain the detailed information required to answer your request about acceptance criteria and the study proving the device meets them.

The document is primarily focused on the FDA's determination of substantial equivalence to a predicate device, which allows the "Randox Ammonia" kit to be marketed. It states the indications for use and mentions the assay's mechanism but does not include:

• A table of acceptance criteria or reported device performance metrics.
• Details about sample sizes for test or training sets, data provenance, or expert qualifications.
• Information on ground truth establishment, adjudication methods, or MRMC studies.

Therefore, I cannot extract the specific information you requested from this document.

Ask a specific question about this device