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Randox Benzodiazepine Calibrator Set: The Randox Benzodiazepine Calibrator set consists of liquid calibrators containing Oxazepam. There are 5 levels of calibrator. They have been developed for use in the calibration of the RX series analysers in human urine, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.

Randox Benzodiazepine Controls Level 1 & 2: The Randox Benzodiazepine Controls are liquid controls containing Oxazepam. There are 2 levels of controls. They have been developed for use in the quality control and validation of Benzodiazepine assay on the RX series analysers in human urine, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.

The Benzodiazepine Calibrator Set contains 5 levels of calibrator containing the specific drug Oxazepam. The Calibrators are spiked at 4 different levels which assess below, at and above the cutoff of 200 ng/ml.

The Benzodiazepine Controls are manufactured at two levels, one below the cutoff and one above the cutoff of 200 ng/ml.

The base matrix used for the manufacture of Randox Benzodiazepine Calibrators and Controls is Drug Free Human Urine.

The Benzodiazepine Calibrators and Controls contain the specific drug Oxazepam. The Oxazepam is supplied by Cerilliant Corporation the accuracy of which is ensured by purity determinations (GC/FID, HPLC and NMR) and gravimetric preparation using balances calibrated with NIST traceable weights.

Randox Benzodiazepine Calibrators and Controls have been designed for in vitro diagnostic use only. They should not be pipetted by mouth and the normal precautions for handling laboratory reagents should be applied. Randox Benzodiazepine Calibrators and Controls contain sodium azide at 0.05%.

The provided document describes the Randox Benzodiazepine Calibrator Set and Randox Benzodiazepine Controls Level 1 and 2. This device is a set of calibrators and controls used for the calibration and quality control of Benzodiazepine assays on Randox RX series analyzers in human urine.

Here's an analysis of the acceptance criteria and study data provided:

1. A table of acceptance criteria and the reported device performance

The document details two types of stability studies, each with specific acceptance criteria and reported performance:

• Day 7: Pass
• Day 21: Pass
• Day 28: Pass
  Controls (Batches 250-251DA, 51110, 61110):
• Day 7: Pass
• Day 21: Pass
• Day 28: Pass
  Conclusion: The Benzodiazepine Calibrators and Controls for three batches are stable for 28 days when opened, recapped and stored at +2°C to +8ºC. |
  | Real-Time Shelf Life (Unopened) | Calibrators: Calibration absorbance achieved at each time point should be 100% ±10% when compared to the fresh assessment.
  Controls: (1) For Control 1, the concentration should be less than the cutoff of 200 ng/ml. (2) For Control 2, the concentration should be greater than the cutoff of 200 ng/ml. | Calibrators (Batch 023-027DA):
• 1 Month: Pass
• 3 Months: Pass
• 6 Months: Pass
• 9 Months: Pass
• 12 Months: Pass
  Conclusion: The Benzodiazepine calibrators were stable for 12 months at +2℃ to +8℃ when stored unopened.
  Controls (Batches 482DA, 483DA):
• 3 Months: Pass
• 4 Months: Pass
• 6 Months: Pass
• 9 Months: Pass
• 12 Months: Pass
  Conclusion: The Benzodiazepine Controls are stable for at least 12 months at +2ºC to +8ºC when stored unopened. |
  | Accelerated Shelf Life (Unopened) | Storage at +37℃ for 5 days is equivalent to 12 months shelf life. (Implicit acceptance criteria: device remains stable at the specified time points under accelerated conditions, indicating stability for the claimed shelf life). | Calibrators (Batch 023-027DA):
• 1 Day: Pass
• 3 Days: Pass
• 5 Days: Pass
• 7 Days: Pass
• 10 Days: Pass
• 12 Days: Pass
  Conclusion: The Benzodiazepine calibrators are stable for at least 12 months at +2ºC to +8ºC when stored unopened. |
  | Value Assignment (Nest Testing) | Precision measured by the CV should be less than or equal to 15%.
  Recovery error of the master lot should be ± 10% for all calibrator and control levels. | The document states "Please see summary table below" and then lists the assigned concentrations for each calibrator and control level (e.g., Calibrator Level 1: 100 ng/ml). It implies that these values were successfully assigned according to the criteria but does not explicitly show the CVs or recovery errors for the tested batches. The passage states that the "concentration is calculated for each new batch... by nest testing," and the table presents the final calculated concentrations, suggesting the criteria were met. |

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

• Open Vial Stability:
  • Test set: Three batches of calibrators (242516, 51110, 61110) were tested, and three batches of controls (250-251DA, 51110, 61110) were tested. For each batch, a set of calibrators/controls was opened and assessed at Day 7, 21, and 28 against a freshly opened set.
  • Data Provenance: The studies were conducted by Randox Laboratories Limited, United Kingdom. The data is prospective, generated specifically for this submission.
• Real-Time Shelf Life:
  • Calibrators: One batch (023-027DA) was tested, with 5 calibrator sets set aside and assessed at 1, 3, 6, 9, and 12 months.
  • Controls: Two batches (482DA, 483DA) were tested, with 5 sets of controls set aside and assessed at 3, 4, 6, 9, and 12 months.
  • Data Provenance: The studies were conducted by Randox Laboratories Limited, United Kingdom. The data is prospective.
• Accelerated Shelf Life:
  • Calibrators: One batch (023-027DA) was tested, with six sets stored at +37°C and assessed at 1, 3, 5, 7, 10, and 12 days.
  • Data Provenance: The studies were conducted by Randox Laboratories Limited, United Kingdom. The data is prospective.
• Value Assignment (Nest Testing):
  • Test set: Ten replicates of the test calibrators/controls were assessed against a master lot. The specific number of batches tested for value assignment is not explicitly stated beyond "each new batch."
  • Data Provenance: The studies were conducted by Randox Laboratories Limited, United Kingdom. The data is prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is Not Applicable to this device. This device is a calibrator and control set for an in vitro diagnostic assay. Its performance is measured by chemical and analytical stability and accuracy against a known standard, not by expert interpretation of clinical images or data. The "ground truth" for the test set (e.g., the concentration of Oxazepam) is established by the manufacturer (Randox) based on gravimetric preparation using NIST traceable weights and purity determinations.

4. Adjudication method for the test set

This information is Not Applicable. Clinical adjudication methods (like 2+1, 3+1) are used for evaluating diagnostic performance involving human interpretation, especially in imaging studies. For a chemical calibrator/control, performance is determined by meeting pre-defined analytical specifications.

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

This information is Not Applicable. This device is not an AI algorithm or a diagnostic tool that involves human readers interpreting cases. It is a calibrator/control for an automated assay.

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

This information is Not Applicable. This device is a calibrator/control, not a standalone algorithm. Its performance is evaluated through analytical stability and value assignment studies in conjunction with the RX series analyzers and Benzodiazepine Assay.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the Randox Benzodiazepine Calibrator Set and Controls is the known concentration of Oxazepam. This is established through:

• Gravimetric preparation: Oxazepam is spiked into the calibrators and controls at various concentrations.
• Traceability to NIST traceable weights: The accuracy of the Oxazepam is ensured by Cerilliant Corporation through purity determinations (GC/FID, HPLC, and NMR) and gravimetric preparation using balances calibrated with NIST traceable weights.
• Drug-free human urine: The base matrix for the calibrators and controls is drug-free human urine, ensuring a clear matrix for spiking.

8. The sample size for the training set

This information is Not Applicable. This device is not an AI/ML algorithm that requires a training set. The "samples" used in its development and validation are the manufactured batches of calibrators and controls themselves, which are then subjected to the stability and value assignment studies.

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 an AI/ML algorithm for this device. The equivalent of "ground truth" for its manufacturing and quality control, as described in point 7, is established through precise chemical formulation, gravimetric preparation, and analytical verification of the Oxazepam concentration and purity traceable to NIST standards.

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