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Quest Diagnostics Serum Chemistry Control is intended for use as a quality control serum to monitor the precision of an individual laboratory's automated and manual-testing procedures.
Quest Diagnostics Serum Chemistry Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Quest Diagnostics Serum Chemistry Control is prepared from human serum to which purified biochemical materials (tissue extracts of human and animal origin), chemicals, preservatives, and stabilizers have been added.

The provided text describes a "Summary of Safety and Effectiveness" for the Quest Diagnostics Serum Chemistry Control, a quality control material. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not involve AI, human readers, or image analysis. Therefore, many of the requested categories are not applicable.

Here's the information that can be extracted or deduced from the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to a legally marketed predicate device (K033387). The performance is characterized by its intended use, form, matrix, other ingredients, and stability claims, which are compared to the predicate.

Study Information

The document describes stability studies as the primary supporting data for the device's claims.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • The document does not specify the sample size (number of control units or replicates) used for the stability studies.
   • The data provenance is from Bio-Rad Laboratories, Irvine, California, USA.
   • The stability studies are described as "Real time studies will be ongoing," which implies they are prospective for the shelf life claim, while the initial open-vial and alternate stability claims would have sufficient data to be submitted.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not Applicable. This is a quality control material for chemical testing, not a diagnostic device requiring expert interpretation of results. The "ground truth" for chemical controls is established through rigorous laboratory testing against reference methods or certified reference materials, not expert consensus in the typical medical imaging sense.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not Applicable. As above, this type of adjudication is not relevant for chemical control materials. Quality control performance is assessed against established statistical limits and analytical targets.

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:

   • Not Applicable. This device is a quality control material for laboratory instruments, not an AI-assisted diagnostic tool or a human-read diagnostic test.

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

   • Not Applicable. This is not an algorithm or AI device. Its performance is intrinsic to the chemical stability and composition of the control material.

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

   • For a quality control material like this, the "ground truth" for its performance (e.g., stability over time) would be established by analytical measurements using validated laboratory methods and potentially comparison to certified reference materials or industry standards. The document states "All supporting data is retained on file at Bio-Rad Laboratories," indicating internal validation.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device that requires a training set.

8. How the ground truth for the training set was established:

   • Not Applicable. As above, no training set is involved.

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For use as a quality control serum to monitor the precision of an individual laboratory's automated and manual-testing procedures.

Quest Diagnostics Serum Chemistry Control is prepared from human serum to which purified biochemical materials (tissue extracts of human and animal origin), chemicals. preservatives, and stabilizers have been added.

Here's an analysis of the provided text regarding the Quest Diagnostics Serum Chemistry Control, focusing on acceptance criteria and study details:

This device is a Quality Control (QC) material, not a diagnostic device that produces patient results or relies on AI. Therefore, many of the requested fields (e.g., number of experts, adjudication methods, MRMC studies, standalone performance, training set) are not applicable to this type of product.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated with a specific number of samples. The determination of stability involves testing material over time, involving multiple aliquots and measurements.
• Data Provenance: The studies were performed by Bio-Rad Laboratories. The country of origin of the data is not specified but is presumably the USA, where Bio-Rad Laboratories is located. The studies are prospective in nature, as they involve testing the product over its claimed stability periods (e.g., real-time shelf life studies).

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

• Not applicable. This is a quality control material where "ground truth" typically refers to the expected values and acceptable ranges for analytes, which are established through extensive analytical testing and statistical analysis, not by expert interpretation in the same way a diagnostic imaging device would be. The "ground truth" for the analytes within the control is determined by the manufacturer's reference methods and value assignment processes.

4. Adjudication method for the test set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, generally for diagnostic accuracy. This device's performance is determined through objective laboratory measurements and statistical analysis against pre-defined stability criteria.

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

• Not applicable. This is a quality control material, not a diagnostic device that would involve human readers or AI assistance in interpreting patient data.

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

• Not applicable. This device is a physical reagent used to monitor the performance of analytical instruments. It does not employ an algorithm or AI.

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

• The "ground truth" for this type of device is the expected concentration/activity of each analyte within the control material, along with established stability profiles. These are determined through:
  • Reference analytical methods: Using highly accurate and precise analytical techniques to assign target values to the analytes in the control.
  • Statistical analysis: To define the acceptable range of variation (precision) for each analyte over its claimed shelf life and open vial stability.
  • Real-time stability studies: Monitoring the material's performance over its stated shelf life and open vial periods to confirm that analyte values remain within established acceptance limits.

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

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

• Not applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device