Search Results

VALIDATE® FERRITIN Calibration Verfication / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analyte, ferntin, on automated instrument systems. The product is intended for use with quantitative assays on the indicated analyzers specified in the labeling.

Each VALIDATE® FERRITIN Calibration Verfication / Linearity Test Kit contains purfied chemicals in a human serum base. Five Iliguit Invelos, 3.0mL each, ranging from 0.5.to.2000 ng/mL typical values, are provided to establish the relationship between theoretical and actual performance of the included analyte ferritin. Material of human origin used in the manufacture of this test kit was tested at the donor level using FDA approved methods and was found to be non-reactive for HBsAG and to antibodies to HCV and HIV-1/2.

Here's an analysis of the provided text regarding the acceptance criteria and study for the VALIDATE® FERRITIN Calibration Verification / Linearity Test Kit:

Acceptance Criteria and Device Performance

Device Study Information:

1. Sample size used for the test set and the data provenance:

   • Test Set Size: Not explicitly stated as a numerical sample size in terms of unique patient samples. The "test set" in this context refers to the five liquid levels (0.5 to 2000 ng/mL typical values) of the VALIDATE® FERRITIN Calibration Verification / Linearity Test Kit itself. These levels are tested on different instruments and over time.
   • Data Provenance: The study was conducted by Maine Standards Company LLC. It involved stability testing (real-time and freeze/thaw) and linearity testing using representative instruments (Beckman Coulter Access II and Roche COBAS 6000). The materials are "purified chemicals in a human serum base." The exact country of origin for the human serum base is not specified, but the submitter is a US company (Maine Standards Company LLC, Cumberland Foreside, ME). The studies appear to be prospective as they involved testing at specific intervals post-manufacture and over a period of 431 days for linearity.

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

   • Not applicable. This device is a quality control material and calibration verification kit. Its "ground truth" is established by the known concentrations of ferritin in each of the five levels, manufactured to have an "equal relationship" among them. Expert adjudication of individual results is not part of this type of study. The concentrations are determined by the manufacturing process and validated against instrument performance.

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

   • Not applicable, as expert adjudication is not relevant for this type of device. The performance is assessed against predefined statistical criteria (e.g., 90-110% recovery) based on the known values of the control material.

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 an in-vitro diagnostic quality control product, not an AI-assisted diagnostic tool that involves human readers.

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

   • Not applicable. This device is a physical calibration verificaion/linearity solution, not a software algorithm. Its performance is evaluated on automated instrument systems directly.

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

   • The "ground truth" for this device is based on pre-defined, manufactured concentrations of ferritin in the different levels of the kit. Level 1 and 5 are "prepared independently by the addition of ferritin to a human serum base," and intermediate levels (2, 3, 4) are prepared by equal part dilutions. The "known relationship between each of the levels of the product (in this case equal deltas as outlined in the CLSI EP6A referenced standard)" serves as the basis for evaluating linearity and calibration verification.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a "training set." The product is manufactured to specific specifications.

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

   • Not applicable, as there is no "training set" for this type of device.

Ask a specific question about this device