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The Randox Laboratories Limited Liquid Protein Calibrator (for neat sample assays) is derived from normal human serum obtained from volunteer donors. It has been developed for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin, Transferrin and Haptoglobin assays (all neat sample assavs).

Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to International Reference Material CRM 470. The constituent concentrations of these Calibrators are present at levels 1, 2, 3, 4 and 5.

This calibrator can be used on Abbott Spectrum, Abbott aeroset, Abbott Architect ഗ്രാമം Architect i2000sr, Ace Analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, Olympus AU800, AU600, AU400, AU2700, AU5400, Selectra vitalab, Synchron CX4 Synchron CX5 Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira plus systems

The Randox Laboratories Limited Liquid Protein Calibrators, should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

For in vitro diagnostic use.

Not Found

This document is a 510(k) premarket notification letter from the FDA to Randox Laboratories, Ltd. for their "Randox Liquid Protein Calibrators (For Neat Sample Assays)". The letter determines that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device. It's for an in vitro diagnostic (IVD) calibrator, which is a different type of medical device with different regulatory requirements and evaluation methods.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study demonstrating performance, an MRMC study, sample sizes for training/test sets, or ground truth establishment relevant to an AI/ML device. That information is not present in this 510(k) letter for a calibrator.

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The Randox Laboratories Limited Liquid Protein Calibrators (for neat sample assays) are liguid calibrators derived from normal human serum obtained from volunteer donors. They have been developed for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin and Transferrin assays (all neat sample assays). Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to material standardised against appropriate International Reference Preparations. The constituent concentrations of these Calibrators are present at levels 0, 1, 2, 3, 4 and 5. These calibrators also contain α-1-Antitrypsin (AAT) and Rheumatoid Factor (RF) for use in the calibration of AAT and RF assays on the Bayer Advia 1650 analyser only.

The Randox Laboratories Liquid Protein Calibrators (for diluted sample assays) are liquid calibrators derived from normal human serum obtained from volunteer donors. They have been developed for the calibration of α-1-acid glycoprotein, IgA, IgG, IgM and Transferrin assays which require sample pre-dilution. Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to material standardised against appropriate International Reference Preparations. The constituent concentrations of these calibrators are present at levels 1, 2, 3, 4 and 5.

Liquid calibrators derived from normal human serum obtained from volunteer donors.

This is a 510(k) premarket notification for "Liquid Protein Calibrators" and the provided text is a letter from the FDA determining substantial equivalence to a predicate device. This type of document, particularly for calibrators, does not typically contain the detailed acceptance criteria and study design information that would be found for a diagnostic device or imaging AI.

Therefore, many of the requested categories simply cannot be extracted from this document.

Here's a breakdown of what can be inferred or directly stated, and where information is missing:

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

• Cannot be extracted. This document is a regulatory clearance letter, not a performance study report. It states that the device is "substantially equivalent" to a legally marketed predicate, implying that its performance is acceptable based on comparison to that predicate, but specific acceptance criteria or performance metrics are not detailed here.

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

• Cannot be extracted. No information about a "test set" in the context of device performance evaluation is provided. The calibrators themselves are derived from "normal human serum obtained from volunteer donors," but this refers to the source material for the calibrators, not a test set for performance validation.

3. 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 / Cannot be extracted. This relates to performance evaluation, which is not detailed in this clearance letter. The document mentions "Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to material standardised against appropriate International Reference Preparations." This describes how the values of the calibrators were established ("ground truth" for the calibrator values themselves), but not a ground truth for a diagnostic test set. It does not mention expert consensus for establishing ground truth as one would for an AI device.

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

• Not applicable / Cannot be extracted. No test set or human interpretation requiring adjudication is mentioned.

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 device is a calibrator, not an AI or diagnostic tool that involves human readers.

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

• Not applicable. This device is a calibrator, not an algorithm.

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

• For the calibrator values: The "ground truth" for the constituent concentrations of the calibrators was established by "immunoturbidimetry with reference to material standardised against appropriate International Reference Preparations." This indicates a reference to established scientific standards and methods.

8. The sample size for the training set

• Not applicable / Cannot be extracted. This device is a calibrator and does not involve a "training set" in the context of machine learning. The calibrators are "derived from normal human serum obtained from volunteer donors," but the number of donors is not specified, nor is this a "training set" in the AI sense.

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

• Not applicable. See point 8.

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