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K Number
K061139
Device Name
BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
Manufacturer
BAYER HEALTHCARE, LLC
Date Cleared
2006-07-06

(73 days)

Product Code
JIT,ADV
Regulation Number
862.1150
Type
Abbreviated
Panel
IM
Reference & Predicate Devices
K051619
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For in vitro diagnostic use in the calibration of quantitative PSA assays on the ADVIA® IMS system.
For in vitro diagnostic use in the calibration of quantitative complexed PSA assays on the ADVIA® IMS system.

Device Description

The Bayer ADVIA® IMS PSA Calibrators and ADVIA® IMS cPSA Calibrators are for values of calibrator material prepared in bovine serum with non-serum constituents added.
The analytes currently in the calibrator material are: PSA in the ADVIA® IMS PSA Calibrator cPSA in ADVIA® IMS cPSA Calibrator

AI/ML Overview

This document is a 510(k) summary for the ADVIA® IMS PSA Calibrator and ADVIA® IMS cPSA Calibrator. It establishes substantial equivalence to a predicate device but does not describe a study that involves performance acceptance criteria against which devices are measured. This type of device (calibrator) would typically undergo studies related to its stability, traceability, and commutability, rather than efficacy studies with clinical endpoints.

Therefore, many of the requested elements for describing an acceptance criteria study are not applicable to the information provided in this document.

Here's a breakdown of the applicable information:

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

    • Not applicable. This document does not present specific performance acceptance criteria for the calibrator itself, nor does it report performance against such criteria. The 510(k) submission focuses on substantial equivalence to a predicate calibrator and its intended use for calibration. Performance of the calibrator would be assessed through its ability to enable accurate and precise measurements by the ADVIA® IMS system when assaying patient samples, which is not detailed here.

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

    • Not applicable. There is no "test set" in the context of device performance evaluation described in this document.

  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. Ground truth establishment by experts is generally not relevant for calibrator devices.

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

    • Not applicable.

  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 not an AI-assisted diagnostic device.

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

    • Not applicable. This is not an algorithm-based device.

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

    • Not applicable.

  8. The sample size for the training set:

    • Not applicable. This is not an AI/machine learning device requiring a training set.

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

    • Not applicable.

Summary of Relevant Information from the Provided Text:

  • Device Type: In vitro diagnostic calibrator material.
  • Intended Use: For in vitro diagnostic use in the calibration of quantitative PSA and complexed PSA assays on the ADVIA® IMS system.
  • Substantial Equivalence: The device is deemed substantially equivalent in intended use, storage and handling, stability, source material, and instructions for use to the previously cleared Bayer Lipoprotein Calibrators (K051619). This is the primary "proof" for this type of device according to the 510(k) process – demonstrating it is as safe and effective as a legally marketed predicate device.
  • Device Description: Prepared in bovine serum with non-serum constituents added. The analytes are PSA and cPSA.

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.