(141 days)
The Elecsys CA 19-9 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys CA 19-9 reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use only.
The Elecsys CA 19-9 CalCheck 5 is a lyophilized product consisting of human CA 19-9 in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
This document describes the Elecsys CA 19-9 CalCheck 5, an assayed control for use in calibration verification and assay range verification for the Elecsys CA 19-9 reagent on Elecsys and cobas e immunoassay analyzers.
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative manner for the performance study. Instead, it states that the device "was evaluated for value assignment and stability." The reported performance is the established "Check Target Values" for each of the five levels of the CalCheck. These values essentially act as the performance targets that the control material is designed to demonstrate when used with the Elecsys CA 19-9 reagent.
Since specific performance metrics like accuracy, precision, or recovery rates against acceptance limits are not provided in the summary, the table below reflects what is available.
| Characteristic | Acceptance Criteria / Target | Reported Device Performance |
|---|---|---|
| Check Targets (U/mL) | ||
| Check 1 | ≤ 3 U/mL | Established as ≤ 3 U/mL |
| Check 2 | 35 U/mL | Established as 35 U/mL |
| Check 3 | 500 U/mL | Established as 500 U/mL |
| Check 4 | 800 U/mL | Established as 800 U/mL |
| Check 5 | 1000 U/mL | Established as 1000 U/mL |
| Stability (Unopened) | Store at 2-8°C | Store at 2-8°C until expiration date |
| Stability (Reconstituted) | 20-25°C: 4 hours | 20-25°C: 4 hours |
| Format | Lyophilized | Lyophilized |
| Matrix | Human serum matrix | Human serum matrix |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size used for the performance evaluation of value assignment and stability. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a 510(k) summary for an in vitro diagnostic control, it's highly likely to be prospective testing performed by the manufacturer, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. For a control material like this, the "ground truth" (i.e., the target values) would typically be established through highly precise and accurate measurement methods by the manufacturer during the production and analytical characterization of the control lots, rather than by external experts in the same way, for instance, a diagnostic imaging AI might use clinical experts.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The development of target values for a quality control material involves robust analytical methods and statistical analysis by the manufacturer, not a consensus or adjudication process involving multiple external experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human interpretation is involved (e.g., radiology AI). The Elecsys CA 19-9 CalCheck 5 is an in vitro diagnostic control material, and its performance is assessed analytically, not through human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not directly applicable in the terms usually associated with AI or imaging devices. The Elecsys CA 19-9 CalCheck 5 itself is a physical control material, not an algorithm. Its performance is assessed as a standalone product (i.e., its ability to yield expected results when measured by the Elecsys CA 19-9 assay) in laboratory settings. The document states it was "evaluated for value assignment and stability," which implies such standalone analytical performance testing was conducted.
7. The Type of Ground Truth Used
The "ground truth" for the Elecsys CA 19-9 CalCheck 5 is the assigned target values for each of its five levels, along with its established stability characteristics. These values are determined by the manufacturer (Roche Diagnostics) through their internal analytical methods and quality control processes during the development and manufacturing of the control material. It is a form of analytical reference standard determination.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical control material, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.