(58 days)
The Elecsys® CA 19-9 CalCheck™ is intended for use in the verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.
The Elecsys® CA 19-9 CalCheck™ is a lyophilized product consisting of CA 19-9 in a buffered human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
The provided document describes the Elecsys® CA 19-9 CalCheck™ and its substantial equivalence to a predicate device. However, it does not contain the detailed performance study information requested in your prompt. This document is a 510(k) summary submitted to the FDA, which typically focuses on demonstrating substantial equivalence to a legally marketed device rather than detailing extensive performance studies with specific statistical acceptance criteria and ground truth establishment methods.
The "Performance Characteristics" section simply states: "The Elecsys® CA 19-9 CalCheck™ was evaluated for value assignment and stability." This is a very high-level statement and lacks the specifics you are looking for.
Therefore, for your request, I can only provide the information that is present in the document.
Missing Information:
The document does not provide the following details:
- A table of acceptance criteria and reported device performance (beyond the general statement that it was "evaluated").
- Sample size used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size with AI assistance.
- Specific details of a standalone (algorithm only) performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
Information Available from the Document:
Here's what can be extracted from the provided text, related to the device and its intended use:
- Device: Elecsys® CA 19-9 CalCheck™
- Intended Use: For use in the verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.
- Performance Evaluation: The device "was evaluated for value assignment and stability."
Because the requested granular details regarding acceptance criteria, study design, ground truth, and sample sizes for performance evaluations are not present in the provided 510(k) summary, I cannot fill in the table or answer most of your specific questions. Regulatory submissions for diagnostic controls often focus on demonstrating that the control material performs as expected in terms of its assigned values and stability, rather than extensive clinical efficacy or reader studies like those for AI-powered diagnostic devices.
§ 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.