(22 days)
The Elecsys PTH 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 PTH quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.
The Elecsys PTH CalCheck 5 is a lyophilized product consisting of human PTH in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided text describes the Elecsys PTH CalCheck 5, an assayed control used for calibration verification and assay range verification. It is not an AI/ML-driven medical device, but rather a control material for laboratory instruments. Therefore, many of the requested criteria related to AI/ML device testing (e.g., sample sizes for test/training sets, expert consensus, MRMC studies, ground truth establishment for AI models) are not applicable to this product.
The performance evaluation described focuses on "value assignment and stability" of the control material, and its substantial equivalence to a predicate device.
However, I can extract information relevant to the acceptance criteria and the study proving it meets these criteria, interpreting them within the context of a laboratory control product rather than an AI/ML diagnostic tool.
Acceptance Criteria for Elecsys PTH CalCheck 5 (Implicit via Comparison to Predicate):
The acceptance criteria for the Elecsys PTH CalCheck 5 are primarily established by demonstrating its substantial equivalence to the predicate device, Elecsys PTH CalCheck (K993642). This means the new device must perform comparably for its intended use, analyte, format, and matrix, and meet or exceed the performance characteristics of the predicate, particularly regarding stability and the ability to serve its control function.
While explicit numerical acceptance criteria are not provided in the text for performance, the comparison table implies that the new device's characteristics must align well with the predicate.
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is the performance evaluation of the Elecsys PTH CalCheck 5, which included "value assignment and stability." The core of this proof lies in the detailed comparison with the predicate device.
Table 1: Acceptance Criteria and Reported Device Performance
As explicit numerical acceptance criteria are not stated for all aspects, the table below reflects the characteristics compared between the candidate and predicate devices, implying these characteristics form the basis of "acceptance" for substantial equivalence. "Reported Device Performance" here refers to the characteristics of the Elecsys PTH CalCheck 5.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Elecsys PTH CalCheck 5) |
|---|---|---|
| Intended Use | Periodic verification of calibration of the Elecsys Parathyroid Hormone test. | An assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys PTH quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only. (Broader scope than predicate) |
| Analyte | PTH | PTH |
| Levels | Three | Five (Increased levels compared to predicate) |
| Assay Measuring Range | 1.20 - 5000 pg/mL | 1.20 - 5000 pg/mL |
| Check Target Values | Check 1: |
§ 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.