(28 days)
For use in the verification of the calibration established by the Elecsys Prolactin II reagent on Elecsys 1010/2010 and MODULAR ANALYTICS E170 Immunoassay analyzers.
The Elecsys Prolactin II CalCheck calibration verification solutions comprise three levels - low, mid and high - each with a defined Prolactin concentration range. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle and the high solution is near the upper limit of the measuring range. Roche Diagnostics has validated that these materials are matrix compatible for use on the Elecsys systems.
The provided text describes the Elecsys Prolactin II CalCheck, a calibration verification material, and its equivalence to a predicate device. However, it does not contain information about a study proving the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy. Instead, it focuses on the regulatory submission and comparison to a legally marketed predicate device for the purpose of demonstrating substantial equivalence.
Therefore, many of the requested elements for describing an acceptance criteria study (such as sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not available in the provided document.
Here's an attempt to extract relevant information wherever possible, and explicitly state when the requested information is not present:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of performance metrics like sensitivity, specificity, accuracy, or reader improvement. The comparison provided is primarily focused on the characteristics and intended use of the new device relative to its predicate.
| Feature / Criterion | Predicate Device (Elecsys Prolactin CalCheck K970147) | Modified Device (Elecsys Prolactin II CalCheck) |
|---|---|---|
| Intended Use | Verification of calibration established by Elecsys Prolactin reagent on Elecsys® 2010 Immunoassay analyzers. | Verification of calibration established by Elecsys Prolactin II reagent on Elecsys 1010/2010 and MODULAR ANALYTICS E170 Immunoassay analyzers. |
| Matrix | Human serum | Buffered equine serum |
| Storage form | Lyophilized | Same (Lyophilized) |
| Target values | Low = 500 µIU/mL, Mid = 5,000 µIU/mL, High = 8,000 µIU/mL | Same (Low = 500 µIU/mL, Mid = 5,000 µIU/mL, High = 8,000 µIU/mL) |
| Traceability | Calibrated against the WHO Standard 84/500 | Same (Calibrated against the WHO Standard 84/500) |
| Stability (Unopened) | Up to the printed expiration date on the bottle labels at 2 - 8°C | Same (Up to the printed expiration date on the bottle labels at 2 - 8°C) |
| Stability (Reconstituted) | 4 hours at 15 - 25°C | Same (4 hours at 15 - 25°C) |
| Device Performance (e.g., accuracy, precision, etc.) | Not explicitly reported as acceptance criteria with numerical performance data in this document. The document primarily establishes substantial equivalence based on the characteristics listed above and intended use. | Not explicitly reported as acceptance criteria with numerical performance data in this document. The document primarily establishes substantial equivalence based on the characteristics listed above and intended use. |
The study described is a comparison study demonstrating substantial equivalence to a legally marketed predicate device (Elecsys Prolactin CalCheck K970147), rather than an explicit "acceptance criteria study" with specific performance thresholds for diagnostic accuracy. The key finding is the determination of substantial equivalence by the FDA.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission focuses on device characteristics and intended use, not clinical trial data with test sets.
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)
This information is not applicable/provided. The device is a "Calibration Verification Material," not a diagnostic device that requires expert interpretation for ground truth establishment in a clinical test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/provided. (See #3 explanation).
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
This information is not applicable/provided. The device is a calibration verification material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is a calibration verification material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a calibration verification material, the "ground truth" would likely be the assigned target values (Low, Mid, High concentrations) traceable to a recognized standard (WHO Standard 84/500), confirmed through analytical methods. This is not "expert consensus" in a clinical sense.
8. The sample size for the training set
This information is not applicable/provided. The device is a calibration verification material, and the provided document does not describe a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. (See #8 explanation).
§ 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.