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510(k) Data Aggregation
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ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET
Elecsys Prolactin II CalSet is used for calibrating the quantitative Elecsys Prolactin II assay on the Elecsys immunoassay systems.
The cobas Elecsys® Prolactin II CalSet consists of a lyophilized buffered equine serum matrix with added recombinant prolactin in two concentration ranges. The CalSet can be used with all reagent lots.
The provided text is for a 510(k) summary for a "cobas Elecsys® Prolactin II CalSet" and does not contain the detailed study information typically requested for AI/ML-based medical devices. The device is a calibrator for an immunoassay system, not an AI-powered diagnostic device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance) are not applicable.
However, based on the context of a 510(k) submission for a calibrator, we can infer some information relevant to "acceptance criteria" and "proof of meeting criteria" in this specific context.
Here's an attempt to answer based solely on the provided document, acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
For a calibrator, the "acceptance criteria" and "performance" are primarily related to its equivalence to a predicate device and its ability to consistently calibrate the associated assay. The document highlights similarities and differences with the predicate.
| Criterion Type | Acceptance Criteria (Inferred from Equivalence) | Reported Device Performance (cobas Elecsys® Prolactin II CalSet) |
|---|---|---|
| Intended Use | Calibrate quantitative Elecsys Prolactin (or equivalent) assay on Elecsys immunoassay systems | Calibrates quantitative Elecsys Prolactin II assay on Elecsys immunoassay systems |
| Analyte Calibrated | Prolactin | Prolactin |
| Standardization | Standardized using 3rd IRP WHO Reference Standard 84/500 | Standardized using 3rd IRP WHO Reference Standard 84/500 |
| Calibrator Levels | Low: approx. 2 µIU/mL, High: approx. 2,000 µIU/mL | Low: approx. 2 µIU/mL, High: approx. 2,000 µIU/mL |
| Storage (Unopened) | Stable at 2-8°C up to expiration date | Stable at 2-8°C up to expiration date |
| Storage (Opened, Analyzer) | Stable at 2-8°C for 8 weeks (predicate) | At 20-25°C, use only once (modified device) |
| Storage (Opened, Freeze) | Not applicable (predicate was liquid) | At -20°C for 3 months (freeze only once) |
Study Proving Device Meets Acceptance Criteria:
The document describes a "Device Comparison" study as the primary means to demonstrate that the new device (cobas Elecsys® Prolactin II CalSet) is "substantially equivalent" to its predicate (Elecsys Prolactin CalSet, K964748). This comparison is presented in a table form, highlighting the similarities. The changes (matrix change to buffered equine serum, storage form to lyophilized, and updated opened storage conditions) are explicitly mentioned as "modifications." The FDA's letter states they "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent." This determination is the proof that the device meets the acceptance criteria for a 510(k) pathway, which primarily involves demonstrating equivalence to a legally marketed predicate.
Missing Information (and why it's missing for this type of device):
The following information is not provided because the device is a calibrator, not an AI/ML diagnostic tool, and the submission is a 510(k) for substantial equivalence to a predicate device.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a calibrator's 510(k) submission focused on equivalence. Performance studies for calibrators typically involve analytical studies (e.g., precision, accuracy using reference values), not patient-level test sets.
- 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 for a calibrator's value is established through metrological traceability to international reference standards, not expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI-powered diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical calibrator kit, not a software algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a calibrator, the "ground truth" for its assigned values (e.g., 2 µIU/mL) would be established by standardization against the "3rd IRP WHO Reference Standard 84/500," as stated in the document. This is a primary reference material, not clinical outcomes or expert consensus.
- The sample size for the training set: Not applicable. There is no machine learning model involved.
- How the ground truth for the training set was established: Not applicable.
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