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510(k) Data Aggregation
(197 days)
Immunoassay for the in vitro quantitative determination of cortisol in human serum, plasma, urine, and saliva. The determination of cortisol is used for the recognition and treatment of functional disorders of the adrenal gland.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Elecsys Cortisol CalSet is used for calibrating the quantitative Elecsys Cortisol assay on the Elecsys immunoassay analyzers.
(1) The Elecsys Cortisol Assay is a two step competitive immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
(2) The Elecsys Cortisol CalSet is a lyophilized product consisting of human serum with added cortisol (synthetic) in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided text describes a 510(k) summary for the Elecsys Cortisol Test System (K070788), a modified device, comparing it to a predicate device (K043175). The key modifications appear to be the addition of new platforms (cobas e 411 and cobas e 601 analyzers) and some refined details regarding sensitivity and expected values for saliva.
Since this is an in-vitro diagnostic (IVD) device, the acceptance criteria are related to analytical performance characteristics rather than clinical outcomes or diagnostic accuracy in the way a medical imaging AI would be. The "study" mentioned isn't a single large clinical trial in the traditional sense, but rather a series of analytical performance evaluations summarized in the comparison tables.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the performance of the predicate device (K043175), with the modified device (K070788) aiming to demonstrate "substantial equivalence." The table below highlights key performance characteristics where data or changes are specifically mentioned. For many features, the modified device performance is simply stated as "Same" as the predicate.
| Acceptance Criteria Category | Specific Metric | Predicate Device (K043175) Performance | Modified Device (K070788) Performance |
|---|---|---|---|
| Measuring Range | Lower limit | 1.00 nmol/L or 0.036 µg/dL (defined by LDL) | 1.00 nmol/L or 0.036 µg/dL (defined by LoD) |
| Upper limit | 1750 nmol/L or 63 µg/dL (max of master curve) | 1750 nmol/L or 63.0 µg/dL (max of master curve) | |
| Values below detection | < 1.0 nmol/L (<0.036 µg/dL) | < 0.50 nmol/L (< 0.018 µg/dL) (Limit of Blank) | |
| Sensitivity | Analytical (LDL) | < 0.500 nmol/L | ≤ 0.5 nmol/L (LoB) |
| Functional | < 2.0 nmol/L | < 1.0 nmol/L (LoD) | |
| Limit of Quantitation | Not explicitly detailed | 8.5 nmol/L (LoQ) | |
| Precision (Saliva) | Within-run CV @ various concentrations | 6.1% CV @ 4.68 nmol/L, 2.7% CV @ 11.5 nmol/L, etc. | SAME |
| Between-run CV @ 0.93 nmol/L | 37.1% CV @ 0.93 nmol/L | 33.4% CV @ 2.08 nmol/L | |
| Between-run CV @ 7.72 nmol/L | 7.2% CV @ 7.72 nmol/L | 11.5% CV @ 8.05 nmol/L | |
| Between-run CV @ 16.9 nmol/L | 6.2% CV @ 16.9 nmol/L | 7.1% CV @ 13.1 nmol/L | |
| Between-run CV @ 34.6 nmol/L | 4.9% CV @ 34.6 nmol/L | 4.9% CV @ 34.6 nmol/L | |
| Between-run CV @ 42.5 nmol/L | 4.1% CV @ 42.5 nmol/L | 4.1% CV @ 42.5 nmol/L | |
| Expected Values (Saliva) | Morning hours (5th-95th percentile) | 1.90-19.1 nmol/L (0.07-0.69 µg/dl) | <19.1 nmol/L (<0.69 µg/dl) (95th percentile) |
| Afternoon hours (5th-95th percentile) | 2.05-11.9 nmol/L (0.07-0.43 µg/dl) | <11.9 nmol/L (<0.43 µg/dl) (95th percentile) |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is the comparison study detailed in the 510(k) submission, which involved generating the performance data for the modified Elecsys Cortisol Test System (K070788) on the new platforms (cobas e 411 and cobas e 601 analyzers) and ensuring these results are substantially equivalent to the predicate device (K043175). The text explicitly states: "The Elecsys Cortisol Test System (modified) is substantially equivalent to other devices legally marketed in the United States. The Elecsys Cortisol Test System (modified) is equivalent to the Elecsys Cortisol Test System (K043175)." The comparison table provides the evidence for this claim, showing "Same" for many features, or updated, comparable data for others (e.g., precision, sensitivity, expected values).
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Precision (Saliva): Not explicitly stated how many individual samples were used for the precision testing, but results are presented at multiple concentration levels, implying repeat measurements on specific samples/pools (e.g., "Between-run" data shows CVs at 5 different concentrations).
- Expected Values (Saliva): 154 healthy individuals.
- Specific sample sizes for other analytical performance characteristics (e.g., measuring range, sensitivity) are not explicitly provided in the summary.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This is an in-vitro diagnostic device (IVD) measuring a biochemical marker (cortisol). The "ground truth" for such a device is established through highly accurate reference methods and the intrinsic concentration of the analyte in samples, not typically through human expert adjudication like in diagnostic imaging. Therefore:
- Number of Experts: Not applicable in the context of IVD performance studies.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
Not applicable for an IVD device measuring analyte concentration. Analytical performance is evaluated against quantitative measurements and statistical methods, not by human adjudication of qualitative results.
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 typically for evaluating the diagnostic performance of systems (often imaging AI) where multiple human readers interpret cases with and without AI assistance. This device is an IVD for quantitative determination of cortisol.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, the performance data presented is standalone algorithm performance. The Elecsys Cortisol Test System is an automated immunoassay. The reported performance characteristics (e.g., measuring range, sensitivity, precision) reflect the algorithm's direct measurement capabilities without direct human interpretation in the results generation. Humans operate the instrument and interpret the final quantitative values, but the performance metrics themselves are tied to the automated assay's analytical capabilities.
7. The Type of Ground Truth Used
- For sensitivity, measuring range, and precision, the ground truth is the known concentration of cortisol in control samples or spiked samples, or the statistical evaluation of repeated measurements of real patient samples.
- For expected values (saliva), the ground truth is derived from quantitative measurements in a population of healthy individuals.
- The "Traceability / Standardization" section states the device is "Standardized against the Enzymun-Test Cortisol method. This in turn was standardized via ID-MS." Isotope Dilution Mass Spectrometry (ID-MS) is often considered a "gold standard" or highly accurate reference method for quantitative measurements, providing the ultimate ground truth for concentration.
8. The Sample Size for the Training Set
- Not explicitly stated and likely not applicable in the same way as machine learning models. This is an immunoassay system, not a machine learning algorithm that is "trained" on a dataset in the modern sense. The "training" for such a system involves the development and optimization of the assay reagents, protocols, and calibration curves. The development would involve numerous samples, but there isn't a distinct "training set" for an algorithm in this context. The "master curve provided with the reagent bar code" is key to the assay's function, implying significant development and standardization data for its creation.
9. How the Ground Truth for the Training Set was Established
- As above, the concept of a "training set" doesn't directly apply. However, the accuracy of the assay's measurements (which forms its "ground truth" for operation) is based on:
- Standardization against ID-MS: This indicates a robust method for establishing accurate concentration values.
- Calibration curves: These are established using calibrators with known concentrations, which are themselves traceable to highly accurate methods. The Elecsys Cortisol CalSet is a "lyophilized product consisting of human serum with added cortisol (synthetic) in two concentration ranges," where the "analyte is spiked into the matrix at the desired concentration levels." These "desired concentration levels" would be the ground truth for calibration.
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