Search Results
Found 1 results
510(k) Data Aggregation
(145 days)
Immunological in vitro assay for the quantitative determination of cortisol in human serum, plasma and urine. 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 the Roche Elecsys® 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.
The ELECSYS® Cortisol Assay a two step sandwich 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.
The information provided describes the Elecsys® Cortisol Assay and its substantial equivalence to a predicate device (Bayer Diagnostics ACS:180 Cortisol Assay). It focuses on comparing the new device's performance characteristics to the predicate device to demonstrate substantial equivalence, rather than detailing a specific study proving the device meets acceptance criteria with predefined thresholds. Therefore, some of the requested information cannot be fully extracted as it pertains to a typical clinical validation study with explicitly stated acceptance criteria and a detailed study design.
Here's the breakdown of what can be extracted and what is not available in the provided text:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" through specific numerical thresholds for each performance characteristic. Instead, it demonstrates performance by comparing the new device's data directly to that of the predicate device, implying that performance comparable to the legally marketed predicate device is the de facto acceptance criteria for substantial equivalence.
| Feature | Acceptance Criteria (Implied: Comparable to Predicate) | New Device (ELECSYS Cortisol) Reported Performance | Predicate Device (Bayer ACS:180 Cortisol) Reported Performance |
|---|---|---|---|
| Intra-assay precision (%CV) (Urine) | Comparable to Predicate's Intra-assay precision | • 2.2% at 22.3 µg/dl • 2.3% at 33.2 µg/dl • 2.9% at 41.9 µg/dl • 2.3% at 61.0 µg/dl | • 5.7% at 3.04 µg/dl • 5.1% at 5.43 µg/dl • 4.5% at 14.90 µg/dl • 6.4% at 18.98 µg/dl • 7.0% at 31.79 µg/dl • 7.5% at 38.67 µg/dl |
| Interassay precision (%CV) (Urine) | N/A (Predicate data not fully provided) | • 2.5% at 23.2 µg/dl • 3.2% at 33.4 µg/dl • 2.5% at 42.1 µg/dl • 1.8% at 58.9 µg/dl Control: 4.7% at 2.82 µg/dl | N/A |
| Total precision (%CV) | Comparable to Predicate's Total precision | N/A | • 9.1% at 3.04 µg/dl • 8.0% at 5.43 µg/dl • 6.4% at 14.90 µg/dl • 8.2% at 18.98 µg/dl • 9.2% at 31.79 µg/dl • 9.7% at 38.67 µg/dl |
| Functional sensitivity | Comparable or better than Predicate's functional sensitivity | < 0.29 µg/dl | 0.2 µg/dl |
| Measuring range | Comparable to Predicate's measuring range | 1.0 - 1750 nmol/L | 5.5 - 2069 nmol/L |
| Limitations (Interference in Urine) | Unaffected by specified concentrations of substances as per Predicate | • 60 mg/dl protein • 750 mmol/l NaCl • 350 mmol/l urea • 5 mmol/l creatinine • 2 mmol/l glucose | • 60 mg/dl protein • 750 mmol/l NaCl • 350 mmol/l urea • 5 mmol/l creatinine • 2 mmol/l glucose |
| On-board stability | Sufficient for clinical use, comparable to predicate | Elecsys® 2010 / E170: 6 weeks Elecsys® 1010: 6 weeks (stored alternately in refrigerator and analyzer at ambient temperature 20-25 C) Up to 20 hr. opened in total | until expiration date on the vial label or cumulative 32 hrs at room temperature. |
| Calibration frequency | Appropriate for maintaining accuracy, comparable to predicate | Elecsys® 2010 / E170: Once per lot, after one month, after 7 days, controls out of range Elecsys® 1010: With every kit, after 7 days (20-25°C), after 3 days (25-32°C), controls out of range | Every 7 days, when changing lot numbers, when replacing system components, when QC results are out of range |
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 given text. The document refers to "performance characteristics" but does not detail the specific study designs, sample sizes, or data provenance (e.g., retrospective/prospective, country of origin) for the tests conducted to derive these characteristics.
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 is a an in vitro diagnostic (IVD) device for quantitative determination of cortisol. The ground truth for such devices is typically established through analytical methods and reference materials, not through expert reading or consensus in the way a diagnostic imaging device would require. Therefore, this question is not applicable in the context of this device and information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As this is an IVD device measuring an analyte, adjudication methods involving human experts (like 2+1 for radiology images) are not applicable. The ground truth is analytical.
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 is an IVD assay, not an AI-powered diagnostic imaging device that assists human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The entire device (ELECSYS® Cortisol Assay) operates as a standalone analytical system to quantitatively determine cortisol. The performance characteristics listed (precision, functional sensitivity, measuring range, etc.) represent the standalone performance of the algorithm and associated instrumentation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an in vitro diagnostic assay like the ELECSYS® Cortisol Assay, the "ground truth" for reported performance characteristics such as precision and sensitivity is established through analytical reference methods and certified reference materials. These involve meticulously prepared samples with known concentrations of cortisol, against which the device's measurements are compared. The document does not explicitly state the specific reference methods or materials used but implies their use through the reporting of these analytical performance metrics.
8. The sample size for the training set
This information is not provided. The document is a 510(k) submission for substantial equivalence, which typically focuses on performance data for the final product, not the developmental or training data used in its creation (especially for traditional IVD assays not based on machine learning in the way a modern AI device would be).
9. How the ground truth for the training set was established
As per point 8, information about a "training set" and its ground truth establishment is not provided and likely not relevant in the context of this type of established IVD technology. The development of such assays involves rigorous analytical testing against reference standards, but this is distinct from the machine learning "training set" paradigm.
Ask a specific question about this device
Page 1 of 1