Search Results
Found 4 results
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.
Ask a specific question about this device
(8 days)
The Elecsys Cortisol is an immunoassay for the in-vitro quantitative determination of cortisol in 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 the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
The Elecsys Cortisol Assay is 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.
Here's an analysis of the acceptance criteria and supporting study for the Elecsys® Cortisol Immunoassay System, based on the provided 510(k) summary:
Device: Elecsys® Cortisol Immunoassay System
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit acceptance criteria in the way a clinical trial might for a new drug. Instead, it provides performance characteristics of the new device and compares them to the predicate, implying that performance comparable to the predicate (and within acceptable analytical ranges for this type of test) is the "acceptance criteria."
| Feature | Acceptance Criteria (Implied by Predicate Performance / Clinical Acceptability for Cortisol Assays) | Reported Device Performance (Elecsys Cortisol Immunoassay) |
|---|---|---|
| Precision | Comparable to or better than the predicate's intra-assay CVs (4.25% CV @ 1.591 ug/dL, 4.97% CV @ 0.702 ug/dL, 5.73% CV @ 0.188 ug/dL, 5.28% CV @ 0.115 ug/dL) and generally acceptable for quantitative immunoassays. | Within-run (E2010):6.1% CV @ 0.170 ug/dL2.7% CV @ 0.417 ug/dL4.0% CV @ 0.547 ug/dL1.5% CV @ 0.576 ug/dL2.8% CV @ 0.718 ug/dLBetween Run:37.1% CV @ 0.034 ug/dL (Note: sample concentration below functional claim of assay)7.2% CV @ 0.280 ug/dL6.2% CV @ 0.613 ug/dL4.9% CV @ 1.25 ug/dL4.1% CV @ 1.54 ug/dL |
| Functional Sensitivity | Clinically relevant detection limit for cortisol in saliva. The predicate did not explicitly state this, but a value < 2.0 nmol/L (< 0.07 ug/dL) is generally considered good for salivary cortisol. | < 2.0 nmol/L (< 0.07 ug/dL) |
| Analytical Sensitivity (LDL) | Comparable to or better than the predicate's LDL (< 0.007 ug/dL) and sufficient for accurate measurement at low physiological levels. | < 0.500 nmoL/L (< 0.018 ug/dL) |
| Method Comparison (Correlation) | Strong correlation (high 'r' value, ideally > 0.9) and good agreement (slope close to 1, intercept close to 0) between the new device and the predicate device across a clinically relevant range of concentrations. | Elecsys Cortisol vs. Salimetrics:Slope = 0.90 (95% CI 0.87-0.94)Intercept= 1.71 (95% CI 1.47-1.96)r= 0.942 |
| Measuring Range | Adequate to cover both normal and pathological cortisol levels. For Elecsys, the range is 1.00 - 1750 nmol/L (0.036 - 63 ug/dL). The predicate's calibrator range was 0.007-1.800 ug/dl. The Elecsys measured range is significantly wider. | 1.00 - 1750 nmol/L (0.036 - 63 ug/dL) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Method Comparison): 326 samples
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is implied to be a direct comparison of patient samples run on both systems.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of immunoassay does not typically involve expert readers for establishing ground truth in the way medical imaging devices do. The "ground truth" for the method comparison is the measurement obtained from the predicate device (Salimetrics HS Salivary Cortisol Enzyme). The results are compared statistically, not against a human interpretation.
4. Adjudication Method for the Test Set
Not applicable for this type of quantitative immunoassay comparison. Adjudication is typically used in subjective interpretation tasks (e.g., radiology readings) to reconcile differing expert opinions. Here, the comparison is direct numerical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. MRMC studies are relevant for devices that involve human interpretation, often assisted by AI, to assess the impact of the device on human performance. This is a standalone quantitative assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the device is a standalone quantitative immunoassay platform. Its performance characteristics (precision, sensitivity, method comparison) are inherently "standalone," meaning they represent the device's performance without human interpretive intervention.
7. The Type of Ground Truth Used
For the method comparison, the "ground truth" was the results obtained from the predicate device (Salimetrics HS Salivary Cortisol Enzyme). For other performance metrics like precision and sensitivity, the ground truth is established through standard laboratory practices using known controls and calibrators, often with traceability to a reference method (e.g., ID-MS for the Elecsys Cortisol).
8. The Sample Size for the Training Set
The document does not specify a separate "training set" in the context of machine learning or AI. For immunoassay development, there are typically reagent optimization phases and validation studies that involve numerous samples and controls, but these are not usually referred to as "training sets" in the same way as in AI/ML development. The provided data for method comparison is a validation dataset.
9. How the Ground Truth for the Training Set Was Established
As there's no explicitly defined "training set" in the AI/ML sense, this question is not directly applicable. If considering the development and optimization of the immunoassay itself, the "ground truth" would be established using reference materials, calibrators, and possibly samples with known cortisol concentrations (e.g., measured by ID-MS or another highly accurate reference method).
Ask a specific question about this device
(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
(39 days)
Ask a specific question about this device
Page 1 of 1