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510(k) Data Aggregation
(268 days)
NHG
The IBL International Cortisol Saliva Luminescence Immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended for point-of-care settings.
Cortisol (also known as hydrocortisone, compound F) is the main glucocorticoid in humans and is produced in the zona fasciculata of the adrenal cortex. 90 % of the circulating cortisol are bound to corticoid binding globulin (CBG, Transcortin), ca. 7 % are bound to albumin and only 1-3 % are unbound. Only the latter part represents the active form of cortisol. The free cortisol is released in saliva and is excreted via the kidneys as a small part among the metabolites of cortisol. The level of free cortisol in blood regulates mainly its secretion in the adrenal cortex in a negative feedback mechanism via CRH (corticotropin releasing hormone) in the hypothalamic region and the ACTH in the pituitary gland, but it is also affected by different situations above all by stress.
In humans, there is a physiological fluctuation of cortisol achieving the highest level in the morning and the lowest during the night. This fluctuation of cortisol plasma level is reflected in saliva normally with a peak in the first 90 minutes after waking up. The cortisol measurement is indicated in adrenal disorders. Due to the diurnal fluctuations of cortisol, a salivary sample collection is an easy method without the stress of repeated venipunctures.
Test principle:
Luminescence immunoassay based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labelled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After addition of the luminescence substrate solution the intensity of the luminescence measured is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.
Device composition:
The device is available in two sizes, 96 tests and 960 tests.
The device consists of an antibody coated 96 well Microtiter Plate, seven Standards (range 0.015 - 3.20 µg/dL, equivalent to 0.15 - 32 ng/mL calibrated to the NIST cortisol), two Controls, Enzyme Conjugate (Cortisol coupled to peroxidase), Chemiluminescence Reagent 1 and 2, 10x concentrated Wash Buffer, Adhesive Foils.
The provided document describes the IBL International Cortisol Saliva Luminescence Immunoassay, a device for in-vitro diagnostic quantitative determination of Cortisol in human saliva, intended as an aid in diagnosing and treating adrenal disorders. The device's performance was evaluated through various analytical studies and a method comparison with a predicate device.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" separate from the "reported device performance." Instead, it describes various performance characteristics and their outcomes, implying that the achieved outcomes met the internal acceptance criteria for substantial equivalence. I will synthesize the reported performance characteristics that implicitly serve as acceptance criteria.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Detection Limits | Sufficiently low | LoB: 0.004 µg/dL |
| LoD/LoQ study performed. | ||
| Specificity (Cross-reactivity) | Interfering substances at high concentrations should not significantly impact results. | Prednisolone: ≥10% cross-reactivity at 10,000 µg/dL. 11-Deoxycortisol: ≥5% cross-reactivity at 10,000 µg/dL. |
| Linearity | Strong linear correlation. | Determined Cortisol concentration (µg/dL) = -0.05 + 1.03 x (expected Cortisol concentration (ug/dL)), with R² = 0.99. Linear range: 0.012 µg/dL (LoQ) to 3.134 µg/dL. |
| Recovery | Acceptable range of recovery. | 93.7% – 109.6% for tested samples with expected concentrations 0.242 µg/dL to 2.528 µg/dL. |
| Precision | Low variability (CV). | Between-lot CV range: 0.4 – 1.7%. Between-operator CV range: 0.8 – 1.8%. |
| Sample Freezing Claim (CV) | CV after freezing should be lower than without freezing. | Mean CV = 4.4% after freezing vs. 7.2% without freezing. |
| Sample Stability | Cortisol concentration within predetermined acceptance range across tested conditions. | Storage Conditions & Stability: |
- 37°C: 1 week
- 18-25°C: 2 weeks
- 2-8°C: 2 weeks
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(587 days)
NHG
For the in-vitro diagnostic quantitative determination of free and protein bound salivary cortisol in human saliva as an aid in the assessment of Cushing Syndrome and Addison's Disease. Measurements of cortisol in saliva are used in the diagnosis and treatment of disorders of the adrenal gland.
The kit consists of a 96 well GARGG (Goat Anti-Rabbit Gamma Globulin) coated microplate (12x8 breakable strip wells), seven ready-to-use calibrators (range 0.1-30 ng/ml) of gravimetrically prepared cortisol from a commercial source (Steraloids) and compared and traced to NIST cortisol, low and high controls, anti-Cortisol (rabbit), 10X concentrated Cortisol (analog)-peroxidase, substrate solution, stop reaction solution and 10X concentrated wash solution.
Here's a breakdown of the acceptance criteria and study information for the Pantex AM/PM Salivary Cortisol EIA Kit, based on the provided text:
The provided text focuses on the analytical performance of the Pantex AM/PM Salivary Cortisol EIA Kit and its equivalence to a predicate device. It demonstrates the device's ability to accurately and reliably measure salivary cortisol levels.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied / Contextual) | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | %CV ≤ 10% (for intra-assay, inter-assay, inter-lot) | Intra-assay: Low (5.4%), Medium (6.7%), High (6.3%) %CV |
| Inter-assay: Low (6.3%), Medium (7.2%), High (2.8%) %CV | ||
| Inter-lot: %CV range of 0.9% to 7.4% for various samples and controls. | ||
| Linearity | Desired Recovery % (Typically 90-110%) | Recovery ranging from 93.0% to 101.4% across 10 concentrations |
| Recovery | Desired Recovery % (Typically 90-110%) | Recovery ranging from 93.7% to 103.9% across 10 spiked samples |
| Reagent Stability | Demonstrated shelf life | 9 months when stored at 2-8°C |
| Sample Stability | Demonstrated stability under various conditions | Room Temperature (20-30°C): Up to 7 days |
| 37°C: Up to 7 days | ||
| 2-8°C: Up to 7 days |
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(197 days)
NHG
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 |
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(162 days)
NHG
An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free cortisol (hydrocortisone and hydroxycorticosterone) in saliva. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
The DRG Salivary Cortisol ELISA KIT is based on the competition principle and the microplate separation. An unknown amount of Cortisol present in the sample and a fixed amount of Cortisol coniugated with horseradish peroxidase compete for the binding sites of mouse polyclonal Cortisol-antiserum coated onto the wells. After one hour incubation the microplate is washed to stop the competition reaction. After addition of the TMB substrate solution the concentration of Cortisol is inversely proportional to the optical density measured.
Here's an analysis of the provided text regarding the DRG Salivary Cortisol ELISA, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied through the performance data presented, as explicit criteria (e.g., "must achieve X correlation") are not stated. The performance is reported against other commercially available methods or standard analytical techniques.
| Performance Metric | Implied Acceptance Criteria (Based on context) | Reported Device Performance |
|---|---|---|
| Method Comparison (vs. LIA) | High correlation (e.g., >0.85) | 0.872 (Study 1, n=114) |
| High correlation (e.g., >0.95) for expanded study | 0.9795 (Expanded Study 1, n=40) | |
| Method Comparison (vs. EIA) | High correlation (e.g., >0.90) | 0.936 (Study 2, n=72) |
| High correlation (e.g., >0.95) for expanded study | 0.9920 (Expanded Study 2, n=40) | |
| Method Comparison (vs. LC-MS) | High correlation (e.g., >0.85) | 0.89056 (Study 3, n=28) |
| Sensitivity (Lowest Detectable Limit) | As low as reasonably achievable for clinical utility (no specific numerical criterion given) | 0.537 ng/mL or 0.0537 ug/dl at 95% confidence limit |
| Specificity (Cross-Reactivity) | Low cross-reactivity with structurally similar compounds | Cortisol: 100%, Corticosterone: 29.00%, Cortisone: 3.00%, most others |
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(8 days)
NHG
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/dL | ||
| 2.7% CV @ 0.417 ug/dL | ||
| 4.0% CV @ 0.547 ug/dL | ||
| 1.5% CV @ 0.576 ug/dL | ||
| 2.8% CV @ 0.718 ug/dL | ||
| Between Run: | ||
| 37.1% CV @ 0.034 ug/dL (Note: sample concentration below functional claim of assay) | ||
| 7.2% CV @ 0.280 ug/dL | ||
| 6.2% CV @ 0.613 ug/dL | ||
| 4.9% CV @ 1.25 ug/dL | ||
| 4.1% 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 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).
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(60 days)
NHG
Salimetrics HS-Cortisol kit is a competitive immunoassay specifically designed for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's disease. Saliva cortisol accurately reflects the amount of serum cortisol in the circulation. This kit is not intended for use with serum or plasma samples.
Test Principle- A microtitre plate is coated with rabbit antibodies to cortisol. Cortisol in standards and unknowns compete with cortisol linked to horseradish peroxidase for the antibody binding sites. After incubation, unbound components are washed away. Bound cortisol peroxidase is measured by the reaction of the peroxidase enzyme on the substrate tetramethylbenzidine (TMB). This reaction produces a blue color. A vellow color is formed after stopping the reaction with sulfuric acid. Optical density is read on a standard plate reader at 450 nm. The amount of cortisol peroxidase detected is inversely proportional to the amount of cortisol present. The optical density readings of the calibrators are used to form a standard curve to which the optical densities of the controls and samples are compared.
Kit Description- The kit consists of an antibody coated 96 well plate, six calibrators at a concentration of 1.800, 0.600, 0.200, 0.067. 0.022, and 0.007 µg/dL of NIST(National Institute of Standards and Technology) cortisol, two controls representing a high (1.00 ug/dL) and low (0.100 ug/dL) level of salivary cortisol, the enzyme conjugate (1600X concentrate), assay diluent containing a pH indicator, wash buffer(10X concentrate), tetramethylbenzidine substrate solution, stop solution, and kit insert.
Here's a breakdown of the acceptance criteria and study information for the Salimetrics HS Salivary Cortisol Enzyme Immunoassay Kit:
Acceptance Criteria and Reported Device Performance
The device's acceptance criteria are framed in comparison to a predicate device (Diagnostic Systems Laboratory Active Cortisol EIA, K850141), focusing on quantitative performance characteristics.
| Characteristic | Acceptance Criteria (Predicate Device K850141) | Reported Device Performance (HS Salivary Cortisol EIA) |
|---|---|---|
| Intra-assay Precision | Coefficient of variation |
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(230 days)
NHG
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