(106 days)
No
The device description details a standard ELISA assay based on chemical reactions and color intensity measurement, with no mention of AI or ML components. The performance studies focus on traditional analytical validation metrics.
No
The device is an in-vitro diagnostic assay for quantitative determination of cortisol to aid in diagnosis, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for the in-vitro-diagnostic quantitative determination of cortisol in human serum and saliva" and "is useful as an aid in the differential diagnosis of Cushing syndrome and Addison's disease." These phrases clearly indicate its diagnostic purpose.
No
The device description clearly describes a solid phase enzyme-linked immunosorbent assay (ELISA) kit, which is a laboratory-based hardware and reagent system for performing chemical reactions and measurements. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The IBL Cortisol enzym linked immunosorbent assay is for the in-vitro-diagnostic quantitative determination of cortisol in human serum and saliva."
This statement directly identifies the device as being for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
Solid phase enzyme-linked immunosorbent assay for the in-vitro diagnostic quantitative determination of free Cortisol in human saliva and of total Cortisol in diluted serum as an aid in the assessment of Cushing Syndrome and Addison's Disease.
Product codes (comma separated list FDA assigned to the subject device)
CGR
Device Description
Solid phase enzyme-linked immunosorbent assay (ELISA) 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 the substrate reaction the intensity of the developed color is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method comparison study:
- 130 saliva samples and 1290 serum samples were tested on the IBL Cortisol ELISA and compared to the Cortisol LIA.
- Saliva: IBL-ELISA = 0.92 x IBL-Luminescence IA + 0.06 µg/dL, r = 0.995; n = 130
- Serum: IBL-ELISA = 1.17 x IBL-Luminescence IA - 2.2 µg/dL, r = 0.997; n = 129
- 33 serum samples from the DGKC quality assessment scheme were compared to GC/MS method.
- Serum: IBL-ELISA = 0.97 x GCMS + 2.3 µg/dL, r = 0.982; n = 33
Interference Studies:
The following blood components have been tested in serum and saliva and do not have a significant effect (+/- 20 % of expected) on the test results up to the concentrations stated below:
- Serum: Hemoglobin (4.0 mg/mL), Bilirubin (0.5 mg/mL), Triglyceride (30 mg/mL).
- Saliva: Thimerosal (0.50 %), Blood (0.125 %), NaN3 (0.60 %).
Analytical Specificity (Cross Reactivity):
- Prednisolone: 29 %
- 11-Desoxy-Cortisol: 16 %
- Corticosterone: 2.4 %
- Cortisone: 3.3 %
- Prednisone: 2.2 %
- 17α-OH-Progesterone: 1.2 %
- Desoxy-Corticosterone: 0.5 %
- 6α-Methyl-17α-OH-Progesterone: 0.3 %
- Cross-reactivity of other substances tested
§ 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
(a)
Identification. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.(b)
Classification. Class II.
0
SUMMARY OF SAFETY AND EFFECTIVENESS FOR IBL CORTISOL ELISA
DEC 2 0 2006
| Manufacturer: | IBL. Immuno Biological Laboratories
Flughafenstrasse 52A, D-22335
Hamburg, Germany |
|----------------------|----------------------------------------------------------------------------------------------------------|
| Contact Information: | Victor Herbst
IBL Immuno Biological Laboratories
Flughafenstrasse 52A, D-22335
Hamburg, Germany |
Device Name / Classification:
The device trade name is the IBL Cortisol ELISA having FDA assigned name: Cortisol (hydrocortisone and hydroxycorticosterone) test system, 21 CFR, 862.1205, categorized as Class II medical devices for the Clinical Chemistry Panel, as Product Code CGR.
Test Principle
Solid phase enzyme-linked immunosorbent assay (ELISA) 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 the substrate reaction the intensity of the developed color is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.
Device Intended Use:
Solid phase enzyme-linked immunosorbent assay for the in-vitro diagnostic quantitative determination of free Cortisol in human saliva and of total Cortisol in diluted serum as an aid in the assessment of Cushing Syndrome and Addison's Disease.
Device Performance
All technical data are included in this 510(k) submission. The normal ranges and stability data will be overtaken from the original Cortisol LIA submission No. K052359 (respectively No. K010790) which is manufactured in same way. All single components keep the same, except the substrate system which uses an ordinary TMB (Tetramethylbenzidine) substrate with a given shelf life of 18months by manufacturer. The shelf lifes are therefore as follows:
1
Stability of kit components at (2 - 8 ℃) :
| Microtiter strips | 12 months |
|---|---|
| Enzyme conjugate. | 9 months |
| Standard A-G | 9 months |
| Kit control 1, 2 | 9 months |
| Wash buffer. Concentrate | 12 months |
| ready to use TMB substrate | 18 months |
| TMB Stop solution | 36 months |
Therefore the complete Kit will have a shelf life of 9 months at 2 - 8 ℃.
Method comparison
A comparison study was performed using 130 saliva and 1290 serum samples. These samples were tested on the IBL Cortisol ELISA and compared to the Cortiso! LIA, The results from measuring the samples in both methods yielded the following correlation:
| Method
Comparison
| versus LIA | Saliva | $IBL-ELISA = 0.92 x IBL-Luminescence IA + 0.06 µg/dL$ | r = 0.995;n = 130 | |
|---|---|---|---|---|
| Serum | $IBL-ELISA = 1.17 x IBL-Luminescence IA - 2.2 µg/dL$ | r = 0.997; n = 129 |
Additionally 33 serum samples from the DGKC (Deutsche Gesllschaft für klinische Chemie, Bonn Germany) quality assessment scheme for hormones which were obtained using a GC/MS method, according to: Siekmann et al., J.Clin.Chem.Clin.Biochem. 20 (1982) 883-892, were used for comparison study to the given GC/MS reference values. The results from measuring the samples yielded the following correlation:
| Method
Comparison
| versus GC/MS | Serum | $IBL-ELISA = 0.97 x GCMS + 2.3 \mu g/dL$ | r = 0.982; n = 33 |
|---|---|---|---|
| -------------------------------------- | ------- | ------------------------------------------ | ------------------- |
Interference Studies
The following blood components have been tested in serum and saliva and do not have a significant effect (+/- 20 % of expected) on the test results up to the concentrations stated below:
| Serum | ||
|---|---|---|
| Conc. | Cortisol (µg/dL) | |
| Hemoglobin | 4.0 mg/mL | 0.06; 0.33; 0.62 |
| Bilirubin | 0.5 mg/mL | 0.07; 0.35; 0.63 |
| Triglyceride | 30 mg/mL | 0.07; 0.40; 0.75 |
| Saliva | ||
| Conc. | Cortisol (µg/dL) | |
| Thimerosal | 0.50 % | 0.19; 0.25; 0.34 |
| Blood | 0.125 % | 0.09; 0.26 |
| NaN3 | 0.60 % | 0.23; 0.31 |
2
The overall performance of the IBL Cortisol ELISA is:
: 1
:
:
| | Substance | Cross
Reactivity (%) | | | | | |
|------------------------------------------------------|-------------------------------|-----------------------------------|------------------------------------------------------------------|------------------|-------------------------|-------------|-----|
| Analytical
Specificity
(Cross
Reactivity) | Prednisolone | 29 | Cross-reactivity
of other
substances
tested