(8 days)
No
The summary describes a standard immunoassay technology and does not mention any AI or ML components.
No
The device is an in-vitro diagnostic immunoassay used for the quantitative determination of cortisol, which aids in the recognition and treatment of functional disorders, but it does not directly perform a therapeutic function.
Yes
The device is an immunoassay for the quantitative determination of cortisol, which is used for the "recognition and treatment of functional disorders of the adrenal gland." This direct reference to "recognition" of disorders indicates a diagnostic purpose.
No
The device is an immunoassay kit intended for use on specific hardware analyzers (Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170). It involves reagents, microparticles, and electrochemiluminescence detection, which are all hardware components and chemical processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "for the in-vitro quantitative determination of cortisol in serum, plasma, urine and saliva." The term "in-vitro" is a key indicator of an IVD.
- Purpose: The determination of cortisol is used for "recognition and treatment of functional disorders of the adrenal gland," which is a diagnostic purpose.
- Sample Type: The device analyzes biological samples (serum, plasma, urine, and saliva) outside of the body.
These characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
Product codes
NHG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Adrenal Gland (via detection of cortisol in serum, plasma, urine, and saliva)
Indicated Patient Age Range
Neonatal to 70 years / All Adults
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: Elecsys Cortisol vs. Salimetrics. 326 samples (0.05-1.83 ug/dl). Slope = 0.90 (95% CI 0.87-0.94), Intercept= 1.71 (95% CI 1.47-1.96), r= 0.942.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision:
E2010
Within-run:
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
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
*sample concentration below functional claim of assay.
Functional Sensitivity:
§ 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
K043175
NOV 2 4 2004
510(k) Summary
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Roche Diagnostics Submitter name, address, 9115 Hague Road contact Indianapolis, IN 46250 (317) 521-3544 Contact Person: Kay A. Taylor Device Name Proprietary name: Elecsys® Cortisol Immunoassay System Common name: Cortisol Test Classification name: Fluorometic, cortisol The Elecsys Cortisol Assay is a two step sandwich immunoassay with Device Description 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. Intended use For the in vitro quantitative determination of cortisol in human serum, plasma, urine and saliva. Note: Serum and plasma cleared under K000270 and urine cleared under K021218. Indications for The determination of cortisol is used for the recognition and treatment of Use functional disorders of the adrenal gland.
1
510(k) Summary, Continued
| Substantial
equivalence | The Elecsys Cortisol Immunoassay is substantially equivalent to other
devices legally marketed in the United States. We claim equivalence to the
Salimetrics HS (high sensitivity) Salivary Cortisol Enzyme cleared under
K011323. Both products are intended for use in the quantitative
determination of cortisol in human saliva. |
| ---------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Substantial The following table compares the Roche Elecsys Cortisol Immunoassay with equivalence the predicate device. comparison
| Feature | Elecsys Cortisol Immunoassay | HS Salivary Cortisol Enzyme
(predicate) |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the in-vitro quantitative
determination of cortisol in
serum, plasma, urine and saliva. | For the in vitro quantitative
determination of cortisol in
saliva. |
| Indication for Use | The determination of cortisol is
used for the recognition and
treatment of functional disorders
of the adrenal gland. | 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. |
| Assay Protocol | Electrochemiluminescent
Immunoassay | Competitive Solid Phase
Immunoassay |
| Traceability /
Standardization | Enzymun Test Cortisol, in turn
standardized via
ID-MS. | N/A |
| Calibration Interval | E170/E2010
After 1 month when using the
same reagent lot After 7 days when using the
same reagent kit E1010 With every reagent kit After 7 days (20-25°C) After 3 days (25-32°C) | N/A |
| Sample Type | Serum, plasma, urine & saliva | Saliva |
2
| Feature | Elecsys Cortisol Immunoassay | HS Salivary Cortisol Enzyme
(predicate) |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Sample Collection
Method | Salivettes (Sarstedt) | Salivettes (Sarstedt) |
| Reagent Stability | Unopened at 2-8°C
• Up to stated expiration
Opened
• 12 weeks at 2-8°
• 8 weeks on E170/ 2010
• 2 weeks on E1010 (20-25°
ambient temp - up to 20
hours opened in total) | Stable at 2-8°C until kit
expiration date |
| Controls | Elecsys PreciControl Universal 1
and 2 | Cortisol Controls |
| Calibrator | Elecsys Cortisol CalSet | Cortisol Standards |
| Measuring Range | 1.00 - 1750 nmol/L
(0.036 - 63 ug/dL) | Calibrator range
0.007-1.800 ug/dl |
| Instrument | Elecsys family of analyzers
(Elecsys 1010, Elecsys 2010 and
Elecsys E170 MODULAR
Analytics Immunoassay
Analyzers) | Standard plate reader |
3
| Expected Values | ||
|---|---|---|
| Morning hours 8-10 AM: | ||
| 1.90 – 19.1 nmol/L | Neonatal | |
| 0.010-3.606 ug/dl | ||
| Afternoon hours 2:30-3:30 PM: | ||
| 2.05 – 11.9 nmol/L | Age 6 months | |
| 0.010-2.890 ug/dl | ||
| Age 2.5-5.5 years | ||
| AM: 0.060-0.700 ug/dl | ||
| PM: 0.08-0.660 ug/dl | ||
| Age 8-11 years | ||
| AM: 0.112-0.904 ug/dl | ||
| PM: ND-0.249 ug/dl | ||
| Age 12-18 years | ||
| AM: 0.046-0.950 ug/dl | ||
| PM: ND-0.296 ug/dl | ||
| Age 21-30 years, males | ||
| AM: 0.112-0.743 ug/dl | ||
| PM: ND-0.308 ug/dl | ||
| Age 21-30 years, females | ||
| AM: 0.272-1.348 ug/dl | ||
| PM: ND-0.359 ug/dl | ||
| Age 31-50 years, males | ||
| AM: 0.122-1.551 ug/dl | ||
| PM: ND – 0.359 ug/dl | ||
| Age 31-50 years, females | ||
| AM: 0.094-1.515 ug/dl | ||
| PM: ND-0.181 ug/dl | ||
| Age 51-70 years, males | ||
| AM: 0.112-0.812 ug/dl | ||
| PM: ND - 0.228 ug/dl | ||
| Age 51-70 years, females | ||
| AM: 0.149-0.739 ug/dl | ||
| PM: 0.022-0.254 ug/dl | ||
| All Adults | ||
| AM: 0.094-1.551 ug/dl | ||
| PM: ND-0.359 ug/dl | ||
| ND=none detected | ||
| Normal 0.004-0.116 ug/dl | ||
| Cushing's 0.141-9.170 ug/dl |
.
4
510(k) Summary, Continued
The performance characteristics of the Elecsys Cortisol Immunoassay and the Substantial predicate device are compared in the table below. equivalence – performance characteristics
| Feature | Elecsys Cortisol Immunoassay | HS Salivary Cortisol Enzyme (predicate) |
|---|---|---|
| Precision | E2010 | |
| Within-run | ||
| 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 | ||
| 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 | ||
| *sample concentration below functional claim of assay. | Intra-assay | |
| 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 | ||
| Functional | ||
| Sensitivity |