(145 days)
No
The summary describes a standard immunoassay with electrochemiluminescence detection and calibration based on a master curve and 2-point calibration. There is no mention of AI, ML, or any related concepts.
No.
The device is an in vitro immunoassay intended for the quantitative determination of cortisol, which is used for the recognition and treatment of functional disorders, but it does not directly treat or diagnose.
Yes
The device is an in vitro assay for the quantitative determination of cortisol, which is used for the recognition and treatment of functional disorders of the adrenal gland. This indicates its use in diagnosing or monitoring health conditions.
No
The device is an in vitro diagnostic (IVD) assay that requires specific hardware (Roche Elecsys® 1010 / 2010 and Modular Analytics E170 Immunoassay Analyzers) to function. It is 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 it is an "Immunological in vitro assay for the quantitative determination of cortisol in human serum, plasma and urine." The phrase "in vitro assay" is a key indicator of an IVD.
- Device Description: The description details a laboratory-based immunoassay ("electrochemiluminescence immunoassay") performed on specific analytical instruments, which is typical for IVD devices.
- Performance Studies: The document includes performance characteristics like precision and functional sensitivity, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device" (K962559; Bayer Diagnostics ACS:180 Cortisol Assay) is common in regulatory submissions for IVDs, where a new device is compared to a previously cleared device.
All of these elements strongly indicate that this device is intended for use outside of the body to examine specimens for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
JFT
Device Description
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.
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
The performance characteristics of the ELECSYS Cortisol and the Predicate Device are compared in the table below.
Intra-assay precision (%CV)
- New Device (ELECSYS Cortisol) - Urine:
- 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
- Predicate Device (Bayer ACS:180 Cortisol):
- 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)
- New Device (ELECSYS Cortisol) - Urine:
- 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
- New Device (ELECSYS Cortisol) - Control:
- 4.7% at 2.82 µg/dl
- Predicate Device: N/A
Total precision (%CV)
- New Device: N/A
- Predicate Device (Bayer ACS:180 Cortisol):
- 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
- ELECSYS Cortisol:
§ 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
1602/218
Introduction
According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence
| Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46250
(317) 521-3831
Contact person: Sherri L. Coenen
Date prepared: April 16, 2002 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Proprietary name: ELECSYS® Cortisol Assay
Common name: Cortisol test
Classification name: Fluorometric, cortisol |
| Device
description | 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. |
1
| Intended use | Immunological in vitro assay for the quantitative determination of cortisol in
human serum, plasma and urine. |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
use | The determination of cortisol is used for the recognition and treatment of
functional disorders of the adrenal gland. |
| Substantial
equivalence | The ELECSYS Cortisol test is equivalent to other devices legally marketed in
the United States. We claim equivalence to the Bayer Diagnostics ACS:180
Cortisol Assay (K962559). |
.
2
Substantial The following table compares the ELECSYS® Cortisol, with the Predicate equivalence -Devices. similarities
| Feature | New Device
ELECSYS Cortisol | Predicate Device
Bayer ACS:180 Cortisol |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | 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 Roche
Elecsys 1010/2010 and
Modular Analytics E170
(Elecsys module) immunoassay
analyzers. | For the quantitative
determination of cortisol in
serum or urine using the
Chiron Diagnostics
ACS:180 Automatic
Chemiluminescence
Systems.
For In Vitro Diagnostic use. |
| Sample type | serum, plasma, urine | serum, urine |
| Assay Protocol | competition assay | competition assay |
| Detection
Protocol | electrochemiluminescence | direct chemiluminescence |
The following table compares the ELECSYS® Cortisol with the Predicate Substantial equivalence – Device. differences
| Feature | New Device
ELECSYS Cortisol | Predicate Device
Bayer ACS:180 Cortisol |
|-----------------|--------------------------------|-----------------------------------------------|
| Measuring range | 1.0 - 1750 nmol/L | 5.5 - 2069 nmol/L |
| Expected values | Urine
36 - 137 ug/24 hrs | Urine
12.1 - 103.8 ug/24 hrs |
| Instrument | Elecsys immunoassay analyzers | ACS:180 automated
chemiluminescence system |
3
Substantial equivalence performance
The performance characteristics of the ELECSYS Cortisol and the Predicate Device are compared in the table below.
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characteristics
| Feature | New Device
ELECSYS Cortisol | Predicate Device
Bayer ACS:180 Cortisol |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Intra-assay
precision (%CV) | Urine
• 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
• 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) | 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 |
4
Substantial equivalence performance characteristics, continued
The performance characteristics of the ELECSYS Cortisol and the Predicate Device are compared in the table below.
| Feature | New Device | Predicate Device |
|---|---|---|
| Functional | ||
| sensitivity | ELECSYS Cortisol | Bayer ACS:180 Cortisol |