(197 days)
Not Found
No
The description focuses on a standard immunoassay technique and calibration method, with no mention of AI or ML.
No
The device is an immunoassay used for the in vitro quantitative determination of cortisol, which aids in the recognition and treatment of adrenal gland disorders, rather than directly treating a condition itself.
Yes
The device is described as an "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." This clearly indicates its use in aiding in the diagnosis and monitoring of medical conditions, which is the definition of a diagnostic device.
No
The device description clearly outlines a two-step competitive immunoassay involving streptavidin microparticles and electrochemiluminescence detection, which are physical components and processes, not solely software. It also mentions a lyophilized product (Elecsys Cortisol CalSet) used for calibration.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Immunoassay for the in vitro quantitative determination of cortisol in human serum, plasma, urine, and saliva." The phrase "in vitro" is a key indicator of an IVD.
- Purpose: The determination of cortisol is used for the "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.
- Technology: It uses an immunoassay, a common technique in IVD testing.
- Analyzer: It is intended for use on "Elecsys and cobas e immunoassay analyzers," which are instruments used in clinical laboratories for diagnostic testing.
- Calibration: The description mentions a "CalSet" used for calibrating the assay, which is typical for quantitative IVD tests.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
(1) 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.
(2) Elecsys Cortisol CalSet is used for calibrating the quantitative Elecsys Cortisol assay on the Elecsys immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
NHG, JIT
Device Description
(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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: ≤ 0.5 nmol/L - LoB
§ 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
KC70788
510(k) Summary - Elecsys Cortisol Test System
| 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 |
| 9115 Hague Rd | |
| Indianapolis IN 46250 | |
| (317) 521-3544 | |
| Contact person: Kay A. Taylor | |
| Date prepared: September 13, 2007 | |
| Device name | Proprietary name: Elecsys Cortisol Immunoassay |
| Elecsys Cortisol CalSet | |
| Common name: Cortisol test | |
| Calibrator | |
| Classification name: Cortisol test system | |
| Calibrator, Secondary | |
| Device description | (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. |
:
1
510(k) Summary - Elecsys Cortisol Test System, Continued
| | Intended use | (1) 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. |
|--|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | (2) Elecsys Cortisol CalSet is used for calibrating the quantitative Elecsys
Cortisol assay on the Elecsys immunoassay analyzers. |
| | Substantial
Equivalence | 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). |
| | Device
Comparison | The following table compares the Elecsys Cortisol Test System (modified)
and the predicate device. The predicate labeling used as the source document
for the comparison is that provided to FDA in K043175. |
Comparison Table
| Feature | Predicate Device
Elecsys Cortisol Assay
(K043175) | Modified Device
Elecsys Cortisol
(K070788) |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagent
Intended
Use/Indication
s for Use | 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. | Same |
| Calibrator
Intended Use | Elecsys Cortisol CalSet is used for
calibrating the quantitative Elecsys
Cortisol assay on the Elecsys
immunoassay analyzers. | Same |
| Platform(s) | Elecsys 1010, Elecsys 2010, and
MODULAR ANALYTICS E170,
analyzers. | Elecsys 1010, Elecsys 2010, and
MODULAR ANALYTICS E170,
cobas e 411 and cobas e 601
analyzers. |
| Assay Protocol | Competitive assay | Same |
| Feature | Predicate Device
Elecsys Cortisol Assay
(K043175) | Modified Device
Elecsys Cortisol
(K070788) |
| Detection | Electrochemiluminescent | Same |
| Total Assay
Duration | 18 minute application | Same |
| Sample Type | Serum, plasma (Li, Na, NH4 Heparin,
K2, K3, Na2 EDTA and Na citrate),
saliva, urine | Same |
| Measuring
Range | 1.00- 1750 nmol/L or 0.036-63 µg/dL
(defined by the lower detection limit
and the maximum of the master curve).
Values below the detection limit are
reported as 1750 nmol/L (>
63 µg/dL) (or up to 17,500 nmol/L or
630 µg/dL for 10-fold diluted samples). | 1.00-1750 nmol/L or 0.036-63.0 µg/dL
(defined by the limit of detection and
the maximum of the master curve).
Values below the limit of blank are
reported as 1750 nmol/L (> 63.0
µg/dL) (or up to 17,500 nmol/L or 630
µg/dL for 10-fold diluted samples). |
| Sensitivity | Saliva | Saliva |
| | Within-run | Within-run - SAME |
| | 6.1% CV @ 4.68 nmol/L | |
| | 2.7% CV @ 11.5 nmol/L | |
| | 4.0% CV @ 15.1 nmol/L | |
| | 1.5% CV @ 15.9 nmol/L | |
| | 2.8% CV @ 19.8 nmol/L | |
| | Between-run | Between-run |
| | 37.1% CV @ 0.93 nmol/L | 33.4% CV @ 2.08 nmol/L |
| | 7.2% CV @ 7.72 nmol/L | 11.5% CV @ 8.05 nmol/L |
| | 6.2% CV @ 16.9 nmol/L | 7.1% CV @ 13.1 nmol/L |
| | 4.9% CV @ 34.6 nmol/L | 4.9% CV @ 34.6 nmol/L |
| | 4.1% CV @ 42.5 nmol/L | 4.1% CV @ 42.5 nmol/L |
| Expected
Values | Expected values for serum, plasma, urine remain unchanged from
K043175 | Same |
| | Saliva:
The following values were determined
in saliva samples from 154 healthy
individuals (5th -95th percentile). | Saliva:
The following values were determined
in saliva samples from 154 healthy
individuals (95th percentile). |
| | Morning hours 8-10 a.m:
1.90-19.1 nmol/L (0.07-0.69 µg/dl) | Morning hours 8-10 a.m: