(56 days)
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No
The summary describes a standard immunoassay using direct chemiluminescent technology and a calibration curve. There is no mention of AI, ML, or related concepts in the device description, performance studies, or other sections.
No.
This device is an in vitro diagnostic (IVD) assay designed for quantitative determination of cortisol, which is used in the diagnosis and treatment of disorders, not for direct therapeutic intervention.
Yes
The device is explicitly stated for "in vitro diagnostic use" and its measurements are "used in the diagnosis and treatment of disorders of the adrenal gland."
No
The device description clearly states it is an "immunoassay using direct chemiluminescent technology" and is intended for use on the "ADVIA Centaur family of analyzers," which are hardware systems. The summary describes performance studies related to specimen equivalence and interferences, which are typical for in vitro diagnostic assays involving chemical reactions and hardware analysis, not software-only devices.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "For in vitro diagnostic use". It also describes the purpose of the device as the "quantitative determination of cortisol in serum, plasma... and urine," which are biological specimens analyzed outside of the body.
- Device Description: The description details a "competitive immunoassay using direct chemiluminescent technology," which is a common method used in laboratory testing of biological samples.
- Intended User/Care Setting: "For prescription use only" indicates that this device is intended for use in a healthcare setting, likely a laboratory, for diagnostic purposes.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in the quantitative determination of cortisol in serum, plasma (EDTA and lithium heparin), and urine using the ADVIA Centaur® XP system.
Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
Product codes (comma separated list FDA assigned to the subject device)
JFT
Device Description
The ADVIA Centaur Cortisol (COR) assay is a competitive immunoassay using direct chemiluminescent technology. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve with the reagent bar code. The ADVIA Centaur Cortisol (COR) assay is intended for use on the ADVIA Centaur family of analyzers. The ADVIA Centaur Calibrator E is a set of 2 level calibrators for the assay. Siemens recommends the use of commercially available quality control materials with at least two levels (low and high).
The ADVIA Centaur COR reagent kit contains the following:
- ADVIA Centaur ReadyPack® primary reagent pack contains Lite Reagent and Solid Phase ● Reagent
Materials Required but Not provided - ADVIA Centaur Calibrator E: consists of 2 levels (low and high) of multi-analyte calibrators: ● lyophilized human plasma spiked with analytes (cortisol, progesterone, and testosterone), sodium azide (0.1%) and preservatives.
Optional Reagents - ADVIA Centaur Multi-Diluent 3 is a human plasma solution with sodium azide (0.1%) ●
- ADVIA Centaur COR Master Curve Material is a set of 7 levels of cortisol (MCM1-7) spiked . in lyophilized human plasma and sodium azide (0.1%).
- Cortisol Urine Reconstitution Buffer is a protein buffer solution with sodium azide (0.1%).
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For prescription use only
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The inclusion of the plasma (EDTA plasma and lithium heparin) sample claim in the Instructions for Use (Package Inserts) for the ADVIA Centaur Cortisol (COR) assay was demonstrated by testing the performance characteristics with the following studies:
- Specimen Equivalence by Method Comparison
- Interferences: EDTA and Heparin
11.1 Specimen Equivalence by Method Comparison
Specimen equivalency was determined with the Deming linear regression model in accordance with CLSI Document EP09-A3 for testing completed using the ADVIA Centaur Cortisol (COR) assay.
Comparison: Dipotassium EDTA Plasma vs. Serum
N = 83
Sample Interval: 0.29-67.06 μg/dL
Slope: 0.95
Intercept: 0.24 μg/dL
Correlation Coefficient (r): 1.00
Comparison: Lithium-Heparin Plasma vs. Serum
N = 99
Sample Interval: 0.29-67.06 μg/dL
Slope: 0.96
Intercept: 0.56 μg/dL
Correlation Coefficient (r): 1.00
11.2 Interferences: EDTA and Heparin
Interference testing for EDTA and heparin was performed in accordance with CLSI guideline EP07-ed3 using the ADVIA Centaur Cortisol (COR) assay. The following results were obtained:
Interferent: Dipotassium EDTA
Interferent Concentration: 9.0 mg/mL
Analyte Concentration: 12.94 ug/dL
Bias (%): 0.5
Interferent: Dipotassium EDTA
Interferent Concentration: 9.0 mg/mL
Analyte Concentration: 50.39 ug/dL
Bias (%): -1.1
Interferent: Heparin
Interferent Concentration: 75 U/mL
Analyte Concentration: 7.85 ug/dL
Bias (%): 2.9
Interferent: Heparin
Interferent Concentration: 75 U/mL
Analyte Concentration: 46.50 ug/dL
Bias (%): -0.1
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.
November 25, 2019
Siemens Healthcare Diagnostics, Inc. Ian Thompson Regulatory Affairs Specialist 511 Benedict Avenue Tarrytown, NY 10591
Re: K192788
Trade/Device Name: ADVIA Centaur Cortisol (COR) Regulation Number: 21 CFR 862.1205 Regulation Name: Cortisol (Hydrocortisone and Hydroxycorticosterone) Test System Regulatory Class: Class II Product Code: JFT Dated: September 26, 2019 Received: September 30, 2019
Dear Ian Thompson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192788
Device Name ADVIA Centaur Cortisol (COR)
Indications for Use (Describe)
For in vitro diagnostic use in the quantitative determination of cortisol in serum, plasma (EDTA and lithium heparin), and urine using the ADVIA Centaur® XP system.
Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
---|---|
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This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92 and the Safe Medical Device Act of 1990.
The assigned 510(k) Number is: K192788
Date Prepared 1.
September 26, 2019
Applicant Information 2.
- Contact: lan Thompson Regulatory Affairs Specialist
| Address: | Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591 |
|----------|-----------------------------------------------------------------------------------|
| Phone: | 914-524-2296 |
Fax: 914-524-2101
Email ian thompson@siemens-healthineers.com
Regulatory Information 3.
Table 1. Regulatory Information for ADVIA Centaur® Cortisol (COR)
Trade Name | ADVIA Centaur® Cortisol (COR) |
---|---|
Device | Fluorometric, Cortisol |
Regulation Description | Cortisol (hydrocortisone and hydroxycorticosterone) test system |
FDA Classification | Class II |
Review Panel | Clinical Chemistry (75) |
Product Code | JFT |
Regulation Number | 21 CFR 862.1205 |
4. Predicate Device Information
Predicate Device Name: ADVIA Centaur® Cortisol (COR)
510(k) Number: K142723
The ADVIA Centaur Cortisol (COR) assay with the plasma (EDTA and lithium heparin) sample claim is substantially equivalent to the ADVIA Centaur Cortisol (COR) assay that was cleared under 510(k) K142723, as shown below in the Substantial Equivalence Information section.
5. Intended Use / Indications for Use
For in vitro diagnostic use in the quantitative determination of cortisol in serum, plasma (EDTA and lithium heparin), and urine using the ADVIA Centaur® XP system.
Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
Special Conditions for Use Statement(s): For prescription use only
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Device Description 6.
The ADVIA Centaur Cortisol (COR) assay is a competitive immunoassay using direct chemiluminescent technology. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve with the reagent bar code. The ADVIA Centaur Cortisol (COR) assay is intended for use on the ADVIA Centaur family of analyzers. The ADVIA Centaur Calibrator E is a set of 2 level calibrators for the assay. Siemens recommends the use of commercially available quality control materials with at least two levels (low and high).
The ADVIA Centaur COR reagent kit contains the following:
-
ADVIA Centaur ReadyPack® primary reagent pack contains Lite Reagent and Solid Phase ● Reagent
Materials Required but Not provided -
ADVIA Centaur Calibrator E: consists of 2 levels (low and high) of multi-analyte calibrators: ● lyophilized human plasma spiked with analytes (cortisol, progesterone, and testosterone), sodium azide (0.1%) and preservatives.
Optional Reagents -
ADVIA Centaur Multi-Diluent 3 is a human plasma solution with sodium azide (0.1%) ●
-
ADVIA Centaur COR Master Curve Material is a set of 7 levels of cortisol (MCM1-7) spiked . in lyophilized human plasma and sodium azide (0.1%).
-
Cortisol Urine Reconstitution Buffer is a protein buffer solution with sodium azide (0.1%). ●
7. Purpose of the Submission
The purpose of this submission is for the addition of plasma (EDTA and lithium heparin) sample claim for the ADVIA Centaur Cortisol (COR) assay.
Substantial Equivalence Information - Comparison of Candidate 8. Device and Predicate Device
The following table demonstrates substantial equivalence between the ADVIA Centaur Cortisol (COR) assay (Candidate Device) that has modified Instructions for Use (Package Inserts) with the addition of the plasma (EDTA and lithium) sample claim and the currently marketed ADVIA Centaur Cortisol (COR) assay (Predicate Device) that was cleared under 510(k) K142723.
Trade Name | Candidate Device | Predicate Device |
---|---|---|
ADVIA Centaur Cortisol (COR) | ||
(Addition of Plasma Claim) | ADVIA Centaur Cortisol (COR) | |
(Unmodified Labeling) | ||
Intended Use | For in vitro diagnostic use in the quantitative determination of cortisol in serum, plasma (EDTA and lithium heparin), and urine using the ADVIA Centaur® XP system. | For in vitro diagnostic use in the quantitative determination of cortisol in serum or urine using the ADVIA Centaur® XP system. |
Indications for Use | Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland. | Same |
Measurement | Quantitative | Same |
Assay Range | Serum and Plasma: 0.50–75 µg/dL | |
Urine: 0.50–53 µg/dL | Serum: 0.50-75 µg/dL | |
Urine: 0.50-53 µg/dL | ||
Operating Principle | Competitive immunoassay | Same |
Technology | Direct chemiluminescent | Same |
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510(k) Summary of Safety and Effectiveness
| Sample Type | Serum, Plasma (EDTA and lithium
heparin), Urine | Serum, Urine |
|----------------------------------|----------------------------------------------------|---------------|
| Sample Volume | 20 µL (serum and plasma) | 20 µL (serum) |
| Traceability/
Standardization | Internal Standards traceable to
GCMS | Same |
| Calibration | 2-point | Same |
| Calibrator/Levels | Calibrator E/2 levels | Same |
| Controls/Levels | Commercial Controls/3 levels | Same |
| Master Curve
Materials | Seven levels (MCM1–7) | Same |
9. Standard/Guidance Document References
The following recognized standards from Clinical Laboratory Standards Institute (CLSI) were used as a basis of the study procedures described in this submission:
- Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline— ● Third Edition (CLSI EP09-A3).
- Interference Testing in Clinical Chemistry; Approved Guideline-Third Edition (CLSI EP07ed3).
Test Principle 10.
The ADVIA Centaur Cortisol (COR) assav is a competitive immunoassay using direct chemiluminescent technology. Cortisol in the patient sample competes with acridinium ester labeled cortisol in the Lite Reagent for binding to polyclonal rabbit anti-cortisol antibody in the Solid Phase. The polyclonal rabbit antibody is bound to monoclonal mouse anti-rabbit antibody, which is covalently coupled to paramagnetic particles in the Solid Phase.
11. Performance Characteristics
The inclusion of the plasma (EDTA plasma and lithium heparin) sample claim in the Instructions for Use (Package Inserts) for the ADVIA Centaur Cortisol (COR) assay was demonstrated by testing the performance characteristics with the following studies:
- Specimen Equivalence by Method Comparison
- . Interferences: EDTA and Heparin
The plasma (EDTA plasma and lithium heparin) sample claim for the ADVIA Centaur Cortisol (COR) assay does not require the collection of additional analytical performance data. Therefore, all analytical performance data previously reviewed for the ADVIA Centaur Cortisol (COR) assay continues to apply to this assay, because the assay was not modified. These performance data are cross-referenced to the 510(k) submission for the plasma claim for the ADVIA Centaur Cortisol assay (K142723).
Specifically, the following studies are not needed for the purpose of this submission:
- Detection Capability (LoB, LoD, LoQ) ●
- Linearity/Assay Range ●
- Precision ●
- Dilution Recovery ●
- Method Comparison with Predicate Device
- Expected Values (Reference Intervals) ●
- Calibrator/Assay Traceability
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- Reagent On-Board Stability and Calibration Interval ●
- Cross reactivity ●
- Interfering substances ●
- Shelf Life Stability .
11.1 Specimen Equivalence by Method Comparison
Specimen equivalency was determined with the Deming linear regression model in accordance with CLSI Document EP09-A3 for testing completed using the ADVIA Centaur Cortisol (COR) assay.
| Comparison | N* | Sample Interval | Slope | Intercept | Correlation
Coefficient (r) |
|-----------------------------------|----|------------------|-------|------------|--------------------------------|
| Dipotassium EDTA Plasma vs. Serum | 83 | 0.29-67.06 μg/dL | 0.95 | 0.24 μg/dL | 1.00 |
| Lithium-Heparin Plasma vs. Serum | 99 | 0.29-67.06 μg/dL | 0.96 | 0.56 μg/dL | 1.00 |
- N = Number of samples tested.
11.2 Interferences: EDTA and Heparin
Interference testing for EDTA and heparin was performed in accordance with CLSI guideline EP07-ed3 using the ADVIA Centaur Cortisol (COR) assay. The following results were obtained:
| Interferent | Interferent
Concentration | Analyte Concentration
(ug/dL) | Bias (%) |
|------------------|------------------------------|----------------------------------|----------|
| Dipotassium EDTA | 9.0 mg/mL | 12.94 | 0.5 |
| | | 50.39 | -1.1 |
| Heparin | 75 U/mL | 7.85 | 2.9 |
| | | 46.50 | -0.1 |
11.3 Clinical Studies
Not applicable.
11.4 Clinical Cut-off
Not applicable.
Conclusions 12.
The ADVIA Centaur Cortisol (COR) assay with the addition of the plasma (EDTA plasma and lithium heparin) sample claim in the Instructions for Use (package insert) is substantially equivalent to the currently marketed ADVIA Centaur Cortisol (COR) assay (K142723).