(38 days)
Not Found
Not Found
No
The summary describes a luminescence immunoassay kit for quantitative determination of cortisol, which is a standard laboratory test method and does not mention any AI or ML components.
No
The device is an in-vitro diagnostic immunoassay for measuring cortisol levels, which aids in diagnosis but does not directly treat or prevent a disease or condition.
Yes
The device is described as "for the in-vitro-diagnostic quantitative determination of cortisol in human serum and saliva" and "useful as an aid in the differential diagnosis of Cushing syndrome and Addison's disease," which explicitly states its diagnostic purpose.
No
The device is described as an "in-vitro-diagnostic quantitative determination of cortisol in human serum and saliva" using a "test kit," which strongly indicates a physical assay and 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 Luminescence Immunoassay is for the in-vitro-diagnostic quantitative determination of cortisol in human serum and saliva."
This statement clearly identifies the device as being intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The IBL Cortisol Luminescence Immunoassay is for the in-vitro-diagnostic quantitative determination of cortisol in human serum and saliva.
The Cortisol LIA kit is useful as an aid in the differential diagnosis of Cushing syndrome and Addison's disease.
Product codes (comma separated list FDA assigned to the subject device)
CGR
Device Description
Not Found
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
Prescription Use
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.)
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.
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
OCT 3 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
IBL- Hamburg GMBH c/o Mr. Gary Lehnus Lehnus & Associates Consulting 150 Cherry Lane Rd. East Stroudsburg, PA 18301
Re: K052359
Trade/Device Name: IBL Cortisol LIA test kit Regulation Number: 21 CFR 862.1205 Regulation Name: Cortisol (hydrocortisone and hydroxycorticosterone) test Regulatory Class: Class II Product Code: CGR Dated: August 15, 2005 Received: August 26, 2005
Dear Mr. Lehnus:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
1
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benem
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: IBL Cortisol LIA test kit
Indications For Use:
The IBL Cortisol Luminescence Immunoassay is for the in-vitro-diagnostic quantitative determination of cortisol in human serum and saliva.
The Cortisol LIA kit is useful as an aid in the differential diagnosis of Cushing syndrome and Addison's disease.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
Division Sign-off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1