IBL CORTISOL LIA TEST KIT

K052359 · Lehnus & Associates Consulting · CGR · Oct 3, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052359
• Device Name: IBL CORTISOL LIA TEST KIT
• Applicant: Lehnus & Associates Consulting
• Product Code: CGR · Clinical Chemistry
• Decision Date: Oct 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1205
• Device Class: Class 2

Intended 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.

Device Story

IBL Cortisol LIA test kit is an in-vitro diagnostic luminescence immunoassay; measures cortisol levels in human serum and saliva samples. Used by clinical laboratories to aid in differential diagnosis of Cushing syndrome and Addison's disease. Principle of operation involves competitive immunoassay format; luminescence signal intensity inversely proportional to cortisol concentration in sample. Healthcare providers use quantitative results to assess adrenal function and support clinical diagnostic decisions.

Clinical Evidence

No clinical data. Performance established via bench testing. Precision: intra-assay mean CV 6.38%, inter-assay mean CV 9.45%. Linearity: mean recovery 105.4% for serum. Spike recovery: mean 105% (range 93-124%). Functional sensitivity: 0.037 µg/dL.

Technological Characteristics

Luminescence immunoassay (LIA) for quantitative detection of cortisol. Analyte: cortisol (hydrocortisone and hydroxycorticosterone). Sample types: human serum and saliva. Regulatory class II; product code CGR.

Indications for Use

Indicated for the quantitative determination of cortisol in human serum and saliva to aid in the differential diagnosis of Cushing syndrome and Addison’s disease. Prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

{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 [phone]. 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 [phone] or [phone] 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

K052359

Page 1 of 1