LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA

K033786 · Ibl GmbH · JIT · Feb 27, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033786
• Device Name: LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA
• Applicant: Ibl GmbH
• Product Code: JIT · Clinical Chemistry
• Decision Date: Feb 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The IBL Testosterone Luminescence Immunoassay is intended for the in vitro quantitative measurement of testosterone (a male sex hormone) in saliva and serum. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Device Story

IBL Testosterone Luminescence Immunoassay is an in vitro diagnostic test for quantitative measurement of testosterone in human saliva and serum samples. Device utilizes luminescence immunoassay technology to detect hormone levels. Intended for clinical laboratory use to assist physicians in diagnosing and monitoring androgen-related disorders, including hypogonadism, impotence, hirsutism, and virilization. Healthcare providers use quantitative results to inform clinical decision-making regarding patient endocrine health and treatment efficacy.

Clinical Evidence

Bench testing only. Precision assessed via intra-assay and inter-assay studies (CVs reported for oral fluid and serum). Linearity demonstrated for oral fluid (1.8–500 pg/mL) and serum (76–20,000 pg/mL). Analytical sensitivity established at 1.8 pg/mL (oral fluid) and 76 pg/mL (serum). Method comparison performed against modified RIA (n=69 for oral fluid, r=0.93; n=71 for serum, r=0.97). No clinical studies performed.

Technological Characteristics

Microplate luminescence immunoassay (LIA). Components: rabbit anti-mouse antibody-coated microtiter plate, mouse anti-testosterone antiserum, enzyme conjugate (alkaline phosphatase), acridan-based chemiluminescence substrate. Requires microplate luminometer. Matrices: oral fluid and serum (serum requires 40x dilution). Traceable to GC-MS and in-house reference standards.

Indications for Use

Indicated for in vitro quantitative measurement of testosterone in saliva and serum to aid in diagnosis and treatment of androgen-related disorders. Patient population includes males with primary/secondary hypogonadism or impotence, and females with hirsutism or virilization associated with tumors, polycystic ovaries, or adrenogenital syndromes.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2,7 2004

IBL-Hamburg, GmbH c/o Mr. Gary Lehnus Regulatory Consultant Lehnus & Associates Consulting 150 Cherry Lane Road East Stroudsburg, PA 18301

Re: k033786

> Trade/Device Name: IBL Testosterone Luminescence Immunoassay Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT: JJX: CDZ Dated: December 2, 2003 Received: December 4, 2003

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).

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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/dsma/dsmamain.html.

Sincerely yours.

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## FEB 2 3 2004

1 of 1

510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

## Indications For Use:

The IBL Testosterone Luminescence Immunoassay is intended for the in vitro quantitative measurement of testosterone (a male sex hormone) in saliva and serum. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Albert Smith
Division Sign-Off

Office of in vitro diagnostic
**Device Evaluation and Safety**

K033786

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)