ACTIVE TESTOSTERONE EIA (DSL-10-4000)

K971823 · Diagnostic Systems Laboratories, Inc. · CDZ · Jun 16, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971823
• Device Name: ACTIVE TESTOSTERONE EIA (DSL-10-4000)
• Applicant: Diagnostic Systems Laboratories, Inc.
• Product Code: CDZ · Clinical Chemistry
• Decision Date: Jun 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1680
• Device Class: Class 1

Intended Use

The DSL-10-4000 ACTIVE™ Testosterone Enzymeimmunoassay (EIA) Kit provides materials før the quantitative measurement of testosterone in serum. This assay is intended for in vitro diagnostic use. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and in females hirsutism and virilization due to tumors, polycystic ovaries and adrenogenital syndrome.

Device Story

DSL 10-4000 ACTIVE™ Testosterone EIA is a competitive binding protein assay for quantitative measurement of testosterone in human serum. Input: serum sample; process: enzyme-labeled testosterone competes with unlabeled testosterone in sample for binding sites on anti-testosterone antibody in microtitration wells; separation achieved via washing/decanting; output: absorbance measured by spectrophotometer. Inverse relationship between enzyme-labeled testosterone bound and sample testosterone concentration. Used in clinical laboratories by trained personnel. Results assist physicians in diagnosing/treating androgen-related disorders, including hypogonadism, puberty disorders, impotence, hirsutism, and virilization.

Clinical Evidence

Bench testing only. Comparative study of 150 human serum samples using the subject EIA kit and the predicate RIA method. Linear regression analysis showed a correlation coefficient of r = 0.93 and equation Y = 0.94(X) + 0.1.

Technological Characteristics

Competitive enzyme immunoassay (EIA) format. Components include microtitration wells coated with anti-testosterone antibody and enzyme-labeled testosterone. Requires external spectrophotometer for absorbance measurement. In vitro diagnostic use.

Indications for Use

Indicated for quantitative measurement of testosterone in human serum to aid in diagnosis and treatment of androgen-related disorders, including primary/secondary hypogonadism, delayed/precocious puberty, male impotence, and female hirsutism/virilization (e.g., tumors, polycystic ovaries, adrenogenital syndromes).

Regulatory Classification

Identification

A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Predicate Devices

• DSL Testosterone RIA

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a black and white logo. The logo appears to be a stylized representation of the letters 'd' and 'l' or 'di', with the 'd' on the left and the 'l' on the right. The letters are connected or overlapping, creating a unique and abstract design. The image quality is somewhat degraded, with some pixelation and artifacts visible.

JUN 16 1997

inostic Systems Labora 445 Medical Center Bouley Webster Texas 77598-4217 1 Tel [phone]

> Customer Assistance Cente Tel [phone] Fax [phone] Email mktg(@dslabs.com

K971823

## SUMMARY OF SAFETY AND EFFECTIVENESS

DSL 10-4000 ACTIVE™ Testosterone EIA Kit Name of Device: Classification Name: Enzymeimmunoassay, Testosterone Analyte Code and Name: Testosterone Regulatory Class:

John Willis Submitter : Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone:[phone]

May 14, 1997 Date:

The DSL ACTIVE™ Testosterone EIA kit was developed for the quantitative measurement of Testosterone in human serum. The EIA format is a competitive binding protein assay. Enzyme-labeled Testosterone competes with un-labeled Testosterone in the serum sample for binding sites with the Anti-Testosterone antibody in microtitration wells. Separation of free from bound Testosterone is achieved by washing and decanting the microtiter plates after incubation. The resultant is analyzed in a spectrophotometer for absorbance. The amount of enzyme-labeled Testosterone bound to the antibody is inversely proportional to the concentration of the Testosterone present in the sample.

The DSL ACTIVE™ Testosterone EIA assay is intended for the quantitative determination of Testosterone in human serum. The measurement of Testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and in females hirsutism and virilization due to tumors, polycyctic ovaries and adrenogenital syndromes.

The DSL ACTIVE™ Testosterone EIA is substantially equivalent to the DSL Testosterone RIA.

To demonstrate substantial equivalence between the two assays, human serum samples (n = 150) were collected and assayed using both methods. Samples were chosen based on expected Testosterone levels so that samples with low, intermediate and high levels would be evaluated. Linear regression analysis of the results obtained for the comparison gave the equation Y = 0.0.94(X) + 0.1 with a correlation coefficient of (r) = 0.93.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling an emblem. The emblem is a stylized representation of three intertwined figures, possibly symbolizing people or services, with the words "SERVICES - USA" appearing above the emblem.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 16 1997

John Willis Director of Requlatory Affairs Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598

Re : K971823 Active Testosterone EIA Requlatory Class: I Product Code: CDZ May 14, 1997 Dated: Received: May 16, 1997

Dear Mr. Willis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known):

Device Name: ACTIVE™ .Testosterone EIA .....

Indications For Use:

ネットのメイン、お出来なら

The DSL-10-4000 ACTIVE™ Testosterone Enzymeimmunoassay (EIA) Kit provides materials før the quantitative measurement of testosterone in serum. This assay is intended for in vitro diagnostic use. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and in females hirsutism and virilization due to tumors, polycystic ovaries and adrenogenital syndrome.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K971823

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use