ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100

K021032 · Scantibodies Laboratory, Inc. · CKG · Jun 3, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021032
• Device Name: ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
• Applicant: Scantibodies Laboratory, Inc.
• Product Code: CKG · Clinical Chemistry
• Decision Date: Jun 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1025
• Device Class: Class 2

Indications for Use

The Scantibodies Laboratory, Inc. Adrenocorticotropic Hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands, such as Cushing's syndrome, adrenocortical insufficiency and the ectopic ACTH syndrome.

Device Story

The ACTH Immunoradiometric (IRMA) Assay is an in vitro diagnostic test used to quantify adrenocorticotropic hormone levels in human plasma samples. The device utilizes an immunoradiometric assay principle, which involves the use of radiolabeled antibodies to bind to the target hormone. The assay is performed in a clinical laboratory setting by trained laboratory personnel. The resulting measurements provide clinicians with quantitative data regarding ACTH levels, which are essential for the differential diagnosis and management of adrenal disorders such as Cushing's syndrome and adrenocortical insufficiency. The output is used by physicians to guide clinical decision-making and therapeutic interventions for patients suspected of having adrenal dysfunction.

Clinical Evidence

No clinical data provided; device is an in vitro diagnostic assay evaluated via bench testing to establish performance characteristics.

Technological Characteristics

Immunoradiometric assay (IRMA) for the quantitative measurement of ACTH in plasma. Class II device, product code CKG. Operates via radiolabeled antibody binding. No software or electronic components described.

Indications for Use

Indicated for the measurement of adrenocorticotropic hormone (ACTH) in plasma to assist in the differential diagnosis and treatment of adrenal gland disorders, including Cushing's syndrome, adrenocortical insufficiency, and ectopic ACTH syndrome.

Regulatory Classification

Identification

An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and a circle of text around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in all capital letters. The logo is black and white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Richard Lenart Quality Control and Assurance Manager Scantibodies Laboratory, Inc. 9336 Abraham Way Santee, CA 92071-2862

JUN 0 3 2002

Re: k021032

> Trade/Device Name: ACTH Immunoradiometric (IRMA) Assay Regulation Number: 21 CFR 862.1025 Regulation Name: Adrenocorticotropic hormone test system Regulatory Class: Class II Product Code: CKG Dated: March 28, 2002 Received: Maarch 29, 2002

Dear Mr. Lenart: ·

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 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 -

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Steven Putman

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

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

Image /page/2/Picture/0 description: The image shows a flashlight shining in a dark room. The flashlight is on the right side of the image, and the beam of light is shining towards the left. The light beam is partially obscured by an object in the middle of the room. The left side of the image is dark, with a striped object in the corner.

## ANTIBODIES Laboratory, Inc.

The Power of Antibodies to Select and Defect

Image /page/2/Picture/3 description: The image shows a logo for Lloyd's Register Quality Assurance. The logo features a large letter "R" inside a circle, with the text "LLOYD'S REGISTER QUALITY ASSURANCE" surrounding the circle. Below the "R" is the text "ISO9001". The text "ISO 9001 QUALITY SYSTEM" is below the logo.

9336 Abraham Way ● Santee, CA 92071-2862 USA ● Phone [phone] ● Fax [phone]

page 1 of 1

## Statement of Indications for Use

510(k) Number (if known): K021032

Device Name: ACTH Immunoradiometric (IRMA) Assav

Indications For Use:

The Scantibodies Laboratory, Inc. Adrenocorticotropic Hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands, such as Cushing's syndrome, adrenocortical insufficiency and the ectopic ACTH syndrome.

Dean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021032

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X