(66 days)
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.
ACTH Immunoradiometric (IRMA) Assav
This appears to be a 510(k) premarket notification approval letter for a medical device (ACTH Immunoradiometric (IRMA) Assay) and not a study report. Therefore, the provided text does not contain the detailed information required to describe acceptance criteria and a study proving device performance in the manner requested.
Specifically, the document is an FDA letter stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not contain:
- A table of acceptance criteria and reported device performance.
- Details on sample size, data provenance, or ground truth establishment for a test set.
- Information on expert adjudication or qualifications.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on standalone algorithm performance.
- Details on the sample size or ground truth for a training set.
The document only states the "Indications For Use" of the ACTH IRMA Assay.
Therefore, I cannot provide the requested information based on the input text.
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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.
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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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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ANTIBODIES Laboratory, Inc.
The Power of Antibodies to Select and Defect
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9336 Abraham Way ● Santee, CA 92071-2862 USA ● Phone (619) 258-9300 ● Fax (619) 258-9366
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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
§ 862.1025 Adrenocorticotropic hormone (ACTH) test system.
(a)
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.(b)
Classification. Class II.