(59 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, and the ectopic ACTH syndrome.
ACTH Immunoradiometric (IRMA) Assay
The provided document is a 510(k) clearance letter from the FDA for a device called "ACTH Immunoradiometic (IRMA) Assay" manufactured by Scantibodies Laboratory, Inc. This letter primarily confirms the substantial equivalence of the device to legally marketed predicate devices.
However, the document does not contain the specific acceptance criteria, study details, or performance data that would typically be found in a study report or a more detailed submission. It states that the FDA "reviewed your Section 510(k) premarket notification" and deemed the device substantially equivalent. The information provided is primarily administrative and regulatory.
Therefore, based solely on the provided text, I cannot generate the requested information about acceptance criteria, detailed study design, sample sizes, ground truth establishment, or multi-reader multi-case studies because that specific data is not present in this regulatory clearance letter.
To provide the requested information, a different document, such as a summary of safety and effectiveness, the 510(k) submission itself, or a published study report, would be needed.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 2 0 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Michael Nordstrom Q/A/RA Manager Scantibodies Laboratory, Inc. 9336 Abraham Way Santee, CA 92071
K050748 Re:
K050746
Trade/Device Name: ACTH Immunoradiometic (IRMA) Assay Regulation Number: 21 CFR 862.1025 Regulation Name: Adrenocorticotropic hormone (ACTH) test system Regulatory Class: Class II Product Code: CKG Dated: March 18, 2005 Received: March 22, 2005
Dear Mr. Nordstrom:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaren b 1 ((t) personal and the equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ase stated in the encrosale) to regars the Medical Device Amendments, or to commerce provision of May 20, 1976, are excordance with the provisions of the Federal Food, DNA ( devices that have occh recuire approval of a premarket approval application (PMA). and Costictle Act (71ct) that to nevice, subject to the general controls provisions of the Act. The r ou may, mercerere, mance and act include requirements for annual registration, listing of general controls provisions of use tice, 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 your device is enassified (600 and controls. Existing major regulations affecting your device it may be subject to back of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in There 21, uncerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I DA 3 ibsualited or war device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must or any I cach statutes and regaranents, including, but not limited to: registration and listing (21 comply with and the 110 (FR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{1}------------------------------------------------
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to bogin manceing your antial equivalence of your device to a legally premarket notification: "The PDF 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, If you desire specific information and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the v mo Diagnostic Dorroo Dradian by reference to premarket notification" (21 CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the I ou may other only 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/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): K050748
Device Name: ACTH Immunoradiometric (IRMA) Assay ____________________________________________________________________________________________________________________________
Indications For Use:
The Scantibodies Laboratory, Inc. Adrenocorticotropic Hormone (ACTH) test
Children Career Mally Massance odronocorticotropic hormone in plass The Scantibodies Laboratory, Inc. Adrenocorticotropic hormone in plasma.
system is a device intended to measure adrenocorticotropic hormone in plasma.
System is a device inte system is a device intended to hicaso offerential diagnosis and treatment of
ACTH measurements are used in the differential diagnosis and treatment of ACTH measurements are used in the such as Cushing's syndrome,
certain disorders of the adrenal glands, such as Cushing's syndrome certain disolueis of the duronal gianas, of the ectopic ACTH syndrome.
Prescription Use A (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 In Vitro Diagnostic Devices (OIVD)
Qutle a. heeler
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
§ 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.