(64 days)
The SPIFE 3000 TITAN GEL IgG IEF Kit is intended for the qualitative identification of IgG-specific oligoclonal banding in paired serum and CSF samples by agarose gel isoelectric focusing and immunoblotting, as an aid in the diagnosis of inflammatory disease of the central nervous system, such as caused by multiple sclerosis
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The provided text is a 510(k) clearance letter from the FDA for a device called "SPIFE 3000 Titan Gel IgG IEF Kit". This document primarily focuses on regulatory approval based on substantial equivalence, and not on the detailed reporting of a study that establishes acceptance criteria and proves the device meets them in the way modern AI/ML device submissions would.
Therefore, the information you're requesting regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in the provided text.
The document states the indications for use: "The SPIFE 3000 TITAN GEL IgG IEF Kit is intended for the qualitative identification of IgG-specific oligoclonal banding in paired serum and CSF samples by agarose gel isoelectric focusing and immunoblotting, as an aid in the diagnosis of inflammatory disease of the central nervous system, such as caused by multiple sclerosis."
However, it does not include the detailed performance study results that would typically define "acceptance criteria" and "reported device performance" in the format you've requested. The FDA's 510(k) clearance process for this type of device (from 2003) often relies on demonstrating substantial equivalence to a predicate device rather than presenting extensive, de novo clinical trial data with predefined acceptance metrics and detailed statistical analysis on a test set.
In summary, the input text does not contain the information necessary to fulfill your request for: a table of acceptance criteria and reported device performance, sample sizes and data provenance for test sets, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 9 2003
Mr. Eric Petersen Vice President Helena Laboratories 1530 Lindbergh Drive Beaumont, TX 77704
Re: K024162
Trade/Device Name: SPIFE 3000 Titan Gel IgG IEF Kit Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E immunological test system Regulatory Class: Class II Product Code: CFF Dated: February 5, 2003 Received: February 6, 2003
Dear Mr. Petersen:
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 (OS) 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: SPIFE 3000 Titan Gel IgG IEF Kit
Indications for Use:
The SPIFE 3000 TITAN GEL IgG IEF Kit is intended for the qualitative identification of IgG-specific oligoclonal banding in paired serum and CSF samples by agarose gel isoelectric focusing and immunoblotting, as an aid in the diagnosis of inflammatory disease of the central nervous system, such as caused by multiple sclerosis
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
J. Reeves for J. Bautista
Division of Clinical La
(Optional Format 1-2-96)
510(k)mber K024162
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).