(80 days)
The SPIFE IFE Pentavalent kits are intended for the qualitative in vitro diagnostic separation of abnormal immunoglobulins in serum using protein electrophoresis and immunofixation on the SPIFE 2000/3000 system. All specimens exhibiting an abnormal immunoglobulin must be retested with antibody specific SPIFE IFE Antisera (G,A,M,K,L) for identification. The test is used as an aid in screening abnormal proteins in conjunction with clinical and other findings.
Not Found
I am sorry, but the provided text is a regulatory clearance letter from the FDA and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.
The document states that the device, "SPIFE® IFE-3 Pentavalent Kit, SPIFE® IFE-6 Pentavalent Kit, SPIFE® IFE-9 Pentavalent Kit, SPIFE® IFE-15 Pentavalent Kit," is substantially equivalent to legally marketed predicate devices. It lists the "Indications for Use" as: "The SPIFE IFE Pentavalent kits are intended for the qualitative in vitro diagnostic separation of abnormal immunoglobulins in serum using protein electrophoresis and immunofixation on the SPIFE 2000/3000 system. All specimens exhibiting an abnormal immunoglobulin must be retested with antibody specific SPIFE IFE Antisera (G,A,M,K,L) for identification. The test is used as an aid in screening abnormal proteins in conjunction with clinical and other findings."
However, it does not provide any specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets), details of a study (sample sizes, data provenance, expert qualifications, adjudication methods, ground truth, training set information), or effectiveness studies (MRMC or standalone performance).
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Image /page/0/Picture/1 description: The image shows a circular logo with an abstract bird-like symbol in the center. The symbol is composed of three curved lines that resemble feathers or wings. Encircling the symbol is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES USA'. The text is arranged along the perimeter of the circle, with the words 'DEPARTMENT' and 'USA' positioned at the top and bottom, respectively.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Helena Laboratories c/o Ms. Patricia Franks Assistant Director of Regulatory Affairs 1530 Lindbergh Dr Beaumont, TX 77704
Re: K061069
Trade/Device Name: SPIFE® IFE-3 Pentavalent Kit, SPIFE® IFE-6 Pentavalent Kit, SPIFE® IFE-9 Pentavalent Kit, SPIFE® IFE-15 Pentavalent Kit Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E Immunological Test System Regulatory Class: Class II Product Code: CFF, DFH, DEH Dated: April 13, 2006 Received: April 17, 2006
JUL - 6 2006
Dear Ms. Franks:
We have reviewed your Scction 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 comments o 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 Nostman 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 it in cran be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In additing Journer 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 complex with all the Act`s requirements, including, but not limited to: registration and listing (21 CFR (207); 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 clectronic 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 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 a vonderice to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0484. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Rebekah Becker
Robert L. Becker, Jr M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KO61069
Device Name: SPIFE IFE Pentavalent Antisera Kits
Indications For Use:
The SPIFE IFE Pentavalent kits are intended for the qualitative in vitro diagnostic separation of abnormal immunoglobulins in serum using protein electrophoresis and immunofixation on the SPIFE 2000/3000 system.
All specimens exhibiting an abnormal immunoglobulin must be retested with antibody specific SPIFE IFE Antisera (G,A,M,K,L) for identification.
The test is used as an aid in screening abnormal proteins in conjunction with clinical and other findings.
Prescription Use AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 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)
Maria Chen
Division Sign-Off
Office of In Vitro Diagnostic Device Evatuation and Safe:
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510kl
§ 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).