(80 days)
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No
The summary describes a laboratory test kit for protein electrophoresis and immunofixation, which are standard biochemical techniques. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is used for in vitro diagnostic separation and screening of abnormal immunoglobulins, which aids in diagnosis and is not directly used for therapy.
Yes
The "Intended Use / Indications for Use" states that the kits are for "qualitative in vitro diagnostic separation of abnormal immunoglobulins" and the test is used "as an aid in screening abnormal proteins in conjunction with clinical and other findings." This directly indicates a diagnostic purpose.
No
The 510(k) summary describes in vitro diagnostic kits (SPIFE IFE Pentavalent kits) used with a hardware system (SPIFE 2000/3000 system) for laboratory testing. This clearly involves physical reagents and hardware, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The SPIFE IFE Pentavalent kits are intended for the qualitative in vitro diagnostic separation of abnormal immunoglobulins in serum..."
This phrase clearly identifies the device as being used for diagnostic purposes outside of the living body (in vitro).
N/A
Intended Use / 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.
Product codes
CFF, DFH, DEH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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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