SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458

K061069 · Helena Laboratories · CFF · Jul 6, 2006 · Immunology

Device Facts

• Record ID: K061069
• Device Name: SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
• Applicant: Helena Laboratories
• Product Code: CFF · Immunology
• Decision Date: Jul 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended 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.

Device Story

SPIFE IFE Pentavalent kits serve as screening tools for abnormal serum immunoglobulins; utilizes agarose gel electrophoresis and immunofixation on SPIFE 2000/3000 system. Input: serum samples. Process: protein separation via electrophoresis followed by immunoprecipitation using pooled antisera (IgG, IgA, IgM, Kappa, Lambda); gel washing; staining with Acid Violet. Output: visualized protein bands on gel. Used in clinical laboratories; operated by trained personnel. Healthcare providers interpret band patterns to identify potential monoclonal/polyclonal abnormalities; positive screens require follow-up identification using monospecific antisera. Benefits: rapid screening of multiple samples per gel to aid in diagnosis of immunoglobulin-related disorders.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

In vitro diagnostic test system for immunofixation electrophoresis. Utilizes SPIFE 2000/3000 instrumentation for automated electrophoresis and staining. Reagents include pentavalent antisera for qualitative separation of immunoglobulins. Class II device (Product Codes CFF, DFH, DEH).

Indications for Use

Indicated for screening abnormal serum immunoglobulins in patients; intended for prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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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