SPIFE

K972274 · Helena Laboratories · CEF · Oct 27, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972274
• Device Name: SPIFE
• Applicant: Helena Laboratories
• Product Code: CEF · Clinical Chemistry
• Decision Date: Oct 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1630
• Device Class: Class 1

Intended Use

This kit is intended for separation and/or quantitations of serum proteins and immunoglobulins using agarose gel electrophoresis. These tests can be useful in diagnosing various disease states which typically exhibit abnormal patterns. Examples of such diseases are inflamatory response, rheumatic fever, liver disease, protein-loss disorders, plasma cell dyscrasias, genetic deficiencies and gammopathies responsible for multiple myeloma, collagen disorders and other chronic infections.

Device Story

SPIFE Electrophoresis System performs agarose gel electrophoresis for separation and quantitation of serum proteins and immunoglobulins. Used in clinical laboratory settings by trained personnel. System automates electrophoresis process; provides visual and quantitative analysis of protein patterns. Healthcare providers use results to identify abnormal protein profiles associated with various pathologies, including multiple myeloma and inflammatory conditions. System facilitates diagnostic assessment of patient serum samples.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Agarose gel electrophoresis system for protein separation. Class I device (Product Code: CEF).

Indications for Use

Indicated for the separation and/or quantitation of serum proteins and immunoglobulins in patients suspected of having disease states characterized by abnormal protein patterns, including inflammatory response, rheumatic fever, liver disease, protein-loss disorders, plasma cell dyscrasias, genetic deficiencies, gammopathies (e.g., multiple myeloma), collagen disorders, and chronic infections.

Regulatory Classification

Identification

A protein (fractionation) test system is a device intended to measure protein fractions in blood, urine, cerebrospinal fluid, and other body fluids. Protein fractionations are used as an aid in recognizing abnormal proteins in body fluids and genetic variants of proteins produced in diseases with tissue destruction.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 27 1997

Pat Franks . Assistant Director, Regulatory Affairs Helena Laboratories 1530 Lindbergh Drive P.O. Box 752 Beaumont, Texas 77704-0752

Re : K972274 SPIFE™ Electrophoresis System & SPE VIS-60 Procedure Requlatory Class: I Product Code: CEF Dated: June 12, 1997 Received: June 18, 1997

Dear Ms. Franks:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਖ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,
Steven Sitman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices ---Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Unknown at this time

Device Name:

SPIFETM Electrophoresis System

Indications for Use:

mis kit is intended for separation and/or quantitations of serum proteins and immunoglobulins using agarose gel electrophoresis.

mese tests can be useful in diagnosing various disease states which typically exhibit abnormal patterns. Examples of such diseases are inflamatory response, rheumatic fever, liver disease, protein-loss disorders, plasma cell dyscrasias, genetic deficiencies and gammopathies responsible for multiple myeloma, collagen disorders and other chronic infections.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 1 (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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