INTERLAB IMMUNOFIXATION TEST(S)

K033187 · Interlab S.R.L. · CFF · Nov 19, 2003 · Immunology

Device Facts

• Record ID: K033187
• Device Name: INTERLAB IMMUNOFIXATION TEST(S)
• Applicant: Interlab S.R.L.
• Product Code: CFF · Immunology
• Decision Date: Nov 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

Interlab Immunofixation Electrophoresis Test is for the qualitative in vitro diagnostic separation and identification of abnormal immunoglobulins (IgG, IgM, IgA) and kappa and lambda light chains in human serum and concentrated urine using cellulose acetate supported on Mylar® for the Microtech 672 PC and IFX 600 instruments. This test is useful as an aid in identifying suspected monoclonal gammopathies.

Device Story

System performs immunofixation electrophoresis to identify monoclonal gammopathies; utilizes cellulose acetate membranes supported on Mylar; processes human serum and concentrated urine samples. Operates on Microtech 672 PC and IFX 600 instruments. Intended for clinical laboratory use by trained personnel. Device separates proteins via electrophoresis; applies specific antisera to identify immunoglobulin classes and light chains. Output consists of electrophoretic patterns for visual interpretation by laboratory professionals to aid in clinical diagnosis of monoclonal gammopathies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System utilizes cellulose acetate membranes supported on Mylar. Electrophoresis-based separation principle. Designed for use with Microtech 672 PC and IFX 600 instruments. In vitro diagnostic use.

Indications for Use

Indicated for qualitative in vitro diagnostic separation and identification of abnormal immunoglobulins (IgG, IgM, IgA) and kappa and lambda light chains in human serum and concentrated urine. Used as an aid in identifying suspected monoclonal gammopathies in patients.

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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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 eagle or bird-like symbol with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side of the symbol.

2098 Gaither Road NOV 1 9 2003 Rockville MD 20850

Food and Drug Administration

Interlab Scientific Instruments SRL c/o Mr. Gary Lehnus Trouble Shooter Consulting, Inc. 150 Cherry Lane Road East Stroudsburg, PA 18301-8804

Re: k033187

> Trade/Device Name: InterLab Immunofixation Electrophoresis Test System Regulation Number: 21 CFR § 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E Immunological Test System Regulatory Class: II Product Code: CFF, JKM Dated: September 30, 2003 Received: October 1, 2003

Dear Mr. Lehnus:

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 (QS) regulation (21 CFR Part 820). 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.

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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 [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/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: InterLab Immunofixation

Electrophoresis Test System

## Indications For Use:

Interlab Immunofixation Electrophoresis Test is for the qualitative in vitro diagnostic separation and identification of abnormal immunoglobulins (IgG, IgM, IgA) and kappa and lambda light chains in human serum and concentrated urine using cellulose acetate supported on Mylar® for the Microtech 672 PC and IFX 600 instruments. This test is useful as an aid in identifying suspected monoclonal gammopathies.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

A.P. Reeves for D.J. O'Leary

(Mivision Sian-Division of Clinical Laboratory Devices

510(k) number K033187

**Prescription Use**
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)