MESACUP TEST MPO, MODEL 11053

K040586 · Rhigene, Inc. · MOB · Mar 22, 2004 · Immunology

Device Facts

• Record ID: K040586
• Device Name: MESACUP TEST MPO, MODEL 11053
• Applicant: Rhigene, Inc.
• Product Code: MOB · Immunology
• Decision Date: Mar 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The MESACUP Test MPO is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG anti-myeloperoxidase (MPO) antibodies in human serum. Clinical (hospital and reference) laboratory personnel are the intended users of the MESACUP Test MPO.

Device Story

MESACUP Test MPO is an ELISA kit for detecting IgG anti-myeloperoxidase (MPO) antibodies in human serum. Input: patient serum samples. Process: samples incubated in MPO-coated 96-well plates; anti-MPO antibodies bind to antigen; unbound proteins washed away; HRP-labeled anti-human IgG added; TMB/H2O2 chromogenic substrate added. Output: color intensity proportional to anti-MPO concentration, measured via spectrophotometry at 450nm. Used in clinical/reference laboratories by trained personnel. Results aid physicians in diagnosing systemic vasculitides, specifically microscopic polyarteritis and crescentic glomerulonephritis.

Clinical Evidence

Clinical performance evaluated in 79 patients with suspected systemic vasculitis and 80 healthy donors. Sensitivity: 36.7% of suspected vasculitis patients tested positive. Specificity: 100% in healthy donors (0/80 positive). Cross-reactivity assessed in autoimmune disease subgroups (RA, Sjögren's, SLE, MCTD, Polymyositis/Dermatomyositis). Method comparison against predicate (N=159) yielded 86.67% positive agreement and 97.67% negative agreement.

Technological Characteristics

Indirect ELISA; microtiter plate solid phase; MPO antigen coating. Conjugate: HRP-goat anti-human IgG. Substrate: TMB/H2O2. Detection: Photometric (450/620 nm). Reportable range: 5-200 U/mL. Assay time: 150 minutes at room temperature. Manual/automated plate processing.

Indications for Use

Indicated for use as an aid in the diagnosis of systemic vasculitides, including microscopic polyarteritis and crescentic glomerulonephritis. Prescription use only.

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Predicate Devices

• The Binding Site Bindazyme Human Anti-MPO Enzyme Immunoassay Kit (k981030)

Submission Summary (Full Text)

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## SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS MESACUP Test MPO February 27, 2004

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The MESACUP Test MPO is compared to a legally marketed predicate device and a substantial equivalence claim made. The predicate device is Bindazyme Human Anti MPO Enzyme Immunoassay Kit (K981030) currently manufactured and marketed by The Binding Site Ltd., Birmingham, U.K.

The MESACUP Test MPO is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with myeloperoxidase antigen. Incubation allows the anti-MPO antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgG immunoglobulins, labeled with horseradish peroxidase (HRP), are added forming complexes with the MPO bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-MPO antibodies. Optical density is read spectrophotometrically at 450nm. The total incubation time (at room temperature) of the assay is 150 minutes. The assay makes use of two callbrators to measure the amount of anti-MPO antibody in patient samples.

The intended use of the device is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG anti-MPO antibodies in human serum. The MESACUP Test MPO is intended for in vitro diagnostic use as an aid in the diagnosis of certain systematic vasculitides such as microscopic polyarteritis and crescentic glomerulonephritis.

Performance indicates that MESACUP Test MPO and the Bindazyme Human Anti MPO Enzyme Immunoassay are equivalent. In-house studies indicate a clinical specificity of 100% for anti-MPO antibodies in a healthy donor serum population on both kits. Additional studies resulted a sensitivity of 37% and 38% with a vasculitis population on both assay respectively for anti-MPO antibodies. In general, the performance characteristics are comparable between the two methods (96% relative agreement).

Ylusk Robe

Yusuke Kobe Vice President Sales and Marketing Department

2/27/2004

Date

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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MAR 2 2 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

RhiGene. Inc. c/o Ms. Nanci Dexter Director of Quality and Regulatory Affairs Corgenix, Inc. 12061 Tejon Street Westminster, CO 80234 Re: k040586 Trade/Device Name: MESACUP Test MPO Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MOB Dated: February 27, 2004 Received: March 5, 2004

Dear Ms. Dexter:

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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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.

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.

Joseph L. Hackett

Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

KO40586 510(k) Number :_______________________________________________________________________________________________________________________________________________________________

Device Name: MESACUP Test MPO

Indications for Use:

The MESACUP TEST MPO is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG anti-myeloperoxidase (MPO) antibodies in human serum. The MESACUP TEST MPO is intended for in vitro diagnostic use as an aid in the diagnosis of certain systemic vasculitides such as microscopic polyarteritis and crescentic glomerulonephritis.

The MESACUPTest MPO is intended to be used by clinical (hospital and reference) laboratories.

### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109) OR

Over-The-Couter Use

Optional Format 1-2-96)

I Reserve for Mr. Chan
Division: Div. Comd.

Division of Clinical Laboratory Devices

510(k) Number K040556