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K-0q IMeridian Bioscience, Inc.Cincinnati, OHMAR 1 6?005SUMMARY OF SAFETY AND EFFECTIVENESSIDENTIFICATION INFORMATIONSUBMITTER'S INFORMATIONThis summary of 510(k) safety and effectiveness is being submitted in accordance with therequirements of SMDA 1990 and 21 CFR 807.20.SUBMITTER'S NAME AND ADDRESS: Meridian Bioscience, Inc.3471 River Hills DriveCincinnati, OH 45244PHONE NUMBER: (513)271-3700FAX NUMBER: (513) 272-5213CONTACT PERSON: Susan RolihOfficial CorrespondentDATE SUMMARY PREPARED: March 11, 2005TRADE NAME: ImmunoCard STAT! Flu A & BBCOMMON NAME: Rapid, qualitative lateral-flow immunoassay for the detection of Influenza A andantigenCLASSIFICATION NAME: Antigen, CF (including CF control), influenza virus A, B, CREGULATION: 866.3330INTENDED USES:ImmunoCard STATI Flu A&B is a rapid, qualitative, lateral-flow immunoassay for detecting bothinfluenza A and influenza B viral nucleoprotein antigens in human nasal wash, nasopharyngealaspirate and nasal and nasopharyngeal swab samples. It is designed to test samples fromcellpediatric and adult patients. It is recommended that all negative test results be confirmed byculture.PREDICATE DEVICES:ImmunoCard STAT! Flu A & B is intended to detect the same analytes as other cleared devicesincluding: Binax NOW Flu A B [a rapid lateral-flow immunoassay cleared to market under 510(k)sK021649 and K0216461 (Binax, Inc. South Portland, ME)· BD Directigen Flu A B [a rapid enzyme immunoassay cleared to market under 510(k) K001364](Becton Dickinson & Co., Sparks, MD)· FLU OIA [an optical immunoassay cleared to market under 510(k) K0235561 (Thermo-Biostar Inc.,Louisville, CO)· Quickvue Influenza A B Test [a rapid lateral-flow immunoassay cleared to market under 510(k)K031899] (Quidel, Inc., San Diego, CA)· Xpext Flu A/B [a rapid immunochromatographic assay cleared to market under 510(k) K031565](Remel, Inc., Lenexa, KS)Tab 6 page 1

Meridian Bioscience, Inc.Cincinnati, OH* Zstatflu Test for Influenza types A & B Virus [an endogenous viral-encoded enzyme assay clearedto market under 510(k) K982429] (ZymeTx, Inc., Oklahoma City, OK)BACKGROUND:Influenza is a highly contagious, epidemic to pandemic acute viral respiratory disease caused byseveral genera for the Orthomyxoviridae family. Influenzavirus A and Influenzavirus B are the twogenera most commonly associated with disease in humans. (1,2) Influenza infection rates tend to behighest in pediatric populations, while serious complications from influenza disease are more commonin the elderly. (2) Clinical signs and symptoms begin after a 1-4 day incubation period and includecough, fever, myalgia and malaise. The clinical presentation of influenza can range from asymptomaticinfection to fatal pneumonia. (1) Influenza co-circulates with other respiratory pathogens, hence it isimportant to differentiate influenza from other respiratory diseases. (2) Antiviral drugs in general haveshown more significant clinical benefit when administered within 48 hours of the appearance ofsymptoms, which obviates the need for the rapid detection of influenza. Not all antiviral drugs areeffective against both influenza A and influenza B, therefore it is important to distinguish between thetwo. (2,4)Influenza A and B can be detected in human respiratory samples by a variety of methods including cellculture, immunofluorescent assay and enzyme immunoassay. Cell culture isolation remains the goldstandard for the detection of influenza, yet the procedure can take 7 days to complete. (1)Immunofluorescent antibody-based tests are moderately sensitive, yet highly dependent on specimenquality and preparation. The rapid detection of influenza using enzyme and microparticle-basedimmunoassays has become an important aspect of patient management in patients of all ages withacute respiratory disease due to influenza. (1,3,4) The results from this test are used to support dataavailable from the patient's clinical evaluation and assist the physician in determining the course ofaction.Type of testImmunoCard STAT! Flu A & B is a rapid, qualitative lateral-flow immunoassay screening test.Specimen typeThe following specimens have been found compatible with ImmunoCard STAT! Flu A & B1. Nasal wash2. Nasopharyngeal aspirate3. Nasopharyngeal swab4. Nasal swabConditions for useImmunoCard STAT! Flu A & B is designed for use by laboratory professionals under the normalenvironmental conditions. The assay, which is stored at 2-8 C when not in use, is brought to roomtemperature prior to use. Normal laboratory lighting, humidity and temperature do not affect theperformance of the assay.ContraindicationsThere are no contraindications associated with the use of this product.Special instrument requirementsNo instruments are used with this product.Tab 6 page 2

Meridian Bioscience, Inc.Cincinnati, OHCombination with other medical devicesNo other medical devices are used in combination with this device.DEVICE DESCRIPTION AND TECHNOLOGICAL PRINCIPLESReagentsimmunoCard STAT! Flu A & B is distributed as a test kit that includes the following reagents:ImmunoCard STATI Flu A & B Test Device: A chromatography strip housed in a plasticframe and enclosed in a foil pouch with a desiccant. The membrane carries immobilizedmonoclonal anti-influenza A and anti-influenza B capture antibodies at the TEST line and goatanti-mouse antibody at the CONTROL line. The strip also contains colloidal gold conjugatedto monoclonal anti-influenza A and anti-influenza B as the detection antibodies.Sample Diluent:preservative.A buffered protein solution containing sodium azide (0.095%) as aPositive Control: Inactivated influenza A and influenza B virus in a buffered solutioncontaining sodium azide (0.095%) as a preservative.Equipment needed to use the deviceThere is no equipment needed to use this device.Interfering substancesWhole blood, at concentrations greater than 0.5% may interfere with the interpretation of testresults.CalibratorsThere are no calibrators used with this device.ControlsThe assay includes an internal CONTROL line that is used to demonstrate that sample has beenapplied, that it has flowed correctly and that the conjugated detector antibody is active at the timeof testing. A colorless to light pink background around the Flu A and Flu B TEST and CONTROLlines serves as a negative control and indicates that reagents were performing correctly at thetime of use.Positive Control Reagent and Sample Diluent (used for a negative control reagent) are suppliedas external controls. These reagents also serve as indicators that the test was performedcorrectly, that the capture and detector antibodies were active at the time of use, and that themembrane supports proper sample flow.wasFailure of the internal and external control to produce the expected results suggests the not performed correctly (ie, incorrect volumeor times used or that reagents were not brought to room temperature prior to testing).Tab 6 page 3

Meridian Bioscience, Inc.Cincinnati, OHTechnological principlesofImmunoCard STAT! Flu A & B uses specific monoclonal antibodies directed at the nucleoproteinsandAinfluenzainfluenza A or influenza B as the capture and detector antibodies. Monoclonaltest device at the reaction site markedmonoclonal influenza B are immobilized on the membrane of theinfluenzaB conjugated to colloidal goldandAinfluenzaMonoclonalrespectively.B,FLU A and FLUwash, nasopharyngeal(nasalare suspended within the membrane. To perform the test, samplethen added to theDiluent,Samplewithaspirate, nasopharyngeal swab, nasal swab) is first dilutedbind the conjugatesampletheinantigensBsample port of the Test Device. Influenza A or influenzaA-gold conjugateinfluenzaThedevice.thedetector antibodies as the sample migrates throughSimilarly, a pinkline.pink-redvisibleaproducingAFLUcomplex will bind at the window site markedsite marked FLUwindowtheatbindscomplexconjugatered line will appear when the influenza B-goldsites.BFLUorAFLUtheeitheratappearslineB. In the absence of antigen, no pink-redpink-red lineGoat anti-mouse antibody is bound at the membrane site marked "Control". A visibleto obtain aFailureshould appear at this position each time a sample or control reagent is tested.failure.visible pink-red control line invalidates the test and is an indication of assayDEMONSTRATION OF EQUIVALENCE TO PREDICATE DEVICESThe Limit of Detection (LOD)preparationsTo determine the LOD, the assay was evaluated with influenza A and influenza B antigen6-1 showsTable(ATCC) diluted in pH 7.2 phosphate buffered saline containing sodium azide (PBSA).the sameisvirions/mLthe LOD for the strains of influenza tested. For the purposes of this evaluation,as TCI[)5o/mL.Table 6-1. LOD determination for ImmunoCard STAT! Flu A & B.VR-1102uFVR823VR101FFluluVR295VR790FuFlu B--VR-822VR97VR95VR547VR544VR897Limit of Detection (LOD)Strain TypeStrain IDB533BBB187Flu AFlu AFlu AFlu AFlu AFlu Av/mL630,000 v/mL530,000 v/mLvlmL15,000 vlmL74,000 v/mL5,300 v/mL35,000 v/mL8,800 v/mL890 v/mL5,600 v/mLLegend: v/mL vidons per milliliterClinical trialstesting on archivalThree independent laboratories and Meridian's Development Laboratory performedpatients. Eachsymptomaticfromcollectedsamplesfrozen (retrospective) or fresh (prospective)Flu A & BSTAT!ImmunoCardandBFluNOWandAFluNOWlaboratory tested the samples by Binax(substantially equivalent devices), ImmunoCard STAT! Flu A & B and culture.Tab 6 page 4

Meridian Bioscience, Inc.Cincinnati, OHThe data in Table 6-2 shows the overall sensitivity and specificity of ImmunoCard STATI Flu A&B inis further divided tocomparison to culture with wash/aspirate and swab samples. In Table 6-3, the datasamples.show the performance of prospective (freshly collected) versus retrospective (frozen)Table 6-2 Performance of Wash/Aspirate Vs Swab samplesWashiAspirate Specimens]3IssuCulture Pos (Std)STissue cultureNeg(Std)Total'1 Binax Flu B InvalidNeg10411712516166149ICS FluAI Tissue CulturePos cimensSwab SLpecimensuCS FluAICSTotalNetP-oNe PoTota33428253Tissue CultureNeg (Std)Total*1 Binax Flu A Invalid, 1 Binax Flu B InvalidFos--Binax Flu A* TtloIBinax Flu B*Flu BICSNeE eoaos--Neg?T otalPosNegTotal370.4272531} 403391428344538342712259037572210417621Table 6-3 Performance of prospective and retrospective samplesPs12820Tissue Culture Pos (Std)TjssueCultureNeg(Std)Total'1 Binax Flu B InvalidNeg3110113CS Flu AI Pos Neg1129TissueCulturePos(Std)2292(Std)NegTissue Culture24031Total*1 Binax Flu A Invalid, I Binax Flu B InvalidFresh samplesPos11516Total15118Pos20Total40231271Binax Flu Tissue Culture Pos(Std)Tissue Culture Neg(Std)Total--15253Pos377CS Flu ANe913100SwabTissue Culture Pos (Std)TissuieCulture Neg (Std)Total24236294411Total/Neg!PosNeg pos Total I 532531128128ICS Flu BTotalNeg2562460 246252t 2158235828228Total50107Pos34215731535Binax Flu AN16105121Pos909245822048050107157Pos6060800 213228082ICS FluBTotalNe126145145151Binax Flu B*TotalNeg2516245245Binax Flu BFlu BBinax FluICS Flu AFrozen sICSWash/AspirateFrozen samplesTotal15118133-SwabBinax Flu B*ICS Flu BBinax Flu AICS Flu AFresh samplesWashiAspirate157Pos43135079280Binax Flu BTotalNeg128145114122Tab 6 page 5157