BINAXNOW PBP2A TEST, MODEL 890-000

K090301 · Binax, Inc. · MYI · Apr 14, 2010 · Microbiology

Device Facts

• Record ID: K090301
• Device Name: BINAXNOW PBP2A TEST, MODEL 890-000
• Applicant: Binax, Inc.
• Product Code: MYI · Microbiology
• Decision Date: Apr 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The BinaxNOW® PBP2a Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of penicillin-binding protein 2a (PBP2a) present in methicillinresistant Staphylococcus aureus (MRSA). The test is performed directly on blood culture samples positive for S. aureus. The BinaxNOW® PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections. Subculturing positive blood cultures is necessary to recover organisms for susceptibility testing or epidemiological typing.

Device Story

The BinaxNOW® PBP2a Test is a rapid immunochromatographic membrane assay; utilizes monoclonal antibodies to detect PBP2a protein directly from S. aureus-positive blood cultures. The test strip, containing immobilized test and control antibodies, is housed in a book-shaped hinged cardboard device. The operator adds a prepared sample to the sample pad; results are read visually at 10 minutes. Used in clinical laboratory settings by trained personnel. The test provides qualitative results to assist in identifying MRSA; however, it does not replace the need for subculturing and standard susceptibility testing for clinical decision-making or epidemiological typing.

Clinical Evidence

Multi-center clinical study (2008-09) at four US hospital laboratories. Evaluated 199 S. aureus samples compared to Cefoxitin disc diffusion, Oxacillin disc diffusion, and automated MIC systems. Overall sensitivity 97.1% (MRSA positive) and specificity 100% (MRSA negative). Reproducibility study across 3 sites, 6 operators, and 5 days showed 100% (599/599) agreement. Analytical sensitivity (LOD) determined to be 2.5 x 10^7 cells/mL.

Technological Characteristics

Immunochromatographic membrane assay; utilizes monoclonal antibodies immobilized on a test strip. Form factor: cardboard, book-shaped hinged device. Reagents include alkaline solutions and pH indicators. Visual readout. No electronic components or software.

Indications for Use

Indicated for the qualitative detection of PBP2a protein in blood culture samples previously identified as positive for S. aureus to aid in the identification of MRSA. Not for diagnosing MRSA or guiding/monitoring treatment.

Regulatory Classification

Identification

An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Predicate Devices

• Mueller Hinton Agar w/4% NaCl w/antibiotics (Remel) (K850291)
• Oxoid PBP2' Latex Agglutination test (k011710)

Submission Summary (Full Text)

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# 510(k) SUMMARY

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 assigned 510(k) number is: k090301

### SUBMITTER

Binax, Inc. 10 Southgate Road Scarborough, Maine 04074 [phone] (Office) [phone] (FAX) Establishment Registration Number: 1221359

APR 1 | 2010

### CONTACT PERSON

Suzanne M. Vogel [e-mail] (email)

DATE PREPARED April 12th, 2010

TRADE NAME BinaxNOW® PBP2a Test

#### COMMON NAME

BinaxNOW® PBP2a Test, BinaxNOW® PBP2a, Binax NOW® PBP2a Test, Binax NOW® PBP2a, NOW® PBP2a Test, NOW® PBP2a

#### CLASSIFICATION NAME

System, Test. Genotypic Detection, Resistant Markers, Staphylococcus Colonies (MYI) (per 21 CFR 866.1640)

#### PREDICATE DEVICES

Mueller Hinton Agar w/4% NaCl w/Antibiotics (Remel) K850291 PBP22 Latex Agglutination Test (Oxoid) K011710

#### DEVICE DESCRIPTION

The BinaxNOW® PBP2a Test is a rapid immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect the PBP2a protein directly from blood cultures which have been identified as being positive for S. aureus. These antibodies and a control antibody are immobilized onto a test strip as two distinct lines and combined with other reagents/pads. This test strip is mounted inside a cardboard, book-shaped hinged test device.

Specimens are aliquots from blood cultures which have been identified as positive for Staphylococcus aureus. After the sample is prepared, it is added to the sample pad at the top of the test strip and the device is closed. Results are read at 10 minutes.

Binax NOW® PBP2a Test 510(k) Notification k090301 Rev. 04/12/10

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## INTENDED USE

The BinaxNOW® PBP2a Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of penicillin-binding protein 2a (PBP2a) present in methicillinresistant Staphylococcus aureus (MRSA). The test is performed directly on blood culture samples positive for S. aureus.

The BinaxNOW® PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections. Subculturing positive blood cultures is necessary to recover organisms for susceptibility testing or epidemiological typing.

#### Performance Characteristics

#### Clinical Performance

The clinical performance of the BinaxNOW® PBP2a Test was established in a multi-center clinical study conducted in 2008-09 at four geographically diverse hospital laboratories within the ાટે.

A total of 199 S. aureus samples were evaluated in the BinaxNOW® PBP2a Test and compared to standard methods used routinely by the laboratories: Cefoxitin (30 ug) disc diffusion, Oxacillin (1 ug) disc diffusion, and automated Minimum Inhibitory Concentration (MIC) Systems. Individual samples were evaluated by multiple laboratory methods, and in all cases there was 100% agreement between the reference methods. Among the clinical samples tested, , only three clinical samples (3/199 or 1.5%) produced discrepant results. Overall, the BinaxNOW PBP2a assay identified 97.1% of the specimens positive for MRSA and 100.0% of the specimens negative for MRSA.

The table below presents BinaxNOW® PBP2a Test performance by reference method. Because each sample was tested on more than one reference method, there are more observations in this table (n=317) than the total number of samples (n=199).

| Reference Method | Positive<br>Agreement<br>(95% CI) | Negative<br>Agreement<br>(95% CI) |
|-------------------------------------------------------|-----------------------------------|-----------------------------------|
| Cefoxitin (30 µg) disc diffusion | 96.9% (62/64)<br>(89.3 - 99.1%) | 100.0% (67/67)<br>(94.6 - 100.0%) |
| Oxacillin (1 µg) disc diffusion | 96.5% (55/57)<br>(88.1 - 99.0%) | 100.0% (58/58)<br>(93.8 - 100.0%) |
| Automated Antimicrobial<br>Susceptibility Test System | 97.6% (41/42)<br>(87.7 - 99.6%) | 100.0% (29/29)<br>(88.3 - 100.0%) |

#### BinaxNOW® PBP2a Test Performance vs. Reference Methods

#### Expected Values

In the clinical evaluation of the BinaxNOW® PBP2a Test conducted in 2008-09 at four geographically diverse hospital laboratories within the US, the overall expected rate of PBP2a (MRSA) was 51.3% (102/199), and among the four site populations the expected positive rate ranged from 48.3% to 61.5%.

Binax NOW® PBP2a Test 510(k) Notification k090301 Rev. 04/12/10

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#### Analytical Reactivity

The human pathogenic Network on Antimicrobial Resistance in Staphylococcus aureus (NARSA) and American Type Culture Collection (ATCC) methicillin-resistant Staphylococcus aureus (MRSA) strains listed below tested positive in the BinaxNOW® PBP2a Test as expected.

#### Methicillin-Resistant Staphylococcus aureus (MRSA)

| Methicillin-Resistant Staphylococcus aureus (MRSA) | |
|----------------------------------------------------|--------------------------------------|
| Bacterium | Bacterium |
| Staphylococcus aureus ATCC 33591 | Staphylococcus aureus NRS643(USA300) |
| Staphylococcus aureus ATCC 33592 | Staphylococcus aureus NRS647(USA300) |
| Staphylococcus aureus ATCC 43300 | Staphylococcus aureus NRS657(USA300) |
| Staphylococcus aureus ATCC 49476 | Staphylococcus aureus NRS658(USA100) |
| Staphylococcus aureus ATCC 51153 | Staphylococcus aureus NRS659(USA300) |
| Staphylococcus aureus ATCC 700698 | Staphylococcus aureus NRS660(USA100) |
| Staphylococcus aureus ATCC 700699 | Staphylococcus aureus NRS661(USA100) |
| Staphylococcus aureus ATCC 700789 | Staphylococcus aureus NRS667(USA300) |
| Staphylococcus aureus ATCC BAA1026 | Staphylococcus aureus NRS670(USA100) |
| Staphylococcus aureus ATCC BAA38 | Staphylococcus aureus NRS671(USA100) |
| Staphylococcus aureus ATCC BAA39 | Staphylococcus aureus NRS672(USA100) |
| Staphylococcus aureus ATCC BAA41 | Staphylococcus aureus NRS673(USA100) |
| Staphylococcus aureus ATCC BAA43 | Staphylococcus aureus NRS674(USA100) |
| Staphylococcus aureus ATCC BAA44 | Staphylococcus aureus NRS679(USA100) |
| Staphylococcus aureus NRS123(USA 400) | Staphylococcus aureus NRS687(USA300) |
| Staphylococcus aureus NRS172 | Staphylococcus aureus NRS688(USA300) |
| Staphylococcus aureus NRS192 | Staphylococcus aureus NRS693(USA300) |
| Staphylococcus aureus NRS193 | Staphylococcus aureus NRS694(USA300) |
| Staphylococcus aureus NRS194 | Staphylococcus aureus NRS697(USA100) |
| Staphylococcus aureus NRS22(USA 600) | Staphylococcus aureus NRS699(USA100) |
| Staphylococcus aureus NRS241 | Staphylococcus aureus NRS710(USA100) |
| Staphylococcus aureus NRS245 | Staphylococcus aureus NRS711(USA100) |
| Staphylococcus aureus NRS248 | Staphylococcus aureus NRS716(USA300) |
| Staphylococcus aureus NRS249 | Staphylococcus aureus NRS717(USA100) |
| Staphylococcus aureus NRS382(USA 100) | Staphylococcus aureus NRS721(USA100) |
| Staphylococcus aureus NRS383(USA 200) | Staphylococcus aureus NRS725(USA300) |
| Staphylococcus aureus NRS384(USA 300) | Staphylococcus aureus NRS732(USA300) |
| Staphylococcus aureus NRS385(USA 500) | Staphylococcus aureus NRS733(USA300) |
| Staphylococcus aureus NRS386(USA 700) | Staphylococcus aureus NRS736(USA300) |
| Staphylococcus aureus NRS387(USA 800) | Staphylococcus aureus NRS739(USA300) |

#### Analytical Specificity (Cross-Reactivity)

To determine the analytical specificity of the BinaxNOW® PBP2a Test, methicillin-susceptible Staphylococcus aureus (MSSA), Staphylococcal strains (other than S. aureus) and non-Staphylococcal strains were tested. All strains tested negative in the BinaxNOW® test except Cryptococcus neoformans and Staphylococcus sciuri.

Binax NOW® PBP2a Test 510(k) Notification k090301 Rev. 04/12/10

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Methicillin-Sensitive Staphylococcus aureus (MSSA)

| Bacterium | Bacterium |
|------------------------------------|----------------------------------------------------|
| Staphylococcus aureus ATCC 33862 | Staphylococcus aureus NRS167 |
| Staphylococcus aureus ATCC 13150 | Staphylococcus aureus NRS168 |
| Staphylococcus aureus ATCC 11632 | Staphylococcus aureus NRS169 |
| Staphylococcus aureus ATCC 14776 | Staphylococcus aureus NRS170 |
| Staphylococcus aureus ATCC 6538P | Staphylococcus aureus NRS171 |
| Staphylococcus aureus ATCC 29213 | Staphylococcus aureus NRS173 |
| Staphylococcus aureus ATCC BAA977 | Staphylococcus aureus NRS174 |
| Staphylococcus aureus NRS164 | Staphylococcus aureus NRS175 |
| Staphylococcus aureus NRS165 | Staphylococcus aureus NRS176 |
| Staphylococcus aureus NRS166 | Staphylococcus aureus NRS177 |
| Staphylococcus aureus ATCC 9144 | Staphylococcus aureus Lafferty |
| Staphylococcus aureus ATCC 51740 | Staphylococcus aureus ATCC 31153 |
| Staphylococcus aureus ATCC 29737 | Staphylococcus aureus ATCC 12600 |
| Staphylococcus aureus ATCC 15564 | Staphylococcus aureus ATCC14993 |
| Staphylococcus aureus ATCC 14775 | Staphylococcus aureus ATCC 33862 |
| Staphylococcus aureus ATCC 25923 . | Staphylococcus aureus subsp. Anaerobius ATCC 35844 |

# Staphylococcal Strains (other than S. aureus)

| Bacterium | ATCC# | Bacterium | ATCC# |
|----------------------------------------------------------|---------------------|----------------------------------------------------------|---------|
| Staphylococcus simulans | 27851 | Staphylococcus equorum | 43958 |
| Staphylococcus warneri | 49454 | Staphylococcus lentus | 700403 |
| Staphylococcus lugdunensis | 43809 | Staphylococcus hyicus | 11249 |
| Staphylococcus sciuri | 29601 | Staphylococcus carnosus | 51365 |
| Staphylococcus saprophyticus | 15305 | Staphylococcus capitis | 35661 |
| Staphylococcus schleiferi | 43808 | Staphylococcus arlettae | 43957 |
| Staphylococcus haemolyticus | 29970 | Staphylococcus piscifermentans | 51136 |
| Staphylococcus kloosii | 43959 | Staphylococcus hominis | 27844 |
| Staphylococcus cohnii | 29972 | Staphylococcus caprae | 51548 |
| Staphylococcus xylosus | 49148 | Staphylococcus pasteuri | 51128 |
| Staphylococcus succinus | 700337 | Staphylococcus chromogenes | 43764 |
| Staphylococcus vitulinus | 51162 | Staphylococcus lutrae | 700373 |
| Staphylococcus pulvereri | 51698 | Staphylococcus muscae | 49910 |
| Staphylococcus intermedius | 29663 | Staphylococcus felis | 49168 |
| Staphylococcus gallinarum | 700401 | Staphylococcus auricularis | 33753 |
| Staphylococcus epidermidis | 14990 | Staphylococcus delphini | 49171 |
| Staphylococcus epidermidis | 12228 | Staphylococcus saccharolyticus | 14953 |
| Staphylococcus epidermidis | 35984 | Staphylococcus schleiferi subsp<br>coagulans | 49545 |
| Staphylococcus fleurettii | BAA-274 | Staphylococcus<br>pseudintermedius | 49444 |
| Bacterium | ATCC# | Bacterium | ATCC# |
| Acinetobacter calcoaceticus | 51432 | Macrococcus caseolyticus | 35662 |
| Aerococcus viridans | 10400 | Macrococcus equipercicus | 51831 |
| Aeromonas hydrophila | 35654 | Micrococcus luteus | 27141 |
| Bacillus cereus | 11778 | Moraxella catarrhalis | 25238 |
| Bacillus subtilis | 6633 | Morganella morganii | 25830-T |
| Bacteroides fragilis | 23745 | Neisseria gonorrhoeae | 49226 |
| Beta Strep Group F | 12392 | Neisseria meningitidis, serogroup A | 13077 |
| Burkholderia cepacia | 25416-T | Neisseria sicca | 9913 |
| Candida parapsilosis | 90018 | Parvimonas micra (formerly<br>Peptostreptococcus micros) | 33270 |
| Candida krusei | 14243 | Pasturella multocida | 51687 |
| Cellulomonas turbata (formerly<br>Oerskovia) | 25835 | Pediococcus acidilactici | 12697 |
| Citrobacter freundii | 8090 | Peptostreptococcus anaerobius | 27337 |
| Citrobacter koseri | 25408 | Planococcus citreus | 14404 |
| Clostridium perfringens | 3624 | Proteus mirabilis | 7002 |
| Corynebacterium xerosus | 7711 | Proteus vulgaris | 33420 |
| Corynebacterium amycolatum | 49368 | Providencia stuartii | 49809 |
| Corynebacterium diphtheriae | 13812 | Pseudomonas aeruginosa | 15442 |
| Corynebacterium glutamicum | 13869 | Pseudomonas fluorescens | 49271 |
| Corynebacterium jeikeium | 43734 | Pseudomonas putida | 49128 |
| Corynebacterium<br>pseudodiphtheriticum | 10700-T | Rhodococcus equi | 10146 |
| Corynebacterium urealyticum | 43042 | Rothis mucilaginosa (Stomatococcus) | 25296 |
| Cryptococcus neoformans | 14116 | Salmonella adelaide | 10718 |
| Escherichia coli (ESBL producer) | Clinical<br>isolate | Serratia marcescens | 13880 |
| Enterobacter aerogenes | 35029 | Stenotrophomonas maltophilia | 12637-T |
| Enterobacter cloacae | 49141 | Streptococcus agalactiae, group B | 13813 |
| Enterococcus avium | 49465 | Streptococcus anginosis (milleri) | 33397 |
| Enterococcus casseliflavus | 12817 | Streptococcus dysgalactiae, group C<br>(strain C74) | 12388 |
| Enterococcus durans | 49135 | Streptococcus dysgalactiae, group G<br>(strain Lf D166B) | 12394 |
| Enterococcus faecalis | 49474 | Streptococcus intermedius (milleri) | 27335 |
| Enterococcus faecium | 12952 | Streptococcus mitis | 49456 |
| Enterococcus gallinarum | 49608 | Streptococcus mutans | 25175 |
| Enterococcus hirae | 10541 | Streptococcus pasteurianus (bovis) | 49133 |
| Enterococcus mundtii | 43187 | Streptococcus pneumoniae | 33400 |
| Enterococcus raffinosus | 49464 | Streptococcus pneumoniae | 49136 |
| Escherichia coli | 10798 | Streptococcus pneumoniae | SSI-1 |
| Finegoldia magna (formerly<br>Peptostreptococcus magnus) | 15794 | Streptococcus pneumoniae | SSI-10A |
| Gemella bergeri | 700627 | Streptococcus pneumoniae | 6301 |
| Haemophilus influenzae | 49247 | Streptococcus pneumoniae | 33938 |
| Haemophilus parainfluenzae | 33392-T | Streptococcus pneumoniae | 49619 |
| Klebsiella oxytoca | 49131 | Streptococcus pneumoniae | 51937 |
| Klebsiella pneumoniae | 49472 | Streptococcus pneumoniae | SSI-14 |
| Klebsiella pneumoniae (ESBL prod<br>and KPC pos) | Clinical<br>isolate | Streptococcus pneumoniae | SSI-7F |
| Kocuria kristinae | BAA752 | Streptococcus pneumoniae | 51938 |
| Kytococcus chroeter | 13884 | Streptococcus pyogenes, group A | 12384 |
| Lactobacillus casei | 393 | Streptococcus salivarius | 13419 |
| Lactococcus garvieae | 49157 | Yeast | ATCC# |
| Leuconostoc mesenteroides | 10877 | Candida albicans | 60193 |
| Listeria monocytogenes, serotype 4b | 19115 | Candida glabrata | 66032 |
| | | Candida tropicalis | 750 |

# Non- Staphylococcal Strains

Binax NOW® PBP2a Test
510(k) Notification k090301 Rev. 04/12/10

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Binax NOW® PBP2a Test
5 IO(k) Notification k090301
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#### Interfering Substances:

The 20 potentially interfering substances listed below produced appropriate results in the BinaxNOW® PBP2a test.

| Anti-Inflammatory Drugs | Test<br>Concentration | Endogenous Blood Components | Test<br>Concentration |
|-------------------------|-----------------------|------------------------------------|-----------------------|
| Acetaminophen | 1324 µmol/L | Hemoglobin | 2 g/L |
| Acetylsalicyclic acid | 3.62 mmol/L | Triglyceride sera | 37 mmol/L |
| Ibuprofen | 2425 µmol/L | Conjugated bilirubin | 342 µmol/L |
| Antibiotics | Test<br>Concentration | Unconjugated bilirubin | 342 µmol/L |
| Amoxicillin | 206 µmol/L | γ- globulin | 120g/L |
| Cephalexin | 337 µmol/L | Anti-coagulant | Test<br>Concentration |
| Chloramphenicol | 155 µmol/L | Sodium Polyanetholesulfonate (SPS) | 1% |
| Ciprofloxacin | 30.2 µmol/L | | |
| Erythromycin | 81.6 µmol/L | | |
| Gentamicin | 21 µmol/L | | |
| Tetracycline | 34 µmol/L | | |
| Sulfisoxazole | 1.12 mmol/L | | |
| Sulfamethoxazole | 1.58 mmol/L | | |
| Trimethoprim | 138 µmol/L | | |
| Vancomycin | 69 µmol/L | | |

#### Analytical Sensitivity:

The analytical limit of detection of the BinaxNOW® PBP2a Test in ATCC strain BAA44 at a turbidity level of 0.03 is 2.5 x 10' cells/mL, and the equivalent concentration in CFU/mL is 2.36 x 10'.

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Binax NOW® PBP2a Test 510(k) Notification k090301 Rev. 04/12/10

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| $3.33x10^7$ | 20/20 | 100 |
|-------------|-------|-----|
| $2.5x10^7$ | 19/20 | 95 |
| $4.94x10^6$ | 13/20 | 65 |
| $2.19x10^6$ | 3/20 | 15 |
| Whole Blood | 0/20 | 0 |

#### Reproducibility Study:

A study of the BinaxNOW® PBP2a Test was conducted at 3 separate sites using panels of blind coded specimens containing negative and positive samples. Participants tested each sample twice on 5 different days. There was 100% (599/599) agreement with expected test results, with no significant differences within run (replicates tested by one operator), between run (5 different days), between sites (3 sites), or between operators (6 operators).

Signed
Suzanne M. Vogel, MPH

Suzanne M. Vogel, MPH Clinical Affairs Binax, Inc.

Date 4/12/10

Binax NOW® PBP2a Test 5 l 0(k) Notification k090301 Rev. 04/12/10

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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing human services, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and is black.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002

Binax. Inc c/o Ms. Suzanne Vogel Department of Clinical Affairs Inverness Medical 10 Southgate Rd. Scarborough, Maine 04074

APR 1 4 2010

Re: K090301

Trade/Device Name: BinaxNOW® PBP2a Test Regulation Number: 21 CFR& 866.1640 Regulation Name: Methicillin Resistant Staphylococcus aureus (MRSA) Regulatory Class: Class II Product Code: MYI Dated: March 29, 2010 Received: March 31, 2010

Dear Ms. Vogel:

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 class II (Special Controls), 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.

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Page 2 - Suzanne Vogel

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Sally attym

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): k090301

Device Name: BinaxNOW® PBP2a Test

Indications for Use:

The BinaxNOW® PBP2a Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of penicillin-binding protein 2a (PBP2a) present in methicillinresistant Staphylococcus aureus (MRSA). The test is performed directly on blood culture samples positive for S. aureus.

The BinaxNOW® PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections. Subculturing positive blood cultures is necessary to recover organisms for susceptibility testing or epidemiological typing.

Prescription Use 2 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Freddie W. Poole

Vision Sign-Off

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Binax NOW® PBP2a Test 510(k) Notification k090301 Rev. 3/29/10

Confidential

Office of In Viterage againstic Device Evaluation and Safety

\$10(k) K09030/