The Clearview® Exact PBP2a Test is a qualitative, in vitro immunochromatographic assay for the detection of penicillin-binding protein 2a (PBP2a) in isolates identified as Staphylococcus aureus, as an aid in detecting methicillin-resistant Staphylococcus aureus (MRSA). The Clearview® Exact PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections.

Device Description

The Clearview® Exact PBP2a Test is a rapid immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect the PBP2a protein directly from bacterial isolates. These antibodies and a control antibody are immobilized onto a nitrocellulose membrane as two distinct lines and combined with a sample pad, a blue conjugate pad, and an absorption pad to form a test strip.

Isolates are sampled directly from the culture plate and eluted into an assay tube containing Reagent 1. Reagent 2 is then added and the dipstick is placed in the assay tube. Results are read visually at 5 minutes.

AI/ML Overview

The Clearview® Exact PBP2a Test is a rapid immunochromatographic assay for detecting penicillin-binding protein 2a (PBP2a) in Staphylococcus aureus isolates, aiding in the detection of methicillin-resistant Staphylococcus aureus (MRSA).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria. However, it reports sensitivity and specificity performance values for the device compared to a reference method. We can infer that the reported performance values were considered acceptable for regulatory clearance.

Performance Metric	Reported Device Performance (Tryptic Soy Agar with 5% sheep blood)	Reported Device Performance (Columbia Agar with 5% sheep blood)	Reported Device Performance (Mueller Hinton with 1 µg oxacillin induction)
Sensitivity	98.1% (95.2-99.3% CI)	99.0% (96.6-99.7% CI)	99.5% (97.4-99.9% CI)
Specificity	98.8% (96.5-99.6% CI)	98.8% (96.5-99.6% CI)	98.8% (96.5-99.6% CI)

2. Sample Size and Data Provenance for the Test Set

Sample Size: A total of 457 S. aureus samples were evaluated in the clinical performance study.
Data Provenance: The study was a multicenter clinical study conducted in 2009 at three geographically-diverse laboratories. The analytical performance section also mentions bacterial strains obtained from the Network on Antimicrobial Resistance in Staphylococcus aureus (NARSA), American Type Culture Collection (ATCC), and a collection from the Department of Infectious Disease Epidemiology of the Imperial College in London, England. This indicates a mix of strains from reference collections and clinical isolates, and at least some data provenance from England in addition to the diverse US laboratories. The study appears to be retrospective in the sense that existing S. aureus samples were evaluated by the new device.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study compares the device's performance to a standard method (cefoxitin disk diffusion), not to human readers' performance with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone study was done. The clinical performance study directly evaluated the performance of the Clearview® Exact PBP2a Test against the reference method without human intervention in the interpretation of the device's results, as it is a visual read test that relies on the device's output. The reproducibility study also tested the device in a standalone manner.

7. Type of Ground Truth Used

The ground truth used for the clinical performance study was cefoxitin (30 ug) disk diffusion, interpreted according to CLSI (Clinical and Laboratory Standards Institute) standards. This is a recognized phenotypic method for determining methicillin resistance in S. aureus.

8. Sample Size for the Training Set

The document does not explicitly mention a dedicated "training set" or its size for the development of the Clearview® Exact PBP2a Test. The analytical performance section mentions that 162 MRSA strains and 112 MSSA strains were tested for analytical reactivity and specificity, which might represent samples used during later stages of development or validation, but it's not explicitly labeled as a training set.

9. How Ground Truth for the Training Set Was Established

Since a distinct training set is not explicitly defined, the method for establishing its ground truth is not detailed. However, for the strains used in analytical performance (162 MRSA and 112 MSSA), it is implied that their methicillin-resistant/sensitive status was known, likely established through standard microbiological identification and susceptibility testing methods (e.g., CLSI guidelines, reference lab testing) given their origin from reputable collections (NARSA, ATCC, Imperial College).

Summary

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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 K091766.

SUBMITTER

FFB 2 4 2010

Binax. Inc. 10 Southgate Road Scarborough, Maine 04074 (207) 730-5733 (Office) (207) 730-5717 (FAX) Establishment Registration Number: 1221359

CONTACT PERSON

Suzanne Vogel suzanne.vogel@invmed.com (email)

DATE PREPARED

February 10, 2010

TRADE NAME Clearview® Exact PBP2a Test

COMMON NAME

Clearview® Exact PBP2a Test, Clearview® Exact PBP2a, Clearview® 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 PBP2' Latex Agglutination Test (Oxoid) K011710

DEVICE DESCRIPTION

INTENDED USE

Clearview Exact® PBP2a 510(k) Notification #091766 Rev. 2/10/10

Confidential

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TECHNOLOGICAL CHARACTERISTICS

The Clearview® Exact PBP2a Test and the Oxoid PBP2' Latex Agglutination Test (K011710) utilize similar technologies to detect PBP2a in MRSA. Both tests use detection with latex conjugates sensitized with a monoclonal antibody against PBP2a.

The Remel Mueller Hinton Agar (K850291) utilizes a different technology involving microbial growth on Mueller Hinton Agar with 4% NaCl and 6 ug/mL Oxacillin.

PERFORMANCE SUMMARY

Clinical Performance

The clinical performance of the Clearview® Exact PBP2a Test was established in a multicenter clinical study conducted in 2009 at three geographically-diverse laboratories.

A total of 457 S. aureus samples were evaluated in the Clearview® Exact PBP2a Test, compared to results of 30 ug cefoxitin disk diffusion and interpreted according to CLSI standards. Performance results by plate type are listed in Table 1 below.

Table 1: Clearview® Exact PBP2a Test Performance Compared to Cefoxitin (30 ug) Disk Diffusion in S. aureus Isolates: Results by Plate Type

Plate Type	Sensitivity	95% C.I.	Specificity	95% C.I.
Tryptic Soy Agarwith 5% sheep blood	98.1%(206/210)	(95.2-99.3%)	98.8%(244/247)	(96.5-99.6%)
Columbia Agarwith 5% sheep blood	99.0%(208/210)	(96.6-99.7%)	98.8%(244/247)	(96.5-99.6%)
Mueller Hintonwith 1 µg oxacillininduction	99.5%(209/210)	(97.4-99.9%)	98.8%(244/247)	(96.5-99.6%)

Analytical Performance

Analytical Reactivity and Specificity

162 strains of methicillin-resistant Staphylococcus aureus (MRSA) and 112 strains of methicillin-sensitive Staphylococus aureus (MSSA) were tested in the Clearview® Exact PBP2a Test with expected results. These bacterial strains were obtained from the Network on Antimicrobial Resistance in Staphylococcus aureus (NARSA), American Type Culture Collection (ATCC) and a collection of strains from Department of Infectious Disease Epidemiology of the Imperial College in London, England.

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Reproducibility Study

A study of the Clearview® Exact 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 97.3% (580/596) agreement with expected test results.

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

Clearview Exact® PBP2a 510(k) Notification #091766 Rev. 2/10/10

Date _________________________________________________________________________________________________________________________________________________________________________

Confidential

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

FEB 2 4 2010

Binax, Inc c/o Suzanne M. Vogel 10 Southgate Road Scarborough, Maine 04074

Re: K091766

Trade/Device Name: Clearview® Exact PBP2a Test. Model 891-000 Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: MYI Dated: February 19, 2010 Received: February 22, 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.

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

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Page 2 - Ms. Vogel

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 (301) 796-5450. 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/ReportaProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sally A. Hoivat, 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 Form

510(k) Number (if known): K091766___________________________________________________________________________________________________________________________________________

Device Name: _ Clearview® Exact PBP2a Test____________________________________________________________________________________________________________________________________

Indications for Use:

The Clearview Exact PBP2a Test is a qualitative, in vitro immunochromatographic assay for the detection of penicillin-binding protein 2a (PBP2a) in isolates identified as Staphylococcus aureus, as an aid in detecting methicillin-resistant Staphylococcus aureus (MRSA). The Clearview" Exact PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections.

Prescription Use __X (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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Freddie Lu. Poole

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 091766

Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
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.(b)
Classification. Class II (performance standards).