(252 days)
No
The device description details a rapid immunochromatographic assay with visual reading of results, and there is no mention of AI, ML, or image processing.
No
The device is an in vitro diagnostic test for detecting a specific protein in bacteria, which aids in identifying MRSA. Its intended use explicitly states it is "not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections," meaning it does not directly treat or prevent disease.
Yes
The device detects penicillin-binding protein 2a (PBP2a) in isolates to aid in detecting methicillin-resistant Staphylococcus aureus (MRSA), which is a diagnostic purpose.
No
The device description clearly outlines a physical test strip with immobilized antibodies, sample pads, and absorption pads, which are hardware components. The results are read visually, indicating a manual interpretation process, not a software-based analysis.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Clearview® Exact PBP2a Test is a qualitative, in vitro immunochromatographic assay..."
The term "in vitro" directly indicates that the test is performed outside of a living organism, which is a defining characteristic of an In Vitro Diagnostic device. The description of the device and its use in detecting a protein from bacterial isolates further confirms its nature as an IVD.
N/A
Intended Use / 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 quide or monitor treatment for MRSA infections.
Product codes
MYI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
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.
Summary of Performance Studies
Clinical Performance: A multicenter clinical study was 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.
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.
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.
Key Results:
Clinical Performance (compared to Cefoxitin (30 ug) Disk Diffusion in S. aureus Isolates):
- Tryptic Soy Agar with 5% sheep blood: Sensitivity 98.1% (206/210) (95% C.I. 95.2-99.3%), Specificity 98.8% (244/247) (95% C.I. 96.5-99.6%)
- Columbia Agar with 5% sheep blood: Sensitivity 99.0% (208/210) (96.6-99.7%), Specificity 98.8% (244/247) (96.5-99.6%)
- Mueller Hinton with 1 µg oxacillin induction: Sensitivity 99.5% (209/210) (97.4-99.9%), Specificity 98.8% (244/247) (96.5-99.6%)
Reproducibility Study: 97.3% (580/596) agreement with expected test results.
Key Metrics
Sensitivity, Specificity, Agreement
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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.
INTENDED USE
Clearview Exact® PBP2a 510(k) Notification #091766 Rev. 2/10/10
Confidential
1
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 quide or monitor treatment for MRSA infections.
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 Agar | ||||
| with 5% sheep blood | 98.1% | |||
| (206/210) | (95.2-99.3%) | 98.8% | ||
| (244/247) | (96.5-99.6%) | |||
| Columbia Agar | ||||
| with 5% sheep blood | 99.0% | |||
| (208/210) | (96.6-99.7%) | 98.8% | ||
| (244/247) | (96.5-99.6%) | |||
| Mueller Hinton | ||||
| with 1 µg oxacillin | ||||
| induction | 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.
2
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
3
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
5
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