(27 days)
Not Found
No
The device description details a rapid immunochromatographic assay with visual interpretation, and there is no mention of AI, ML, or image processing.
No
The device is an in vitro diagnostic test designed to detect PBP2a as an aid in detecting MRSA, and it is explicitly stated that it is "not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections," indicating it is not a therapeutic device.
No
The "Intended Use / Indications for Use" explicitly states: "The Alere™ PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections." While it aids in detecting MRSA, it disclaims diagnostic intent.
No
The device description clearly outlines a physical immunochromatographic assay with a test strip, antibodies, and reagents, which are hardware components. The results are read visually, not through software analysis.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Alere™ 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 the defining characteristic of an in vitro diagnostic device. The description of the device and its function further supports this, as it involves testing bacterial isolates from culture plates.
N/A
Intended Use / Indications for Use
The Alere™ 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 Alere™ PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections.
Product codes
MYI
Device Description
The Alere™ 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.
lsolates are sampled directly from the culture plate and eluted into an assay tube containing 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
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The clinical performance of the Alere™ PBP2a Test was established in a multi-center clinical study conducted in 2009 at three geographically-diverse laboratories.
A total of 457 S. aureus samples were evaluated in the Alere™ PBP2a Test, compared to results of 30 ue 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 Alere™ 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.
A study of the Alere™ PBP2a Test was conducted at 3 separate sites using panels of blind coded specimens containing negative and positive samples.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance: A multi-center clinical study conducted in 2009 at three geographically-diverse laboratories. A total of 457 S. aureus samples were evaluated compared to results of 30 ue cefoxitin disk diffusion and interpreted according to CLSI standards.
Key results are:
| 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 with expected results.
Reproducibility Study: A study 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity ranging from 98.1% to 99.5%.
Specificity 98.8%.
Agreement with expected test results of 97.3%.
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: _______________________________________________________________________________________________________________________________________________
JUL 26 2012
SUBMITTER
Alere Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 Establishment Registration Number: 1221359
CONTACT PERSON
Angela Drysdale (207) 730-5737 (Office) (207) 730-5717 (FAX) Angela.drysdale@alere.com (email)
DATE PREPARED
6/27/2012
TRADE NAME Alere™ PBP2a Test
COMMON NAME Alere™ PBP2a Test, Alere™ PBP2a
CLASSIFICATION NAME
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (per 21 CFR 866.1640)
CLASSIFICATION Class II
PRODUCT CODE MYI
PANEL Microbiology
PREDICATE DEVICES Alere™ PBP2a Test, K091766
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1
DEVICE DESCRIPTION
The Alere™ 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.
lsolates are sampled directly from the culture plate and eluted into an assay tube containing Reagent 2 is then added and the dipstick is placed in the assay tube. Results are read visually at 5 minutes.
INTENDED USE
The Alere™ PBP2a Test is a qualitative, in vitro immunochromatographic assay for the detection of penicillinbinding protein 2a (PBP2a) in isolates identified as Staphylococus aureus, as an aid in detecting methicillinresistant Staphylococcus aureus (MRSA). The Alere™ PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections.
TECHNOLOGICAL CHARACTERISTICS
The Alere™ PBP2a Test uses lateral flow immunochromatographic technology. The test is a rapid immunoassay that employs specific antibodies immobilized onto a solid phase to detect PBP2a from bacterial isolates.
PERFORMANCE SUMMARY
Clinical Performance
The clinical performance of the Alere™ PBP2a Test was established in a multi-center clinical study conducted in 2009 at three geographically-diverse laboratories.
A total of 457 S. aureus samples were evaluated in the Alere™ PBP2a Test, compared to results of 30 ue cefoxitin disk diffusion and interpreted according to CLSI standards. Performance results by plate type are listed in Table 1 below.
Table 1: Alere™ 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%) |
2
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 Alere™ 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.
Reproducibility Study
A study of the Alere™ 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
Angela Drysdale Director of Clinical Affairs Alere Scarborough, Inc.
Date
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 with three wing-like shapes, positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Alere Scarborough, Inc. c/o Angela Drysdale Director of Clinical Affairs 10 Southgate Road Scarborough, ME 04074
JUL 26 2012
Re: K121905 Trade Name: Alere™PBP2a Test Regulation Number: 21 CFR §866.1640 Regulation Name: Antimicrobial susceptibility test powder. Regulatory Class: Class II Product Code: MYI Dated: June 27, 2012 Received: June 29, 2012
Dear Ms. Drysdale:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section
4
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 Part 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,
Jayaat
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
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Alere™ PBP2a Test
Indications For Use:
The Alere™ 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 Alere™ 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 _ (Part 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - (CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Selyatry
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121905;
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