(35 days)
Not Found
No
The device description and performance studies focus on bacteriophage amplification and immunoassay technology, with no mention of AI or ML algorithms for data analysis or interpretation.
No
Explanation: This device is an in vitro diagnostic test designed to identify Staphylococcus aureus and determine its methicillin susceptibility directly from positive blood cultures. It aids in diagnosis and treatment decisions but does not directly treat or cure a disease.
Yes
The device is explicitly described as a "qualitative in vitro diagnostic test for the timely identification of Staphylococcus aureus (S. aureus) and determination of methicillin susceptibility (MSSA) or methicillin resistance (MRSA) directly from positive blood cultures." Its purpose is to aid physicians in the detection of MRSA/MSSA, which is characteristic of a diagnostic device.
No
The device description clearly outlines a physical test kit involving reaction tubes, bacteriophage, reagents, and a Detector with sample wells and windows for visual interpretation of results (color lines). This indicates a hardware component is essential to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The KeyPath™ MRSA/MSSA Blood Culture Test – BT is a qualitative in vitro diagnostic test for the timely identification of Staphylococcus aureus (S. aureus) and determination of methicillin susceptibility (MSSA) or methicillin resistance (MRSA) directly from positive blood cultures."
This statement clearly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The KeyPath™ MRSA/MSSA Blood Culture Test – BT is a qualitative in vitro diagnostic test for the timely identification of Staphylococcus aureus (S. aureus) and determination of methicillin susceptibility (MSSA) or methicillin resistance (MRSA) directly from positive blood cultures.
The Test uses bacteriophage amplification to identify the presence of S. aureus and assess the phenotypic response of the target organism to cefoxitin, an indicator of oxacillin (a methicillin analog) resistance.
The assay is performed directly on positive blood culture specimens that are determined as Gram Positive Cocci in singles (GPC) or as Gram Positive Cocci in Clusters (GPCC) by Gram stain.
The KeyPath™ MRSA/MSSA Blood Culture Test - BT is performed directly on positive blood culture specimens from BD BACTEC™ blood culture bottles (Plus Aerobic/F, Plus Anaerobic/F, Standard/10 Aerobic/F and Standard Anaerobic/F).
The Test is indicated for use in conjunction with other laboratory and clinical data available to the physician as an aid in the detection of MRSA/MSSA from positive blood cultures.
Subculturing of positive blood cultures is necessary for additional susceptibility test determinations, differentiation of mixed growth and for epidemiological typing.
Product codes (comma separated list FDA assigned to the subject device)
OUS
Device Description
The KeyPath™ MRSA/MSSA Blood Culture Test - BT (KeyPath™ Test) is a bacteriophage amplification-enabled immunoassay to identify Staphylococcus aureus and determine its resistance or susceptibility to cefoxitin from positive blood cultures, which have been determined to have Gram Positive Cocci in singles (GPC) or Gram Positive Cocci in Clusters (GPCC) by Gram stain. This method utilizes the specificity of bacteriophage/bacteria interactions and their natural amplification processes to produce a surrogate signal. In the presence of S. aureus, bacteriophage will replicate, increasing to a detectable concentration. In the absence of S. aureus or the presence of bacteria other than S. aureus, the KeyPath™ Test bacteriophage do not replicate and remain undetectable. In addition, susceptible strains of S. aureus do not grow in the presence of cefoxitin and therefore do not support bacteriophage amplification, while resistant strains will grow and support bacteriophage amplification.
To perform the KeyPath™ Test, a sample of the positive blood culture is added to each of the two provided reaction tubes, each comprised of KeyPath™ Test bacteriophage and proprietary reagents that enhance the growth of S. aureus and suppress other organisms. One Reaction Tube (Blue) is used for S. aureus identification. The second Reaction Tube (Red) is used for resistance/susceptibility testing. Following incubation, a small amount of the sample from each Tube is pipetted onto corresponding sample wells on the Detector. If the specimen contains S. aureus a pink-to-dark red/ purple Test Line (T) will appear in the Blue ID Window of the Detector.
If the sample is positive for S. aureus, Resistance/Susceptibility is then determined by reading the Red RS Window. Resistance (MRSA) is determined by the development of a visible pink-to-dark red/purple line at the Test Line (T) in the Red RS Window, while Susceptibility (MSSA) is determined by the absence of a visible colored line at the Test Line (T) in the Red RS Window.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Blood Culture
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Laboratory
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Media Interference Study
Study description and methods: Performance of the KeyPath™ MRSA/MSSA Blood Culture Test - BT was analyzed in presence of 10 µL (nominal) and 20µL (twice the nominal volume) of blood culture matrix from appropriate bottles. Five replicates of 16 strains (4 MRSA, 4 MSSA and 8 NSA) were tested. For test matrix and positive controls, blood culture bottles containing blood from volunteers were inoculated with approximately 100 CFU of bacteria and grown to alarm in the BACTEC™ 9050. Negative controls were comprised of un-inoculated blood culture mix containing blood. No interference was demonstrated if the correct results for each strain type were observed.
Results and conclusions:
- Negative controls - For both SA and SN bottles the KeyPath™ Test returned negative results (NSA) in all replicates.
- Positive controls - For both SA and SN bottles, the KeyPath™ Test returned the expected results in all replicates.
- Test matrix - For both SA and SN bottles, the KeyPath™ Test returned the expected results in all replicates.
All test results are as expected. Blood culture matrix from SA and SN bottles does not interfere with the KeyPath™ MRSA/MSSA Blood Culture Test - BT.
Performance Study
Study description and methods: A panel of ≥ 20 MRSA, ≥ 20 MSSA and ≥ 20 NSA clinical blood culture isolates from unique patients was tested in the KeyPath™ MRSA/MSSA Blood Culture Test - BT. BACTEC™ Standard/10 Aerobic/F (SA) and Standard Anaerobic/F (SN) bottles were charged with blood from healthy volunteers per IRB-approved study protocol MP2007A. Bottles were inoculated with approximately 100 CFU from fresh overnight cultures. Testing and external daily controls were performed per Package Insert instructions (181-00005 Rev. A) within 24 hours of alarm. Bottles that did not alarm within 3 days were discarded.
Results and conclusions: For all evaluations of S. aureus identification and determination of resistance and susceptibility, the KeyPath™ MRSA/MSSA Blood Culture Test - BT functioned as intended and the levels of positive and negative agreement observed were as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Table 6.3 - S. aureus identification summary, SA bottles
Positive Agreement: 100% (95% CI: 92.1 to 100)
Negative Agreement: 100% (95% CI: 90.0 to 100)
Table 6.4 - Resistance summary, SA bottles
Positive Agreement: 95.5% (95% CI: 77.2 to 99.9)
Negative Agreement: 95.7% (95% CI: 78.1 to 99.9)
Table 6.5 - S. aureus Identification Summary, SN bottles
Positive Agreement: 97.8% (95% CI: 88.2 to 100)
Negative Agreement: 100% (95% CI: 88.4 to 100)
Table 6.6 - Methicillin Resistance Testing Summary, SN bottles
Positive Agreement: 95.2% (95% CI: 76.2 to 99.9)
Negative Agreement: 95.7% (95% CI: 78.1 to 99.9)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
KeyPath™ MRSA/MSSA Blood Culture Test - BT (K102342)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.2050 Staphylococcal typing bacteriophage.
(a)
Identification. A staphylococcal typing bacteriophage is a device consisting of a bacterial virus intended for medical purposes to identify pathogenic staphylococcal bacteria through use of the bacteria's susceptibility to destruction by the virus. Test results are used principally for the collection of epidemiological information.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
0
MAR 3 0 2012
510(k) SUMMARY
MICROPHAGE's KeyPath™ MRSA/MSSA Blood Culture Test – BT
MicroPhage, Inc. 2400 Trade Centre Ave. Longmont, CO 80503
Phone: 303-652-5049 Facsimile: 303-652-5080
Contact Person: Drew Smith, PhD.
Date Prepared: February 24, 2012
Name of Device and Name/Address of Sponsor
KeyPath™ MRSA/MSSA Blood Culture Test - BT
MicroPhage, Inc. 2400 Trade Centre Ave. Longmont, CO 80503
Common or Usual Name
Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-susceptible Staphylococcus aureus (MSSA) from positive blood culture bottles test
Classification Name
Staphylococcal typing bacteriophage
Regulation
21 C.F.R. § 866.2050
Product Code
ous
Classification Panel
Microbiology
Predicate Devices
KeyPath™ MRSA/MSSA Blood Culture Test - BT (K102342)
1
Intended Use / Indications for Use
The KeyPath™ MRSA/MSSA Blood Culture Test – BT is a qualitative in vitro diagnostic test for the timely identification of Staphylococcus aureus (S. aureus) and determination of methicillin susceptibility (MSSA) or methicillin resistance (MRSA) directly from positive blood cultures.
The Test uses bacteriophage amplification to identify the presence of S. aureus and assess the phenotypic response of the target organism to cefoxitin, an indicator of oxacillin (a methicillin analog) resistance.
The assay is performed directly on positive blood culture specimens that are determined as Gram Positive Cocci in singles (GPC) or as Gram Positive Cocci in Clusters (GPCC) by Gram stain.
The KeyPath™ MRSA/MSSA Blood Culture Test - BT is performed directly on positive blood culture specimens from BD BACTEC™ blood culture bottles (Plus Aerobic/F, Plus Anaerobic/F, Standard/10 Aerobic/F and Standard Anaerobic/F).
The Test is indicated for use in conjunction with other laboratory and clinical data available to the physician as an aid in the detection of MRSA/MSSA from positive blood cultures.
Subculturing of positive blood cultures is necessary for additional susceptibility test determinations, differentiation of mixed growth and for epidemiological typing.
Technological Characteristics
The KevPath™ MRSA/MSSA Blood Culture Test - BT (KevPath™ Test) is a bacteriophage amplification-enabled immunoasay to identify Staphylococcus aureus and determine its resistance or susceptibility to cefoxitin from positive blood cultures, which have been determined to have Gram Positive Cocci in singles (GPC) or Gram Positive Cocci in Clusters (GPCC) by Gram stain. This method utilizes the specificity of bacteriophage/bacteria interactions and their natural amplification processes to produce a surrogate signal. In the presence of S. aureus, bacteriophage will replicate, increasing to a detectable concentration. In the absence of S. aureus or the presence of bacteria other than S. aureus, the KevPath™ Test bacteriophage do not replicate and remain undetectable. In addition, susceptible strains of S. aureus do not grow in the presence of cefoxitin and therefore do not support bacteriophage amplification, while resistant strains will grow and support bacteriophage amplification.
To perform the KeyPath™ Test, a sample of the positive blood culture is added to each of the two provided reaction tubes, each comprised of KeyPath™ Test bacteriophage and proprietary reagents that enhance the growth of S. aureus and suppress other organisms. One Reaction Tube (Blue) is used for S. aureus identification. The second Reaction Tube (Red) is used for resistance/susceptibility testing. Following incubation, a small amount of the sample from each Tube is pipetted onto corresponding sample wells on the Detector. If the specimen contains S. aureus a pink-to-dark red/ purple Test Line (T) will appear in the Blue ID Window of the Detector.
If the sample is positive for S. aureus, Resistance/Susceptibility is then determined by reading the Red RS Window. Resistance (MRSA) is determined by the development of a visible pink-to-dark red/purple line at the Test Line (T) in the Red RS Window, while Susceptibility (MSSA) is determined by the absence of a visible colored line at the Test Line (T) in the Red RS Window.
2
Performance Data
Study Design
The purpose of this submission is to establish equivalent performance of the KeyPath™ MRSA/MSSA Blood Culture Test - BT in additional bottle types, as compared to cleared bottle types. Previously cleared bottle types are BACTEC™ Plus Aerobic/F and Plus Anaerobic/F. The additional bottle types for which clearance is being sought are BACTEC™ Standard /10 Aerobic/F and Standard Anaerobic/F.
A Media Interference Study was performed to demonstrate that blood culture matrix does not act as an interferent in the KeyPath™ Test; and a performance study was performed to demonstrate that the KevPath™ Test shows ≥ 95% positive and negative agreement for S. aureus identification and determination of methicillin resistance.
Media Interference Study
Study description and methods
Performance of the KevPath™ MRSA/MSSA Blood Culture Test ~ BT was analyzed in presence of 10 µL (nominal) and 20µL (twice the nominal volume) of blood culture matrix from appropriate bottles. Five replicates of 16 strains (4 MRSA, 4 MSSA and 8 NSA) were tested. For test matrix and positive controls, blood culture bottles containing blood from volunteers were inoculated with approximately 100 CFU of bacteria and grown to alarm in the BACTEC™ 9050. Negative controls were comprised of un-inoculated blood culture mix containing blood. No interference was demonstrated if the correct results for each strain type were observed.
Results and conclusions
Negative controls - For both SA and SN bottles the KeyPath™ Test returned negative results (NSA) in all replicates, as shown in Tables 6.1 and 6.2.
Positive controls - For both SA and SN bottles, the KeyPath™ Test returned the expected results in all replicates, as shown in Tables 6.1 and 6.2.
Test matrix - For both SA and SN bottles, the KeyPath™ Test returned the expected results in all replicates, as shown in Tables 6.1 and 6.2.
3
| KP Test Result | ||||
|---|---|---|---|---|
| Condition | Type | MRSA | MSSA | NSA |
| Negative Control | None | 0 | 0 | 20 |
| Control | MRSA | 20 | 0 | 0 |
| MSSA | 0 | 20 | 0 | |
| NSA | 0 | 0 | 40 | |
| Test | MRSA | 20 | 0 | 0 |
| MSSA | 0 | 20 | 0 | |
| NSA | 0 | 0 | 40 |
Table 6.1 – Summary Data for SA Bottle Interference Summary data for SA bottle interference
Table 6.2 – Summary Data for SN Bottle Interference Summary data for SN bottle interference
| KP Test Result | ||||
|---|---|---|---|---|
| Condition | Type | MRSA | MSSA | NSA |
| Negative Control | None | 0 | 0 | 20 |
| Control | MRSA | 20 | 0 | 0 |
| MSSA | 0 | 20 | 0 | |
| NSA | 0 | 0 | 40 | |
| Test | MRSA | 20 | 0 | 0 |
| MSSA | 0 | 20 | 0 | |
| NSA | 0 | 0 | 40 |
All test results are as expected. We conclude that blood culture matrix from SA and SN bottles does not interfere with the KeyPath™ MRSA/MSSA Blood Culture Test - BT.
4
Performance Study
Study description and methods
A panel of ≥ 20 MRSA, ≥ 20 MSSA and ≥ 20 NSA clinical blood culture isolates from unique patients was tested in the KeyPath™ MRSA/MSSA Blood Culture Test - BT.
BACTEC™ Standard/10 Aerobic/F (SA) and Standard Anaerobic/F (SN) bottles were charged with blood from healthy volunteers per IRB-approved study protocol MP2007A. Bottles were inoculated with approximately 100 CFU from fresh overnight cultures.
Testing and external daily controls were performed per Package Insert instructions (181-00005 Rev. A) within 24 hours of alarm. Bottles that did not alarm within 3 days were discarded.
Results and conclusions
Tables 6.3 and 6.4 summarize the SA bottle data for S. aureus identification, and determination of resistance and susceptibility within S. aureus, respectively. Tables 6.5 and 6.6 summarize the SN bottle data for S. aureus identification, and determination of resistance and susceptibility within S. aureus, respectively.
. Table 6.3 - S. aureus identification summary, SA bottles
Analysis: S. oureus Identification
Image /page/4/Figure/9 description: The image shows a table of data related to SA bottles and KeyPath. The table includes a reference section with values 45 and 35, and a statistic section with positive and negative agreement percentages. Both positive and negative agreement are at 100%, with 95% confidence intervals ranging from 92.1 to 100 and 90.0 to 100, respectively.
Table 6.4 - Resistance summary, SA bottles
Analysis: Methicillin resistance
SA bottles
Image /page/4/Figure/13 description: The image shows a 2x2 contingency table comparing two methods, KeyPath and Reference. The table displays the counts of agreements and disagreements between the two methods. The top left cell shows 21, indicating the number of instances where both KeyPath and Reference are positive. The bottom right cell shows 22, indicating the number of instances where both KeyPath and Reference are negative.
| Statistic | Percent | 95 % CI | |
|---|---|---|---|
| Lower | Upper | ||
| Positive Agreement | 95.5 | 77.2 | 99.9 |
| Negative Agreement | 95.7 | 78.1 | 99.9 |
5
Image /page/5/Figure/0 description: The image shows an analysis of S. aureus Identification using SN bottles. A 2x2 table compares KeyPath to a reference, with values 44 and 0 in the first row, and 1 and 30 in the second row. The totals are 45 and 30. A table shows the positive agreement is 97.8% with a 95% confidence interval of 88.2 to 100, and the negative agreement is 100% with a 95% confidence interval of 88.4 to 100.
Table 6.5 - S. aureus Identification Summary, SN bottles
Table 6.6 - Methicillin Resistance Testing Summary, SN bottles
Analysis: Methicillin resistance
SN bottles
| Reference | |||
|---|---|---|---|
| + | - | ||
| KeyPath | + | 20 | 1 |
| - | 1 | 22 | |
| Total | 21 | 23 |
| Statistic | Percent | 95 % CI | |
|---|---|---|---|
| Lower | Upper | ||
| Positive Agreement | 95.2 | 76.2 | 99.9 |
| Negative Agreement | 95.7 | 78.1 | 99.9 |
For all evaluations of S. aureus identification and determination of resistance and susceptibility, the KeyPath™ MRSA/MSSA Blood Culture Test - BT functioned as intended and the levels of positive and negative agreement observed were as expected.
Substantial Equivalence
The KeyPath™ MRSA/MSSA Blood Culture Test - BT, when used on samples from BACTEC™ Standard/10 Aerobic/F or Standard Anaerobic/F bottles, is as safe and effective as the KeyPath™ MRSA/MSSA Blood Culture Test - BT when used on samples from cleared bottle types (BACTEC™ Plus Aerobic/F and Plus Anaerobic/F). The KeyPath™ MRSA/MSSA Blood Culture Test - BT technological characteristics and principles of operation are unchanged. Other than the addition of bottle types, the intended use is unchanged. The expanded intended use raises no new issues of safety or effectiveness. Performance data demonstrate that the KeyPath™ MRSA/MSSA Blood Culture Test – BT, when used on samples from BACTEC™ Standard/10 Aerobic/F or Standard Anaerobic/F bottles, is as safe and effective as the KeyPath™ MRSA/MSSA Blood Culture Test – BT when used on samples from cleared bottle types (BACTEC™ Plus Aerobic/F and Plus
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Thus, the KeyPath™ MRSA/MSSA Blood Culture Test – BT is substantially Anaerobic/F). equivalent when used with additional BACTEC™ bottle types.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of curved lines.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
MAR 3 0 2012
MicroPhage, Inc. c/o Drew Smith, Ph.D. Chief Science Officer 2400 Trade Centre Ave Longmont, CO 80503
Re: K120563
Trade/Device Name: KeyPath™ MRSA/MSSA Blood Culture Test-BT Regulation Number: 21 CFR § 866.2050 Regulation Name: Staphylococcal typing bacteriophage Regulatory Class: I Product Code: OUS Dated: February 24, 2012 Received: February 24, 2012
Dear Dr. Smith:
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 medical device-related adverse events) (21 CFR 803); and good manufacturing practice
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Page 2 - Drew Smith Ph.D.
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,
Silla Adams
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
9
Indications for Use Statement
K120563 510(k) Number (if known):
Device Name: KeyPath™ MRSA/MSSA Blood Culture Test - BT
Indications for Use:
The KeyPath™ MRSA/MSSA Blood Culture Test – BT is a qualitative in vitro diagnostic test for the timely identification of Staphylococcus aureus (S. aureus) and determination of methicillin susceptibility (MSSA) or methicillin resistance (MRSA) directly from positive blood cultures.
The Test uses bacteriophage amplification to identify the presence of S. aureus and assess the phenotypic response of the target organism to cefoxitin, an indicator of oxacillin (a methiciliin analog) resistance.
The assay is performed directly on positive blood culture specimens that are determined as Gram Positive Cocci in singles (GPC) or as Gram Positive Cocci in Clusters (GPCC) by Gram stain.
The KeyPath™ MRSAMSSA Blood Culture Test - BT is performed directly on positive blood culture specimens from BD BACTEC™ blood culture bottles (Plus Aerobic/F, Plus Anaerobic/F, Standard/10 Aerobic/F and Standard Anaerobic/F).
The Test is indicated for use in conjunction with other laboratory and clinical data available to the physician as an aid in the detection of MRSA/MSSA from positive blood cultures.
Subculturing of positive blood cultures is necessary for additional susceptibility test determinations, differentiation of mixed growth and for epidemiological typing
Prescription Use × (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 Device Evaluation (ODE)
Sudali lu-Pode
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120563
16