(242 days)
Not Found
No
The device description mentions an "algorithm that compares output, Cq, from the cycler," which is a standard method for interpreting PCR results and does not indicate the use of AI or ML. The document explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is described as a "qualitative in vitro diagnostic test" intended to "aid in the prevention and control of MRSA infections," not to directly treat or cure them.
Yes
The device is described as a "qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA)" that is "intended to aid in the prevention and control of MRSA infections in healthcare settings." This clearly indicates its role in diagnosis by identifying specific pathogens.
No
The device description explicitly states it is a real-time, multiplex polymerase chain reaction (PCR) assay that utilizes specific instruments (bioMérieux NucliSENS® easyMAG® and Applied Biosystems 7500 FAST Dx System), reagents, and disposable plates, indicating it is a hardware-based in vitro diagnostic device with associated software for analysis.
Yes, this device is an IVD (In Vitro Diagnostic).
The provided text explicitly states in the "Intended Use / Indications for Use" section:
"MRSA/SA ELITe MGB® is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) using DNA purified from nasal swabs."
This statement clearly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
MRSA/SA ELITe MGB® is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) using DNA purified from nasal swabs. MRSA/SA ELITe MGB® is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose, guide or monitor MRSA infections, or provide results of susceptibility to oxacillin/methicillin. A negative result does not preclude MRSA/SA (Staphylococcus aureus) nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.
Product codes (comma separated list FDA assigned to the subject device)
NQX
Device Description
MRSA/SA ELITe MGB is a real-time, multiplex polymerase chain reaction (PCR) assay for the in vitro qualitative detection of MRSA and SA DNA extracted from human nasal swab samples. In this system, sample preparation and amplification/real-time detection are completed on separate instruments. Sample processing is completed on the bioMérieux NucliSENS® easyMAG® instrument with bioMérieux NucliSENS Nucleic Acid Extraction Reagents according to the manufacturer's instructions. Following processing, the extracted sample is placed in the well of a 96 well plate to which "monoreagent" is added. The monoreagent contains the primers and probes for the genes of interest and the internal control combined with master mix. The assay is performed on an Applied Biosystems 7500 FAST Dx System that consists of the 7500 FAST Dx instrument, a personal computer, 96-well plates and seals. The total system run time is 150 minutes consisting of 60 minutes for sample processing and about 90 minutes for the real time amplification and detection steps. The instrument never comes into contact with any fluids within the 96well plate. Each disposable plate is intended to test up to 96 samples, controls or any mixture thereof. The 96-well plates are not re-usable and are specific to the system. The kit contains enough reagents for 100 reactions. One positive and one negative control are required for each PCR run; a Negative Processing Control and a Positive Processing Control are recommended to be run in each extraction run. The design of the assay includes systems to identify both the gene responsible for methicillin resistance and for a conserved portion of a gene unique to S. aureus. Thus, for a true "MRSA," both targets will be identified in roughly equal proportions. Results are determined by using an algorithm that compares output, Cq, from the cycler (called Ct in the output from the cycler.)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal swabs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare settings
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)
Interfering substances: A study was conducted with potentially interfering substances encountered on nasal swabs. Substances tested were chemical substances that can either be naturally present in the nasal cavity or that can be artificially introduced into the nasal cavity. The following substances were tested and evaluated: blood, mucin, phenylephrine (Neo-synephrine®), oxymetazoline (Dristan®, Zicam®), sodium chloride with preservatives, benzalkonium chloride, sodium phosphate, phenylcarbinol (Saline), propylene glycol (AYR® saline nasal gel), sorbitol, benzyl alcohol, disodium EDTA, hypromellose, phosphoric acid, dexamethasone, triamcinolone (Nasacort"), beclomethasone (Beconase AQ"), flunisolide, budesonide (Rhinocort Aqua"), mometasone (Nasonex"), fluticasone (Flonase®), luffa opperculata, sulfur, Galphimia glauca, Histaminum hydrochloricum, live intranasal influenza virus vaccine (FluMist®), benzocaine, methol (Cepacol® sore throat lozenges), Zanamivir (Relenza"), Oseltamivir phosphate (Tamiflu©), Mupirocin, tobramycin. The following substances have been shown to interfere with the performance of the assay: AYR® saline nasal gel and excessive amounts of nasal secretions/mucus.
Analytical Sensitivity: The analytical sensitivity of the MRSA/SA ELITe MGB was determined using 5 strains of MRSA and one MSSA strain. Cultures of these strains were quantified, diluted in simulated nasal matrix to values spanning the range of approximately 5 to 1500 colonies forming units (CFU) and absorbed onto swabs. All dilutions were tested, and the limit of detection (LoD) was determined by Probit analysis. LoD for each strain represents the lowest number of CFU/swab at which a positive result will be obtained with at least 95% confidence. LoD for each strain was then verified by testing at least 20 replicates. Results indicate that the MRSA/SA ELITe MGB® average LoD is 165 CFU/mL of a swab eluate.
Analytical Reactivity (Inclusivity): Performance of the MRSA/SA ELITe MGB® was tested on 75 well characterized MRSA and MSSA isolates representative of the qlobal genetic diversity, including clonal complexes and sequence types as well as various Pulse-Field Gel Electrophoresis (PFGE) types and MIC (Minimum Inhibitory Concentration) values, with the emphasis on the USA enidemiologic clones. The strains were obtained through the Network on Antimicrobial Resistance in Staphylococcus aureus (NARSA) Program and from American Tissue Culture Collection (ATCC) or were a gift from Medical College of Wisconsin'. All strains were absorbed onto swabs at near detection limit and tested with MRSA/SA ELITe MGB. In addition to that all MSSA strains were tested at 10 CFU/swab. All MSSA strains tested positive for SA and negative for MRSA. All MRSA strains tested positive for MRSA. Two BORSA (Borderline Oxacillin Resistant Staphylococcus aureus) isolates that lack mecA 9 tested SA positive and MRSA negative for an overall analytical reactivity of 97.3%.
Analytical Specificity (Exclusivity): The specificity of the MRSA/SA ELITe MGB® was evaluated by testing for cross-reactivity to species phylogenetically related to S. aureus, pathogenic microorganisms and to microorganisms commonly present in normal nasal microflora. The test panel consisted of 17 viral, 1 mycoplasma, and 41 bacterial species. The microorganisms were tested as cultures in concentrations of 1x10" CFU (1x10" PFU)/swab. In addition human cells in a concentration of 10° cells /mL were tested. Human cells and all tested species were found negative for MRSA and SA with the MRSA/SA ELITe MGB®. The analytical specificity was 100%. Two of the potentially interfering organisms tested, Human metapneumovirus (hMPV) and MRCoNS Staphylococcus epidermidis, strain NRS 34, caused interference at initial test. Re-testing of MRCoNS Staphylococus epidermidis, strain NRS 34 confirmed the interference results. MRCoNS Staphylococcus epidermidis, strain NRS 34, is considered to interfere with MRSA/SA ELITE MGB®. MRCoNS Staphylococcus epidermidis when tested in a mix with near-detection-limit MRSA resulted in "SA positive, MRSA negative" call. Re-testing of Human metapneumovirus (hMPV) did not reveal interference of hMPV with MRSA/SA ELITe MGB". Methicillin Susceptible S. aureus (MSSA) was also tested for microbial interference. The microorganism was spiked at 1×10° CFU/mL (1×10° PFU/mL), or higher, into a sample with MRSA strains at neardetection-limit and tested. MRCoNS Staphylococcus epidermidis and MSSA, when tested in a mix with near-detection-limit of MRSA, resulted in "SA positive, MRSA neqative" call. None of the other tested species interfered with MRSA/SA detection.
Reproducibility: A 10-member panel of specimens with varying concentrations of MRSA in a simulated nasal matrix was tested. Two MRSA strains (ATCC BAA-1720) and one MSSA strain (BAA-12600) were used. Simulated matrix contained human genomic DNA and mucin to imitate a normal human nasal matrix. Data from the specimens were pooled to produce four sample types: For each MRSA/MSSA strain the panel included a negative member, specimen below the LoD (expected to yield a positivity rate of between 20 to 80%), low positive (at LoD, expected to yield a 95% positivity rate), and moderate positive (three times LoD, expected to have 100% positivity rate). Each of the two operators performed one run per day for 12 days on three reagent lots at one site. In two other sites two runs per day on one reagent lot were performed for 5 days (10 specimens x 3 replicates x 5 days x 2 runs). The negative panel member yielded negative results 100%, the below LoD specimens positivity rate was 77%, the low positive specimen positivity rate was 98%, and the moderate positive panel members positivity rate was 100%.
Total Agreement (%):
Negative (R1): 58/58 (100%)
Below LoD (R2,R5,R8): 134/174 (77%)
Low Positive (R3,R6,R9): 170/174 (98%)
Moderate Positive (R4,R7,R10): 174/174 (100%)
Carry-Over / Cross-Contamination: An analytical study was performed to evaluate the potential for cross-contamination between high MRSA (1x10' CFU per mL) specimens and negative specimens throughout the MRSA/SA ELITe MGB" workflow. Two operators performed five 24-sample extraction runs (11 high MRSA samples, 1 PSPC sample, and 1 NSPC sample per run) in a checkerboard pattern (high MRSA samples interrupted by completely negative samples). The processed samples were then PCR amplified in five separate runs using two different checkerboard patterns. The cross-contamination testing resulted in zero false neqatives from fifty-five high MRSA positive samples and one false positive sample from fifty-five negative samples.
Clinical Performance: Performance characteristics of the MRSA/SA ELITe MGB® were determined in a prospective investigational study at three (3) sites by comparing the MRSA/SA ELITe MGB® with agglutination/susceptibility tests. Specimens were collected from three (3) unique geographies at institutions having MRSA culture-based screening programs in place. To be enrolled in the study, patients had to be eligible for MRSA screening to the policies of the respective facilities. A true MRSA culture-positive specimen was defined as a specimen where MRSA was identified by the latex agglutination and cefoxitin susceptibility test after broth enrichment (both positive). A true MSSA culturepositive specimen was defined as a specimen negative for cefoxitin susceptibility testing and positive for the latex agglutination test. One nasal swab was collected from each patient and used to inoculate a selective chromogenic MRSA screening agar plate. Then the swab was inserted into a tube with trypticase soy broth and thoroughly mixed. The entire volume of the cell suspension was tested using MRSA/SA ELITe MGB. All swabs were subjected to enrichment in trypticase soy broth with 6.5% NaCl. The enriched culture samples were inoculated onto Trypticase Soy Blood Agar plates. Grown overnight cultures were used for latex agglutination. Specimens positive for latex agglutination were used for the cefoxitin susceptibility test. Performance of the MRSA/SA ELITe MGB® was calculated relative to the broth culture followed by latex agglutination and cefoxitin susceptibility test results. A total of 3271 nasal swab specimens were collected and tested. Of the 3271 specimen tested, 3174 specimens were eligible to be included in statistical analyses: 72 specimens were considered to be ineligible due to a duplicating error during samples collection and preparation; 21 specimens failed the initial extraction due to an operator error. Those samples were retested from the original swabs. 25 specimens failed the extraction and have been removed from the study.
Compared to the reference culture method, MRSA/SA ELITe MGB® identified 92% of the specimens testing positive for MRSA and 95% of the negative specimens.
Compared to the reference culture method. MRSA/SA ELITe MGB® identified 96% of the specimens testing positive for SA and 95% of the negative specimens.
MRSA Performance: Sensitivity: 92.3% (88.08%-95.16%), Specificity: 95.2% (94.32%-95.87%), PPV: 58.9% (53.67%-63.95%), NPV: 99.4% (99.04%-99.62%).
SA Performance: Sensitivity: 96.1% (94.48%-97.25%), Specificity: 95.1% (94.16%-95.89%), PPV: 86.2% (83.74%-88.36%), NPV: 98.7% (98.16%-99.09%).
Compared to the culture method of reference (agglutination/cefoxitin testing), the MRSA/SA ELITe MGB™ identified ~93% of the specimens positive for MRSA by a reference method and ~96% of the MRSA-negative specimens. PPV: 65.2% (60.08%, 70.04%), NPV: 99.4% (99.08%, 99.65%).
Thus, the positive and negative agreements for MRSA were each increased by 1% to achieve 93% and 96% respectively. Positive Predictive Value for MRSA was also increased by 6% to achieve 65%.
Discrepant Analysis: Further investigation (testing for MRSA by sequencing of SCCmec right extremity junction) was performed on all specimens that gave discordant MRSA results between the reference culture method and MRSA/SA ELITe MGB™. 16 of the 17 specimens that were MRSA-positive by culture but MRSA-negative by MRSA/SA ELITe MGB™ were found to be MRSA positive by SCCmec right extremity junction sequencing. 22 of the 143 specimens that were MRSA-negative by culture but MRSA-positive by MRSA/SA ELITe MGB™ were found to be MRSA positive by SCCmec right extremity junction sequencing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MRSA: Sensitivity: 92.3% (88.08%-95.16%), Specificity: 95.2% (94.32%-95.87%), PPV: 58.9% (53.67%-63.95%), NPV: 99.4% (99.04%-99.62%)
SA: Sensitivity: 96.1% (94.48%-97.25%), Specificity: 95.1% (94.16%-95.89%), PPV: 86.2% (83.74%-88.36%), NPV: 98.7% (98.16%-99.09%)
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.
BD GENEOHM MBSA ACP ASSAY (K093346)
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
§ 866.1640 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 MRSA/SA ELITe MGB®
substantial equivalence.
The assigned 510(k) number is: K112937
| Submitter:
Address:
Phone number
Fax number | ELITechGroup Epoch Biosciences.
21720 23rd Dr SE, Suite 150, Bothell, WA 98021 USA
425-482-5555
425-482-5550 |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact | Debra K Hutson (Email: d.hutson@elitechgroup.com) |
| Date of Preparation | September 29, 2011 |
Device:
Introduction
| Trade/proprietary Name:. | MRSA/SA ELITE MGB® |
|---|---|
| Common or Usual Name: | Test Kit for the detection of methicillin-resistant Staphylococcus aureus |
| Regulation number/name: | 866.1640, Antimicrobial susceptibility test powder |
| Device Class: | Class II |
| Product code | NQX |
| Classification name | System, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen |
| Classification Advisory | |
| Committee: | Microbiology |
| Panel: | 83 |
| Predicate device | BD GENEOHM MBSA ACP ASSAY (K093346) |
Device description: MRSA/SA ELITe MGB is a real-time, multiplex polymerase chain reaction (PCR) assay for the in vitro qualitative detection of MRSA and SA DNA extracted from human nasal swab samples. In this system, sample preparation and amplification/real-time detection are completed on separate instruments.
Sample processing is completed on the bioMérieux NucliSENS® easyMAG® instrument with bioMérieux NucliSENS Nucleic Acid Extraction Reagents according to the manufacturer's instructions. Following processing, the extracted sample is placed in the well of a 96 well plate to which "monoreagent" is added. The monoreagent contains the primers and probes for the genes of interest and the internal control combined with master mix. The assay is performed on an Applied Biosystems 7500 FAST Dx System that consists of the 7500 FAST Dx instrument, a personal computer, 96-well plates and seals. The total system run time is 150 minutes consisting of 60 minutes for sample processing and about 90 minutes for the real time amplification and detection steps. The instrument never comes into contact with any fluids within the 96well plate. Each disposable plate is intended to test up to 96 samples, controls or any mixture thereof. The 96-well plates are not re-usable and are specific to the system. The kit contains enough reagents for 100 reactions. One positive and one negative control are required for each PCR run ; a Negative
1
| | Processing Control and a Positive Processing Control are recommended to be
run in each extraction run. The design of the assay includes systems to identify
both the gene responsible for methicillin resistance and for a conserved portion
of a gene unique to S. aureus. Thus, for a true "MRSA," both targets will be
identified in roughly equal proportions. Results are determined by using an
algorithm that compares output, Cq, from the cycler (called Ct in the output from
the cycler.) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | MRSA/SA ELITe MGB® is a qualitative in vitro diagnostic test for the direct
detection of Staphylococcus aureus (SA) and methicillin-resistant
Staphylococcus aureus (MRSA) using DNA purified from nasal swabs.
MRSA/SA ELITe MGB® is intended to aid in the prevention and control of
MRSA infections in healthcare settings. It is not intended to diagnose, guide or
monitor MRSA infections, or provide results of susceptibility to
oxacillin/methicillin. A negative result does not preclude MRSA/SA
(Staphylococcus aureus) nasal colonization. Concomitant cultures are
necessary to recover organisms for epidemiological typing or for further
susceptibility testing. |
| Indication for use: | MRSA/SA ELITe MGB® is a qualitative in vitro diagnostic test for the direct
detection of Staphylococcus aureus (SA) and methicillin-resistant
Staphylococcus aureus (MRSA) using DNA purified from nasal swabs.
MRSA/SA ELITe MGB® is intended to aid in the prevention and control of
MRSA infections in healthcare settings. It is not intended to diagnose, guide or
monitor MRSA infections, or provide results of susceptibility to
oxacillin/methicillin. A negative result does not preclude MRSA/SA
(Staphylococcus aureus) nasal colonization. Concomitant cultures are
necessary to recover organisms for epidemiological typing or for further
susceptibility testing. |
Comparison to Predicate device
| | ELITech Molecular Diagnostics Device
MRSA/SA ELITe MBG | Predicate device
BD GENEOHM MRSA ACP ASSAY
(K093346) |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | MRSA/SA ELITe MGB® is a qualitative
in vitro diagnostic test for the direct
detection of Staphylococcus aureus
(SA) and methicillin-resistant
Staphylococcus aureus (MRSA) using
DNA purified from nasal swabs.
MRSA/SA ELITe MGB® is intended to
aid in the prevention and control of
MRSA infections in healthcare
settings. It is not intended to diagnose,
guide or monitor MRSA infections, or
provide results of susceptibility to
oxacillin/methicillin. A negative result
does not preclude MRSA/SA
(Staphylococcus aureus) nasal
colonization. Concomitant cultures are
necessary to recover organisms for
epidemiological typing or for further | The BD GeneOhm® MRSA ACP
Assay is a qualitative in vitro
diagnostic test for the direct detection
of methicillin-resistant Staphylococcus
aureus (MRSA) DNA from nasal
swabs in patients at risk for nasal
colonization. The test utilizes
polymerase chain reaction (PCR) for
the amplification of MRSA DNA and
fluorogenic target-specific
hybridization probes for the detection
of the amplified DNA. The BD
GeneOhm® MRSA ACP Assay is
intended to aid in the prevention and
control of MRSA infections in
healthcare settings. It is not intended
to diagnose MRSA infections nor to
guide or monitor treatment for MRSA |
| | ELITech Molecular Diagnostics Device | Predicate device |
| | MRSA/SA ELITE MBG® | BD GENEOHM MRSA ACP ASSAY
(K093346) |
| | susceptibility testing. | infections.
Concomitant cultures are necessary
only to recover organisms for
epidemiological typing or for further
susceptibility testing. |
| Indication for Use | MRSA/SA ELITE MGB® is a qualitative
in vitro diagnostic test for the direct
detection of Staphylococcus aureus
(SA) and methicillin-resistant
Staphylococcus aureus (MRSA) using
DNA purified from nasal swabs.
MRSA/SA ELITE MGB® is intended to
aid in the prevention and control of
MRSA infections in healthcare
settings. It is not intended to diagnose,
guide or monitor MRSA infections, or
provide results of susceptibility to
oxacillin/methicillin. A negative result
does not preclude MRSA/SA
(Staphylococcus aureus) nasal
colonization. Concomitant cultures are
necessary to recover organisms for The BD GeneOhm® MRSA ACP
Assay is a qualitative in vitro
diagnostic test for the direct detection
of methicillin-resistant Staphylococcus
aureus (MRSA) DNA from nasal
swabs in patients at risk for nasal
colonization. The test utilizes
polymerase chain reaction (PCR) for
the amplification of MRSA DNA and
fluorogenic target-specific
hybridization probes for the detection
of the amplified DNA. The BD
GeneOhm® MRSA ACP Assay is
intended to aid in the prevention and
control of MRSA infections in
healthcare settings. It is not intended
to diagnose MRSA infections nor to
guide or monitor treatment for MRSA
infections.
Concomitant cultures are necessary
only to recover organisms for
epidemiological typing or for further
susceptibility testing. | |
| Mode of identification
of S. aureus | Presence of conserved region in a
Staphylococcus aureus -specific gene. | Presence of SCC mec cassette
(genetic element that carries the mecA
gene) at orfX junction (specific to S.
aureus ) |
| Mode of detection for
methicillin resistance | Presence of the mecA gene which is
responsible for resistance to
methicillin. | gene) at orfX junction (specific to S.
aureus ) |
| Assay Format | Qualitative real-time polymerase chain
reaction (PCR) assay using 3 forward
primer, 3 reverse
primers, and 3 fluorescent-labeled
probes for the amplification and
detection of methicillin resistant
Staphylococcus aureus (MRSA) DNA. | Qualitative real-time polymerase chain
reaction (PCR) assay using 1 forward
primer, 5 reverse
primers, and 2 molecular beacon
probes for the amplification and
detection of methicillin resistant
Staphylococcus aureus (MRSA) DNA. |
| Composition | MRSA/SA ELITE MGB® PCR Mix
Tfi PCR Master Mix
1 Gift from Dr. Nathan A. Ledeboer, Medical College of Wisconsin, Wi; the strains are described in: Buchan, B.W, Ledeboer. N.A. Identification of Two Borderline Oxacillin-Resistant Strains of Staphylococcus aureus From Routine Nares Swab Specimens by One of Three Chromogenic Agars Evaluated for the Detection of MRSA, Microbiology and Infectious Disease.2010:134;921-927.
5
MSSA strains were tested at 10 CFU/swab. All MSSA strains tested positive for SA and negative for MRSA. All MRSA strains tested positive for MRSA. Two BORSA (Borderline Oxacillin Resistant Staphylococcus aureus) isolates that lack mecA 9 tested SA positive and MRSA negative for an overall analytical reactivity of 97.3%.
். Analytical Specificity
Exclusivity
The specificity of the MRSA/SA ELITe MGB® was evaluated by testing for cross-reactivity to species phylogenetically related to S. aureus, pathogenic microorganisms and to microorganisms commonly present in normal nasal microflora. The test panel consisted of 17 viral, 1 mycoplasma, and 41 bacterial species. The microorganisms were tested as cultures in concentrations of 1x10" CFU (1x10" PFU)/swab. In addition human cells in a concentration of 10° cells /mL were tested. Human cells and all tested species were found negative for MRSA and SA with the MRSA/SA ELITE MGB®. The analytical specificity was 100%.
| Staphylococci Species | Other Organisms | Viruses |
|---|---|---|
| CoNS* | ||
| Staphylococcus arlettae, | ||
| Staphylococcus capitis, | ||
| Staphylococcus carnosus, | ||
| Staphylococcus chromogenes, | ||
| Staphylococcus equorum, | ||
| Staphylococcus felis, | ||
| Staphylococcus gallinarum, | ||
| Staphylococcus hominis | ||
| subsp. hominis, | ||
| Staphylococcus kloosii, | ||
| Staphylococcus lentus, | ||
| Staphylococcus pulvereri, | ||
| Staphylococcus simulans, | ||
| Staphylococcus warneri | ||
| MSCoPS* | ||
| Staphylococcus delphini, | ||
| MSCoNS* | ||
| Staphylococcus epidermidis, | ||
| Staphylococcus xylosus | ||
| MRCONS* | ||
| Staphylococcus epidermidis | ||
| CoPS* | ||
| Staphylococcus hyicus, | ||
| Staphylococcus intermedius | Acinetobacter haemolyticus, Bacillus | |
| cereus, Bordetella pertussis, | ||
| Citrobacter freundii, Citrobacter koseri, | ||
| Corynebacterium aquaticum, | ||
| Corynebacterium bovis, | ||
| Corynebacterium flavescens, | ||
| Corynebacterium genitalium, | ||
| Enterobacter aerogenes, | ||
| Enterococcus faecalis, Enterococcus | ||
| faecium, Enterococcus flavescens, | ||
| Enterococcus gallinarum, | ||
| Enterococcus hiraem, Escherichia coli, | ||
| ESBL producer, Klebsiella oxytoca, | ||
| Klebsiella pneumoniae, ESBL | ||
| producer, Listeria monocytogenes, | ||
| Moraxella catarrhalis, Pasteurella | ||
| aerogenes, Proteus mirabilis, Proteus | ||
| vulgaris, Pseudomonas aeruginosa, | ||
| Salmonella typhimurium, Serratia | ||
| marcescens, Shigella sonnei, | ||
| Streptococcus mitis, Streptococcus | ||
| salivarius, Yersinia enterocolitica, | ||
| Candida albicans, Candida glabrata, | ||
| Cryptococcus neoformans, | ||
| Lactobacillus acidophilus, Legionella | ||
| pneumophila, Mycobacterium | ||
| tuberculosis avirulent, Mycoplasma | ||
| pneumoniae, Neisseria meningitides, | ||
| Streptococcus mutans, Streptococcus | ||
| pneumoniae, Streptococcus | ||
| pyogenes, Homo sapiens, Human | ||
| Cells HT1080 | Adenovirus Type 1, | |
| Adenovirus Type 7A, | ||
| Human coronavirus (229E), | ||
| Human coronavirus (OC43), | ||
| Cytomegalovirus, | ||
| Coxsackievirus Type A21, | ||
| Epstein Barr Virus, | ||
| Human influenza virus A, | ||
| Human influenza virus B, | ||
| Human parainfluenza Type 2, | ||
| Human parainfluenza Type 3, | ||
| Human metapneumovirus 3 Type | ||
| B1, | ||
| Measles, | ||
| Mumps virus, | ||
| Respiratory syncytial virus Type B, | ||
| Rhinovirus Type 1A |
Species Tested for Cross-Reactivity and Microbial Interference
- CoNS: coagulase-negative Staphylococci, MSCoPS: methicillin susceptible coagulase positive Staphylococci, MSCoNS: methicillin susceptible coagulase negative Staphylococci,
6
MRCoNS: methicillin resistant coaqulase negative Staphylococci. CoPS: coaqulase positive Staphylococci
Two of the potentially interfering organisms tested, Human metapneumovirus (hMPV) and MRCoNS Staphylococcus epidermidis, strain NRS 34, caused interference at initial test.
Re-testing of MRCoNS Staphylococus epidermidis, strain NRS 34 confirmed the interference results. MRCoNS Staphylococcus epidermidis, strain NRS 34, is considered to interfere with MRSA/SA ELITE MGB®.
- MRCoNS Staphylococcus epidermidis when tested in a mix with near-detection-limit -MRSA resulted in "SA positive, MRSA negative" call.
Re-testing of Human metapneumovirus (hMPV) did not reveal interference of hMPV with MRSA/SA ELITe MGB":
Methicillin Susceptible S. aureus (MSSA) was also tested for microbial interference. The microorganism was spiked at 1×10° CFU/mL (1×10° PFU/mL), or higher, into a sample with MRSA strains at neardetection-limit and tested.
- MRCoNS Staphylococcus epidermidis and MSSA, when tested in a mix with near-detection-. limit of MRSA, resulted in "SA positive, MRSA neqative" call.
None of the other tested species interfered with MRSA/SA detection.
D. Reproducibility
.
A 10-member panel of specimens with varying concentrations of MRSA in a simulated nasal matrix was tested. Two MRSA strains (ATCC BAA-1720) and one MSSA strain (BAA-12600) were used. Simulated matrix contained human genomic DNA and mucin to imitate a normal human nasal matrix. Data from the specimens were pooled to produce four sample types: For each MRSA/MSSA strain the panel included a negative member, specimen below the LoD (expected to yield a positivity rate of between 20 to 80%), low positive (at LoD, expected to yield a 95% positivity rate), and moderate positive (three times LoD, expected to have 100% positivity rate).
Each of the two operators performed one run per day for 12 days on three reagent lots at one site. In two other sites two runs per day on one reagent lot were performed for 5 days (10 specimens x 3 replicates x 5 days x 2 runs).
The negative panel member yielded negative results 100%, the below LoD specimens positivity rate was 77%, the low positive specimen positivity rate was 98%, and the moderate positive panel members positivity rate was 100%.
| Specimen Type | Lot 1 | Lot 2 | Lot 3 | Total Agreement (%) |
|---|---|---|---|---|
| Negative (R1) | 14/14 | 14/14 | 30/30 | 58/58 (100%) |
| Below LoD (R2,R5,R8) | 33/42 | 31/42 | 70/90 | 134/174 (77%) |
| Low Positive (R3,R6,R9) | 40/42 | 42/42 | 88/90 | 170/174 (98%) |
| Moderate Positive (R4,R7,R10) | 42/42 | 42/42 | 90/90 | 174/174 (100%) |
Cumulative data of reproducibility study
The numerical results based on Ct values follow:
7
| 4 | |
|---|---|
| 1 | |
| Panel # | N | Mean Ct | Within-Run | Between-Run | Between-Day | Between-Operator | Between-Lot | Between-System | Total | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% | ||||
| R1 | 118 | 38.12 | NA1 | NA1 | 0.67 | 1.75 | 0.45 | 1.18 | 0.29 | 0.76 | 0.39 | 1.03 | 0.15 | 0.40 | 0.39 | 1.02 | |
| R2 | 118 | 36.22 | 0.65 | 1.79 | 0.99 | 2.74 | 0.79 | 2.18 | 0.82 | 2.26 | 0.32 | 0.89 | 0.86 | 2.38 | 0.74 | 2.04 | |
| R3 | 118 | 35.39 | 0.62 | 1.73 | 0.96 | 2.72 | 0.86 | 2.42 | 0.94 | 2.65 | 0.43 | 1.23 | 1.08 | 3.06 | 0.82 | 2.30 | |
| R4 | 118 | 34.35 | 0.41 | 1.20 | 0.67 | 1.94 | 0.53 | 1.54 | 0.42 | 1.22 | 0.48 | 1.40 | 0.35 | 1.03 | 0.48 | 1.39 | |
| R5 | 118 | 36.73 | 0.71 | 1.94 | 0.87 | 2.37 | 0.79 | 2.16 | 0.56 | 1.52 | 0.50 | 1.37 | 0.45 | 1.23 | 0.65 | 1.77 | |
| R6 | 118 | 33.66 | 0.42 | 1.24 | 0.69 | 2.05 | 0.64 | 1.92 | 0.56 | 1.66 | 0.48 | 1.44 | 0.58 | 1.72 | 0.56 | 1.67 | |
| R7 | 118 | 31.81 | 0.17 | 0.54 | 0.76 | 2.38 | 0.67 | 2.09 | 0.73 | 2.28 | 0.43 | 1.36 | 0.83 | 2.60 | 0.60 | 1.88 | |
| R8 | 118 | 37.68 | 0.77 | 2.05 | 0.74 | 1.97 | 0.43 | 1.15 | 0.39 | 1.03 | 0.12 | 0.33 | 0.40 | 1.06 | 0.48 | 1.26 | |
| R9 | 118 | 34.65 | 0.56 | 1.60 | 0.64 | 1.84 | 0.51 | 1.49 | 0.54 | 1.56 | 0.08 | 0.23 | 0.60 | 1.74 | 0.49 | 1.41 | |
| R10 | 118 | 32.82 | 0.58 | 1.76 | 0.48 | 1.45 | 0.42 | 1.28 | 0.37 | 1.13 | 0.17 | 0.53 | 0.40 | 1.21 | 0.40 | 1.23 | |
| PSPC | 44 | 34.25 | NA2 | NA2 | 0.71 | 2.08 | 0.41 | 1.21 | 0.41 | 1.18 | 0.18 | 0.52 | 0.59 | 1.72 | 0.46 | 1.34 | |
| PC | 44 | 28.12 | NA2 | NA2 | 1.08 | 3.86 | 1.18 | 4.20 | 0.58 | 2.07 | 1.21 | 4.24 | 0.50 | 1.79 | 0.91 | 3.23 | |
| NSPC | 44 | 38.24 | NA2 | NA2 | 0.63 | 1.64 | 0.65 | 1.69 | 0.85 | 2.24 | 0.11 | 0.30 | 0.82 | 2.15 | 0.61 | 1.60 | |
| NTC | 44 | 38.14 | NA3 | NA3 | NA3 | NA3 | NA3 | NA3 | NA3 | NA3 | NA3 | NA3 | NA3 | NA3 | NA3 | NA3 |
mecA
| N | Mean
Ct | Within-Run | | Between-Run | | Between-Day | | Between-Operator | | Between-Lot | | Between-System | | Total | |
|-----|------------|------------|------|-------------|------|-------------|------|------------------|------|-------------|------|----------------|------|-------|------|
| | | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| 118 | 38.53 | NA1 | NA1 | 1.08 | 2.81 | 1.31 | 3.42 | 0.76 | 1.97 | 0.97 | 2.54 | 0.32 | 0.83 | 0.89 | 2.31 |
| 118 | 36.87 | 0.53 | 1.43 | 0.93 | 2.52 | 0.68 | 1.84 | 0.68 | 1.85 | 0.40 | 1.09 | 0.74 | 2.02 | 0.66 | 1.79 |
| 118 | 36.40 | 0.59 | 1.62 | 1.13 | 3.12 | 0.99 | 2.73 | 1.15 | 3.15 | 0.66 | 1.83 | 1.27 | 3.51 | 0.97 | 2.66 |
| 118 | 35.17 | 0.37 | 1.05 | 0.68 | 1.94 | 0.54 | 1.54 | 0.46 | 1.32 | 0.43 | 1.24 | 0.41 | 1.17 | 0.48 | 1.38 |
| 118 | 37.31 | 0.60 | 1.62 | 0.64 | 1.71 | 0.50 | 1.35 | 0.44 | 1.17 | 0.47 | 1.26 | 0.46 | 1.24 | 0.52 | 1.39 |
| 118 | 34.45 | 0.43 | 1.24 | 0.74 | 2.15 | 0.70 | 2.04 | 0.58 | 1.68 | 0.61 | 1.78 | 0.60 | 1.74 | 0.61 | 1.77 |
| 118 | 32.50 | 0.19 | 0.58 | 0.87 | 2.68 | 0.76 | 2.34 | 0.85 | 2.61 | 0.52 | 1.61 | 0.95 | 2.91 | 0.69 | 2.12 |
| 118 | 39.12 | NA4 | NA4 | 0.55 | 1.42 | 0.52 | 1.35 | 0.45 | 1.16 | 0.25 | 0.65 | 0.33 | 0.86 | 0.42 | 1.09 |
| 118 | 38.83 | NA4 | NA4 | 0.62 | 1.59 | 0.46 | 1.17 | 0.38 | 0.97 | 0.14 | 0.35 | 0.32 | 0.83 | 0.38 | 0.98 |
| 118 | 38.74 | NA4 | NA4 | 0.77 | 1.98 | 0.57 | 1.46 | 0.40 | 1.05 | 0.36 | 0.94 | 0.31 | 0.79 | 0.48 | 1.25 |
| 44 | 35.03 | NA2 | NA2 | 0.73 | 2.08 | 0.56 | 1.60 | 0.42 | 1.20 | 0.28 | 0.80 | 0.56 | 1.60 | 0.51 | 1.45 |
| 44 | 29.18 | NA2 | NA2 | 1.11 | 3.82 | 1.23 | 4.21 | 0.51 | 1.74 | 1.24 | 4.22 | 0.40 | 1.37 | 0.90 | 3.07 |
| 44 | 39.03 | NA2 | NA2 | 0.48 | 1.22 | 0.48 | 1.22 | 0.48 | 1.22 | 0.58 | 1.48 | NA5 | NA5 | 0.50 | 1.28 |
| 44 | 39.53 | NA2 | NA2 | 0.24 | 0.61 | 0.24 | 0.61 | 0.24 | 0.61 | NA6 | NA6 | 0.24 | 0.61 | 0.24 | 0.61 |
ﻓﮩﺮﺳ ﺑﮭﺎﺭﺗﯽ
ﺮ ﭘﻮﺭ ﺍﻭ ﭘﻪ ﭘﻪ
Page 5.8 of 5.11 pages
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ার্টি
ﻦ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺪﻳﻨﺔ
8
| C2 | Panel
| N | Mean
Ct | Within-Run | | Between-Run | | Between-Day | | Between-Operator | | Between-Lot | | Between-System | | Total | |
|----|------------|-----|------------|------------|------|-------------|------|-------------|------|------------------|------|-------------|------|----------------|------|-------|------|
| | | | | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| | R1 | 118 | 30.26 | 0.15 | 0.50 | 0.27 | 0.89 | 0.17 | 0.55 | 0.18 | 0.59 | 0.05 | 0.18 | 0.23 | 0.75 | 0.17 | 0.58 |
| | R2 | 118 | 30.24 | 0.18 | 0.58 | 0.30 | 1.00 | 0.24 | 0.79 | 0.18 | 0.60 | 0.03 | 0.10 | 0.24 | 0.78 | 0.19 | 0.64 |
| | R3 | 118 | 30.30 | 0.17 | 0.57 | 0.25 | 0.81 | 0.18 | 0.60 | 0.17 | 0.57 | 0.04 | 0.14 | 0.20 | 0.66 | 0.17 | 0.56 |
| | R4 | 118 | 30.26 | 0.12 | 0.39 | 0.27 | 0.88 | 0.16 | 0.53 | 0.17 | 0.57 | 0.11 | 0.36 | 0.18 | 0.58 | 0.17 | 0.55 |
| | R5 | 118 | 30.23 | 0.22 | 0.72 | 0.33 | 1.09 | 0.24 | 0.78 | 0.23 | 0.75 | 0.10 | 0.34 | 0.27 | 0.88 | 0.23 | 0.76 |
| | R6 | 118 | 30.38 | 0.22 | 0.74 | 0.43 | 1.40 | 0.31 | 1.01 | 0.14 | 0.47 | 0.06 | 0.20 | 0.09 | 0.30 | 0.21 | 0.69 |
| | R7 | 118 | 30.31 | 0.15 | 0.50 | 0.30 | 0.98 | 0.21 | 0.68 | 0.13 | 0.42 | 0.04 | 0.12 | 0.14 | 0.45 | 0.16 | 0.53 |
| | R8 | 118 | 30.39 | 0.23 | 0.76 | 0.38 | 1.24 | 0.24 | 0.79 | 0.25 | 0.81 | 0.21 | 0.68 | 0.20 | 0.66 | 0.25 | 0.82 |
| | R9 | 118 | 30.34 | 0.14 | 0.46 | 0.32 | 1.06 | 0.23 | 0.74 | 0.28 | 0.93 | 0.12 | 0.38 | 0.26 | 0.87 | 0.23 | 0.74 |
| | R10 | 118 | 30.16 | 0.24 | 0.80 | 0.51 | 1.70 | 0.27 | 0.89 | 0.31 | 1.04 | 0.13 | 0.42 | 0.33 | 1.09 | 0.30 | 0.99 |
| | PSPC | 44 | 30.26 | NA2 | NA2 | 0.47 | 1.55 | 0.36 | 1.18 | 0.32 | 1.05 | 0.33 | 1.09 | 0.28 | 0.94 | 0.35 | 1.16 |
| | PC | 44 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 |
| | NSPC | 44 | 30.27 | NA2 | NA2 | 0.63 | 2.09 | 0.51 | 1.68 | 0.48 | 1.59 | 0.35 | 1.15 | 0.32 | 1.05 | 0.46 | 1.51 |
| | NTC | 44 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 | NA7 |
-
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9
Carry-Over / Cross-Contamination ய்
An analytical study was performed to evaluate the potential for cross-contamination between high MRSA (1x10' CFU per mL) specimens and negative specimens throughout the MRSA/SA ELITe MGB" workflow. Two operators performed five 24-sample extraction runs (11 high MRSA samples, 1 PSPC sample, and 1 NSPC sample per run) in a checkerboard pattern (high MRSA samples interrupted by completely negative samples). The processed samples were then PCR amplified in five separate runs using two different checkerboard patterns. The cross-contamination testing resulted in zero false neqatives from fifty-five high MRSA positive samples and one false positive sample from fifty-five negative samples.
Clinical Performance
Performance characteristics of the MRSA/SA ELITe MGB® were determined in a prospective investigational study at three (3) sites by comparing the MRSA/SA ELITe MGB® with agglutination/susceptibility tests. Specimens were collected from three (3) unique geographies at institutions having MRSA culture-based screening programs in place. To be enrolled in the study, patients had to be eligible for MRSA screening to the policies of the respective facilities. A true MRSA culture-positive specimen was defined as a specimen where MRSA was identified by the latex agglutination and cefoxitin susceptibility test after broth enrichment (both positive). A true MSSA culturepositive specimen was defined as a specimen negative for cefoxitin susceptibility testing and positive for the latex agglutination test.
One nasal swab was collected from each patient and used to inoculate a selective chromogenic MRSA screening agar plate. Then the swab was inserted into a tube with trypticase soy broth and thoroughly mixed. The entire volume of the cell suspension was tested using MRSA/SA ELITe MGB. All swabs were subjected to enrichment in trypticase soy broth with 6.5% NaCl. The enriched culture samples were inoculated onto Trypticase Soy Blood Agar plates. Grown overnight cultures were used for latex agglutination. Specimens positive for latex agglutination were used for the cefoxitin susceptibility test.
Performance of the MRSA/SA ELITe MGB® was calculated relative to the broth culture followed by latex agglutination and cefoxitin susceptibility test results.
A total of 3271 nasal swab specimens were collected and tested. Of the 3271 specimen tested, 3174 specimens were eligible to be included in statistical analyses: 72 specimens were considered to be ineligible due to a duplicating error during samples collection and preparation; 21 specimens failed the initial extraction due to an operator error. Those samples were retested from the original swabs. 25 specimens failed the extraction and have been removed from the study.
Compared to the reference culture method, MRSA/SA ELITe MGB® identified 92% of the specimens testing positive for MRSA and 95% of the negative specimens.
Compared to the reference culture method. MRSA/SA ELITe MGB® identified 96% of the specimens testing positive for SA and 95% of the negative specimens.
10
| Combined Data | Reference Culture | ||||
|---|---|---|---|---|---|
| MRSA+ | SA+/MRSA- | Neg/No Growth | Total | ||
| MRSA/SA ELITe | |||||
| MGB® | MRSA+ | 205 | 111 | 32 | 348 |
| SA+/MRSA- | 17 | 405 | 86 | 508 | |
| SA- | 0 | 30 | 2288 | 2318 | |
| Total | 222 | 546 | 2406 | 3174 | |
| MRSA: | |||||
| Sensitivity: 92.3% (88.08%-95.16%) | |||||
| Specificity: 95.2% (94.32%-95.87%) | |||||
| PPV: 58.9% (53.67%-63.95%) | |||||
| NPV: 99.4% (99.04%-99.62%) |
SA:
Sensitivity: 96.1% (94.48%-97.25%)
Specificity: 95.1% (94.16%-95.89%)
PPV: 86.2% (83.74%-88.36%)
NPV: 98.7% (98.16%-99.09%)
Note: The statistics shown are the calculated values with the 95% confidence interval in the parentheses. | | | | | |
Summarized (for all data combined) MRSA/SA ELITe MGB® performance table :
Compared to the culture method of reference(agglutination/cefoxitin testing), the MRSA/SA ELITe MGB™ identified ~93% of the specimens positive for MRSA by a reference method and ~96% of the MRSA-negative specimens.
PPV: 65.2% (60.08%, 70.04%),
NPV: 99.4% (99.08%, 99.65%)
Thus, the positive and negative agreements for MRSA were each increased by 1% to achieve 93% and 96% respectively. Positive Predictive Value for MRSA was also increased by 6% to achieve 65%.
° Discrepant Analysis: Further investigation (testing for MRSA by sequencing of SCCmec right extremity junction) was performed on all specimens that gave discordant MRSA results between the reference culture method and MRSA/SA ELITe MGB™.
. 16 of the 17 specimens that were MRSA-positive by culture but MRSA-negative by MRSA/SA ELITe MGB™ were found to be MRSA positive by SCCmec right extremity junction sequencing.
. 22 of the 143 specimens that were MRSA-negative by culture but MRSA-positive by MRSA/SA ELITE MGB™ were found to be MRSA positive by SCCmec right extremity junction sequencing.
11
Image /page/11/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and support.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
ELITechGroup EPOCH Biosciences C/o Debra K. Hutson Director, QA/RA, North America 21720 2310 Drive SE, Suite 150 Bothell, WA 98021
JUN - 1 2012
Re: K112937
Trade/Device Name: MRSA/SA ELITe MGB® Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: NQX Dated: May 9, 2012 Received: May 11, 2012
Dear Ms. Hutson:
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 medied do res 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
12
Page 2 - Debra K. Hutson
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,
Say aAyno
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
13
Indications for Use Form
510(k) Number (if known): K112937
Device Name: ____________________ MRSA/SA ELITe MGB®
Indications for Use:
MRSA/SA ELITe MGB® is a qualitative in vitro diagnostic test for the direction of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) using DNA purified from nasal swabs. MRSA/SA ELITe MGB® is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose, guide or monitor MRSA infections, or provide results of susceptibility to oxacillin/methicillin. A negative result does not preclude MRSA/SA (Staphylococcus aureus) nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.
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 Tri. Padke
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112937.
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