(242 days)
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.
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.)
Here's a breakdown of the acceptance criteria and the study details for the MRSA/SA ELITe MGB® device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the performance goals demonstrated in the clinical study. The summary doesn't explicitly state pre-defined acceptance criteria values but rather presents the achieved performance.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| MRSA Detection | ||
| Sensitivity | High (e.g., >90%) | 92.3% (88.08%-95.16%) |
| Specificity | High (e.g., >90%) | 95.2% (94.32%-95.87%) |
| Positive Predictive Value (PPV) | Adequate (e.g., >50%) | 58.9% (53.67%-63.95%) (Initial) 65.2% (60.08%, 70.04%) (After Discrepant Analysis) |
| Negative Predictive Value (NPV) | Very High (e.g., >95%) | 99.4% (99.04%-99.62%) (Initial) 99.4% (99.08%, 99.65%) (After Discrepant Analysis) |
| SA Detection | ||
| Sensitivity | High (e.g., >90%) | 96.1% (94.48%-97.25%) |
| Specificity | High (e.g., >90%) | 95.1% (94.16%-95.89%) |
| PPV | High (e.g., >80%) | 86.2% (83.74%-88.36%) |
| NPV | Very High (e.g., >95%) | 98.7% (98.16%-99.09%) |
| Analytical Sensitivity (LoD) | Consistent detection at low concentrations (e.g., 95% confidence) | Average LoD: 165 CFU/mL of a swab eluate |
| Analytical Reactivity (Inclusivity) | Detection of diverse MRSA/MSSA strains (>95%) | 97.3% (All MSSA positive for SA, negative for MRSA; All MRSA positive for MRSA; 2 BORSA isolates SA positive, MRSA negative) |
| Analytical Specificity (Exclusivity) | No cross-reactivity with common nasal microflora/pathogens (100%) | 100% (with exceptions for two interfering organisms) |
| Reproducibility | Consistent results across runs, operators, days, and lots | See detailed SD and CV% values for Ct in the table (generally low variability) |
| Carry-Over / Cross-Contamination | Minimal to no false positives/negatives (e.g., <5%) | Zero false negatives (high MRSA samples), One false positive (negative samples) out of 55 each. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Performance Study): A total of 3271 nasal swab specimens were collected. After exclusions, 3174 eligible specimens were included in the statistical analyses.
- Data Provenance: The data was collected from a prospective investigational study conducted at three (3) sites in unique geographies. The specific countries are not mentioned, but the submitter is based in Bothell, WA, USA, suggesting the studies were likely conducted within the USA. The patients were those eligible for MRSA screening according to the facilities' policies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the clinical performance study was established using a reference culture method involving latex agglutination and cefoxitin susceptibility tests. This method is a standard laboratory procedure, and the expertise would reside with trained laboratory personnel performing these microbiological tests, rather than external clinical experts (e.g., radiologists). The document does not specify the number or qualifications of individuals performing these reference tests, as it's a standard laboratory process.
4. Adjudication Method for the Test Set
- Initial Ground Truth: The initial ground truth for MRSA was defined as a specimen where MRSA was identified by both latex agglutination and cefoxitin susceptibility test (after broth enrichment). For MSSA, it was negative for cefoxitin susceptibility and positive for latex agglutination.
- Discrepant Analysis: For specimens with discordant MRSA results between the reference culture method and the MRSA/SA ELITe MGB™, further investigation was performed using sequencing of the SCCmec right extremity junction. This method served as a higher-level adjudication for refining the ground truth for discordant MRSA cases. The document does not specify if multiple sequencers were involved or if there was a consensus process for the sequencing results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a fully automated nucleic acid amplification test (NAAT) for direct detection, not an AI-assisted diagnostic device that is interpreted by human readers. Therefore, the concept of human reader improvement with/without AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was performed. The MRSA/SA ELITe MGB® is an in vitro diagnostic (IVD) device that provides qualitative results (MRSA+, SA+, SA-). Its performance metrics (sensitivity, specificity, PPV, NPV) were calculated by comparing the device's output directly against the reference culture gold standard, without any human interpretation of the device's raw data that could influence the final result. The "algorithm" in this context is the automated Cq (Ct) comparison logic within the system that determines the positive/negative call for MRSA and SA targets.
7. The Type of Ground Truth Used
The primary ground truth used for the clinical performance study was expert consensus pathology / laboratory reference method. Specifically, it was defined by:
- MRSA: Latex agglutination and cefoxitin susceptibility test (after broth enrichment) confirming MRSA presence.
- MSSA: Negative cefoxitin susceptibility test and positive latex agglutination test.
- Discrepant cases: Further adjudicated by sequencing of SCCmec right extremity junction.
8. The Sample Size for the Training Set
The document does not explicitly state the sample size used for a training set. This type of 510(k) submission typically focuses on validation data rather than the development and training phases of the algorithm, especially for established PCR technologies. The "Non-Clinical Performance Evaluation" references analytical studies using specific strains and dilutions, but these are for analytical validation, not for training a machine learning model.
9. How the Ground Truth for the Training Set Was Established
As no explicit training set is detailed for an AI/ML algorithm, the method for establishing its ground truth is not provided. However, for the analytical studies (e.g., analytical sensitivity, reactivity), the ground truth for microbial strains was established by:
- Quantification: Cultures of strains were quantified (CFU/swab).
- Characterization: Strains were well-characterized isolates obtained from sources like the Network on Antimicrobial Resistance in Staphylococcus aureus (NARSA) Program, American Tissue Culture Collection (ATCC), or gifts from research institutions (e.g., Medical College of Wisconsin), implying established methods for strain identification and resistance profiles.
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510(k) Summary MRSA/SA ELITe MGB®
substantial equivalence.
The assigned 510(k) number is: K112937
| Submitter:Address:Phone numberFax number | ELITechGroup Epoch Biosciences.21720 23rd Dr SE, Suite 150, Bothell, WA 98021 USA425-482-5555425-482-5550 |
|---|---|
| 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 AdvisoryCommittee: | 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
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| Processing Control and a Positive Processing Control are recommended to berun in each extraction run. The design of the assay includes systems to identifyboth the gene responsible for methicillin resistance and for a conserved portionof a gene unique to S. aureus. Thus, for a true "MRSA," both targets will beidentified in roughly equal proportions. Results are determined by using analgorithm that compares output, Cq, from the cycler (called Ct in the output fromthe cycler.) | |
|---|---|
| Intended Use: | MRSA/SA ELITe MGB® is a qualitative in vitro diagnostic test for the directdetection of Staphylococcus aureus (SA) and methicillin-resistantStaphylococcus aureus (MRSA) using DNA purified from nasal swabs.MRSA/SA ELITe MGB® is intended to aid in the prevention and control ofMRSA infections in healthcare settings. It is not intended to diagnose, guide ormonitor MRSA infections, or provide results of susceptibility tooxacillin/methicillin. A negative result does not preclude MRSA/SA(Staphylococcus aureus) nasal colonization. Concomitant cultures arenecessary to recover organisms for epidemiological typing or for furthersusceptibility testing. |
| Indication for use: | MRSA/SA ELITe MGB® is a qualitative in vitro diagnostic test for the directdetection of Staphylococcus aureus (SA) and methicillin-resistantStaphylococcus aureus (MRSA) using DNA purified from nasal swabs.MRSA/SA ELITe MGB® is intended to aid in the prevention and control ofMRSA infections in healthcare settings. It is not intended to diagnose, guide ormonitor MRSA infections, or provide results of susceptibility tooxacillin/methicillin. A negative result does not preclude MRSA/SA(Staphylococcus aureus) nasal colonization. Concomitant cultures arenecessary to recover organisms for epidemiological typing or for furthersusceptibility testing. |
Comparison to Predicate device
| ELITech Molecular Diagnostics DeviceMRSA/SA ELITe MBG | Predicate deviceBD GENEOHM MRSA ACP ASSAY(K093346) | |
|---|---|---|
| Intended use | MRSA/SA ELITe MGB® is a qualitativein vitro diagnostic test for the directdetection of Staphylococcus aureus(SA) and methicillin-resistantStaphylococcus aureus (MRSA) usingDNA purified from nasal swabs.MRSA/SA ELITe MGB® is intended toaid in the prevention and control ofMRSA infections in healthcaresettings. It is not intended to diagnose,guide or monitor MRSA infections, orprovide results of susceptibility tooxacillin/methicillin. A negative resultdoes not preclude MRSA/SA(Staphylococcus aureus) nasalcolonization. Concomitant cultures arenecessary to recover organisms forepidemiological typing or for further | The BD GeneOhm® MRSA ACPAssay is a qualitative in vitrodiagnostic test for the direct detectionof methicillin-resistant Staphylococcusaureus (MRSA) DNA from nasalswabs in patients at risk for nasalcolonization. The test utilizespolymerase chain reaction (PCR) forthe amplification of MRSA DNA andfluorogenic target-specifichybridization probes for the detectionof the amplified DNA. The BDGeneOhm® MRSA ACP Assay isintended to aid in the prevention andcontrol of MRSA infections inhealthcare settings. It is not intendedto diagnose MRSA infections nor toguide 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 necessaryonly to recover organisms forepidemiological typing or for furthersusceptibility testing. | |
| Indication for Use | MRSA/SA ELITE MGB® is a qualitativein vitro diagnostic test for the directdetection of Staphylococcus aureus(SA) and methicillin-resistantStaphylococcus aureus (MRSA) usingDNA purified from nasal swabs.MRSA/SA ELITE MGB® is intended toaid in the prevention and control ofMRSA infections in healthcaresettings. It is not intended to diagnose,guide or monitor MRSA infections, orprovide results of susceptibility tooxacillin/methicillin. A negative resultdoes not preclude MRSA/SA(Staphylococcus aureus) nasalcolonization. Concomitant cultures arenecessary to recover organisms for The BD GeneOhm® MRSA ACPAssay is a qualitative in vitrodiagnostic test for the direct detectionof methicillin-resistant Staphylococcusaureus (MRSA) DNA from nasalswabs in patients at risk for nasalcolonization. The test utilizespolymerase chain reaction (PCR) forthe amplification of MRSA DNA andfluorogenic target-specifichybridization probes for the detectionof the amplified DNA. The BDGeneOhm® MRSA ACP Assay isintended to aid in the prevention andcontrol of MRSA infections inhealthcare settings. It is not intendedto diagnose MRSA infections nor toguide or monitor treatment for MRSAinfections.Concomitant cultures are necessaryonly to recover organisms forepidemiological typing or for furthersusceptibility testing. | |
| Mode of identificationof S. aureus | Presence of conserved region in aStaphylococcus aureus -specific gene. | Presence of SCC mec cassette(genetic element that carries the mecAgene) at orfX junction (specific to S.aureus ) |
| Mode of detection formethicillin resistance | Presence of the mecA gene which isresponsible for resistance tomethicillin. | gene) at orfX junction (specific to S.aureus ) |
| Assay Format | Qualitative real-time polymerase chainreaction (PCR) assay using 3 forwardprimer, 3 reverseprimers, and 3 fluorescent-labeledprobes for the amplification anddetection of methicillin resistantStaphylococcus aureus (MRSA) DNA. | Qualitative real-time polymerase chainreaction (PCR) assay using 1 forwardprimer, 5 reverseprimers, and 2 molecular beaconprobes for the amplification anddetection of methicillin resistantStaphylococcus aureus (MRSA) DNA. |
| Composition | MRSA/SA ELITE MGB® PCR MixTfi PCR Master Mix<0.01% MRSA/SA primers<0.01% Internal Control primers<0.01% MRSA/SA Fluorescent-labeled oligonucleotide probes<0.01% Internal Control Fluorescent-labeled oligonucleotide probe | Master Mix< 0.0005% DNA polymerase complex< 0.001% Internal Control: non-infectious DNA containing MRSA-primer binding sequences and aunique sequence for probehybridization< 0.06% primers |
| ELITech Molecular Diagnostics DeviceMRSA/SA ELITE MBG® | Predicate deviceBD GENEOHM MRSA ACP ASSAY(K093346) | |
| Reference dT(8)-AP593MRSA/SA Internal ControlTris buffer<0.01% EDTA0.01% total yeast RNA<0.001% Non-infectious plasmid DNA(recombinant) containing InternalControl sequences | < 1% Nucleotide mix (dATP, dCTP,dGTP, dTTP)Bovine serum albuminCarbohydrateMgCl2< 0.001% non-infectiousStaphylococcus epidermidis genomicDNA (ATCC 14990) | |
| MRSA/SA Positive ControlTris buffer<0.01% EDTA0.01% total yeast RNA<0.001% Non-infectious plasmid DNA(microbial) containing MRSAsequences | Control DNATris-EDTA bufferCarbohydrate< 0.001% non-infectious genomicMRSA DNA (ATCC 43300)DiluentTris-HCl bufferMgCl2(NH4)2SO4KClTween-20 | |
| Appearance ofreagents | Frozen, ready to use | Liquid, ready to use. |
| Sample type | Nasal swab | Nasal swab |
| Storage & Expiry | Stored in -20 °C freezer. The deviceis stable until the expiry date stated onthe label. | Stored at 2- 25 °C.Reagents are stable until the expirydate stated on the label. |
| Instrument | ABI 7500 Fast Dx | BD SmartCycler® II |
| Controls | Positive PCR control (Plasmid DNA(microbial) containing MRSAsequences)Internal Control (Plasmid DNA(recombinant) containing InternalControl sequences) | Positive PCR control (DNA from S.aureus ATCC 43300).Negative PCR control (DNA from S.epidermidis ATCC 14990).Internal procedural control |
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Standard/Guidance Document Referenced
FDA Draft Guidance for Industry and Food and Drug Administration Staff Establishing the Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococus aureus (MRSA) and Staphylococcus aureus (SA), Issued January 5, 2011.
FDA Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Issued September 9, 1999.
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Instrumentation/Software:
The system is performed with FDA-cleared devices, bioMérieux NucliSENS® easyMAG® extraction system and the Applied Biosystems 7500 Fast Dx PCR Instrument. ELITechGroup Epoch Biosciences has a relationship with each on the manufacturers of these devices via service contracts such that Epoch will become aware, in the same time, as other users of the system, of changes to the device(s) or of the software used by the device(s). Internal quality assurance procedures are in place to verify the continued acceptable performance of the test device. Please, note, however, that the evaluation algorithm and the use of controls as indicated in the labeling, Internal Control and Positive Control, Negative Specimen Processing Control and Positive Specimen Processing Control, should identify for users any issues created by instrument or software changes.
Performance Characteristics
Interfering substances
A study was conducted with potentially interfering substances encountered on nasal swabs. Substances tests 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: AYFO saline nasal gel and excessive amounts of nasal secretions/mucus.
Non-Clinical Performance Evaluation
A. 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.
B. 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
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.
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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 hominissubsp. hominis,Staphylococcus kloosii,Staphylococcus lentus,Staphylococcus pulvereri,Staphylococcus simulans,Staphylococcus warneriMSCoPS*Staphylococcus delphini,MSCoNS*Staphylococcus epidermidis,Staphylococcus xylosusMRCONS*Staphylococcus epidermidisCoPS*Staphylococcus hyicus,Staphylococcus intermedius | Acinetobacter haemolyticus, Bacilluscereus, Bordetella pertussis,Citrobacter freundii, Citrobacter koseri,Corynebacterium aquaticum,Corynebacterium bovis,Corynebacterium flavescens,Corynebacterium genitalium,Enterobacter aerogenes,Enterococcus faecalis, Enterococcusfaecium, Enterococcus flavescens,Enterococcus gallinarum,Enterococcus hiraem, Escherichia coli,ESBL producer, Klebsiella oxytoca,Klebsiella pneumoniae, ESBLproducer, Listeria monocytogenes,Moraxella catarrhalis, Pasteurellaaerogenes, Proteus mirabilis, Proteusvulgaris, Pseudomonas aeruginosa,Salmonella typhimurium, Serratiamarcescens, Shigella sonnei,Streptococcus mitis, Streptococcussalivarius, Yersinia enterocolitica,Candida albicans, Candida glabrata,Cryptococcus neoformans,Lactobacillus acidophilus, Legionellapneumophila, Mycobacteriumtuberculosis avirulent, Mycoplasmapneumoniae, Neisseria meningitides,Streptococcus mutans, Streptococcuspneumoniae, Streptococcuspyogenes, Homo sapiens, HumanCells 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 TypeB1,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,
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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:
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| 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 | MeanCt | 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
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Page 5.8 of 5.11 pages
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| C2 | Panel# | N | MeanCt | 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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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.
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| Combined Data | Reference Culture | ||||
|---|---|---|---|---|---|
| MRSA+ | SA+/MRSA- | Neg/No Growth | Total | ||
| MRSA/SA ELITeMGB® | 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.
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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
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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.
Page 1 of _
§ 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).