(223 days)
Remel Spectra™ ESBL is a selective and differential growth medium for use in primary isolation and presumptive identification of Extended Spectrum β Lactamase (ESBL)-producing Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca and Proteus mirabilis to aid in prevention and control of these bacteria in a healthcare setting. Testing may be performed from either perirectal swabs or fresh stool specimens. Remel Spectra™ ESBL is not intended to diagnose ESBL infection, or to guide or monitor treatment.
Do not report Spectra™ ESBL positive screening results. Subculture of presumptive positive colonies to non-selective medium (e.g. Tryptic Soy Agar with 5% sheep blood) is required for organism identification, confirmatory testing for ESBL, susceptibility testing and epidemiological typing.
A lack of growth or the absence of pink, blue-turquoise-green or tan colonies on Spectra™ ESBL does not preclude the presence of ESBL producing organisms.
Spectra™ ESBL contains a combination of antibacterial agents which aid in inhibiting non-ESBL Enterobacteriaceae and suppress the growth of some AmpC organisms and other non-ESBL flora. Peptones supply amino acids and essential nutrients which promote the growth of enteric gram-negative bacilli. Sodium chloride is a source of essential electrolytes and maintains osmotic equilibrium. Phosphate buffers are added to maintain the pH.
A mixture of chromogens forms a substrate for two enzymes: βgalactosidase and glucuronidase that are differentially expressed in different species of bacteria resulting in blue/turquoise-green or pink colonies. Other ESBL-producing organisms that do not utilize the chromogenic substrates may produce tan colonies through deamination of tryptophan. Non-target organisms generally appear cream colored or are naturally pigmented green or brown.
The provided text describes the performance evaluation of the Remel Spectra™ ESBL device. The following information details the acceptance criteria and study findings:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (18 hours) | Reported Device Performance (24 hours) |
|---|---|---|---|
| Sensitivity | High agreement with reference method for ESBL-producing organisms | 98.5% (95.8-99.5% CI) | 99.0% (96.5-99.7% CI) |
| Specificity | High agreement with reference method for non-ESBL-producing organisms | 89.6% (87.6-91.3% CI) | 88.7% (86.6-90.4% CI) |
| Positive Percent Agreement (PPA) | High agreement of Spectra Colony ID and ESBL Phenotype with reference method | 99.0% (96.5-99.7% CI) | 100.0% (98.2-100% CI) |
| Negative Percent Agreement (NPA) | High agreement of Spectra Colony ID and ESBL Phenotype with reference method | 89.8% (87.8-91.5% CI) | 88.9% (86.9-90.7% CI) |
| Reproducibility (Positive Agreement) | 100% agreement with expected colony color for ESBL-producing organisms | 100% (210/210) | N/A (Reproducibility done for overall ESBL detection) |
| Reproducibility (Negative Agreement) | No false positive results with non-ESBL-producing strains | 100% (60/60) | N/A (Reproducibility done for overall ESBL detection) |
| Reactivity | Expected growth and colony color for confirmed ESBL-producing strains | 100% (all 48 tested strains grew with expected colony color) | N/A |
| Cross-reactivity | Most non-target organisms (common fecal flora) should not grow; those that do should be differentiable or have high cephalosporin MICs | 19 non-ESBL Enterobacteriaceae and 3 non-Enterobacteriaceae grew. All but 3 of these had high cephalosporin MICs. | N/A |
Note: The document implicitly defines "high agreement" as the acceptance criterion for sensitivity, specificity, PPA, and NPA, demonstrated by the reported percentages and confidence intervals. Reproducibility, reactivity, and cross-reactivity have explicit criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: A total of 1176 prospective rectal swab (439) and fecal (737) surveillance specimens.
- Data Provenance: Clinical data collected prospectively from three different clinical hospitals in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. It mentions that the ground truth was "obtained from growth on MacConkey agar with a 10μg cefpodoxime disk […], followed by biochemical identification and disk diffusion phenotypic confirmatory antimicrobial susceptibility testing for ESBLs as outlined in the Clinical and Laboratory Standards Institute document M100-S23." This implies adherence to a standardized protocol rather than individual expert consensus for each case.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method involving multiple human readers for the test set. The reference method (ground truth) appears to be based on a standardized laboratory protocol.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The study evaluates the performance of the Remel Spectra™ ESBL device against a laboratory-based reference method, not against human readers with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This study directly assesses the standalone performance of the Remel Spectra™ ESBL agar medium as a diagnostic tool. The interpretation of results ("Manual, visual") is performed by laboratory personnel, but the "device" itself (the culture medium) provides the observable outcome (colony color and growth) which is then interpreted. So, in essence, it's a standalone diagnostic performance assessment of the medium.
7. The Type of Ground Truth Used:
The ground truth was established by a laboratory-based reference method, which included:
- Growth on MacConkey agar with a 10µg cefpodoxime disk.
- Selection of colonies from within the zone of inhibition.
- Biochemical identification.
- Disk diffusion phenotypic confirmatory antimicrobial susceptibility testing for ESBLs as outlined in the Clinical and Laboratory Standards Institute document M100-S23.
8. The Sample Size for the Training Set:
The document does not mention a specific "training set" in the context of machine learning or AI models. This device is a culture medium, and its development (which would be analogous to a training phase) involves formulation and empirical testing, rather than a data-driven training set in the AI sense. The "Reactivity" and "Reproducibility" studies involve a limited number of isolates (48 confirmed ESBL-producing strains for reactivity; 9 blinded ESBL and Non-ESBL isolates for reproducibility) that could be considered part of the development/validation process.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" in the AI sense, this question is not directly applicable. For the isolates used in "Reactivity" and "Reproducibility" studies, their ESBL status was "confirmed" (for reactivity) and "expected" (for reproducibility), implying that a definitive laboratory method was used to classify them prior to testing with the Spectra™ ESBL. This would likely follow similar gold standard methods as the clinical study's ground truth.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2017
REMEL, INC. CYNTHIA KNAPP DIRECTOR R&D, AST AND PHARMA, MICROBIOLOGY 12076 SANTA FE DRIVE LENEXA KS 66215
Re: K162620
Trade/Device Name: Remel Spectra ESBL Regulation Number: 21 CFR 866.1700 Regulation Name: Culture medium for antimicrobial susceptibility tests Regulatory Class: II Product Code: JSO Dated: March 29, 2017 Received: March 30, 2017
Dear Ms. Knapp:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ribhi Shawar -A
For
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162620
Device Name Remel Spectra ESBL
Indications for Use (Describe)
Remel Spectra ESBL is a selective and differential growth medium for use in primary isolation and presumptive identification of Extended Spectrum B Lactamase (ESBL)-producing Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca and Proteus mirabilis to aid in prevention of these bacteria in a healthcare setting. Testing may be performed from either perirectal swabs or fresh stool specimens. Remel Spectra ESBL is not intended to diagnose ESBL infection, or to guide or monitor treatment.
Do not report Spectra ESBL positive screening results. Subculture of presumptively positive colonies to nonselective medium (e.g., Tryptic Soy Agar with 5% sheep blood) is required for organism identification, confirmatory testing for ESBL, susceptibility testing and epidemiological typing.
A lack of growth or the absence of pink, blue-turquoise-green or tan colonies on Spectra ESBL does not preclude the presence of ESBL producing organisms.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Contact Information: | Cynthia KnappDirector R&D, AST and PharmaMicrobiology DivisionRemel Products1 Thermo Fisher WayOakwood Village, Ohio 44146Phone: 1 (800) 871-8909 ext 332-4117Fax: 1(440) 735-4573Email: Cindy.knapp@thermofisher.com |
|---|---|
| Date Prepared: | April 28, 2017 |
| Proprietary Name: | Remel Spectra™ ESBL |
| Common Name: | Chromogenic ESBL |
| Device Classification: | 21 CFR 866.1700: Culture medium for antimicrobial susceptibilitytests. |
| Intended Use: | Remel Spectra™ ESBL is a selective and differential growth medium foruse in primary isolation and presumptive identification of ExtendedSpectrum β Lactamase (ESBL)-producing Escherichia coli, Klebsiellapneumoniae, Klebsiella oxytoca and Proteus mirabilis to aid inprevention and control of these bacteria in a healthcare setting.Testing may be performed from either perirectal swabs or fresh stoolspecimens. Remel Spectra™ ESBL is not intended to diagnose ESBLinfection, or to guide or monitor treatment.Do not report Spectra™ ESBL positive screening results. Subculture ofpresumptive positive colonies to non-selective medium (e.g. TrypticSoy Agar with 5% sheep blood) is required for organism identification,confirmatory testing for ESBL, susceptibility testing andepidemiological typing. |
| Device Description | A lack of growth or the absence of pink, blue-turquoise-green or tancolonies on Spectra™ ESBL does not preclude the presence of ESBLproducing organisms.Spectra™ ESBL contains a combination of antibacterial agents whichaid in inhibiting non-ESBL Enterobacteriaceae and suppress the growthof some AmpC organisms and other non-ESBL flora. Peptones supplyamino acids and essential nutrients which promote the growth ofenteric gram-negative bacilli. Sodium chloride is a source of essential |
44146
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Image /page/4/Picture/0 description: The image contains the logo for Thermo Fisher Scientific. The words "Thermo Fisher" are in red, and the word "SCIENTIFIC" is in black and located below the other words. The logo is simple and clean, with a focus on the company's name.
electrolytes and maintains osmotic equilibrium. Phosphate buffers are added to maintain the pH.
A mixture of chromogens forms a substrate for two enzymes: βgalactosidase and glucuronidase that are differentially expressed in different species of bacteria resulting in blue/turquoise-green or pink colonies. Other ESBL-producing organisms that do not utilize the chromogenic substrates may produce tan colonies through deamination of tryptophan. Non-target organisms generally appear cream colored or are naturally pigmented green or brown.
Formulation:
| Peptone Mix | 12.0 g |
|---|---|
| Sodium Chloride | 5.0 g |
| Phosphate Buffers | 4.0 g |
| Chromogenic Mix | 4.0 g |
| Antibiotic Mix | 0.28 g |
| Agar | 15.0 g |
| Demineralized Water | 1000.0 ml |
| pH 6.9 ± 0.2 @ 25°C |
REAGENTS (CLASSICAL FORMULA)*
H 6.9 ± 0.2 @ 25°C
*Adjusted as required to meet performance standards.
Device Comparison:
Substantial Equivalence Information:
Predicate K number: K160512, HardyCHROM™ ESBL
| Characteristic | Remel Spectra™ ESBL | HardyCHROM™ ESBL |
|---|---|---|
| Similarities | ||
| Regulation | 21 CFR 866.1700 | Same |
| Product Code | JSO | Same |
| Device Class | II | Same |
| Intended Use | Remel Spectra™ ESBL is a selective and differential growth medium for use in primary isolation and presumptive identification of | HardyCHROM™ ESBL is a selective and differential chromogenic medium which is intended for the qualitative and presumptive |
| Extended Spectrum B Lactamase(ESBL)- producing Escherichia coli,Klebsiella pneumoniae, Klebsiellaoxytoca and Proteus mirabilis toaid in prevention and control ofthese bacteria in a healthcaresetting. Testing may be performedfrom either perirectal swabs orfresh stool specimens. RemelSpectra™ ESBL is not intended todiagnose ESBL infection, or toguide or monitor treatment. | detection from stool specimens of:1) Enterobacteriaceae that arepotentially non-susceptible toceftazidime and cefpodoxime; and2) Extended-spectrum beta-lactamase (ESBL)-producingEscherichia coli, Klebsiellapneumoniae and Klebsiellaoxytoca. | |
| Do not report Spectra™ ESBLpositive screening results.Subculture of presumptivelypositive colonies to non-selectivemedium (e.g. Tryptic Soy Agar with5% sheep blood) is required fororganism identification,confirmatory testing for ESBL,susceptibility testing andepidemiological typing. | The test is performed on stoolspecimens from patients at risk ofharboring Enterobacteriaceae thatare non-susceptible to 3rdgeneration cephalosporins orESBL-producing E. coli, K.pneumoniae and K. oxytoca, and isintended as an aid in thedetection, identification ofcolonization and control of thesebacteria in a healthcare setting.HardyCHROM™ ESBL is notintended to diagnose infection orto guide or monitor treatment forinfections. Results can beinterpreted after incubation for18-24 hours. Subculture to non-selective medium is required forconfirming identification,antimicrobial susceptibility testingand epidemiological typing. | |
| A lack of growth or the absence ofpink, blue-turquoise-green or tancolonies on Spectra™ ESBL doesnot preclude the presence of ESBLproducing organisms. | A lack of growth or the absence ofpink, blue or yellow/gold colonieson HardyCHROM™ ESBL does notpreclude the presence ofEnterobacteriaceae that are non-susceptible to 3rd generationcephalosporins orESBL producing organisms. | |
| Inoculation | Direct Specimen | Same |
| Specimen Type | ClinicalFecal Specimens andPerirectal Swabs | ClinicalFecal Specimens |
| Test Methodology | Manual | Same |
| Incubation Temperature | Incubation at 35+/-2°C | Same |
| Interpretation of Results | Manual, visual | Same |
| Shelf Life | 12 weeks | Same |
| Incubation Length | 18-24 hours | Same |
| Organisms Detected | ESBL producing strains of E. coli, K.pneumoniae, K. oxytoca and P.mirabilis | ESBL-producing strains of E. coli, K.pneumoniae, and K. oxytoca3rd generation cephalosporin non-susceptible Enterobacteriaceae |
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ThermoFisher
s c I E N T I F I C
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Summary of Performance Testing - Clinical
The performance of Remel Spectra™ ESBL was evaluated at three different clinical hospitals in the United States. A total of 1176 prospective rectal swab (439) and fecal (737) surveillance specimens were evaluated. Results from Spectra™ ESBL at 18-24 hours incubation were compared to those obtained from growth on MacConkey agar with a 10μg cefpodoxime disk between the 1° and 2° quadrants and selection of colonies from within the zone of inhibition, followed by biochemical identification and disk diffusion phenotypic confirmatory antimicrobial susceptibility testing for ESBLs as outlined in the Clinical and Laboratory Standards Institute document M100-S23.
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Table 1. Gender and Demographic Summary of Subjects in Spectra™ ESBL Clinical Study
| Location | ||||
|---|---|---|---|---|
| Gender | Site 1 | Site 2 | Site 3 | Total |
| Female | 206 | 183 | 159 | 548 |
| Male | 232 | 226 | 167 | 625 |
| Unknown | 0 | 0 | 3 | 3 |
| Total | 4381 | 4092 | 3292 | 1176 |
² All perirectal swabs
² 408/409 fresh stool 1/409 perirectal swab
3 All fresh stool
Table 2. Age and Demographic Summary of Subjects in Spectra™ ESBL Clinical Study
| Age Range | Location | |||
|---|---|---|---|---|
| Site 1 | Site 2 | Site 3 | Total | |
| ≤18 | 8 | 24 | 0 | 32 |
| 19-40 | 59 | 48 | 77 | 184 |
| 41-65 | 179 | 128 | 165 | 472 |
| 66-95 | 192 | 209 | 87 | 488 |
| Total | 4381 | 4092 | 3293 | 1176 |
1 All perirectal swabs
² 408/409 fresh stool 1/409 perirectal swab
3 All fresh stool
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18/24 Hours Incubation: Clinical isolates Combined Site performance for Table 3a Remel Spectra™ ESBL
| Overall 18 hr | Reference Method | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Remel Spectra™ESBL | Positive1 | 201 | 107 | 308 |
| Negative2 | 3 | 925 | 928 | |
| Total | 204 | 1032 | 1236 | |
| Sensitivity | $201/204 = 98.5% (95.8-99.5%)^3$ | |||
| Specificity | $925/1032 = 89.6% (87.6-91.3%)$ | |||
| Overall 24 hr | Reference Method | |||
| Positive | Negative | Total | ||
| Remel Spectra™ESBL | Positive | 203 | 117 | 320 |
| Negative | 2 | 914 | 916 | |
| Total | 205 | 1031 | 1236 | |
| Sensitivity | $203/205 = 99.0% (96.5-99.7%)$ | |||
| Specificity | $914/1031 = 88.7% (86.6-90.4%)$ |
¹Pink, Tan, Blue/Turquoise Green colonies.
2Colonies other than Pink, Tan, Blue/Turquoise Green, or No Growth
395% Confidence Interval
Note: For perirectal swabs at both 18 and 24h, sensitivity was 110/11 = 99.1% (94.2-99.8%) and specificity was 313/349 = 89.7% (86.1-92.5%). For stool samples after 18h, sensitivity was 91/93 = 97.8% (92.5-99.4%) and specificity was 612/683 = 89.6% (87.1-91.7%) while after 24h, sensitivity and specificity were 9,94 = 98.9% (94.2-99.8%) and 601/682 = 88.1% (85.5-90.3%) respectively.
Table 3b 18/24 Hours Incubation Organisms recovered on Spectra™ ESBL at Combined sites: comparison of colony color to isolate ID/confirmed ESBL phenotype
| Overall 18 hr | Spectra Colony ID and ESBLPhenotype4 | ||||
|---|---|---|---|---|---|
| Positive | Negative | Total | |||
| Remel Spectra™ESBL | Positive1 | 203 | 1055 | 308 | |
| Negative2 | 2 | 926 | 928 | ||
| Total | 205 | 1031 | 1236 | ||
| PPA | 203/205 = 99.0% (96.5-99.7%)3 | ||||
| NPA | 926/1031 = 89.8% (87.8-91.5%) | ||||
| Overall 24 hr | Spectra Colony ID and ESBLPhenotype | ||||
| Positive | Negative | Total | |||
| Remel Spectra™ESBL | Positive | 206 | 1146 | 320 | |
| Negative | 0 | 916 | 916 | ||
| Total | 206 | 1030 | 1236 | ||
| PPA | 206/206 = 100.0% (98.2-100%) | ||||
| NPA | 916/1030 = 88.9% (86.9-90.7%) |
4Pink, Tan, Blue/Turquoise Green colonies.
2Colonies other than Pink, Tan, Blue/Turquoise Green, or No Growth
395% Confidence Interval
4 ESBL positive E. coli, K. pneumoniae, K. oxytoca or P. mirabilis
§104/105 Enterobacteriaceae sp
§113/114 Enterobacteriaceae sp
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Interfering Substances:
Substances known to be present in fecal samples and/or perirectal swabs were evaluated for potential interference with the growth and/or chromogenic reaction of target organisms on Spectra™ ESBL. The highest concentration of each substance tested in a liquefied stool matrix at which no interference was observed is shown in Table 4.
Table 4 Substances evaluated for interference with growth and/or colony color on Spectra™ ESBL
| Substance | Concentration at Which NoInterference Was Observed |
|---|---|
| Barium sulfate | 1.56 mg/mL1 |
| Bisacodyl | 50% (w/v)2 |
| Blood | 5.0% v/v |
| Fletcher's Castoria | 10% v/v |
| Glycerin | 50% (w/v)2 |
| Imodium AD® | 10% v/v |
| Kaopectate® | 10% v/v |
| KY Jelly | 5.0% w/v1 |
| Metronidazole | 1.56 mg/mL1 |
| Miconazole | 5.0% w/v1 |
| Mucin | 5% (w/v) |
| Mylanta® ES | 0.5% v/v1 |
| Nanoxynol-9 | 50% w/v |
| Pepcid® AC | 0.5% v/v1, 2 |
| Pepto-Bismol® | 10% v/v |
| Preparation H® | 5.0% w/v1 |
| Preparation H®Wipes | 5.0% v/v1 |
| Prilosec OTC® | 1.0% v/v1, 2 |
| Tagamet HB 200® | 10% v/v2 |
| Vancomycin | 1.56 mg/mL1 |
| Vaseline® | 5.0% w/v1 |
Shown to be inhibitory at higher concentration
2 1 suppository or tablet dissolved in 10mLPBS, then added to stool
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Reproducibility
The reproducibility study of the Spectra™ ESBL was evaluated by testing nine (9) blinded ESBL and Non-ESBL isolates at three (3) sites. The testing occurred over five (5) consecutive work days with at least two (2) operators at each site and using 2 target levels of each panel member (10t and 10° CFU/mL) to ensure reproducibility and to document proficiency in the performance of the test (i.e. 9 isolates x 2 operators x 5 sites). At both target levels there was 100% agreement with expected colony color for all the ESBL-producing organisms (210/210) and there were no false positive results with either of the non-ESBL-producing strains (0/60) (Table 5).
| Positive Agreement | Negative Agreement | ||||||
|---|---|---|---|---|---|---|---|
| N | Spectra™ESBLpositive | % | N | Spectra™ESBLNegative | % | ||
| Day 1 | 42 | 42 | 100 | 12 | 12 | 100 | |
| Day 2 | 42 | 42 | 100 | 12 | 12 | 100 | |
| Day 3 | 42 | 42 | 100 | 12 | 12 | 100 | |
| Day 4 | 42 | 42 | 100 | 12 | 12 | 100 | |
| Day 5 | 42 | 42 | 100 | 12 | 12 | 100 | |
| Overall | 210 | 210 | 100 | 60 | 60 | 100 |
Table 5. Reproducibility Study for detection of ESBL producing E. coli (3), K. pneumoniae (3) and K. oxytoca (1) and non ESBL producing E. coli (1) and K. pneumoniae (1)
Reactivity
The ability of Spectra™ ESBL to support growth of ESBL producing organisms was evaluated by testing a total of 48 confirmed ESBL-producing strains: 27 E. coli, 8 K. pneumoniae, 7 K. oxytoca and 6 P. mirabilis. Each of the strains grew with the expected colony color when diluted in saline and inoculated on Spectra™ ESBL at a concentration of 103 cfu/plate.
Cross Reactivity
One hundred ten (110) microorganisms including 61 strains of confirmed non-ESBL producing Enterobacteriaceae and 49 strains of non-Enterobacteriaceae species (representing gram negative rods, yeast, fungi, streptococci, enterococci, staphylococci and related organisms) were evaluated with Spectra™ ESBL. Nineteen (19) non-ESBL Enterobacteriaceae isolates grew on Spectra™ ESBL, as well as 3 non-Enterobacteriaceae (2 Acinetobacter spp. and 1 Pseudomonas aeruginosa). All the Enterobacteriaceae that grew had a typical colony color expected for an ESBL isolate, except for
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Salmonella spp., which appeared transparent. Of the 22 isolates that exhibited growth, all but 3 had high cephalosporin MIC's (with or without the clavulanic acid) and would be expected to grow on Spectra™ ESBL. Overall, cross reactivity testing showed that most non-target organisms known to be common fecal flora, will not grow on Spectra™ ESBL. Acinetobacter and other non-Enterobacteriaceae organisms that grew can be differentiated from target organisms by color; however, further testing should be performed on well-isolated pink, blue-turquoise-green or tan colonies obtained on Spectra™ ESBL to confirm ID and ESBL status.
CONCLUSION
The analytical and clinical data demonstrate that Spectra™ ESBL is substantially equivalent to the legally marketed predicate device.
§ 866.1700 Culture medium for antimicrobial susceptibility tests.
(a)
Identification. A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.(b)
Classification. Class II (performance standards).