(223 days)
Not Found
No
The device is a growth medium that relies on chemical reactions and visual interpretation of colony color for presumptive identification. There is no mention of computational analysis, algorithms, or learning processes.
No.
The device is for primary isolation and presumptive identification of ESBL-producing bacteria to aid in prevention and control of these bacteria, and is explicitly stated not to be intended to diagnose, guide, or monitor treatment.
No
The "Intended Use / Indications for Use" section explicitly states, "Remel Spectra™ ESBL is not intended to diagnose ESBL infection, or to guide or monitor treatment." It is a selective and differential growth medium for primary isolation and presumptive identification, not a diagnostic tool for infections.
No
The device is a growth medium (agar plate) containing chemical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for "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." This is a diagnostic purpose, even though it's a presumptive identification and not a definitive diagnosis of infection.
- Specimen Type: It is used with "perirectal swabs or fresh stool specimens," which are human specimens.
- Device Description: It describes a "selective and differential growth medium" containing components that interact with biological samples (bacteria) to produce a result (colony growth and color).
- Performance Studies: The document includes performance studies evaluating the device's sensitivity and specificity in detecting the target organisms from clinical specimens. This is a standard requirement for IVD devices.
- Predicate Device: A predicate device (K160512, HardyCHROM™ ESBL) is listed, which is common for IVD submissions to the FDA.
While the device is not intended to diagnose ESBL infection or guide treatment, its purpose of identifying specific bacteria from human specimens to aid in prevention and control in a healthcare setting clearly falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JSO
Device Description
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.
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 degrees C
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
perirectal swabs or fresh stool specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare setting
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study:
Study Type: Clinical evaluation
Sample Size: 1176 prospective rectal swab (439) and fecal (737) surveillance specimens.
Key Results:
Overall 18 hr incubation:
Sensitivity: 201/204 = 98.5% (95% CI: 95.8-99.5%)
Specificity: 925/1032 = 89.6% (95% CI: 87.6-91.3%)
Overall 24 hr incubation:
Sensitivity: 203/205 = 99.0% (95% CI: 96.5-99.7%)
Specificity: 914/1031 = 88.7% (95% CI: 86.6-90.4%)
Reproducibility study:
Sample Size: Nine (9) blinded ESBL and Non-ESBL isolates, tested over five (5) consecutive work days with at least two (2) operators at each of three (3) sites, using 2 target levels of each panel member (10^4 and 10^0 CFU/mL).
Key Results:
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).
Reactivity Study:
Sample Size: 48 confirmed ESBL-producing strains (27 E. coli, 8 K. pneumoniae, 7 K. oxytoca and 6 P. mirabilis).
Key Results: Each of the strains grew with the expected colony color when diluted in saline and inoculated on Spectra™ ESBL at a concentration of 10^3 cfu/plate.
Cross Reactivity Study:
Sample Size: One hundred ten (110) microorganisms including 61 strains of confirmed non-ESBL producing Enterobacteriaceae and 49 strains of non-Enterobacteriaceae species.
Key Results: 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall 18 hr:
Sensitivity: 201/204 = 98.5% (95.8-99.5%)
Specificity: 925/1032 = 89.6% (87.6-91.3%)
Overall 24 hr:
Sensitivity: 203/205 = 99.0% (96.5-99.7%)
Specificity: 914/1031 = 88.7% (86.6-90.4%)
18 hr PPA: 203/205 = 99.0% (96.5-99.7%)
18 hr NPA: 926/1031 = 89.8% (87.8-91.5%)
24 hr PPA: 206/206 = 100.0% (98.2-100%)
24 hr NPA: 916/1030 = 88.9% (86.9-90.7%)
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.
K160512, HardyCHROM™ ESBL
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
§ 866.1700 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).
0
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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.
1
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
2
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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3
Image /page/3/Picture/0 description: The image contains the logo for Thermo Fisher Scientific. The words "Thermo Fisher" are in red, with "SCIENTIFIC" in black below it. The logo is simple and modern.
510(k) Summary
| Contact Information: | Cynthia Knapp
Director R&D, AST and Pharma
Microbiology Division
Remel Products
1 Thermo Fisher Way
Oakwood Village, Ohio 44146
Phone: 1 (800) 871-8909 ext 332-4117
Fax: 1(440) 735-4573
Email: 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 susceptibility
tests. |
| Intended Use: | 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. |
| Device Description | 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 |
44146
4
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, 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. | detection from stool specimens of: |
- Enterobacteriaceae that are
potentially non-susceptible to
ceftazidime and cefpodoxime; and - Extended-spectrum beta-
lactamase (ESBL)-producing
Escherichia coli, Klebsiella
pneumoniae and Klebsiella
oxytoca. |
| | Do not report Spectra™ ESBL
positive screening results.
Subculture of presumptively
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. | The test is performed on stool
specimens from patients at risk of
harboring Enterobacteriaceae that
are non-susceptible to 3rd
generation cephalosporins or
ESBL-producing E. coli, K.
pneumoniae and K. oxytoca, and is
intended as an aid in the
detection, identification of
colonization and control of these
bacteria in a healthcare setting.
HardyCHROM™ ESBL is not
intended to diagnose infection or
to guide or monitor treatment for
infections. Results can be
interpreted after incubation for
18-24 hours. Subculture to non-
selective medium is required for
confirming identification,
antimicrobial 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. | A lack of growth or the absence of
pink, blue or yellow/gold colonies
on HardyCHROM™ ESBL does not
preclude the presence of
Enterobacteriaceae that are non-
susceptible to 3rd generation
cephalosporins or
ESBL producing organisms. |
| Inoculation | Direct Specimen | Same |
| Specimen Type | Clinical
Fecal Specimens and
Perirectal Swabs | Clinical
Fecal 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. oxytoca
3rd generation cephalosporin non-
susceptible Enterobacteriaceae |
5
ThermoFisher
s c I E N T I F I C
6
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.
7
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
8
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 ESBL
Phenotype4 | | |
|------------------------|--|-----------|------------------------------------------|----------|-------|
| | | | 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 ESBL
Phenotype | | |
| | | | 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
9
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 No
Interference 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
10
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™ | ||||||
| ESBL | |||||||
| positive | % | N | Spectra™ | ||||
| ESBL | |||||||
| Negative | % | ||||||
| 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.