Remel Spectra ESBL

K162620 · Remel, Inc. · JSO · May 1, 2017 · Microbiology

Device Facts

• Record ID: K162620
• Device Name: Remel Spectra ESBL
• Applicant: Remel, Inc.
• Product Code: JSO · Microbiology
• Decision Date: May 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1700
• Device Class: Class 2

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. 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.

Device Story

Selective and differential culture medium; utilizes antibacterial agents to suppress non-ESBL flora; enables recovery of target ESBL-producing Enterobacteriaceae (E. coli, K. pneumoniae, K. oxytoca, P. mirabilis) from stool or perirectal swabs. Contains peptones for growth and chromogenic substrates for visual differentiation. Operated by laboratory technicians in clinical settings. Input: clinical specimen (stool/swab). Output: visual colony growth (pink, blue-turquoise-green, or tan). Interpretation: manual, visual assessment of colony color. Clinical utility: screening tool for colonization control; requires mandatory subculture to non-selective media for confirmatory identification and susceptibility testing. Benefits: facilitates rapid presumptive identification of ESBL-producing organisms to support hospital infection control measures.

Clinical Evidence

Prospective clinical study at 3 sites (n=1194 subjects; 737 stool, 439 perirectal swabs). Compared Spectra ESBL to reference culture (MacConkey agar with cefpodoxime disk). Combined sensitivity 98.5% (18h) and 99.0% (24h); specificity 89.6% (18h) and 88.7% (24h). PPV 65.9% (18h) and 64.4% (24h). Study confirms device performance for presumptive screening.

Technological Characteristics

Selective/differential culture medium. Contains antibacterial agents (suppress non-ESBL/AmpC organisms), peptones (nutrients), sodium chloride (osmotic balance), and chromogenic substrates (galactosidase/glucuronidase/tryptophan hydrolysis). Form factor: agar plate. Manual visual interpretation. Aerobic incubation at 35±2°C for 18-24 hours. No software or electronic components.

Indications for Use

Indicated for primary isolation and presumptive identification of ESBL-producing E. coli, K. pneumoniae, K. oxytoca, and P. mirabilis from perirectal swabs or fresh stool specimens to aid in infection control in healthcare settings. Not for diagnosing ESBL infection or guiding/monitoring treatment.

Regulatory Classification

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.

Predicate Devices

• HardyCHROM ESBL (K160512)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <span> <div style="display:inline-block;">☑</div> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <div style="display:inline-block;">☐</div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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### 510(k) Summary

| Contact Information: | Cynthia Knapp<br>Director R&D, AST and Pharma<br>Microbiology Division<br>Remel Products<br>1 Thermo Fisher Way<br>Oakwood Village, Ohio 44146<br>Phone: [phone] ext 332-4117<br>Fax: [phone]<br>Email: [e-mail] |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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<br>tests. |
| Intended Use: | Remel Spectra™ ESBL is a selective and differential growth medium for<br>use in primary isolation and presumptive identification of Extended<br>Spectrum β Lactamase (ESBL)-producing Escherichia coli, Klebsiella<br>pneumoniae, Klebsiella oxytoca and Proteus mirabilis to aid in<br>prevention and control of these bacteria in a healthcare setting.<br>Testing may be performed from either perirectal swabs or fresh stool<br>specimens. Remel Spectra™ ESBL is not intended to diagnose ESBL<br>infection, or to guide or monitor treatment.<br><br>Do not report Spectra™ ESBL positive screening results. Subculture of<br>presumptive positive colonies to non-selective medium (e.g. Tryptic<br>Soy Agar with 5% sheep blood) is required for organism identification,<br>confirmatory testing for ESBL, susceptibility testing and<br>epidemiological typing. |
| Device Description | A lack of growth or the absence of pink, blue-turquoise-green or tan<br>colonies on Spectra™ ESBL does not preclude the presence of ESBL<br>producing organisms.<br>Spectra™ ESBL contains a combination of antibacterial agents which<br>aid in inhibiting non-ESBL Enterobacteriaceae and suppress the growth<br>of some AmpC organisms and other non-ESBL flora. Peptones supply<br>amino acids and essential nutrients which promote the growth of<br>enteric gram-negative bacilli. Sodium chloride is a source of essential |

44146

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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<br>(ESBL)- producing Escherichia coli,<br>Klebsiella pneumoniae, Klebsiella<br>oxytoca and Proteus mirabilis to<br>aid in prevention and control of<br>these bacteria in a healthcare<br>setting. Testing may be performed<br>from either perirectal swabs or<br>fresh stool specimens. Remel<br>Spectra™ ESBL is not intended to<br>diagnose ESBL infection, or to<br>guide or monitor treatment. | detection from stool specimens of:<br>1) Enterobacteriaceae that are<br>potentially non-susceptible to<br>ceftazidime and cefpodoxime; and<br>2) Extended-spectrum beta-<br>lactamase (ESBL)-producing<br>Escherichia coli, Klebsiella<br>pneumoniae and Klebsiella<br>oxytoca. |
| | Do not report Spectra™ ESBL<br>positive screening results.<br>Subculture of presumptively<br>positive colonies to non-selective<br>medium (e.g. Tryptic Soy Agar with<br>5% sheep blood) is required for<br>organism identification,<br>confirmatory testing for ESBL,<br>susceptibility testing and<br>epidemiological typing. | The test is performed on stool<br>specimens from patients at risk of<br>harboring Enterobacteriaceae that<br>are non-susceptible to 3rd<br>generation cephalosporins or<br>ESBL-producing E. coli, K.<br>pneumoniae and K. oxytoca, and is<br>intended as an aid in the<br>detection, identification of<br>colonization and control of these<br>bacteria in a healthcare setting.<br>HardyCHROM™ ESBL is not<br>intended to diagnose infection or<br>to guide or monitor treatment for<br>infections. Results can be<br>interpreted after incubation for<br>18-24 hours. Subculture to non-<br>selective medium is required for<br>confirming identification,<br>antimicrobial susceptibility testing<br>and epidemiological typing. |
| | A lack of growth or the absence of<br>pink, blue-turquoise-green or tan<br>colonies on Spectra™ ESBL does<br>not preclude the presence of ESBL<br>producing organisms. | A lack of growth or the absence of<br>pink, blue or yellow/gold colonies<br>on HardyCHROM™ ESBL does not<br>preclude the presence of<br>Enterobacteriaceae that are non-<br>susceptible to 3rd generation<br>cephalosporins or<br>ESBL producing organisms. |
| Inoculation | Direct Specimen | Same |
| Specimen Type | Clinical<br>Fecal Specimens and<br>Perirectal Swabs | Clinical<br>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.<br>pneumoniae, K. oxytoca and P.<br>mirabilis | ESBL-producing strains of E. coli, K.<br>pneumoniae, and K. oxytoca<br>3rd generation cephalosporin non-<br>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™<br>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™<br>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<br>Phenotype4 | | |
|------------------------|--|-----------|------------------------------------------|----------|-------|
| | | | Positive | Negative | Total |
| Remel Spectra™<br>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<br>Phenotype | | |
| | | | Positive | Negative | Total |
| Remel Spectra™<br>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 No<br>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®<br>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™<br>ESBL<br>positive | % | | N | Spectra™<br>ESBL<br>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.