← Product Code [JSS](/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSS) · K123418

# GRAM-NEGATIVE QUICKFISH BC (K123418)

_Advandx, Inc. · JSS · Jul 21, 2013 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSS/K123418

## Device Facts

- **Applicant:** Advandx, Inc.
- **Product Code:** [JSS](/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSS.md)
- **Decision Date:** Jul 21, 2013
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.2660
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Indications for Use

Gram-Negative QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli and/or Pseudomonas aeruginosa and/or Klebsiella pneumoniae on smears from positive blood cultures containing gram-negative bacilli observed on Gram stain. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The Gram-Negative QuickFISH BC assay is indicated for use as an aid in the diagnosis of E. coli, and/or K. pneumoniae, and/or P. aeruginosa bacteremia.

## Device Story

The Gram-Negative QuickFISH™ BC Blood Culture Identification Kit is an in vitro diagnostic test used for the rapid identification of specific gram-negative bacteria directly from positive blood culture bottles. The device utilizes fluorescence in situ hybridization (FISH) technology to detect target microbial nucleic acid sequences. The process involves preparing a smear from a positive blood culture, applying the QuickFISH probe, incubating, and washing. The results are visualized using a fluorescence microscope. The device is intended for use by trained laboratory personnel in a clinical laboratory setting to provide rapid identification, which can assist clinicians in optimizing antimicrobial therapy for patients with bloodstream infections.

## Clinical Evidence

No clinical data provided in the document; the document is a 510(k) clearance letter.

## Technological Characteristics

Fluorescence in situ hybridization (FISH) assay; utilizes fluorescently labeled oligonucleotide probes for microbial identification; requires fluorescence microscopy for visualization; manual test procedure; in vitro diagnostic kit.

## Regulatory Identification

A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
K123418

B. Purpose for Submission:
To evaluate submitted data to make a substantial equivalence determination for the Gram-Negative QuickFISH™ BC Blood Culture Identification Kit to aid in the identification of Escherichia coli and/or Pseudomonas aeruginosa and/or Klebsiella pneumonia from smears from positive blood cultures containing gram-negative bacilli observed on Gram stain.

C. Measurand:
Escherichia coli and/or Pseudomonas aeruginosa and/or Klebsiella pneumonia species-specific ribosomal ribonucleic acid (rRNA) from smears from positive blood cultures containing gram-negative bacilli observed on Gram stain.

D. Type of Test:
Gram-Negative QuickFISH BC is a qualitative fluorescence *in situ* hybridization (FISH) assay using peptide nucleic acid (PNA) probes that hybridize to species – specific rRNA sequences from Escherichia coli, Pseudomonas aeruginosa or Klebsiella pneumoniae.

E. Applicant:
AdvanDx, Inc.

F. Proprietary and Established Names:
Gram-Negative QuickFISH™ BC Blood Culture Identification Kit

G. Regulatory Information:
1. Regulation section:
866.2660
2. Classification:
Class I
3. Product code:
JSS

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4. Panel:

83- Microbiology

H. Intended Use:

1. Intended use(s):

Gram-Negative QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli and/or Pseudomonas aeruginosa and/or Klebsiella pneumoniae on smears from positive blood cultures containing gram-negative bacilli observed on Gram stain.

Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.

The Gram-Negative QuickFISH BC assay is indicated for use as an aid in the diagnosis of E. coli, and/or K. pneumoniae, and/or P. aeruginosa bacteremia.

2. Indication(s) for use:

Gram-Negative QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli and/or Pseudomonas aeruginosa and/or Klebsiella pneumoniae on smears from positive blood cultures containing gram-negative bacilli observed on Gram stain.

Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.

The Gram-Negative QuickFISH BC assay is indicated for use as an aid in the diagnosis of E. coli, and/or K. pneumoniae, and/or P. aeruginosa bacteremia.

3. Special conditions for use statement(s):

For prescription use only.

3. Special instrument requirements:

AdvanDx Microscope Dual Band Filter (Cat. No. AC007)
AdvanDx QuickFISH™ Slides (Cat. No. CS012)
AdvanDx Slide Station 10 Slide Warmer (Cat. No. AC028)
AdvanDx QuickFISH™ Mixing Station (Cat. No. AC030)
AdvanDx Filter Vials (Cat. No. AC008)
Fluorescence microscope equipped with a 60x or 100x-oil objective

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I. Device Description:

Gram-Negative QuickFISH BC is a FISH assay using species-specific PNA probes hybridizing to Escherichia coli, Pseudomonas aeruginosa Klebsiella pneumoniae to provide rapid species identification from smears made from positive Gram-negative blood cultures within approximately 20 minutes.

J. Substantial Equivalence Information:

1. Predicate device name(s):
i. GNR Traffic Light PNA FISH (k101558)

2. Predicate K number(s):
k101558

3. Comparison with predicate:

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|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|   | Gram-Negative *QuickFISH*^{TM} BC (k123418) | GNR Traffic Light PNA FISH (k101558)  |
|  Intended Use | Gram-Negative QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of *Escherichia coli* and/or *Pseudomonas aeruginosa* and/or *Klebsiella pneumoniae* on smears from positive blood cultures containing gram-negative bacilli observed on Gram stain.

Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.

The Gram-Negative QuickFISH BC assay is indicated for use as an aid in the diagnosis of *E. coli*, and/or *K. pneumoniae*, and/or *P. aeruginosa* bacteremia. | GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of *Escherichia coli*, and/or *Klebsiella pneumoniae*, and/or *Pseudomonas aeruginosa* on smears made from positive blood cultures containing Gram- negative rods observed on Gram stain.

Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing, and/or differentiation of mixed growth.

GNR Traffic Light PNA FISH is indicated as an aid in the diagnosis of *Escherichia coli*, and/or *Klebsiella pneumoniae*, and/or *Pseudomonas aeruginosa* bacteremia.  |

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|  Indication for Use | Gram-Negative QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli and/or Pseudomonas aeruginosa and/or Klebsiella pneumoniae on smears from positive blood cultures containing gram-negative bacilli observed on Gram stain.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
The Gram-Negative QuickFISH BC assay is indicated for use as an aid in the diagnosis of E. coli, and/or K. pneumoniae, and/or P. aeruginosa bacteremia. | GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli, and/or Klebsiella pneumoniae, and/or P. aeruginosa on smears made from positive blood cultures containing Gram- negative rods observed on Gram stain.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing.
GNR Traffic Light PNA FISH is indicated as an aid in the diagnosis of Escherichia coli, and/or Klebsiella pneumoniae, and/or P. aeruginosa bacteremia.  |
| --- | --- | --- |
|  Technology | Fluorescence in situ hybridization using PNA probes | Same  |
|  Probe Sequence | Targeting rRNA sequences for E. coli, and/or P. aeruginosa and/or K. pneumoniae | Same sequences.  |
|  Sample Type | Positive blood cultures from standard automated blood culture device | Same  |
|  Interpretation of Results | Qualitative fluorescence microscopy | Same  |
|  Specimen Preparation | Standard automated blood culture device | Same  |

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|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Device | Gram-Negative *QuickFISH™* BC (k123418) | GNR Traffic Light PNA FISH (k101558)  |
|  Fixation Reagents | *Two solutions:*
QuickFix 1: Ethanol based
QuickFix 2: Methanol based | *One solution:*
3 mL PBS with detergent  |
|  PNA Probe Reagent(s) | 1.5 mL PNA Probes in *two solutions:*
Gram-Negative PNA Blue: 6 quenching probes
Gram-Negative PNA Yellow: 1 PNA probe each for *E. coli and P. aeruginosa* and 2 PNA probes for *K. pneumoniae* | 1.5 mL PNA Probes in a *single solution:*
1 PNA probe each for *E. coli, P. aeruginosa and K. pneumoniae*  |
|  Wash Solution | None | Wash solution with Tris/HCl: 0.3 M, NaCl: 0.9 M, 6% (v/v) Triton X-100  |
|  Mounting Solution | None | 3 mL photobleaching inhibitor in glycerol  |
|  Hybridization | • 1 drop *S. aureus*/CNS PNA directly to sample
• Add coverslip
• Incubate 30 minutes | • Performed at 55°C
• Mix 1 drop each of *Staphylococcus* PNA Blue and
• Staphylococcus PNA Yellow on a coverslip
• Invert coverslip onto sample
• Incubate 15-20 minutes  |
|  Washing and Mounting Procedures | None | Rinse, stringent wash, mount cover slip  |
|  Time to Result | ~20-25 minutes | 1.5 hours  |
|  Controls | Positive and Negative Controls on same slide as sample | Positive and Negative Controls must be bought or made separately  |

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K. Standard/Guidance Document Referenced (if applicable):

Not applicable.

L. Test Principle:

The QuickFISH™ technology uses species-specific Peptide Nucleic Acid (PNA) probes in a fluorescence *in situ* hybridization format. PNA is a synthetic molecule that differs from DNA at the backbone. In PNA, the counterpart of the sugar phosphate backbone of DNA and RNA is a polyamide formed by repetitive units of N-(2-aminoethyl) glycine. Bases (i.e., A, T, C, and G) are attached to this backbone to provide a molecular design that allows PNA to hybridize (i.e., by specific base pairing) to complementary DNA or RNA sequences. The hybridization with PNA probes occurs in accordance with Watson-Crick base-pairing rules. QuickFISH™ uses species-specific probes targeting rRNA several thousand rRNA molecules in sufficient concentration to allow individual cells to be detected and identified directly by fluorescent-labeled probes.

A mixture of a fluorescein-labeled *E. coli* specific PNA probe (green), a tetramethylrhodamine labeled *P. aeruginosa* PNA probe (red), and a tetramethylrhodamine and fluorescein-labeled *K. pneumoniae* specific PNA probe (yellow) is added to a smear prepared from a gram-negative bacilli positive blood culture. The probe mixture also includes quencher labeled PNA probes that serve to bind unreacted fluorescent labeled probes to suppress unwanted signal. After the fluorophore-labeled PNA probes and quencher-labeled PNA probes are added to a smear prepared from a culture, hybridization is performed at 55°C for 15-20 minutes. The smear is then ready for examination by fluorescence microscopy. *E. coli*, *P. aeruginosa*, and *K. pneumoniae* cells become fluorescent by specific binding of the fluorophore-labeled PNA probes while maintaining cell morphology.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

A reproducibility study was performed using the Gram-Negative QuickFISH™ BC. The assay was performed on 20 isolates including 5 isolates each of *E. coli* (green positive), *P. aeruginosa* (red positive), and *K. pneumoniae* (yellow positive), and one isolate each of *K. oxytoca*, *E. aerogenes*, *S. marcenscens*, *A. baumannii*, *P. mirabilis* (negatives) in triplicate on three separate days at three separate sites. Reproducibility was > 95%.

b. Linearity/assay reportable range:

Not applicable

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c. Traceability, Stability, Expected values (controls, calibrators, or methods):

QuickFISH™ slides are provided in individually sealed pouches with nitrogen and a desiccant. Slides must be used immediately after breaking pouch seal and within expiration. Slides are stored at 2-8°C. Fixed QuickFISH™ smears may be left on the slide warmer at 55 ± 1°C for up to 5 minutes. Prepared smears which are not used within 5 minutes can be kept at room temperature for 1 hour prior to testing or may be stored at 2-8 °C for up to 1 day before testing. QuickFISH™ smears should be tested immediately following fixation; however, if smears were stored at 2-8 °C or room temperature they must be placed on the slide warmer for approximately 5 minutes at 55 ± 1°C before adding the hybridization reagents.

QuickFISH™ fixed microscope slides with controls (i.e. CS012) consist of the following strains for the Gram-Negative QuickFISH™ BC:

**Positive Controls:**

Escherichia coli:
ATCC 11775, 35218, 10536, 11229, 23848: Green

Pseudomonas aeruginosa:
ATCC 27853, 10145, 9027, 35032, NCTC 10662: Red

Klebsiella pneumoniae:
ATCC 13882, 13883, 10031, 35657, 4352: Yellow

**Negative Controls:**

Klebsiella oxytoca ATCC 43086: No fluorescence
Enterobacter aerogenes ATCC 13048: No fluorescence
Serratia marcescens ATCC 14756: No fluorescence
Acinetobacter baumannii ATCC 19606: No fluorescence
Pseudoonas putida ATCC 49128: No fluorescence

**Compatibility Study:**

A compatibility study was performed with the same control strains listed above for the following bottle types:

BACTEC:
(Lytic 10 anaerobic, aerobic plus, anaerobic plus, PEDS Plus, Standard 10 aerobic, Standard anaerobic)

BacT/ALERT:
(SA, SN)

VERSA TREK
(REDOX 1 aerobic)

The study demonstrated that these bottle types were compatible. The Gram-Negative QuickFISH™ BC is not compatible with bottles supplemented with charcoal and VERSA TREK Redox-2 anaerobic bottles. All results were as

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expected. The strains may not represent the range of genetic diversity for each species.

# Fixed Smear Stability:

A stability assessment was performed on fixed slides on each of the strains listed above at  $55^{\circ}\mathrm{C}$  for 0 and  $5\mathrm{min}$  at, room temperature 5, 15, 30,  $60\mathrm{min}$ ; at  $2 - 8^{\circ}\mathrm{C}$  for 1, 4, 18 and  $24\mathrm{h}$ . Expected results were attained with each test and demonstrated that the assay was stable in all tested conditions.

# d. Detection Limit:

The limit of detection (LoD) for each species was approximated at  $2.3 \times 10^{5}$  CFU/ml for  $E.$  coli (ATCC 11775),  $4.0 \times 10^{5}$  CFU/ml for  $P.$  aeruginosa (ATCC 27853) and  $4.5 \times 10^{5}$  CFU/ml for  $K.$  pneumoniae (ATCC 13882), as an average of 3 tests per species. These LoDs were established by evaluating half-log serial dilutions of aliquots from contrived positive blood cultures containing these species, diluting approximately three orders of magnitude below the limit of detection.

# Co-infection Studies:

Co-infection studies were performed for the Gram-Negative QuickFISH™ BC assay using growth from BACTEC Standard/10 blood culture bottles with sterile human blood added. To determine the LoD of each species in a mixed infection for dual identification, one species was inoculated at  $10^{6}$  CFU/ml while the competing organism was introduced at increasing 10-fold increments.

|  Co-Infection LoDs  |   |   |
| --- | --- | --- |
|  1stStrain | 2ndStrain | LoD of 2ndStrain  |
|  E. coli | P. aeruginosa | 5.34 x 105  |
|  E. coli | K. pneumoniae | 9.59 x 105  |
|  P. aeruginosa | E. coli | 5.79 x 105  |
|  P. aeruginosa | K. pneumoniae | 8.94 x 105  |
|  K. pneumoniae | E. coli | 6.85 x 105  |
|  K. pneumoniae | P. aeruginosa | 4.31 x 105  |

# Analytical Sensitivity:

The sensitivity of the Gram-Negative QuickFISH™ BC assay was established using 16 strains of  $E.$  coli, 21 strains of  $P.$  aeruginosa and 12 strains of  $K.$  pneumoniae. All strains of each species gave the expected green-positive, red-positive and yellow positive results, respectively.

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# e. Analytical Specificity:

The specificity of the Gram-Negative QuickFISH™ BC assay was established using 86 other strains of gram-negative bacilli. 78 of the 86 produced the expected negative results and 8 provided false positive results. The false positive results represent 7 species and 4 genera. The false positive results are summarized in the table below:

|  Cross-reactivity*:  |   |   |
| --- | --- | --- |
|  Species | Strain ID | False Positive Result  |
|  Acinetobacter radioresistens | ATCC 43998 | Red  |
|  Pseudomonas fulva | ATCC 31418 | Red  |
|  Pseudomonas fulva | ATCC 14592 | Red  |
|  Escherichia albertii | ATCC 17582 | Green  |
|  Escherichia fergusonii | ATCC 35469 | Green  |
|  Shigella dysenteriae (serogroup A) | ATCC 9361 | Green  |
|  Shigella flexneri (serogroup B) | ATCC 9199 | Green  |
|  Shigella sonnei (serogroup D) | ATCC 9290 | Green  |

*All other strains tested returned the expected negative results.

Wet analytical studies demonstrated that Brevudimonas diminuta ATCC 19146, Escherichia fergusonii ATCC 33821 and Herbaspirillum huttiense ATCC14670 did not cross-react. In silico studies and historical evidence indicates that a possibility of cross-reactivity may still remain for these strains.

# f. Assay Cut-off:

Not applicable

# g. Media Interference Studies

A media compatibility study was performed using the following blood culture bottle types: BacT/Alert (SA and SN), BACTEC (Lytic 10, Aerobic Plus, Anaerobic Plus, PEDS Plus, Standard 10 Aerobic, Standard Anaerobic) and VersaTREK REDOX-1 Aerobic. Organisms used included the 5 positive control strains for each species of  $E$  coli,  $P$  aeruginosa and  $K$  pneumoniae species and the 5 negative control strains listed above listed above. Results showed the Gram-Negative QuickFISH™ BC to be compatible with all of the above mentioned blood culture bottle types. All results were as expected.

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2. Comparison studies:

a. Method comparison with predicate device:

The performance of the Gram-Negative QuickFISH™ BC was compared to the predicate using conventional culture and bacterial identification methods.

b. Matrix comparison:

Not applicable.

3. Clinical Studies:

a. Clinical Sensitivity:

The performance of the Gram-Negative QuickFISH™ BC was compared to results obtained from routine identification methods for the identification of Gram-negative bacilli from blood cultures. The clinical studies were performed at 5 clinical laboratory sites in the U.S. A total of 263 patients and 43 spiked samples are included in these analyses. The breakdown of performance by analyte was as follows:

|  Clinical Performance Data for Gram-Negative QuickFISH™ BC vs. Reference Identification Methods by Blood Cultures Positive with Gram-Negative Bacilli (all sites)  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  Gram-Negative QuickFISH BC | E. coli | P. aeruginosa | K. pneumoniae | Other  |
|  E. coli | 91^{1,3} | 0 | 0 | 0  |
|  P. aeruginosa | 0 | 52^{2} | 0 | 1  |
|  K. pneumoniae | 1 | 0 | 60^{3} | 0  |
|  Negative | 2 | 1 | 0 | 99  |
|  Total | Positive Percent Agreement 96.8% (91/94) 95% CI (91.0-98.9) | Positive Percent Agreement 98.1% (52/53) 95% CI (90.1-99.7) | Positive Percent Agreement 100% (60/60) 95% CI (94.0-100) | Negative Percent Agreement 99.0% (99/100) 95% CI (94.6-99.8)  |

1 Includes 9 blood cultures spiked with clinical strains of E. coli.
2 Includes 34 blood cultures spiked with clinical strains of P. aeruginosa.
3 Includes 1 mixed culture of E. coli and K. pneumoniae.

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In the clinical studies, bottles were stored at room temperature after Gram stain and before Gram-Negative QuickFISH™ BC testing. The time between Gram stain and preparation of the Gram-Negative QuickFISH™ BC slides varied from less than 1/2 hour to greater than 48 hours. The following were discrepancies in the study:

- There was one false positive result for *P. aeruginosa* in a specimen that was infected with *Pseudomonas fulva*, a known limitation.
- There was one false positive for *K. pneumoniae* that was co-infected with *E. coli*, *Serratia marcenscens* and *Streptococcus mutans* (also accounting for 1 false negative result for *E. coli*).
- There were 2 other false negative results for *E. coli*, whose times between collection and processing were 15h 25 min and 29h 30 min, respectively.
- There was 1 false negative for *P. aeruginosa*, whose time between collection and processing was 9h 4 min.

Other organisms encountered in the clinical study include *Proteus mirabilis*, *Serratia marcescens*, *Enterobacter cloacea*, *Morganella morganii*, *Bacteroides fragilis*, *Citrobacter koseri*, *Proteus mirabilis*, *Staphylococcus aureus*, *Klebsiella oxytoca*, *Moraxella spp*, *Citrobacter freundii*, *Haemophilis parainfluenzae*, *Capnocytophaga spp*, *Eikenella corodens*, *Acinetobacter spp*, *Enterococcus faecium*, *Bordotella helmesii*, *Acinetobacter baumannii*, *Diptheroids*, *Providencia stuartii*, *Streptococcus mutans*, *Pantoea agglomerans*, *Streptococcus mitis*, *Lactococcus lactis*, *Pseudomonas fulva*, *Staphylococcus epidermidis*, *Prevotella bivia*, *Streptococcus gallolyticus*, *Burkholderia cepacia*, *Bacillus spp*, *Ochrobactrum anthropic*, *Prevotella intermedia*, *Hafnia alvei*, *Stenotrophomonas maltophilia*, *Enterobacter aerogenes*, *Acinetobacter spp*, *Pseudomonas fluoresens*, *Capnocytophaga spp*, *Providencia rettgeri*, *Salmonella spp*, and *Pseudomonas putida*.

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|  Performance Data for Gram-Negative QuickFISH™ BC vs. Reference Identification Methods by Blood Culture Bottle Types (all samples)  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  Bottle Type | E. coli Positive Percent Agreement | P. aeruginosa Positive Percent Agreement | K. pneumoniae Positive Percent Agreement | Negative Percent Agreement  |
|  Total BACTEC (Plus Aerobic and Lytic/10 Anaerobic) | 98.6% (69/70)
95% CI (92.3-99.8) | 100% (33/33)
95% CI (89.6-100) | 100% (41/41)
95% CI (89.6-100) | 98.5% (65/66)
95% CI (89.6-99.7)  |
|  Total BacT/ALERT (SA Aerobic and SN Anaerobic) | 91.7% (22/24)
95% CI (74.2-97.7) | 95% (19/20)
95% CI (76.4-99.1) | 100% (19/19)
95% CI (83.2-100) | 91.6% (34/34)
95% CI (89.9-100)  |

b. Clinical specificity:
See table above.

c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable.

4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
E. coli: multiple bright green fluorescent rods in multiple fields.
K. pneumoniae: multiple bright yellow fluorescent rods in multiple fields.
P. aeruginosa: multiple bright red fluorescent rods in multiple fields.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The information submitted in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSS/K123418](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSS/K123418)

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