← Product Code [LON](/productcode/LON) · K063301 # BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML (K063301) _Becton, Dickinson & CO · LON · Dec 8, 2006 · Microbiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K063301 ## Device Facts - **Applicant:** Becton, Dickinson & CO - **Product Code:** [LON](/productcode/LON.md) - **Decision Date:** Dec 8, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.1645 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Indications for Use The BD Phoenix™ Automated Microbiology System is intended for the rapid identification and in vitro antimicrobial susceptibility testing of isolates from pure culture of most aerobic and facultative anaerobic Gram-negative and Gram-positive bacteria of human origin. ## Device Story BD Phoenix Automated Microbiology System performs antimicrobial susceptibility testing (AST). System utilizes sealed, self-inoculating polystyrene trays containing dried reagents and AST broth (cation-adjusted Mueller-Hinton with 0.01% Tween 80). Input: pure culture bacterial isolates suspended in broth (0.5 McFarland). Operation: instrument incubates panels at 35°C; monitors growth via colorimetric oxidation-reduction (redox) indicator; blue-to-pink-to-colorless transition indicates growth. Readings taken every 20 minutes (4-16 hours). Output: MIC values and categorical interpretations (SIR). Expert system software applies CLSI-derived rules to interpret results. Used in clinical microbiology laboratories; operated by trained technicians. Benefits: rapid, automated quantitative susceptibility determination to guide antibiotic therapy. ## Clinical Evidence Clinical and challenge isolates tested across multiple US sites. Performance compared to CLSI reference broth microdilution method. For cefepime (Gram-negative), EA was 98.0% and CA was 96.7% (n=1384). Intra-site reproducibility >90%, inter-site >95%. ## Technological Characteristics Broth microdilution system; molded polystyrene panels (136 wells); redox indicator for growth detection; optical turbidity measurement; continuous incubation at nominal temperature; automated software interpretation; standalone instrument. ## Regulatory Identification A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases. ## Special Controls *Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.” ## Predicate Devices - VITEK® System (PMA No. N50510) - BD Phoenix™ Automated Microbiology System with Gatifloxacin ([K020321](/device/K020321.md)) - Ofloxacin ([K020323](/device/K020323.md)) - Levofloxacin ([K020322](/device/K020322.md)) ## 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. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k063301 B. Purpose for Submission: To remove limitation for Proteus species (spp.) on the BD Phoenix™ gram-negative ID/AST or AST only Phoenix panels C. Measurand: Cefepime 0.5 – 64 µg/mL D. Type of Test: Antimicrobial Susceptibility Test (AST) colorimetric oxidation-reduction, growth-based E. Applicant: Becton, Dickinson & Company F. Proprietary and Established Names: BD Phoenix™ Automated Microbiology System – Cefepime 0.5 – 64 µg/mL G. Regulatory Information: 1. Regulation section: 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: II 3. Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use(s): Cefepime at concentrations of 0.5 – 64 µg/mL on the Gram Negative (GN) ID/AST or AST only Phoenix panels is intended for use with the BD Phoenix Automated Microbiology System for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most {1} Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and non-Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus. 2. Indication(s) for use: This application is indicated for cefepime with the removal of the limitations for Proteus spp. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Not Applicable I. Device Description: This submission is for AST Panel only. The ID System was not reviewed. The BD Phoenix™ Automated Microbiology System includes instrumentation and software, sealed and self-inoculating molded polystyrene trays with 136 micro-wells containing dried reagents, and specific inoculum broth formulations for ID and AST Indicator. The organism to be tested must be a pure culture and be preliminarily identified as gram positive or gram negative. Colonies are then suspended in broth, and equated to a 0.5 McFarland with the recommendation to use the BD CrystalSpec™ Nephelometer. A further dilution is made into an AST broth, which contains an AST indicator, prior to inoculating the panel. The AST broth is a cation-adjusted formulation of Mueller-Hinton broth containing 0.01% Tween 80. After adding the indicator solution to the AST inoculum the color is blue and after inoculation and incubation changes to pink then to colorless as reduction in the panel well proceeds. Inoculated panels are barcode scanned and loaded into the BD Phoenix™ Automated Microbiology System instrument where the panels are continuously incubated at 35°C. The AST has a final inoculum of 5 × 10⁵ CFU/ml. The instrument incubates, reads and records the results of the biochemical substrates and antimicrobial agents and interprets the reactions to give an ID of the isolate and MIC value and category interpretation of the antimicrobial agents. Organisms growing in the presence of a given antimicrobic agent reduce the indicator, signaling organism growth and resistance to the antimicrobic agent. Organisms killed or inhibited by a given antimicrobic do not cause reduction of the indicator and therefore do not produce a color change. Additional interpretation is done using software driven "EXPERT" System using rules derived from the CLSI documentation. Readings are taken every 20 minutes with an AST result available between 4-16 hours. This is only an autoread result; no manual readings are possible with this system. J. Substantial Equivalence Information: {2} 1. Predicate device name(s): VITEK® System 2. Predicate 510(k) number(s): N50510 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | 1. Intended Use | Intended for the in vitro rapid identification (ID) and quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most bacteria. | Same | | 2. Isolates | Isolated colonies from culture used | Isolated colonies from culture used | | 3. Result Reported | Report results as minimum inhibitory concentration (MIC) and categorical interpretation (SIR) | Report results as minimum inhibitory concentration (MIC) and categorical interpretation (SIR) | | 4. Incubation Time | <16 hours | <16 hours | | 5. Type of Test | Automated | Automated | | Differences | | | | --- | --- | --- | | Item | Device | Predicate | | 1. Results achieved | Results are determined from serial twofold dilutions of antimicrobial agents | Results are determined from extrapolation of doubling dilutions | | 2. Sample Preparation | Inoculum density equated to 0.5 McFarland standard | Inoculum density equated to 1.0 McFarland standard | | 3. Technology | Automated growth based enhanced by use of a redox indicator (colorimetric oxidation-reduction) to detect organism growth. | Automated growth based with detection using an attenuation of light measured by an optical scanner. | # K. Standard/Guidance Document Referenced (if applicable): "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test Systems; Guidance for Industry and FDA"; CLSI M7 (M100-S16) "Methods for {3} Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard." L. Test Principle: The AST portion of the BD Phoenix™ Automated Microbiology System is a broth based microdilution method that utilizes a redox indicator (colorimetric oxidation-reduction) to enhance detection of organism growth. The MIC is determined by comparing growth in wells containing serial two-fold dilutions of an antibiotic to the growth in "growth control wells" which contains no antibiotic. M. Performance Characteristics (if/when applicable): 1. Analytical performance: A clinical trial was conducted with the new cefepime formulation to demonstrate that accuracy and reproducibility is acceptable. The QC performance was within the expected ranges as shown under the "Traceability, Stability... Section." a. Precision/Reproducibility: Fifteen gram-negative on-scale organisms were evaluated for site to site and inter site reproducibility demonstrating >95% reproducibility. The ten isolate study described in the guidance document was used (10 organisms tested 3 times on 3 days at 3 sites). b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Quality Control was performed on every test occasion with the following results. BD Phoenix™ produced acceptable QC results as compared to the reference method results >95% of the time. Cefepime QC Table | ORGANISM | conc. (μg/mL) | Reference | | BD Phoenix™ | | | | --- | --- | --- | --- | --- | --- | --- | | | | | | | | | | E. cloacae ATCC 11061 Expected Range: 2 – 16 μg/mL | 2 | | | | 6 | | | | 4 | | 27 | | 19 | | | | 8 | | 49 | | 52 | | | | 16 | | 7 | | 15 | | | | 32 | | | | 1 | | | | | | | | | | | E. coli ATCC 25922 Expected Range: ≤0.5 μg/mL | ≤0.5 | | 82 | | 93 | | | | | | | | | | | | | | | | | | | P. aeruginosa ATCC 27853 Expected Range: | ≤0.5 | | 1 | | | | | | 1 | | 45 | | 8 | | | | 2 | | 36 | | 83 | | {4} 5 | 1 - 8 μg/mL | 4 | | 1 | | 1 | | | --- | --- | --- | --- | --- | --- | --- | | | 8 | | | | 1 | | | | | | | | | | | P. aeruginosa | 4 | | 63 | | 89 | | | ATCC 35032 | 8 | | 20 | | 3 | | | Expected Range: | 16 | | | | | | | 2 - 8 μg/mL | 32 | | | | 1 | | | | | | | | | | Inoculum density control: The organism suspension density of the ID broth was equivalent to a 0.5 McFarland standard using the BBL™ CrystalSpec™ Nephelometer which was verified each day of testing. Internal data was used to demonstrate that the use of the BBL™ CrystalSpec™ Nephelometer would produce reproducible results. Five different instruments were used. d. Detection limit: Not Applicable e. Analytical specificity: Not Applicable f. Assay cut-off: Not Applicable 2. Comparison studies: a. Method comparison with predicate device: The broth dilution reference panel was prepared according to the CLSI recommendation and was used to compare with the BD Phoenix™ results. Clinical testing was performed at several sites. The testing included both fresh clinical isolates and stock isolates along with a challenge set with known results. The test device had a growth rate of >90%. The performance chart below includes clinical trial results with the new cefepime formulation to remove limitation for Proteus spp. GN Accuracy Summary Clinical and Challenge | | EA Tot | EA N | EA % | Eval EA Tot | Eval EA N | Eval EA % | CA N | CA % | #R | min | maj | vmj | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Clinical | 1092 | 1075 | 98.4 | 247 | 231 | 93.5 | 1068 | 97.8 | 33 | 22 | 2 | 0 | | Challenge | 292 | 282 | 96.6 | 111 | 104 | 93.7 | 271 | 92.8 | 55 | 19 | 0 | 2 | | Combined | 1384 | 1357 | 98.0 | 358 | 335 | 93.6 | 1339 | 96.7 | 88 | 41 | 2 | 2 | EA-Essential Agreement CA-Category Agreement R-resistant isolates vmj - very major discrepancies maj - major discrepancies min - minor discrepancies Essential agreement (EA) is when the BD Phoenix™ panels agree with the reference test panel results exactly or within one doubling dilution of the reference {5} method. Category agreement (CA) is when the BD Phoenix™ panel result interpretation (SIR) agrees exactly with the reference panel result interpretation. Evaluable EA is when the MIC result is on scale for both the BD Phoenix™ and the reference and have on-scale EA. The 2 vmj errors tested positive for ESBL both in BD Phoenix™ and the reference method. Interpretation for both isolates with the BD Phoenix™ would be changed to "Resistant" making it in agreement with the reference method. b. Matrix comparison: Not Applicable 3. Clinical studies: a. Clinical Sensitivity: Not Applicable b. Clinical specificity: Not Applicable 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: Enterobacteriaceae ≤8(S); 16(I); ≥32(R) Pseudomonas aeruginosa ≤8(S); 16(I); ≥32(R) N. Proposed Labeling: The expected value range, interpretive criteria and QC for gram negative panels are included in the package insert. The labeling is sufficient and satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 6 --- **Source:** [https://fda-staging.innolitics.com/device/K063301](https://fda-staging.innolitics.com/device/K063301) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com