← Product Code [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON) · K040716 # BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML (K040716) _Becton, Dickinson & CO · LON · May 14, 2004 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K040716 ## Device Facts - **Applicant:** Becton, Dickinson & CO - **Product Code:** [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON.md) - **Decision Date:** May 14, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.1645 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Indications for Use The BD PhoenixTM 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 System uses sealed, self-inoculating polystyrene trays with 136 micro-wells containing dried reagents; organism pure culture suspended in broth, equated to 0.5 McFarland standard using nephelometer, and diluted in AST broth with redox indicator. Instrument incubates panels at 35°C; performs continuous monitoring; reads colorimetric oxidation-reduction changes every 20 minutes. Growth in presence of antibiotic reduces indicator (color change); inhibition prevents reduction. Software-driven 'EXPERT' system interprets results based on NCCLS standards to provide MIC values and categorical interpretations. Used in clinical microbiology laboratories; operated by trained laboratory personnel. Benefits include rapid, automated susceptibility testing (4-16 hours) compared to manual methods. ## Clinical Evidence Performance evaluated using clinical, stock, and challenge isolates across multiple US sites. Comparison made against NCCLS reference broth microdilution method. Metrics included Essential Agreement (EA) and Category Agreement (CA). Reproducibility study (intra- and inter-site) showed >90% intra-site and >95% inter-site reproducibility for Gram-positive isolates. ## Technological Characteristics Automated microbiology system; molded polystyrene trays with 136 micro-wells; colorimetric oxidation-reduction sensing principle; 35°C incubation; software-driven expert system for rule-based interpretation; utilizes cation-adjusted Mueller-Hinton broth with 0.01% Tween 80; barcode scanning for panel identification. ## 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 PhoenixTM Automated Microbiology System with Gatifloxacin ([K020321](/device/K020321.md)) - BD PhoenixTM Automated Microbiology System with Ofloxacin ([K020323](/device/K020323.md)) - BD PhoenixTM Automated Microbiology System with 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 DEVICE ONLY TEMPLATE A. 510(k) Number: k040716 B. Purpose of Submission: Addition of penicillin to the BD Phoenix™ Automated Microbiology System C. Analyte: Penicillin 0.0625 – 32 µg/mL Gram-Positive AST D. Type of Test: Antimicrobial Susceptibility Test (Quantitative) colorimetric oxidation-reduction, growth-based E. Applicant: Becton, Dickinson & Company F. Proprietary and Established Names: BD Phoenix™ Automated Microbiology System – Penicillin Gram-Positive Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product Code: LON 4. Panel: 83 H. Intended Use: 1. Intended use(s): BD Phoenix™ Automated Microbiology System: The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration of gram-negative aerobic and facultative anaerobic bacteria belonging to the family Enterobacteriaceae and non-Enterobacteriaceae and gram-positive bacteria belonging to the genera Staphylococcus and Enterococcus. The BD Phoenix™ GP Panel: The BD Phoenix™ Automated Microbiology System is intended for the in vitro rapid identification (ID) and quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus and Enterococcus. {1} Page 2 of 6 2. **Indication(s) for use:** This submission is for the addition of the antibiotic penicillin at concentrations of 0.0625 – 32 µg/mL to the gram positive susceptibility panel. 3. **Special condition for use statement(s):** Prescription use only 4. **Special instrument Requirements:** Not applicable ## I. Device Description: 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 goes to pink 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 NCCLS standards. Readings are taken every 20 minutes with an ID result available between 2-12 hours and an AST result available between 4-16 hours. This is only an autoread result; there are no manual readings possible. ## J. Substantial Equivalence Information: 1. **Predicate device name(s):** VITEK® System 2. **Predicate K number(s):** N50510 {2} Page 3 of 6 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | 1. | Isolated colonies from culture used | Isolated colonies from culture used | | 2. | Report results as minimum inhibitory concentration (MIC) and categorical interpretation (SIR) | Report results as minimum inhibitory concentration (MIC) and categorical interpretation (SIR) | | 3. | <16 hours | <16 hours | | Differences | | | | Item | Device | Predicate | | 1. | Results are determined from serial twofold dilutions of antimicrobial agents | Results are determined from extrapolation of doubling dilutions | | 2. | Inoculum density equated to 0.5 McFarland standard | Inoculum density equated to 1.0 McFarland standard | | 3. | 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 (AST) Systems; Guidance for Industry and FDA”; NCCLS M7 (M100-S14) “Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard.” L. Test Principle: The system employs conventional, colorimetric, fluorogenic and chromogenic substrates to identify the genus and species of the isolate. 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 contain no antibiotic. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility within sites was determined using the QC isolates for >95% reproducibility. Between sites was performed at three sites for >95% reproducibility on 15 isolates. {3} Page 4 of 6 b. Linearity/assay reportable range: Not applicable c. Traceability (controls, calibrators, or method): The recommended QC isolate was tested a sufficient number of times with acceptable results with the reference method. The Phoenix results demonstrated that the system can produce QC results in the recommended range. | ORGANISM | conc. | Reference | | Phoenix | | | --- | --- | --- | --- | --- | --- | | | | | | | | | E. faecalis ATCC 29212 Expected Range: 1 – 4 μg/mL | <=1 | | 3 | | | | | 2 | | 135 | | 86 | | | 4 | | 2 | | 51 | | | 8 | | | | 1 | | | | | | | | | S. aureus ATCC 29213 Expected Range: 0.25 – 2 μg/mL | 0.5 | | 2 | | 7 | | | 1 | | 28 | | 53 | | | >1 | | 110 | | 78 | | | | | | | | | | | | | | | The main purpose of the S. aureus ATCC 29213 QC organism is to demonstrate that it is a penicillinase producer with an expected range of $\geq 0.25$. Both reference and BD QC results have a mode of $>1$ therefore this QC is acceptable. E. faecalis 29212 appears to be a better indicator of the activity of penicillin. Inoculum density control: The organism suspension density of the ID broth was equivalent to a $0.5\,\mathrm{McFarland}$ standard using the $\mathrm{BBL}^{\mathrm{TM}}$ CrystalSpec™ Nephelometer which was verified each day of testing. Internal data was used to demonstrate that the use of the $\mathrm{BBL}^{\mathrm{TM}}$ 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: {4} Page 5 of 6 a. Method comparison with predicate device: The NCCLS recommended broth dilution reference panel was prepared according to the NCCLS standards. Clinical testing was performed at four 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 99.5%. A comparison was provided to the reference method with the following agreement. All Staph spp. with MIC of <0.25 were tested with β-lactamase test as recommended in NCCLS standards. The testing was done with both the test device and reference device. | | EA Tot | EA N | EA % | Eval EA Tot | Eval EA N | Eval EA % | CA N | CA % | #R | min | maj | vmj | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Clinical | 1167 | 1088 | 93.2 | 249 | 229 | 92.0 | 1137 | 97.4 | 879 | N/A | 10 | 20 | | Challenge | 89 | 87 | 97.8 | 20 | 20 | 100.0 | 87 | 97.8 | 43 | N/A | 1 | 1 | | Combined | 1256 | 1175 | 93.6 | 269 | 249 | 92.6 | 1224 | 97.5 | 922 | N/A | 11 | 21 | EA-Essential Agreement CA-Category Agreement R-resistant isolates maj-major discrepancies vmj-very major discrepancies min- minor discrepancies NA – No intermediate range therefore no minor errors possible 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 method. Category agreement (CA) is when the BD Phoenix™ panel result interpretation agrees exactly with the reference panel result interpretation. The 13 S. epidermidis vmj errors would have been correctly categorized as resistant with the use of β-lactamase test that is part of the Phoenix expert system. These would result in 8 vmj errors instead of 21. 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: Staphylococcus spp. ≤0.12 (S), ≥0.25 (R) Enterococcus spp. ≤8 (S), ≥16 (R) The expected value range, interpretative criteria and QC are the same as recommended by NCCLS. All values will be included in the package insert. {5} Page 6 of 6 N. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K040716](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K040716) **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