← Product Code [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON) · K073589 # BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS (K073589) _Becton, Dickinson & CO · LON · Mar 5, 2008 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K073589 ## Device Facts - **Applicant:** Becton, Dickinson & CO - **Product Code:** [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON.md) - **Decision Date:** Mar 5, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.1645 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Intended 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 System performs automated identification and antimicrobial susceptibility testing (AST) of bacterial isolates. Input: pure culture bacterial isolates inoculated into Phoenix ID/AST broth. Process: broth microdilution method using molded polystyrene panels with 136 micro-wells containing dried reagents; redox indicator detects growth; turbidity measured. Instrument incubates panels at 35°C; optical readings taken every 20 minutes. Output: identification of isolate, minimum inhibitory concentration (MIC) values, and category interpretations (S, I, R, N). Used in clinical microbiology laboratories by trained technicians. Output assists clinicians in selecting appropriate antimicrobial therapy by determining bacterial susceptibility to specific agents. ## Clinical Evidence Performance evaluated using clinical, stock, and challenge isolates across multiple US sites. Comparison made against CLSI 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 streptococcal isolates. ## Technological Characteristics System consists of an automated instrument, software, and molded polystyrene panels (136 micro-wells). Uses broth microdilution method with redox indicator and turbidity measurement for growth detection. Incubation at 35°C. Connectivity: Automated system. Software-based interpretation of optical readings. ## 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), [K060324](/device/K060324.md)) - BD Phoenix™ Automated Microbiology System with Ofloxacin ([K020323](/device/K020323.md)) - BD Phoenix™ 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} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k073589 B. Purpose for Submission: Addition of Daptomycin to the BD Phoenix™ Automated Microbiology System C. Measurand: Daptomycin 0.0313 – 16 µg/mL D. Type of Test: Antimicrobial Susceptibility Test (AST) (Qualitative) colorimetric oxidation-reduction, growth-based E. Applicant: Becton, Dickinson & Company F. Proprietary and Established Names: BD Phoenix™ Automated Microbiology System – Daptomycin 0.0313 – 16 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 {1} 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use(s): Daptomycin at a concentration of 0.0313 – 16 µg/mL on the Streptococcus 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 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 premarket notification is indicated for the addition of the antimicrobial agent Daptomycin at concentrations of 0.0313 – 16 µg/mL to Streptococcus ID/AST or AST only Phoenix panels for testing Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Streptococcus pyogenes. 3. Special conditions for use statement(s): For 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, a wetting agent. After adding the indicator solution to the AST inoculum the color turns to blue. After inoculation and incubation, the color changes to pink then to colorless as reduction in the panel well proceeds. 2 {2} Inoculated panels are barcode scanned and loaded into the BD Phoenix™ Automated Microbiology System instrument where the panels are 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 however, the AST result is only available between 4-16 hours. This is only an autoread result; no manual readings are possible with this system. ## J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK® System 2. Predicate 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 | {3} | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | 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-S18) "Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard." # L. Test Principle: 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. Precision/Reproducibility: Thirty-three isolates were evaluated for site to site and inte-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). {4} b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): The FDA and CLSI recommended Quality Control (QC) isolate, S. pneumoniae ATCC 49619 was tested on every test occasion with the reference method and the BD Phoenix™. The mode of the BD Phoenix™ was one well dilution higher than the reference method. The reference method QC results were in range for every day tested. The BD Phoenix™ was tested a sufficient number of times to demonstrate that the system can produce QC results in the recommended ranges. Daptomycin QC Table | ORGANISM | conc. (μg/mL) | Reference | | BD Phoenix™ | | | --- | --- | --- | --- | --- | --- | | | | | | | | | S. pneumoniae ATCC 49619 Expected Range: 0.0625 – 0.5 μg/mL | 0.0625 | 1 | | | | | | 0.125 | 71 | | 17 | | | | 0.25 | 47 | | 100 | | | | 0.5 | 5 | | 4 | | | | 1 | | | 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: {5} The broth dilution reference panel was prepared according to FDA and CLSI recommendation and was used to compare with the BD Phoenix™ results. The broth reference panel for Streptococcus spp. other than S. pneumoniae was set up on Mueller Hinton broth adjusted to a calcium content of 50 mg/mL, supplemented with 2% to 5% lysed horse blood, inoculated with a direct colony suspension and incubated in ambient air at 35°C for 20 – 24 hours as recommended by FDA and CLSI. 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%. A comparison was provided to the reference method with the following agreement. Strep Accuracy Summary Clinical and Challenge | | EA Tot | EA N | EA % | Eval EA Tot | Eval EA N | Eval EA % | CA N | CA % | #NS | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Clinical | 649 | 615 | 94.8 | 644 | 610 | 94.7 | 647 | 99.7 | 1 | | Challenge | 19 | 19 | 100 | 19 | 19 | 100 | 19 | 100 | 0 | | Combined | 668 | 634 | 94.9 | 663 | 629 | 94.9 | 666 | 99.7 | 1 | EA-Essential Agreement CA-Category Agreement NS-Not susceptible; there is only a susceptible category 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. Evaluable EA is when the MIC result is on scale for both the BD Phoenix™ and the reference and have on-scale EA. There appears to be a slight trend where the test device is more susceptible than the reference method as reflected in the Accuracy study. There is one not susceptible isolate due to S. pyogenes. b. Matrix comparison: Not Applicable 3. Clinical studies: a. Clinical Sensitivity: Not Applicable b. Clinical specificity: Not Applicable {6} 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: S. pyogenes, S. agalactiae, and S. dysagalactiae subsp. equisimilis ≤1 (S) The MIC interpretive criteria for Streptococcus spp. other than S. pneumoniae are applicable only to tests performed by broth dilution using Mueller Hinton broth adjusted to a calcium content of 50 mg/mL, supplemented with 2% to 5% lysed horse blood, inoculated with a direct colony suspension and incubated in ambient air at 35°C for 20 – 24 hours as recommended by CLSI. The current absence of data on Daptomycin resistant isolates precludes defining any categories other than "Susceptible." Isolates yielding test results suggestive of a "Non-susceptible" category should be retested, and if the result is confirmed, the isolate should be submitted to a reference laboratory for further testing. N. Proposed Labeling: The labeling is sufficient and it 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. --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K073589](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K073589) **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. 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