← Product Code [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON) · K060444 # BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML (K060444) _Becton, Dickinson & CO · LON · Apr 12, 2006 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K060444 ## Device Facts - **Applicant:** Becton, Dickinson & CO - **Product Code:** [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON.md) - **Decision Date:** Apr 12, 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 automated antimicrobial susceptibility testing (AST). System uses molded polystyrene trays with 136 micro-wells containing dried reagents and AST indicator. Pure culture isolates are suspended in broth (0.5 McFarland), diluted in AST broth, and inoculated into panels. Instrument continuously incubates panels at 35°C; monitors colorimetric oxidation-reduction (blue to pink/colorless) via optical scanning every 20 minutes. Software interprets growth patterns to determine MIC values and categorical interpretations (SIR) using CLSI-derived rules. System provides automated results in 4-16 hours; no manual readings. Healthcare providers use MIC results to guide antimicrobial therapy for bacterial infections. ## Clinical Evidence Performance evaluated via multi-site clinical study (4 sites) comparing Phoenix™ results to CLSI broth dilution reference method. Combined data for Cefepime (n=1789) showed 95.2% EA and 92.9% CA. Combined data for Ceftriaxone (n=1872) showed 95.8% EA and 90.9% CA. Reproducibility >95%. Quality control testing met acceptance criteria. ## Technological Characteristics Broth-based microdilution AST system. Uses redox indicator (colorimetric oxidation-reduction) for growth detection. Instrumentation includes barcode scanner, incubator (35°C), and optical reader. Trays are molded polystyrene with 136 micro-wells. Connectivity: Automated system with software-driven expert rules. Sterilization: Not specified. ## 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)) - BD Phoenix™ Automated Microbiology System Cefepime-0.5-64 µg/mL ([K032675](/device/K032675.md)) - BD Phoenix™ Automated Microbiology System Ceftriaxone-0.5-64 µg/mL ([K032655](/device/K032655.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} Page 1 of 7 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K060444 B. Purpose for Submission: Submission of the antibiotics Cefepime at concentrations of 0.5 - 64 µg/mL and Ceftriaxone at concentrations of 0.5 - 64 µg/mL, for additional organism groups to the Gram Negative ID/AST or AST only Phoenix™ panel. C. Measurands: Cefepime at 0.5 - 64 µg/mL Ceftriaxone at 0.5 - 64 µg/mL D. Type of Test: Antimicrobial Susceptibility Test (Quantitative and Qualitative) 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, and Ceftriaxone - 0.5 – 64 µg/mL, Gram Negative (GN) panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial 2. Classification: Class II 3. Product Code: LON 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use(s): Cefepime at concentrations of 0.5 - 64 µg/mL, and Ceftriaxone at concentrations of 0.5 - 64 µg/mL, on the Phoenix™ Gram Negative ID/AST and AST only panel is intended for use with the Phoenix™ system in clinical {1} Page 2 of 7 laboratories as an *in vitro* test to determine the susceptibility of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for *Enterobacteriaceae* and non-*Enterobacteriaceae* to antimicrobial agents when used as instructed in the Phoenix™ system user’s manual. The BD Phoenix™ Automated Microbiology System is intended for the *in vitro* quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most gram-negative aerobic and facultative anaerobic bacteria belonging to the family *Enterobacteriaceae* and non-*Enterobacteriaceae* and gram-positive bacteria belonging to the genera *Staphylococcus*, *Streptococcus* and *Enterococcus*. 2. Indication(s) for use: Submission of the antibiotics cefepime at concentrations of 0.5 - 64 µg/mL and ceftriaxone at concentrations of 0.5 – 64 µg/mL, for additional organism groups to the Gram Negative ID/AST or AST only Phoenix™ panel. 3. Special condition for use statement(s) All *Proteus* species will be suppressed from reporting cefepime (FEP) in the Phoenix™ system. All *Proteus vulgaris*/penneri will be suppressed from reporting ceftriaxone (CRO) in the Phoenix™ system. An alternate method should be performed when these combinations have been identified. Prescription Use Only 4. Special instrument Requirements: Not Applicable I. Device Description: This submission is for the 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 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 broth containing Tween 80. After adding the indicator solution to the AST inoculum, the color is blue, and after inoculation and incubation, it changes to pink then 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 resulting AST has a final inoculum of 5 × 10⁵ CFU/ml. The instrument incubates, reads and records the results of the antimicrobial agents and interprets the reactions to obtain a MIC value and category interpretation of the antimicrobial agents. {2} Page 3 of 7 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 Clinical and Laboratory Standards Institute (CLSI). Readings are taken every 20 minutes with 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 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | Intended use | Intended for the in vitro rapid quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most bacteria. | same | | Isolates | Isolated colonies from culture used | Isolated colonies from culture used | | Results | Report results as minimum inhibitory concentration (MIC) and categorical interpretation (SIR) | Report results as minimum inhibitory concentration (MIC) and categorical interpretation (SIR) | | Incubation conditions | <16 hours | <16 hours | | Type of Test | Automated | Automated | | Differences | | | | --- | --- | --- | | Item | Device | Predicate | | Reading algorithm | Results are determined from serial twofold dilutions of antimicrobial agents | Results are determined from extrapolation of doubling dilutions | | 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. | {3} Page 4 of 7 K. Standard/Guidance Document Referenced (if applicable): “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA”; CLSI M7 (M100-S16) “Methods for 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 contain no antibiotic. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility Intersite and Intrasite testing demonstrated >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 method): Quality Control was performed during the testing of all isolates on each day of testing with the following results. The table below includes the concentrations tested around the expected range with the frequency of the reference and the Phoenix™ results at each concentration. Cefepime | Organism | Concentration μg/ml | Reference Results | Phoenix™ Results | Organism | Concentration μg/mL | Reference Results | Phoenix™ results | | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | | | | | E. coli ATCC 25922 Expected Range <=0.5 μg/mL | <= 0.5 | 190 | 196 | P. aeruginosa ATCC 27853 Expected Range 1 - 8 μg/mL | <= 0.5 | | | | | 1 | | | | 1 | 123 | 3 | | | 2 | | | | 2 | 64 | 178 | | | 4 | | | | 4 | 2 | 16 | | | 8 | | | | 8 | | | | | 16 | | | | 16 | | | | | 32 | | | | 32 | | | | | 64 | | | | 64 | | | {4} Page 5 of 7 # Ceftriaxone | Organism | Concentration μg/ml | Reference Results | Phoenix™ Results | Organism | Concentration μg/mL | Reference Results | Phoenix™ results | | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | | | | | E. coli ATCC 25922 Expected Range <=0.5 μg/mL | <= 0.5 | 182 | 190 | P. aeruginosa ATCC 27853 Expected Range 8 - 64 μg/mL | <= 0.5 | | | | | 1 | | | | 1 | | | | | 2 | | | | 2 | | | | | 4 | | | | 4 | 6 | | | | 8 | | | | 8 | 126 | 91 | | | 16 | | | | 16 | 36 | 95 | | | 32 | | | | 32 | 7 | | | | 64 | | | | 64 | 3 | 1 | Phoenix produced acceptable QC results as compared to the reference method results >95% of the time. 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 used to compare with the Phoenix™ results. 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. Performance charts below include all data, original and the additional organisms for fresh and challenge organisms. Cefepime (FEP) - GN Clinical and Challenge Data for Enterobacteriaceae and non-Enterobacteriaceae and Additional Organism Groups, but with all Proteus removed | | EA Tot | EA N | EA % | Eval EA Tot | Eval EA N | Eval EA % | CA Tot | CA N | CA % | #R | min | maj | vmj | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Combined | 1789 | 1703 | 95.2 | 625 | 558 | 89.3 | 1789 | 1662 | 92.9 | 226 | 113 | 8 | 6 | {5} Page 6 of 7 Ceftriaxone (CRO) - GN Clinical and Challenge Data for Enterobacteriaceae and non-Enterobacteriaceae and Additional Organism Groups, but with Proteus vulgaris/ penneri removed | | EA Tot | EA N | EA % | Eval EA Tot | Eval EA N | Eval EA % | CA Tot | CA N | CA % | #R | min | maj | vmj | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Combined | 1872 | 1794 | 95.8 | 491 | 426 | 86.8 | 1872 | 1702 | 90.9 | 376 | 163 | 4 | 3 | EA-Essential Agreement maj-major discrepancies CA-Category Agreement vmj-very major discrepancies R-resistant isolates 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 method. Category agreement (CA) is when the BD Phoenix™ panel result interpretation agrees exactly with the reference panel result interpretation. Evaluable (Eval) are results that are within the test range and on scale. 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: | Cefepime | <=8 (S), 16 (I), >=32 (R) | | --- | --- | | Ceftriaxone | <=8(S), 16-32 (I), >=64 (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 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. {6} Page 7 of 7 --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K060444](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K060444) **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