← Product Code [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON) · K063486 # BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY (K063486) _Becton, Dickinson & CO · LON · Mar 7, 2007 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K063486 ## Device Facts - **Applicant:** Becton, Dickinson & CO - **Product Code:** [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON.md) - **Decision Date:** Mar 7, 2007 - **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™ Automated Microbiology System performs antimicrobial susceptibility testing (AST) on bacterial isolates. System utilizes molded polystyrene trays with 136 micro-wells containing dried reagents and specific inoculum broth. Pure culture colonies suspended in broth, equated to 0.5 McFarland standard, and inoculated into AST broth containing redox indicator. Panels barcode-scanned and incubated at 35°C in instrument. Redox indicator changes color (blue to pink to colorless) based on organism growth in presence of serial two-fold dilutions of minocycline (1-32 µg/mL). Instrument reads color changes every 20 minutes; software interprets results to determine MIC and categorical interpretation (SIR). BDXpert software applies CLSI-derived rules to interpret results; automatically suppresses Shigella species susceptibility criteria. System provides automated, rapid AST results (4-16 hours) to clinicians to guide antimicrobial therapy decisions. ## Clinical Evidence Performance evaluated using clinical, stock, and challenge isolates compared to CLSI reference broth microdilution method. Metrics include Essential Agreement (EA) and Category Agreement (CA). Reproducibility evaluated at three sites using gram-negative isolates in triplicate over three days; intra-site reproducibility >90%, inter-site >95%. ## Technological Characteristics Broth-based microdilution AST system. Materials: molded polystyrene trays. Sensing: colorimetric oxidation-reduction (redox) indicator. Energy: 35°C incubation. Connectivity: barcode-scanned, instrument-integrated. Software: rule-based expert system. 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), [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} Page 1 of 6 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K063486 B. Purpose for Submission: Submission of the antibiotic Minocycline, at concentrations of 1-32 µg/mL, to the Gram Negative ID/AST or AST only Phoenix™ panel. C. Measurands: Minocycline at concentrations of 1-32 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 – Minocycline at 1-32 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): Minocycline at 1-32 µg/mL on the Phoenix™ Gram Negative ID/AST or AST only Phoenix™ panel 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 aerobic and facultative anaerobic gram-negative and gram-positive bacteria from pure culture {1} Page 2 of 6 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: 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. Submission of the antibiotic Minocycline, at concentrations of 1-32 µg/mL to the Gram Negative ID/AST or AST only Phoenix™ panel is for the testing of Acinetobacter species, Enterobacter aerogenes, Escherichia coli, Klebsiella species, Shigella species. 3. Special condition for use statement Prescription Use Only BDXpert rules software will automatically suppress the final susceptibility interpretative criteria of Shigella species against minocycline. 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 the 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 biochemical substrates and antimicrobial agents and interprets the reactions to give a 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 {2} 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 6 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. Minocycline | Organism | Concentration μg/ml | Reference Results | Phoenix™ Results | | --- | --- | --- | --- | | | | | | | E. coli ATCC 25922 Expected Range 0.25-1.0 μg/mL | <=1 | 195 | 197 | | | 2 | | 7 | | | 4 | | | | | 8 | | | | | 16 | | | | | 32 | | | | | >32 | | | | | NC | 2 | | | | | | | Phoenix produced acceptable QC results as compared to the reference method results >95% of the time. The mode for the {4} Page 5 of 6 Phoenix is the same as for the mode for the Reference results. No QC trending was observed. 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. A total of 2081 isolates were tested, 109 were challenge and 1972 were Clinical isolates. The clinical isolates were comprised of 42.0% fresh, 34.5% recent isolates and 23.5% stock isolates with the following performance (see table below). There were 2173 isolates evaluated of which 2081 were appropriate for the panel. The performance data are displayed in the table below. Minocycline - GN Clinical and Challenge Data for Enterobacteriaceae and Acinetobacter spp | | EA Tot | EA N | EA % | Eval EA Tot | Eval EA N | Eval EA % | CA Tot | CA N | CA % | #R | min | maj | vmj | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Clinical | 1972 | 1854 | 94.0 | 956 | 911 | 95.3 | 1618 | 1496 | 92.5 | 332 | 108 | 13 | 1 | | Challenge | 109 | 106 | 97.2 | 70 | 69 | 98.6 | 93 | 78 | 83.9 | 12 | 14 | 1 | 0 | | Combined | 2081 | 1960 | 94.2 | 1026 | 980 | 95.5 | 1711 | 1574 | 92.0 | 344 | 122 | 14 | 1 | EA-Essential Agreement CA-Category Agreement R-resistant isolates maj-major discrepancies vmj-very major discrepancies min- minor discrepancies {5} Page 6 of 6 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. The performance for Minocycline tested against challenge isolates produced an EA of 97.2%, the Evaluable EA was 98.6% and a CA of 83.9%. There were 14 min generated by the Challenge set, all within EA. There were no vmj and 1 maj. The EA and the Eval. EA for the challenge set were both good. The overall performance was an EA 94.2% and a CA of 92%. Therefore the data are acceptable. The test device had a growth rate of >95%. 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: | ORGANISMS | | | --- | --- | | Enterobacteriaceae | <=4 (S), 8 (I), >=16 (R) | | Acinetobacter species | <=4 (S), 8 (I), >=16 (R) | N. Proposed Labeling The expected value range, interpretive criteria and QC for gram negative panels are included in the package insert as recommended by CLSI. BDXpert rules software will automatically suppress the final susceptibility interpretative criteria of Shigella species against minocycline. 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/K063486](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K063486) **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