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BD Diagnostic Systems, BD MAX System (Molecular, 2018)

BD Diagnostic Systems, BD MAX System (Molecular, 2018)

Automated molecular platforms, October 2018

Contact Information

BD Diagnostic Systems
Chris Busa
Sparks, MD

Name of instrument BD MAX System
Country where designed/Manufactured/Reagents manufactured U.S./U.S./U.S., Canada
Instrument FDA cleared or approved/Platform yes/preanalytical and analytical
First year sold in U.S./Sold internationally/Installed 2010/2010/2010
Dimensions in inches (H × W × D)/Footprint in square feet/Noise generated in dB 28.5 × 37 × 29.7/5/64 at 48 background
Supplied with UPS/BTU yes/—
Physical contamination control features unitized reagent strip, dedicated pipette tips, microfluidic PCR cartridge with microvalves, pipettor flight path avoids crossing strips or tubes
List price/Price for sample extraction and amplification detection modules
Purchase options/Minimum test volume requirements straight purchase, reagent rental, lease/specimen dependent (as low as 10–15 µL)
Co. performs installation, operation, and performance qualifications/Electrical requirements yes/100–240 VAC, ~50–60 Hz, 10 A
Labor and parts warranties/Advanced operator training 1 year (≤3 year contracts optional)/yes
Delivery time/Delivery charges/Installer/Time to install on site 90 day, or less from contract/—/BD/1.5 days
Training location/No. of techs that can receive initial training/Length of training/Retraining at company facility on site/flexible/1 day/yes
Test menu GBS, MRSA XT, C. difficile, StaphSR, enteric bacterial panel, extended bacterial panel, enteric parasite panel, CT-GC-TV, vaginal panel; open system general-purpose reagents for user-defined protocols: DNA and TNA extraction kits and generic DNA and TNA master mix with and without internal process control
No. of tests for which analyzer has FDA-cleared applications/CE mark
Tests available on instrument in U.S./Outside U.S. GBS, MRSA XT, C. difficile, StaphSR, enteric bacterial, extended bacterial panel, enteric parasite, CT-GC-TV, vaginal panel/—
Tests not available in U.S. but submitted to FDA/Available in other countries only
Research-use-only assays/Tests in development CRE/—
Open-channel capabilities/Start-up and preparation time yes/less than 1 minute per specimen
Model type of sample-handling system/Maximum sample load capacity fully automated, integrated extraction and amplification detection/24
Minimum specimen volume/Sample volume flexibility/Other sample volumes available specimen dependent (as low as 10–15 µL)/yes/volumes range up to 750 µL
Minimum dead volume/Pediatric sample volume/Primary tube sampling 50–200 µL/specimen dependent/no
Sample tube sizes/Sample barcode reading/Autodiscrimination in 1D or 2D uses standard 4 mL tube format/yes/—
Sample barcode languages/Sample types available in open mode Codabar codes 39, Interleaved 2 of 5, EAN, UCC code 128, 2D capability/—
Clot detection/Open extraction platform/Sample types (open extraction) no/yes/swab, swab in transport medium, urine, plasma, CSF, stool
Amplification reagents or methods supported real-time PCR for most probe types, melt analysis
No. of different assays onboard at once/Programmed or calibrated at once designed for multiple assays up to 24 samples/significant number
Tests per container set/Multiple reagent configurations supported unitized reagent strips, one test per strip, 24 strips per kit/yes
Reagent container placed directly on system/Onboard test auto inventory yes/yes
Determines reagent volume in container/Reagent barcode reading/Reagents barcoded yes/yes/yes
Monitors expiration date/Auto lot recognition or calibration yes/yes
Auto detection of adequate reagent or specimen/Reagents available yes/liquid and dry
Reagent reconstitution required/Chemical contamination control no/no (system has a closed-unit test format disposable)
Onboard test auto inventory/Capable of inventory monitoring by barcode yes/no
System is open to homebrew/General-purpose reagents allowed yes/yes
Same capabilities when third-party reagent used/Lot sequestering available yes (with user-supplied primers and probes in open-system format)/on terms
Closed-vial stability for amplification reagents/Extraction reagents 12 months/12 months
Storage temp. requirement for amplification reagents/Extraction reagents room temperature/room temperature
Shipment temp. requirement for amplification reagents/Extraction reagents room temperature/room temperature
Minimum/Maximum reagent shelf-life guarantee 3 months/12–24 months
Autocalibration or autocalibration alert/Multipoint calibration supported no/yes
Assay calibrations required by end user/Calibrants can be stored onboard —/no
Multiple calibrant lots stored for same assay/Required calibration frequency yes/determined and validated by user
Length of assay calibration/Typical calibration frequency determined and validated by user/determined and validated by user
Onboard real-time QC/Supports multiple QC lot numbers per assay no/no
Auto shutdown*/Instrument warm-up time/Onboard software reviews QC no/none/—
Total number of controls per batch for 24 tests/48 tests/72 tests/96 tests user validates and defines external run control protocol
Walkaway capacity/Tech hands-on time (both for batch of 96 samples) 1–12 samples in <1.5 hrs.; 24 samples in 2 hrs./~1 min. per sample
Uses disposable pipette tips/Maximum number of pipette tips stored yes/self-contained in unitized reagent strip
Time between start and initial result/Instrument automatic shutdown 1–12 samples in <1.5 hrs.; 24 samples in 2 hrs./automatic move to standby
Startup programmable/Remote system monitoring/Waste required for disposables no/no/biohazard waste
Windows technology/Mouse or touchscreen/Modular add-on capability no/mouse/no
Service contracts available/Mean time between failures/To repair failures 5 and 7 days per week/180 days/<24 hrs. from field service visit
Turnaround time for problem solving by phone/Email/Field service <1 hr. after hours/same day (next day after hours)/next business day
No. of U.S. field reps/Service engineer on-site response time/Hours and days available —/next business day/24–7
Guaranteed response time/Modem servicing avail./System diagnose own malfunctions —/no/yes
Order parts via modem/Onboard error codes/Maintenance training demo module no/yes/no
Average maintenance time for lab personnel/Onboard maintenance records weekly: 10 min./—
Preventive maintenance per year for sample extraction/Amplification detection 1/1 (for total system)
Downtime for preventive maintenance/Spare parts on site 4 hrs./no
Software and LIS interface:
• Patient demographics and insurance data available via rules-based architecture no
• Data retrieval or Internet connectivity
• Online real-time help, QC, stats, and management reports/Evaluates results validity no/yes
• Priority processing no
• Supports accession No. redundancy/Specimen carrier and level identification yes/—
• Unique barcode per container/Multistop routing (1 tube to many workstations) yes/no
• Specimen scheduling/Routes test to workstation/Automatic reflex, repeat, dilutions no/no/no
• Sample storage and retrieval software supports CLSI standards
• LIS(s) interfaced live with lab automation systems/How LIS(s) interfaced with LAS
• QC results transferred automatically to LIS/Data-management capability
• Interfaces operational in active user sites yes
• Rules-based control subsystem/Process control via control subsystem
• LIS operates simultaneously with assays running
• Uses LOINC to transmit orders and results/Unidirectional interface capability
• Results immediately transmitted to LIS/Interface available to auto specimen-handling system
• Stores QC lot files/Worklist edit capability/Viewable PCR graphs yes/yes/yes
• Can print, archive, transmit data yes
Distinguishing features (supplied by company) next-generation platform for molecular testing, automating cell lysis, nucleic acid extraction, PCR setup, amplification, and detection
*for calibration and controls
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.