Who is the manufacturer of MALDI BIOTYPER CA (MBT-CA) SYSTEM?

Bruker Daltonics, Inc. filed the 510(k) submission for MALDI BIOTYPER CA (MBT-CA) SYSTEM (K130831).

What is the FDA product code for MALDI BIOTYPER CA (MBT-CA) SYSTEM?

PEX. It is classified under 21 CFR 866.3361 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for MALDI BIOTYPER CA (MBT-CA) SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MALDI BIOTYPER CA (MBT-CA) SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MALDI BIOTYPER CA (MBT-CA) SYSTEM

K130831 · Bruker Daltonics, Inc. · PEX · Nov 21, 2013 · Microbiology

Device Facts

Record ID	K130831
Device Name	MALDI BIOTYPER CA (MBT-CA) SYSTEM
Applicant	Bruker Daltonics, Inc.
Product Code	PEX · Microbiology
Decision Date	Nov 21, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3361
Device Class	Class 2

Intended Use

The Bruker Daltonics, Inc. MALDI Biotyper CA System is a qualitative in vitro diagnostic mass spectrometer system for the identification of Gram-negative bacterial colonies cultured from human specimens using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) mass spectrometry technology. The MALDI Biotyper CA System is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Gram-negative bacterial infections.

Device Story

The MBT-CA System is a benchtop MALDI-TOF mass spectrometer used in clinical microbiology laboratories to identify Gram-negative bacterial colonies. The operator transfers an isolated colony from culture media (e.g., blood, chocolate, or MacConkey agar) onto a reusable steel target plate, adds matrix (α-Cyano-4-hydroxycinnamic acid), and allows it to crystallize. The system uses a laser to ionize microbial proteins (primarily ribosomal proteins). These ions are accelerated through a flight tube; the time-of-flight is measured to determine the mass-to-charge ratio. The resulting mass spectrum acts as a molecular fingerprint. The system software compares this spectrum against a reference library to generate a log(score) (0.00–3.00). A score ≥2.00 indicates high-confidence identification; 1.70–1.99 indicates low-confidence. If the initial direct transfer analysis yields a low score, an ethanol/formic acid extraction procedure is performed. Microbiologists review the output alongside Gram stain and morphology to confirm identification. This process provides faster, more accurate identification than traditional biochemical methods, aiding in timely clinical decision-making for bacterial infections.

Clinical Evidence

Performance validated via method comparison study of 2,263 fresh and stored isolates against 16s bi-directional sequencing and biochemical methods. High-confidence identification (log score ≥2.0) achieved 96.07% accuracy; combined high/low confidence identification achieved 98.19% accuracy. Precision/repeatability studies across 12 days, 3 operators, 3 instruments, and multiple reagent lots showed consistent performance. Specificity studies confirmed no false identifications for non-claimed organisms (anaerobes, mycobacteria, yeast). Stability studies confirmed sample/matrix integrity for up to 24 hours and 12 months respectively.

Technological Characteristics

MALDI-TOF mass spectrometer (microflex LT/SH); 337 nm nitrogen laser; polished steel 48-spot target plates; HCCA matrix; US IVD Bacterial Test Standard (BTS) for calibration; mass range 2,000–20,000 m/z. Software performs automated spectral acquisition and peak list comparison against a reference library. Connectivity via local client-server architecture. Sterilization: N/A (reusable steel plates cleaned per protocol).

Indications for Use

Indicated for the identification of Gram-negative bacterial colonies cultured from human specimens to aid in the diagnosis of Gram-negative bacterial infections. For prescription use only.

Regulatory Classification

Identification

A mass spectrometer system for clinical use for the identification of microorganisms is a qualitative in vitro diagnostic device intended for the identification of microorganisms cultured from human specimens. The device is comprised of an ionization source, a mass analyzer, and a spectral database. The device is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed documentation for device software, including, but not limited to, standalone software applications and hardware-based devices that incorporate software. (2) Premarket notification submissions must include database implementation methodology, construction parameters, and quality assurance protocols. (3) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling. (4) As part of the risk management activities performed under 21 CFR 820.10(c) design and development, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument. (5) Premarket notification submissions must include details on the appropriate end user device training program that will be offered while marketing the device.

Predicate Devices

Vitek® MS (K124067)

Related Devices

K163536 — MALDI Biotyper CA (MBT-CA) System, MBT smart CA System · Bruker Daltonik GmbH · Jul 26, 2017
K142677 — MALDI Biotyper CA System · Bruker Daltonics, Inc. · Mar 27, 2015
K251495 — MBT Compass HT CA Software; MBT FAST Shuttle US IVD · Bruker Daltonics GmbH & Co. KG · Aug 13, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ #### 510(k) SUMMARY | Date of Summary: | October 28, 2013 | |----------------------------|---------------------------------------------------------------------------------------------------| | Product Name | MBT-CA System | | Sponsor: | Bruker Daltonics, Inc 40 Manning Road, Billerica, MA 01821 | | Correspondent | MDC Associates, LLC Fran White, Regulatory Consultant 180 Cabot Street Beverly, MA 01915 | | Device Identification | | | Trade or Proprietary Name: | MALDI Biotyper CA System | | Common or Usual Name: | Mass spectrometer for clinical multiplex test systems | | Product Code: | PEX | | Regulation Section: | 21 CFR 862.3361 Instrumentation for clinical multiplex test sys | 21 CFR 862.3361 Instrumentation for clinical multiplex test systems Class II (special controls) Microbiology #### Substantial Equivalency Device Class: Panel: The Bruker Daltonics, Inc MBT-CA System is substantially equivalent to the Vitek® MS MALDI-TOF mass spectrometer system (K124067). Table 1 compares the characteristics of the MBT-CA System (New Device) and the Vitek® MS (predicate device). {1}------------------------------------------------ # Comparison of New Device with Predicate Device # TABLE 1: Substantial Equivalency Table | Similarities | | | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | NEW DEVICE Bruker Daltonics, Inc MBT-CA System (K130831) | PREDICATE DEVICE Vitek® MS (K124067) | | Product Codes | PEX | PEX | | Intended use | The Bruker Daltonics, Inc MALDI Biotyper CA System is a qualitative in vitro diagnostic mass spectrometer system for the identification of Gram-negative bacterial colonies cultured from human specimens using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) mass spectrometry technology. The MALDI Biotyper CA System is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Gram negative bacterial infections. | The Vitek® MS is a mass spectrometer system using matrix-assisted laser desorption/ionization-time to flight (MALDI-TOF) for the identification of microorganisms cultured from human specimen. The VITEK MS is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and yeast infections. | | Sample type | Isolated colony from any patient sample source. Acceptable media: • Columbia blood agar with 5% sheep blood • Trypticase soy agar with 5% sheep Blood • Chocolate agar • MacConkey Agar | Isolated colony from any patient sample source. Acceptable media: • Columbia blood agar with 5% sheep blood • Trypticase soy agar with 5% sheep Blood • Chocolate polyvitex agar • Campylosel agar • MacConkey Agar • Modified Sabouraud dextrose Agar • ChromID CPS | | Type of Test | Automated Mass Spectrometry System | Automated Mass Spectrometry System | | Matrix | α-Cyano-4-hydroxycinnamic acid | α-Cyano-4-hydroxycinnamic acid | | Method of Testing | Bacteria: Direct testing If after initial analysis the log(score) is reported at < 2.00, organisms are processed using the extraction procedure. | Bacteria: Direct testing | | Similarities | | | | Characteristic | NEW DEVICE Bruker Daltonics, Inc MBT-CA System (K130831) | PREDICATE DEVICE Vitek® MS (K124067) | | Result Reporting | Organism identification is reported with high confidence if the log(score) is $\ge$ 2.00. An organism identification is reported with low confidence if the log(score) is between 1.70 and <2.00. | A single identification is displayed, with a confidence value from 60.0 to 99.9, when one significant organism or organism group is retained. "Low-discrimination" identifications are displayed when more than one but not more than four significant organisms or organism groups are retained. When more than four organisms or organism groups are found, or when no match is found, the organism is considered unidentified. | | Matching Algoritm | Calculates matches by comparing a new spectrum against each single reference entry of a reference database. | Uses a proprietary process called "mass binning." In this process, the spectrum between 3,000 and 17,000 Daltons are divided into 1300 pre-defined intervals called "bins". Next, an algorithm based on supervised machine learning known as the "Advanced Spectrum Classifier", is used to determine how informative each bin was in differentiating that species from all other species in the database. | | Recorded mass range | 2,000 - 20,000 m/z | 2,000 - 20,000 m/z | {2}------------------------------------------------ {3}------------------------------------------------ | Differences | | | | |----------------|----------------------------------------------------------------|----------------------------------------------------------------|--| | Characteristic | NEW DEVICE Bruker Daltonics, Inc MBT-CA System (K130831) | PREDICATE DEVICE Vitek® MS (K124067) | | | Culture Age | Bacteria growth should be between 18h to 36h | Bacteria and yeast growth should be between 24 to 72 hours. | | | Calibration | Bruker US IVD Bacterial Test Standard (BTS) | E. coli ATCC 8739 | | | MALDI Target | US IVD 48 Spot Target | VITEK MS-DS Target Slides | | | Plate | 48 positions reusable steel targets | • 48 positions disposable plastic targets | | | MALDI-TOF MS | Bruker microflex | Shimadzu AXIMA® Assurance MS | | | instruments | (benchtop) | (floor standing) | | | Database | MALDI Biotyper for Clinical Applications (MBT-CA) | VITEK MS V2.0 Knowledge Base | | These differences do not affect substantial equivalence of the MBT-CA System and Vitek® MS system. Both systems are mass spectrometer systems using matrix-assisted laser desorption/ionization-time to flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens. The differences noted above do not impact the intended use and do not raise questions as to the safety and effectiveness of the test (new) device. ### Intended Use The Bruker Daltonics, Inc MALDI Biotyper CA System is a qualitative in vitro diagnostic mass spectrometer system for the identification of Gram-negative bacterial colonies cultured from human specimens using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) mass spectrometry technology. The MALDI Biotyper CA System is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Gram negative bacterial infections. ### Methodology Biochemical methods are currently the most commonly used methods for the identification of microorganisms. Organisms are tested against a range of reagents and organism identification is based on a microorganism's reaction to these reagents. The MBT-CA System uses a different methodology for organism identification based on unique protein patterns of the microorganisms obtained from mass spectrometry. The test organism's spectrum (a pattern of mass peaks) is compared with a reference spectra library (database). Using biostatistical analysis, a probability ranking of the organism identification is generated. The probability ranking is represented as a log(score) between 0.00 and 3.00. Organism identification is reported with high confidence if the log(score) is ≥ 2.00. An organism identification is reported with low confidence if the log(score) is between 1.70 and <2.00. {4}------------------------------------------------ Organisms to be identified with the MBT-CA System should be isolated for purity on appropriate isolation media. Direct Transfer (DT): An individual colony from an overnight subculture plate is transferred to a selected position on an US IVD 48 Spot Target plate (target). The target is air dried and US IVD HCCA portioned (matrix) is added. The standard solvent (50% acetonitrile / 47.5% HzO / 2.5% trifluoroacetic acid) in the matrix solution extracts proteins (mainly ribosomal proteins, which are present in high concentration) from the microorganisms. When dried matrix crystallizes, the inoculated target is ready to be analyzed on the MBT-CA System. If after initial analysis the log(score) is reported at < 2.00, organisms can be processed using the extraction procedure and analysis repeated. Extraction Procedure (Ext): If after initial analysis the log(score) is reported at < 2.00, organisms are processed using the extraction procedure and analysis repeated. For this purpose, isolated colonies from the overnight subculture plate are extracted using ethanol / formic acid procedure. Afterwards they are transferred to the target and treated as described above. ### MALDI-TOF Analysis: Samples are analyzed using MALDI (matrix-assisted laser desorption/ionization) TOF (time-of-flight) mass spectrometry. The matrix transfers protons onto the extracted proteins and absorbs UV light. A laser in the MALDI- TOF mass spectrometer irradiates the matrix sample composite, causing evaporation and release of positively charged intact proteins and peptides ("soft" ionization technique). These ions are electrostatically accelerated over a short distance and arrive in the flight tube at a mass-dependent speed. As different proteins/peptides have different masses, ions arrive at the detector at different times (time of flight). The system measures the time (in the nanosecond range) between pulsed acceleration and the corresponding detector signal, the speed is converted into an exact molecular mass. The mass-to-charge ratio of an ion is proportional to the square of its drift time. Highly abundant microbial proteins (mainly ribosomal proteins) result in a mass spectrum with characteristic mass and intensity distribution. It is species-specific for many bacteria and is interpreted as a molecular fingerprint to identify the test organism. Data acquisition is controlled with MBT-CA Software. The spectrum of the unknown organism is first transformed into a peak list. Using a biostatistical algorithm, this peak list is compared to the reference peak lists of organisms in the reference library (database) and a log(score) is generated. A higher log(score) indicates a higher degree of similarity to the organism in the reference library. Organism identification is reported with high confidence if the log(score) is ≥ 2.00. An organism identification is reported with low confidence if the log(score) is between 1.70 and <2.00. The log(score) ranges, defined in the MBT-CA System, are indicative of the probability of organism identification. Results should be reviewed by a trained microbiologist and final organism identification should be based on all relevant information available. This information includes but is not limited to: Gram staining, colony morphology, growth characteristics, sample matrix, etc. {5}------------------------------------------------ ### Performance Data #### Precision/Repeatability: Validation of the whole MALDI Biotyper CA System was performed on twelve (12) working days with two (2) runs/day following manufacturer's instructions for use. Ten (10) test organisms were tested in triplicate in each run. The study also tested multiple sources of system variability including three (3) test operators, three (3) microflex LT/SH instruments, three (3) target lots, three (3) BTS lots and three (3) Matrix lots. As triplicates of each test organism were prepared and tested in each run, a total of 72 MALDI Biotyper CA System identifications were carried out for each test organism. Overall results from the precision/repeatability study are presented below. | Test Organism | # samples measured | # samples passed (DT) | # samples passed (DT+Ext) | |------------------------------|--------------------|--------------------------|------------------------------| | Acinetobacter baumannii | 72 | 62 (86.1%) | 72 (100%) | | Pseudomonas aeruginosa | 72 | 70 (97.2%) | 72 (100%) | | Stenotrophomonas maltophilia | 72 | 70 (97.2%) | 72 (100%) | | Enterobacter cloacae | 72 | 70 (97.2%) | 72 (100%) | | Escherichia coli | 72 | 71 (98.6%) | 72 (100%) | | Hafnia alvei | 72 | 72 (100%) | 72 (100%) | | Proteus mirabilis | 72 | 72 (100%) | 72 (100%) | | Brevundimonas diminuta* | 72 | 72 (100%) | 72 (100%) | | Haemophilus influenzae | 72 | 72 (100%) | 72 (100%) | | Moraxella catarrhalis | 72 | 72 (100%) | 72 (100%) | #### Table 2: Overall Precision per Test Organism * Brevundimonas diminuta was tested but is not included in the claim. #### Table 3: Overall Precision per Test Organism Average log(score) | Test Organism | # samples measured | Average log(score) [DT+Ext] | |------------------------------|--------------------|-----------------------------| | Acinetobacter baumannii | 72 | 2.172 ± 0.113 | | Pseudomonas aeruginosa | 72 | 2.368 ± 0.121 | | Stenotrophomonas maltophilia | 72 | 2.364 ± 0.078 | | Enterobacter cloacae | 72 | 2.138 ± 0.064 | | Escherichia coli | 72 | 2.385 ± 0.097 | | Hafnia alvei | 72 | 2.452 ± 0.095 | | Proteus mirabilis | 72 | 2.587 ± 0.079 | | Brevundimonas diminuta* | 72 | 2.489 ± 0.045 | | Haemophilus influenzae | 72 | 2.344 ± 0.118 | | Moraxella catarrhalis | 72 | 2.523 ± 0.080 | * Brevundimonas dimiuta was tested but is not included in the claim. Based upon the data presented, the study confirms repeatability and precision of the MALDI Biotyper CA System independent from: - System Operators - microflex LT/SH instruments - Target Production Lots - Matrix Lots ● - BTS Lots {6}------------------------------------------------ ### Limit of Detection/Dynamic Range: The Limit of Detection study was designed to establish the estimated dynamic range of sample size for both the Direct Transfer (DT) and Extraction method (Ext) procedure. Seven (7) frequently occurring clinically relevant test organisms were chosen for this study. Cell density and cell concentration were estimated by measuring the optical density of the suspension at a wavelength of 600nm. Approximately 3x10° cells/mL were reported to correspond to an optical density of OD600 = 1 according to the commonly used McFarland Standard. All suspensions were tested in duplicate. Each cell stock was diluted to a minimum five (5) concentrations and tested in duplicate. A cell concentration was considered within the dynamic range if the MBT-CA correctly identified the organism for both replicates with a log(score) of ≥2.00. Study results concluded that the estimated dynamic range for the direct and extracted method is as follows: | Technique | Lower limit [cells/µL] | Upper limit [cells/µL] | |-----------------|---------------------------|---------------------------| | Direct Transfer | 6.3x103-1.4x104 | 1.4x106- $\geq$ 6.5x107 | | Extraction | 9.0x103-1.3x105 | 1.1x107- $\geq$ 6.9x107 | ### Specificity: The goal of the specificity study was to validate the performance of the proposed MALDI Biotyper CA System reference library by ensuring that organisms not included in the reference library would not yield an incorrect identification and would be reported as "No Identification." Additionally, the study was designed to further demonstrate that the MALDI Biotyper CA System identification is not impacted when closely related species not included in the reference library are run on the system. The study was conducted in two phases. In phase one, organisms currently not included in the initial system reference library were tested via Direct Transfer and extraction method to ensure that the organisms would not be falsely identified by the MALDI Biotpyer CA system. Organisms tested fell into the following five groupings: - Anaerobe bacteria । - -Mycobacteria - Gram-Negative bacteria (not currently claimed within the library) । - -Gram-Positive bacteria - -Yeast species Results from this phase are presented below: | Table 4: Phase 1: Summary Results | | | |-----------------------------------|--|--| |-----------------------------------|--|--| | Organism | Strain | # of "No Identification" | | # of false identification | |-------------------------------------------|------------|--------------------------|-------|------------------------------| | | | DT | Ext | | | Bacteroides fragilis | DSM 2151 | 2 / 2 | 2 / 2 | 0 | | Bacteroides fragilis | DSM 9669 | 2 / 2 | 2 / 2 | 0 | | Prevotella copri | DSM 18205T | 2 / 2 | 2 / 2 | 0 | | Prevotella buccae | DSM 19025T | 2 / 2 | 2 / 2 | 0 | | Mycobacterium fortuitum ssp. fortuitum | DSM 43477 | 2 / 2 | 2 / 2 | 0 | {7}------------------------------------------------ | Organism | Strain | # of “No Identification” DT | # of “No Identification” Ext | # of false identification | |-------------------------------------------|------------|--------------------------------|---------------------------------|------------------------------| | Mycobacterium fortuitum ssp. fortuitum | DSM 46621T | 2 / 2 | 2 / 2 | 0 | | Neisseria gonorrhoeae | DSM 9188T | 2 / 2 | 2 / 2 | 0 | | Neisseria gonorrhoeae | DSM 15130 | 2 / 2 | 2 / 2 | 0 | | Erwinia tasmaniensis | DSM 17949 | 2 / 2 | 2 / 2 | 0 | | Erwinia tasmaniensis | DSM 17950 | 2 / 2 | 2 / 2 | 0 | | Vagococcus fluvialis | DSM 5731T | 2 / 2 | 2 / 2 | 0 | | Vagococcus fluvialis | DSM 21402 | 2 / 2 | 2 / 2 | 0 | | Facklamia hominis | CCUG 59179 | 2 / 2 | 2 / 2 | 0 | | Facklamia hominis | CCUG 49614 | 2 / 2 | 2 / 2 | 0 | | Guehomyces pullulans | CBS 2532T | 2 / 2 | 2 / 2 | 0 | | Guehomyces pullulans | CBS 2542 | 2 / 2 | 2 / 2 | 0 | | Cyberlindnera mississippiensis | CBS 7023T | 2 / 2 | 2 / 2 | 0 | | Cyberlindnera mississippiensis | CBS 7027 | 2 / 2 | 2 / 2 | 0 | In phase two of the study testing, Burkholderia cepacia/multivorans/gladioli were investigated via Direct transfer and extraction method to ensure that closely related organisms can be differentiated when tested on the MALDI Biotyper CA System. Results from this phase of testing are reported below: | Organism | Strain | # of Correct Identifications | | # of false identification | |--------------------------|----------------------|---------------------------------|-------|------------------------------| | | | DT | Ext | | | Burkholderia cepacia | DSM 9241 | 2 / 2 | 2 / 2 | 0 | | Burkholderia cepacia | DSM 50181 | 2 / 2 | 2 / 2 | 0 | | Burkholderia multivorans | 1A11237234 4v MVD | 2 / 2 | 2 / 2 | 0 | | Burkholderia multivorans | H480 MCRF | 2 / 2 | 2 / 2 | 0 | | Burkholderia gladioli | DSM 8361 | 2 / 2 | 2 / 2 | 0 | | Burkholderia gladioli | LMG 6956 | 2 / 2 | 2 / 2 | 0 | ### Table 5: Phase 2: Summary Results Phase 1 data demonstrates with high confidence that Anaerobes, Mycobacteria, Gram-negative, Grampositive and Yeast organisms not included in the MALDI Biotyper CA database are not identified confirming the specificity of the MALDI Biotyper CA reference library when following product instructions for use for both DT and extraction method. Phase 2 data confirms that closely related species can be unambiguously identified by the MALDI Biotyper CA System. ### Mixed Culture: Although MALDI Biotyper CA System users will be instructed to select only a single isolated colony for identification on the MALDI Biotyper CA System this study was conducted to assess the effect of testing a mixed culture on MALDI Biotyper CA identification. Pseudomonas aeruginosa, a frequently occurring Gram negative bacterium was chosen as the target organism for this study. Four (4) non-target organisms consisting of gram-negative and gram-positive bacteria where introduced with the target organism at varying concentrations to determine the affect a mixed culture would have on {8}------------------------------------------------ #### MBT-CA identification. | Condition | Target Organism Amount | Non-Target Organism Amount | # of MALDI Biotyper CA False Identifications | |-----------|---------------------------|-------------------------------|-------------------------------------------------| | A | 100% | 0% | 0/32 | | B | 75% | 25% | 0/32 | | C | 50% | 50% | 0/32 | | D | 25% | 75% | 0/32 | #### Table 6: Summary of Mixed Culture Study Although system users will be instructed to test a single isolated colony on the MALDI Biotyper CA System, it is important to note that when a mixed culture is analyzed on the system, no false results are obtained and the impact on final test results is greatly reduced when compared to the issues observed with alternative biochemical methods. ### Media and Colony Stability In accordance with product instructions for use, customers are advised that primary or secondary isolation plates of recommended media [Trypticase Soy Agar with 5% sheep blood (TSA), Columbia Blood Agar with 5% sheep blood (CBA), MacConkey Agar (MAC), and Chocolate Agar (Choc)] may be held for up to 12 hours at room temperature prior to testing on the MALDI Biotyper CA System. This study was conducted to confirm the acceptability of the recommended agar/media and stability of the colony for up to 12 hours prior to analysis. Testing was conducted using seven (7) gram-negative organisms at two different incubation time points (18h, 24h). After initial incubation, isolates were further tested at two (2) temperatures (18°C, 25°C) for 12 hours post-incubation. | Media | ≥2.0 Identification (DT) | False Identification (DT) | ≥2.0 Identification (Ext) | False Identification (Ext) | |-------|-----------------------------|------------------------------|------------------------------|-------------------------------| | TSA | 288/288 | 0/288 | 288/288 | 0/288 | | CBA | 284/288 | 0/288 | 288/288 | 0/288 | | MAC | 263/288 | 0/288 | 288/288 | 0/288 | | CHOC | 288/288 | 0/288 | 288/288 | 0/288 | #### Table 7: Summary of Media and Colony Stability Study The study results confirm that the following culture media can be used on the MALDI Biotyper CA System: - · Trypticase Soy Agar with 5% sheep blood (TSA) - Columbia Blood Agar with 5% sheep blood (CBA) - · MacConkey Agar (MAC) - · Chocolate Agar (CHOC) Study results conclude that sample colony is stable for up to 12 hours post-incubation. ### Influence of Agar Media This study was completed in order to demonstrate that impurities such as salts, peptides or carbohydrates introduced from culture media do not interfere with MALDI Biotyper CA identification. In {9}------------------------------------------------ addition, the study set-out to prove that isolation media alone would not generate mass spectra leading to false identification on the MBT-CA system. TSA, CBA, MAC and CHOC agars were tested by the following methods: - Each agar media was inoculated using the Direct Transfer (DT) and Extraction (Ext) method alone (6) six times each. - -Three (3) frequently occurring Enterobacteriacea and non-fermenting Gram Negative Bacteria were transferred to the target plate in duplicate via DT and Ext method to serve as a control. - -Each target organism was then inoculated in duplicate via DT and Ext method such that a sample agar media was included with the isolate. A summary of results obtained is provided below: | | Agar Alone | | Target Organism Alone | | Target Organism + Agar | | |-------|--------------|---------|-----------------------|------------|------------------------|------------| | Media | # replicates | % No ID | # replicates | % False ID | # replicates | % False ID | | TSA | 12/12 | 100 | 12/12 | 0 | 10/12 | 0 | | CBA | 12/12 | 100 | 12/12 | 0 | 12/12 | 0 | | MAC | 12/12 | 100 | 12/12 | 0 | 12/12 | 0 | | CHOC | 12/12 | 100 | 12/12 | 0 | 12/12 | 0 | #### Table 8: Summary of Influence of Agar Media Study The study confirms that the media recommended for use on the MALDI Biotyper CA System do not interfere with MBT-CA performance or organism identification. # Organism Stability prior to MALDI Biotyper CA System Analysis This study was conducted to assess isolate stability on the target plate prior to matrix overlay via Direct Transfer (DT) and Extraction (Ext) method. In addition, the study set out to confirm the stability of extracted material prior to target plate inoculation. To test for isolate stability on the target plate prior to matrix overlay via DT, three (3) common gram negative bacteria were inoculated eight times and overlaid with matrix at five (5) different time points. After matrix overlay, isolates were tested in accordance with product instructions. For the Ext method, colonies were prepared following the extraction technique per product instructions for use. Extracts were overlaid with matrix at five (5) different time points and tested per product instructions. For the third phase of testing, the three (3) gram negative isolates were extracted twice. The extracts were stored at controlled room temperature for up to 24 hours and tested at five (5) time points in replicates of eight. A summary of results obtained is provided below: | Test Phase | Testing Condition | Measurands | Correct Identification | False Identification | |----------------------|-------------------|------------|------------------------|----------------------| | Direct Transfer (DT) | 0 min | 24 | 24/24 | 0/24 | | Direct Transfer (DT) | 15 min | 24 | 24/24 | 0/24 | | Direct Transfer (DT) | 30 min | 24 | 24/24 | 0/24 | | Direct Transfer (DT) | 60 min | 24 | 24/24 | 0/24 | | Direct Transfer (DT) | 120 min | 24 | 24/24 | 0/24 | ### Table 9: Summary of Organism Stability Prior to MBT-CA Analysis Study {10}------------------------------------------------ | Test Phase | Testing Condition | Measurands | Correct Identification | False Identification | |-------------------------|-------------------|------------|------------------------|----------------------| | Extraction Method (Ext) | 0 min | 6 | 6/6 | 0/6 | | | 10 min | 6 | 6/6 | 0/6 | | | 20 min | 6 | 6/6 | 0/6 | | | 30 min | 6 | 6/6 | 0/6 | | | 60 min | 6 | 6/6 | 0/6 | | Extract #1 | 0 hour | 24 | 24/24 | 0/24 | | | 1 hour | 24 | 24/24 | 0/24 | | | 4 hours | 24 | 24/24 | 0/24 | | | 8 hours | 24 | 24/24 | 0/24 | | | 24 hours | 24 | 24/24 | 0/24 | | Extract #2 | 0 hour | 24 | 24/24 | 0/24 | | | 1 hour | 24 | 24/24 | 0/24 | | | 4 hours | 24 | 24/24 | 0/24 | | | 8 hours | 24 | 24/24 | 0/24 | | | 24 hours | 24 | 24/24 | 0/24 | Study results confirm that samples are stable on the target plate when tested via DT or Ext method for up to sixty (60) minutes prior to analysis. In addition, extracts are stable for up to 24 hours when stored at room temperature. ### Sample Stability overlaid with Matrix This study was conducted to prove the stability of test organisms on the spotted target plate following matrix addition at various temperature and relative humidity conditions. In addition, the study served to prove that matrix alone will not influence MBT-CA identification. Three (3) gram negative target organisms were cultured on Columbia Blood Agar (CBA) and aging experiments were done at two (2) different temperature and relative humidity testing condition, two (2) target plates were inoculated and each contained four target spots of directly transferred test organism, four spots of extracted test organism and eight spots of matrix solution alone. All spots containing test organism were then overlaid with matrix in accordance with product instructions for use and tested immediately and then stored at one of the testing conditions and retested at 4±1 hour, 8±1 hour and 24±1 hour. The results of the testing are summarized below: | Test Condition | Test Age | Test Organism Correct Identification | Matrix “No Peaks Found” | |--------------------------|----------|--------------------------------------|-------------------------| | DT 20 ± 1°C, 40 ± 5% | 0 hour | 24/24 | 8/8 | | | 4 hours | 24/24 | 8/8 | | | 8 hours | 24/24 | 8/8 | | | 24 hours | 24/24 | 8/8 | | Ext 20 ± 1°C, 40 ± 5% | 0 hour | 24/24 | 8/8 | | | 4 hours | 24/24 | 8/8 | | | 8 hours | 24/24 | 8/8 | | | 24 hours | 24/24 | 8/8 | #### Table 10: Summary of Sample Stability overlaid with Matrix {11}------------------------------------------------ | Test Condition | Test Age | Test Organism Correct Identification | Matrix "No Peaks Found" | |--------------------------|----------|--------------------------------------|-------------------------| | DT 20 ± 1°C, 70 ± 5% | 0 hour | 24/24 | 8/8 | | DT 20 ± 1°C, 70 ± 5% | 4 hours | 24/24 | 8/8 | | DT 20 ± 1°C, 70 ± 5% | 8 hours | 23/24 | 8/8 | | DT 20 ± 1°C, 70 ± 5% | 24 hours | 24/24 | 8/8 | | Ext 20 ± 1°C, 70 ± 5% | 0 hour | 24/24 | 8/8 | | Ext 20 ± 1°C, 70 ± 5% | 4 hours | 24/24 | 8/8 | | Ext 20 ± 1°C, 70 ± 5% | 8 hours | 24/24 | 8/8 | | Ext 20 ± 1°C, 70 ± 5% | 24 hours | 24/24 | 8/8 | | DT 25 ± 1°C, 30 ± 5% | 0 hour | 24/24 | 8/8 | | DT 25 ± 1°C, 30 ± 5% | 4 hours | 24/24 | 8/8 | | DT 25 ± 1°C, 30 ± 5% | 8 hours | 24/24 | 8/8 | | DT 25 ± 1°C, 30 ± 5% | 24 hours | 24/24 | 8/8 | | Ext 25 ± 1°C, 30 ± 5% | 0 hour | 24/24 | 8/8 | | Ext 25 ± 1°C, 30 ± 5% | 4 hours | 24/24 | 8/8 | | Ext 25 ± 1°C, 30 ± 5% | 8 hours | 24/24 | 8/8 | | Ext 25 ± 1°C, 30 ± 5% | 24 hours | 24/24 | 8/8 | | DT 25 ± 1°C, 70 ± 5% | 0 hour | 24/24 | 8/8 | | DT 25 ± 1°C, 70 ± 5% | 4 hours | 24/24 | 8/8 | | DT 25 ± 1°C, 70 ± 5% | 8 hours | 18/24 | 8/8 | | DT 25 ± 1°C, 70 ± 5% | 24 hours | 24/24 | 8/8 | | Ext 25 ± 1°C, 70 ± 5% | 0 hour | 24/24 | 8/8 | | Ext 25 ± 1°C, 70 ± 5% | 4 hours | 24/24 | 8/8 | | Ext 25 ± 1°C, 70 ± 5% | 8 hours | 23/24 | 8/8 | | Ext 25 ± 1°C, 70 ± 5% | 24 hours | 24/24 | 8/8 | All study results confirmed that inoculated test organisms once overlaid with matrix are stable for up to 24 hours at room temperature. In addition, matrix alone does not interfere or influence MBT-CA identification. # Bacterial Test Standard (BTS) Stability The Bruker Bacterial Test Standard is an in vitro diagnostic product for mass spectrum calibration and optimization as well as a performance control for the identification of microorganisms with the MBT-CA System. The testing summarized below was done to determine the stability of unreconstituted and reconstituted BTS material. In one study, accelerated and shipping stability of BTS was assessed using three (3) lots of BTS material. Shipping and accelerated stability conditions were simulated by storing eight (8) vials of each BTS lot in a climate controlled chamber at 37±2ºC for one (1), two (2) and three (3) weeks. At each time interval, two (2) vials of each BTS lot were removed, allowed to acclimate to room temperature, reconstituted and spotted on sixteen (16) target plate positions (each vial) and three (3) cross-joint positions. Target plates were then analyzed in accordance with product instructions for use. {12}------------------------------------------------ In the second study, real-time stability of BTS was assessed using three (3) lots of BTS material. The three lot of material were maintained at recommended storage conditions per product instructions (< 18°C) and tested at 3, 6, 9, 12 and 18 months following the same process as described above. In the third and final study, in-use (reconstituted) stability of BTS was assessed using four vials of a single lot of BTS reagent. All four vials were reconstituted in accordance with product instructions for use. Two (2) vials each were then pooled. Testing was carried out in replicates of eight (8) immediately following reconstitution then frozen and retested at 1, 2, 3, 4, 5 and 6 months. The summary of the results of the three (3) studies are provided below: | Study | Test Age | av. log(score) Lot# 1, Vial 1 | av. log(score) Lot# 1, Vial 2 | av. log(score) Lot# 2, Vial 1 | av. log(score) Lot# 2, Vial 2 | av. log(score) Lot# 3, Vial 1 | av. log(score) Lot# 3, Vial 2 | |-----------------------------------|-----------|----------------------------------|----------------------------------|----------------------------------|----------------------------------|----------------------------------|----------------------------------| | Accelerated/Shipping Stability | No Aging | 2.334 ± 0.027 | 2.353 ± 0.023 | 2.344 ± 0.024 | 2.351 ± 0.019 | 2.370 ± 0.031 | 2.345 ± 0.023 | | | 1 week | 2.385 ± 0.030 | 2.362 ± 0.042 | 2.337 ± 0.034 | 2.364 ± 0.039 | 2.372 ± 0.034 | 2.353 ± 0.023 | | | 2 weeks | 2.384 ± 0.021 | 2.365 ± 0.043 | 2.344 ± 0.054 | 2.381 ± 0.034 | 2.372 ± 0.021 | 2.349 ± 0.026 | | | 3 weeks | 2.391 ± 0.022 | 2.372 ± 0.027 | 2.369 ± 0.031 | 2.347 ± 0.037 | 2.332 ± 0.031 | 2.349 ± 0.033 | | Real-Time Stability | No Aging | 2.293 ± 0.030 | 2.276 ± 0.038 | 2.333 ± 0.057 | 2.320 ± 0.031 | 2.274 ± 0.041 | 2.250 ± 0.031 | | | 3 months | 2.391 ± 0.049 | 2.387 ± 0.042 | 2.358 ± 0.050 | 2.380 ± 0.036 | 2.296 ± 0.027 | 2.303 ± 0.019 | | | 6 months | 2.318 ± 0.035 | 2.340 ± 0.036 | 2.349 ± 0.035 | 2.338 ± 0.024 | 2.298 ± 0.029 | 2.296 ± 0.027 | | | 9 months | 2.361 ± 0.037 | 2.346 ± 0.027 | 2.356 ± 0.029 | 2.348 ± 0.028 | 2.348 ± 0.028 | 2.320 ± 0.023 | | | 12 months | 2.310 ± 0.024 | 2.327 ± 0.020 | 2.292 ± 0.033 | 2.292 ± 0.022 | 2.262 ± 0.028 | 2.284 ± 0.026 | | | 18 months | 2.414 ± 0.026 | 2.410 ± 0.043 | 2.338 ± 0.027 | 2.346 ± 0.014 | 2.340 ± 0.034 | 2.344 ± 0.026 | #### Table 11: Summary of BTS Stability | Study | Test Age | av. log(score) Lot# 1, Vial 1 | av. log(score) Lot# 1, Vial 2 | |---------------------|----------|----------------------------------|----------------------------------| | In-Use Stability | No Aging | 2.413 ± 0.038 | 2.392 ± 0.022 | | | 1 month | 2.396 ± 0.030 | 2.353 ± 0.054 | | | 2 months | 2.331 ± 0.020 | 2.360 ± 0.020 | | | 3 months | 2.365 ± 0.022 | 2.371 ± 0.034 | | | 4 months | 2.359 ± 0.017 | 2.362 ± 0.025 | | | 5 months | 2.332 ± 0.024 | 2.292 ± 0.044 | | | 6 months | 2.293 ± 0.023 | 2.240 ± 0.044 | The shipping/accelerated stability study confirmed that BTS is stable for three (3) weeks at temperatures up to 37±2°C. Two of these weeks account for the shipping and one for the long-term storage. Realtime stability testing confirms that BTS is stable for up to 18 months when stored in accordance with product claims. (Bruker only claims stability for 12 months, though.) Lastly, in-use stability confirms that reconstituted BTS is stable for five (5) months when stored in accordance with product claims. # HCCA portioned (Matrix) Stability HCCA portioned (Matrix) is used when processing test organisms for identification on the MBT-CA system. Matrix must be reconstituted prior to use. These studies were conducted to determine the stability of unreconstituted matrix as well as in-use (reconstituted) matrix. {13}------------------------------------------------ In one study, accelerated/shipping stability was assessed using a single lot of matrix. Shipping conditions were simulated by storing the matrix at 37±2ºC for two (2) weeks while accelerated stability studies conducted subsequently at the same temperature for 14 weeks. All testing was done using a common gram negative organism. At each time interval, matrix was removed, allowed to acclimate to room temperature, reconstituted and testing was done via direct transfer (DT) and extraction (Ext) method using two (2) targets in replicates of eight (8) in accordance with product instructions for use. A second study assessed the real time stability of HCCA matrix using three (3) lots of material. All test lots were stored at the recommended storage condition per product instructions 2-8℃. All three lots were tested on two (2) target plates in replicates of eight (8) and tested at 3, 6, 9, 12 and 18 months in keeping with the process described for accelerated/shipping stability. A third study assessed the recommended stability of reconstituted matrix for one (1) week at controlled room temperature (20-25℃). Three (3) lots of matrix material were reconstituted in accordance with product instructions for use and stored in a climate controlled chamber at 20±1ºC for seven (7) days. Testing was conducted at day one (1), three (3) and seven (7) using three (3) common gram negative bacteria on two (2) target plates, in replicates of eight. In addition, matrix alone was inoculated onto eight (8) positions at each time point. A fourth study was conducted to assess the stability of reconstituted matrix at stressed temperatures for up to twelve (12) hours. A single lot of matrix material was reconstituted in accordance with product instructions for use and stored in a climate controlled chamber at 15±1ºC and 30±1ºC for twelve (12) hours. Testing was conducted at 6±1 hours and 12±1 hours using three (3) common gram negative bacteria on two (2) target plates, in replicates of eight. In addition, matrix alone was inoculated onto eight (8) positions at each time point. The results of the four (4) studies are summarized below: | Study | Test Condition | Test Age | # MBT-CA ID ≥2.0, (Target 1) | # "no ID", (Target 1) | # "false ID", (Target 1) | # MBT-CA ID ≥2.0, (Target 2) | # "no ID", (Target 2) | # "false ID", (Target 2) | |-------------------------------------------------------------|-------------------------------|-----------|--------------------------------------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------------|--------------------------|-----------------------------| | Accelerated/ Shipping Stability | Matrix Lot #1 | No Aging | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 1 week | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 2 weeks | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 4 weeks | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 7 weeks | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 16 weeks | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | Real-Time Stability | Matrix Lot #1 | No Aging | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 3 months | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 6 months | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 9 months | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 12 months | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 18 months | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | Matrix Lot #2 | No Aging | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 3 months | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 6 months | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 9 months | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 12 months | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | Study | Test Condition | Test Age | # MBT-CA ID ≥2.0, (Target 1) | # "no ID", (Target 1) | # "false ID" (Target 1) | # MBT-CA ID ≥2.0, (Target 2) | # "no ID", (Target 2) | # "false ID", (Target 2) | | | Matrix Lot #3 | 18 months | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | No Aging | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 3 months | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 6 months | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 9 months | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 12 months | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | | | 18 months | 16/16 | 0/16 | 0/16 | 16/16 | 0/16 | 0/16 | | In-Use Stability at Controlled Room Temperature | Matrix Lot #1; 20±1°C | No Aging | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | | 1 day | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | | 3 days | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | | 7 days | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | Matrix Lot #1; 25±1°C | No Aging | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | | 1 day | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | | 3 days | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | | 7 days | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | Matrix Lot #2; 20±1°C | No Aging | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | | 1 day | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | | 3 days | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | | 7 days | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | Matrix Lot #3; 20±1°C | No Aging | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | | 1 day | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | | 3 days | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | | 7 days | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | In-Use Stability at Controlled Room Temperature | Matrix Lot #1; Matrix Only | No Aging | # "no peaks found ID", (Target 1); T=20°C 8/8 | | | # "no peaks found ID", (Target 2); T=20°C 8/8 | | | | | | 1 day | 8/8 | | | 8/8 | | | | | | 3 days | 8/8 | | | 8/8 | | | | | | 7 days | 8/8 | | | 8/8 | | | | | Matrix Lot #2; Matrix Only | No Aging | # "no peaks found ID", (Target 1); T=25°C 8/8 | | | # "no peaks found ID", (Target 2); T=25°C, 8/8 | | | | | | 1 day | 8/8 | | | 8/8 | | | | | | 3 days | 8/8 | | | 8/8 | | | | | | 7 days | 8/8 | | | 8/8 | | | | | Matrix Lot #3; Matrix Only | No Aging | 8/8 | | | 8/8 | | | | | | 1 day | 8/8 | | | 8/8 | | | | | | 3 days | 8/8 | | | 8/8 | | | | | | 7 days | 8/8 | | | 8/8 | | | | In-Use Stability at Stressed Temperatures | Matrix Lot #1; 15±1°C | No Aging | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | | 6 hours | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | | 12 hours | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | Matrix Lot #1; 30±1°C | No Aging | 24/24 | 0/24 | 0/24 | 24/24 | 0/24 | 0/24 | | | | 6 hours | 24/24 | 0/24 | 0/24…

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