Colibri System

K193138 · Copan Wasp Srl · QQV · Dec 27, 2021 · Microbiology

Device Facts

• Record ID: K193138
• Device Name: Colibri System
• Applicant: Copan Wasp Srl
• Product Code: QQV · Microbiology
• Decision Date: Dec 27, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3378
• Device Class: Class 2

Intended Use

The Colibrí System is an in vitro diagnostic device comprised of the Colibrí Vision System and Colibrí Preparation Station for use with the bioMérieux VITEK MS or Bruker MALDI Biotyper CA mass spectrometry systems for qualitative identification of isolated colonies of Gram-negative and Gram-positive bacterial species grown on solid culture media. The Colibrí System is a semiautomated pre-analytical processor that picks isolated colonies designated by the operator and uses a pipetting system to prepare MALDI-TOF MS (Matrix-Assisted Laser Desorption/Ionization-Time Of Flight Mass Spectrometry) target slides. The Colibrí software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOF MS analyzer. The Colibrí System is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory findings, including Gram staining, to aid in the diagnosis of bacterial infections. The Colibrí System has not been validated for use in identification of yeast species.

Device Story

Semi-automated pre-analytical processor for MALDI-TOF MS target preparation. Input: culture plates with isolated bacterial colonies. Process: operator uses Colibrí Vision System to acquire digital images and designate colonies; Colibrí Preparation Station automatically picks designated colonies, spots them onto MALDI targets, and overlays with matrix. Output: prepared MALDI target slides; electronic communication of sample identity and position to downstream mass spectrometer (bioMérieux VITEK MS or Bruker MALDI Biotyper CA). Used in clinical laboratories by trained professionals. Benefits: automates manual colony picking and spotting, reducing variability and labor; improves workflow efficiency. Healthcare providers use resulting organism identification to aid in diagnosis of bacterial infections.

Clinical Evidence

Bench testing only. Studies included colony picking accuracy (100% correct picking), positional effect, inclusivity (123-124 strains), specificity (off-panel strains), reproducibility (1800 spots), cross-contamination, and colony/spot stability. Overall agreement for VITEK MS was 97.2% (inclusivity) and 99.9% (reproducibility). For Bruker MALDI Biotyper CA, performance varied by species/target; Gram-positive identification showed lower confidence, with labeling recommending manual eDT/Ext procedures for low-confidence results. No false positives or wrong identifications reported in key studies.

Technological Characteristics

System comprises Colibrí Vision System (digital imaging) and Colibrí Preparation Station (automated pipetting). Uses direct transfer method for MALDI-TOF MS target preparation. Compatible with VITEK MS-DS, MBT Biotarget 96, and 48-spot reusable targets. Connectivity: electronic data transmission to mass spectrometer. Software: proprietary Colibrí Vision and Preparation software. Sterilization: not applicable (instrument).

Indications for Use

Indicated for qualitative identification of isolated Gram-negative and Gram-positive bacterial colonies grown on solid culture media. Intended for use by trained healthcare professionals in clinical labs to aid in bacterial infection diagnosis. Not validated for yeast, mold, Nocardia, or Mycobacteria.

Regulatory Classification

Identification

A clinical mass spectrometry microorganism identification and differentiation system is a qualitative in vitro diagnostic device intended for the identification and differentiation of microorganisms from processed human specimens. The system acquires, processes, and analyzes spectra to generate data specific to a microorganism(s). The device is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infection.

Special Controls

Clinical mass spectrometry microorganism identification and differentiation system must comply with the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) The intended use statement must include a detailed description of what the device detects, the type of results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended, when applicable. (2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt with an indication for in vitro diagnostic use. (3) The labeling required under § 809.10(b) of this chapter must include: (i) A detailed device description, including all device components, control elements incorporated into the test procedure, instrument requirements, ancillary reagents required but not provided, and a detailed explanation of the methodology and all pre-analytical methods for processing of specimens, and algorithm used to generate a final result. This must include a description of validated inactivation procedure(s) that are confirmed through a viability testing protocol, as applicable. (ii) Performance characteristics for all claimed sample types from clinical studies with clinical specimens that include prospective samples and/or, if appropriate, characterized samples. (iii) Performance characteristics of the device for all claimed sample types based on analytical studies, including limit of detection, inclusivity, reproducibility, interference, cross-reactivity, interfering substances, carryover/cross-contamination, sample stability, and additional studies regarding processed specimen type and intended use claims, as applicable. (iv) A detailed explanation of the interpretation of test results for clinical specimens and acceptance criteria for any quality control testing. (4) The device's labeling must include a prominent hyperlink to the manufacturer's website where the manufacturer must make available their most recent version of the device's labeling required under § 809.10(b) of this chapter, which must reflect any changes in the performance characteristics of the device. FDA must have unrestricted access to this website, or manufacturers must provide this information to FDA through an alternative method that is considered and determined by FDA to be acceptable and appropriate. (5) Design verification and validation must include: (i) Any clinical studies must be performed with samples representative of the intended use population and compare the device performance to results obtained from an FDA-accepted reference method and/or FDA-accepted comparator method, as appropriate. Documentation from the clinical studies must include the clinical study protocol (including predefined statistical analysis plan, if applicable), clinical study report, and results of all statistical analyses. (ii) Performance characteristics for analytical and clinical studies for specific identification processes for the following, as appropriate: (A) Bacteria, (B) Yeasts, (C) Molds, (D) Mycobacteria, (E) Nocardia, (F) Direct sample testing ( *e.g.,* blood culture),(G) Antibiotic resistance markers, and (H) Select agents ( *e.g.,* pathogens of high consequence).(iii) Documentation that the manufacturer's risk mitigation strategy ensures that their device does not prevent any device(s) with which it is indicated for use, including incorporated device(s), from achieving their intended use ( *e.g.,* safety and effectiveness of the functions of the indicated device(s) remain unaffected).(iv) A detailed device description, including the following: (A) Overall device design, including all device components and all control elements incorporated into the testing procedure. (B) Algorithm used to generate a final result from raw data ( *e.g.,* how raw signals are converted into a reported result).(C) A detailed description of device software, including validation activities and outcomes. (D) Acquisition parameters ( *e.g.,* mass range, laser power, laser profile and number of laser shots per profile, raster scan, signal-to-noise threshold) used to generate data specific to a microorganism.(E) Implementation methodology, construction parameters, and quality assurance protocols, including the standard operating protocol for generation of reference entries for the device. (F) For each claimed microorganism characteristic, a minimum of five reference entries for each organism (including the type strain for microorganism identification), or, if there are fewer reference entries, a clinical and/or technical justification, determined by FDA to be acceptable and appropriate, for why five reference entries are not needed. (G) DNA sequence analysis characterizing all type strains and at least 20 percent of the non-type strains of a species detected by the device, or, if there are fewer strain sequences, then a clinical and/or technical justification, determined by FDA to be acceptable and appropriate, must be provided for the reduced number of strains sequenced. (H) As part of the risk management activities, an appropriate end user device training program, which must be offered as an effort to mitigate the risk of failure from user error.

Predicate Devices

• bioMérieux VITEK MS System (K181412)
• Bruker MALDI Biotyper CA System (DEN170081)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The FDA logo is in blue.

December 27, 2021

COPAN WASP S.r.l.

% Enrico Bisson Consultant Studio D'ingegneria Enrico Bisson Via Marzia 9 Abano Terme, 35031 Italy

#### Re: K193138

Trade/Device Name: Colibri System Regulation Number: 21 CFR 866.3378 Regulation Name: Clinical mass spectrometry microorganism identification and differentiation system Regulatory Class: Class II Product Code: QQV, QBN Dated: June 16, 2020 Received: June 19, 2020

#### Dear Enrico Bisson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ribhi Shawar. Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K193138

Device Name Colibrí System

#### Indications for Use (Describe)

The Colibrí System is an in vitro diagnostic device comprised of the Colibrí Vision System and Collbrí Preparation Station for use with the bioMérieux VITEK MS or Bruker MALDI Biotyper CA mass spectrometry systems for qualitative identification of isolated colonies of Gram-negative bacterial species grown on solid culture media. The Collbri System is a semi-automated pre-analytical processor that picks isolated by the operator and uses a pipetting system to prepare MALDI-TOF MS (Matrix-Assisted Laser Desorption/Ionization-Time Of Flight Mass Spectrometry) target slides. The Colibri software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOF MS analyzer.

The Colibrí System is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory finding Gram staining, to aid in the diagnosis of bacterial infections.

The Colibrí System has not been validated for use in identification of yeast species.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------------|
| X Prescription Use (Part 21 CER 801 Subnart D) | Over-The-Counter I Ise (21 CER 801 Subnart C) |

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#### I. SUBMITTER

| Applicant Name: | Copan WASP Srl |
|------------------------------------|------------------------------------|
| | Via A. Grandi 32 |
| | 25125 Brescia, Italy |
| | [phone] |
| | [e-mail] |
| | |
| Contact Person | Enrico Bisson |
| | ISOPLAN CONSULTING |
| | Studio di Ingegneria Enrico Bisson |
| | Via Marzia, 9 |
| | 35031 Abano Terme (PD), Italy |
| | [phone] [phone] |
| | [e-mail] |
| Establishment Registration Number: | 3009288740 |
| Date Prepared: | December 23, 2021 |

#### II. DEVICE NAME

| Proprietary Name | Colibrí System |
|---------------------|------------------------------------------------------------------------------------------------------|
| Common/Usual Name | Colibrí System |
| Classification Name | Clinical mass spectrometry microorganism identification and differentiation system (21 CFR 866.3378) |
| Device Class | II |
| Product Code | QQV, QBN |
| Panel | Microbiology |

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#### III. LEGALLY MARKETED PREDICATE DEVICE

| Device Name | VITEK MS |
|---------------|----------|
| 510(K) Number | K181412 |

No reference Devices were used in this submission.

IV. DEVICE DESCRIPTION

The Copan Colibrí System is designed to be used as an accessory of the downstream MALDI-TOF analyzers automating various manual steps in the workflow for the preparation of samples for the identification of isolated colonies of microorganisms cultured from the human body.

The Colibrí System automates the preparation of MALDI target slides for the bioMérieux VITEK MS or the Bruker MALDI Biotyper CA System that are used in clinical laboratories for identification and differentiation of organisms grown on plated media by Matrix-Assisted Laser Desorption/Ionization Time-of Flight Mass Spectrometry (MALDI-TOF MS). The system comprises the Colibrí Vision System and Colibrí Preparation Station and pipette tips as consumables. After appropriate plate incubation, the operator using the graphical User Interface (Image Reading Interface) chooses the plates exhibiting adequate growth and selects the isolated colonies to be processed assigning the automatic ID tasks. By using the Collbrí Vision System, specific colonies to be picked are designated by the operator on a digital plate. The Operator manually loads the plates in the Colibri Preparation Station where colonies are automatically picked, spotted on the target slide and overlayed with the matrix.

When used in conjunction with the bioMérieux VITEK MS, the Colibrí System can prepare the 48spot target slides by performing the direct spotting of colonies. The calibrator used for quality control is manually applied by the operator at the end of the automated colony spotting. When used in conjunction with the Bruker MALDI Biotyper CA System, the Colibrí System can prepare either reusable 48-spot or disposable 96-spot targets by performing the Direct Transfer Sample Procedure. The BTS used for quality control is manually applied by the operator at the and of the automated colony spotting.

The Colibrí software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOF MS analyzers.

Colibri System requires three different calibrations. None of these calibration activities require user intervention if not in terms of periodical cleaning of the mechanical component as described in the dedicated section of the User Manual. Set-up calibration is performed during the device initial setup for the camera units positioned on the Colibrí Vision System and on the Colibrí Preparation Station. Auto-calibration is performed at the end of the initial set-up and periodically during the preventive maintenance to check that, in the Colibri Preparation Station, all the mechanical references can be found inside the positioning tolerances, that the I/Os are responsive. Run-time calibration is

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performed during the normal usage to automatically check the proper functioning of the Colibrí Vision System and the Colibri Preparation Station.

#### V. INTENDED USE/INDICATIONS FOR USE

The Colibrí System is an in vitro diagnostic device comprised of the Colibrí Vision System and Colibri Preparation Station for use with the bioMérieux VITEK MS or Bruker MALDI Biotyper CA mass spectrometry systems for qualitative identification of isolated colonies of Gram-negative and Gram-positive bacterial species grown on solid culture media. The Colibrí System is a semiautomated pre-analytical processor that picks isolated colonies designated by the operator and uses a pipetting system to prepare MALDI-TOF MS (Matrix-Assisted Laser Desorption/Ionization-Time Of Flight Mass Spectrometry) target slides. The Colibrí software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOF MS analyzer.

The Colibrí System is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory findings, including Gram staining, to aid in the diagnosis of bacterial infections.

The Colibrí System has not been validated for use in identification of yeast species.

#### VI. COMPARISON TO PREDICATE DEVICE

The Colibrí System is designed to automatize the standard manual workflow for the preparation of targets for MALDI-TOF MS identification via Direct Colony Transfer decreasing the risk of crosscontamination among colonies grown on the culture plate and scratching from the media plate surface. Specifically, the Vision System aids the operator in selecting a single, well-isolated colony. The Preparation Station allows the automatic picking of the preselected colony, its spotting in the available position and the addition of the manufacturer recommended matrix.

With reference to the sample preparation flow, comparison with the predicate is provided in the following tables:

| Similarities | | | |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | New Device | Primary Predicate Device | Other |
| Device Name<br>(K number) | Colibrí System<br>(K193138) | VITEK MS<br>(K181412) | MALDI Biotyper CA System<br>(DEN170081) |
| Device<br>Classification | Class II (special controls) | Class II (special controls) | Class II (special controls) |
| Regulation<br>Number | 21 CFR 866.3378 Clinical Mass<br>Spectrometry Microorganism<br>Identification and Differentiation<br>System | 21 CFR 866.3378 Clinical Mass<br>Spectrometry Microorganism<br>Identification and Differentiation<br>System | 21 CFR 866.3378 Clinical Mass<br>Spectrometry Microorganism<br>Identification and Differentiation<br>System |
| Product Code | QQV: Automated System for<br>Sample Preparation And | QBN: Mass Spectrometry, Maldi<br>Tof, Microorganism Identification, | QBN: Mass Spectrometry, Maldi<br>Tof, Microorganism Identification. |
| | Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry | Cultured Isolates | Cultured Isolates |
| Indications for Use | The Colibrí System is an in vitro diagnostic device comprised of the Colibrí Vision System and Colibrí Preparation Station for use with the bioMérieux VITEK MS or Bruker MALDI Biotyper CA mass spectrometry systems for qualitative identification of isolated colonies of Gram-negative and Gram-positive bacterial species grown on solid culture media. The Colibrí System is a semi-automated pre-analytical processor that picks isolated colonies designated by the operator and uses a pipetting system to prepare MALDI-TOF MS (Matrix-Assisted Laser Desorption/Ionization-Time Of Flight Mass Spectrometry) target slides. The Colibrí software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOFMS analyzer. The Colibrí System is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory findings, including Gram staining, to aid in the diagnosis of bacterial infections. The Colibrí System has not been validated for use in identification of yeast species. | VITEK MS is a mass spectrometry system using matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens. The VITEK MS system 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, yeast and mould infections. (list of claimed organisms omitted for brevity; refer to K181412) | The MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification and differentiation of microorganisms cultured from human specimens. The MALDI Biotyper CA System 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 fungal infections. (list of validated organisms omitted for brevity; refer to DEN1 70081) |
| Sample/Media Type | Isolated bacterial colonies from any patient source on plated culture media.<br><br>Acceptable media when Colibrí System is used in connection with VITEK MS:<br>• Columbia blood agar with 5% sheep blood<br>• Trypticase soy agar with 5% sheep blood<br>• Chocolate agar<br>• MacConkey Agar<br><br>Acceptable media when Colibrí System is used in connection with MALDI Biotyper CA: | Isolated bacterial colonies from any patient source on plated culture media.<br><br>Acceptable media:<br>• Columbia blood agar with 5% sheep blood<br>• Trypticase soy agar with 5% sheep blood<br>• Chocolate polyvitex agar<br>• MacConkey agar | Isolated bacterial colonies from any patient source on plated culture media.<br><br>Acceptable media:<br>• Columbia blood agar with 5% sheep blood (Gram-negative bacteria)<br>• Trypticase soy agar with 5% sheep blood (Gram-negative bacteria)<br>• Chocolate agar (Gram-negative bacteria, Gram-positive bacteria)<br>• MacConkey Agar (Gram-negative bacteria)<br>• Columbia CNA agar with 5% sheep blood (Gram-positive bacteria) |
| | • sheep blood<br>• Trypticase soy agar with 5%<br>sheep Blood<br>• Chocolate agar<br>• MacConkey Agar<br>• Columbia CNA agar with 5%<br>sheep blood<br>• Bordet Gengou Agar with 15%<br>sheep blood<br>Note: media are selected among<br>those recommended forthe<br>Legally marketed Predicate<br>Devices and suitable for Gram-<br>negative and Gram-positive<br>bacteria.<br>Strains used to evaluate Colibrí<br>System performance<br>characteristics have been selected | | • Bordet Gengou Agar with 15%<br>sheep blood ( <i>Bordetella</i> species |
| | among those claimed from the<br>Legally marketed Predicate<br>devices. | | |
| Method of<br>Sample<br>Preparation | Direct spotting to target/slide of<br>Gram-negative and Gram-positive<br>bacteria. | Direct spotting to slide of Gram-<br>negative and Gram-positive<br>bacteria. | Bacteria: Direct spotting to target<br>of Gram-negative and Gram-<br>positive bacteria. |
| | A portion of microbial colony<br>from an agar plate is automatically<br>spotted on a VITEK MS-DS target<br>slide or MALDI Biotyper target by<br>using the pipetting system. | A portion of microbial colony from<br>an agar plate is manually applied to<br>a spot of VITEK MS-DS target<br>slide using a 1uL loop. | An isolated colony of bacteria is<br>smeared as a thin film using a<br>sterile colony transfer device,<br>directly onto a sample position on a<br>cleaned US IVD 48 Spot Target or<br>an unused sample position of a<br>MBT Biotarget 96 US IVD plate. |
| Target Slide | When connected with VITEK MS,<br>VITEK MS-DS Target Slides, 48<br>positions disposable plastic targets<br>When connected with Bruker<br>MALDI Biotyper CA, following<br>targets may be processed:<br>Bruker US IVD 48 Spot target<br>Bruker MBT Biotarget 96 US IVD<br>plate. | following target may be processed positions disposable plastic targets | IVD 48 Spot Target<br>MBT Biotarget 96 US IVD plate. |
| Matrix | 1 µL VITEK MS-CHCA matrix is<br>automatically applied to the spot<br>using the pipetting system.<br>The dried target slide is then<br>manually loaded into the VITEK<br>MS instrument.<br>1 µL US IVD HCCA portioned is<br>automatically applied to the spot<br>using the pipetting system.<br>The dried target slide is then<br>manually loaded into the MALDI<br>Biotyper CA instrument. | 1 µL VITEK MS-CHCA is applied<br>to the spot using a pipette.<br>The dried target slide is then<br>manually loaded into the VITEK<br>MS instrument. | 1 µL US IVD HCCA portioned is<br>applied to the spot using a pipette.<br>The dried target slide is then<br>manually loaded into the MALDI<br>Biotyper CA instrument |
| Calibration/ | For VITEK MS: Escherichia coli | Escherichia coli ATCC 8739 | US IVD Bacterial Test Standard |
| Quality<br>Controls | ATCC 8739 (calibrator strain) and Klebsiella aerogenes ATCC 13048 (positive control strain) are manually spotted in predetermined positions.<br>For MALDI Biotyper CA: US<br>IVD Bacterial Test Standard<br>(BTS) is manually spotted before loading in the instrument. | (calibrator strain) and Klebsiella aerogenes ATCC 13048 (positive<br>control strain) are manually spotted in predetermined positions | (BTS) is manually spotted before<br>loading in the instrument. |
| Culture<br>Stability | For Bacteria:<br>When connected with VITEK MS,<br>incubation of culture should be 18<br>- 72hrs (18-48hrs for Chocolate<br>Agar).<br>When connected with MALDI<br>Biotyper CA, incubation of culture<br>should be 18-48hrs (+12hrs<br>storage at RT). | For Bacteria:<br>Incubation of culture should be 18<br>-72hrs | For Bacteria:<br>Incubation of culture should be<br>between 18-48hrs (+12hrs<br>storage at RT). |
| Spot Stability | When connected with VITEK MS, after matrix addition, targets are<br>stable for 48h at room temperature<br>when held on the Colibrí deck and<br>for 72h when held in the original<br>box.<br>When connected with MALDI<br>Biotyper CA, after matrix addition<br>targets are stable for 24h at room<br>temperature. | After matrix addition, targets are<br>stable for 72h when held in the<br>original box. | After matrix addition, targets are<br>stable for 24h at room temperature |
| MALDI-TOF<br>MS Analyzer | bioMérieux VITEK MS<br>Bruker MALDI Biotyper CA | bioMérieux VITEK MS | Bruker MALDI Biotyper CA |
| Method of<br>Testing | When connected with VITEK MS,<br>direct testing from isolated<br>colonies.<br><br>When connected with Bruker<br>MALDI Biotyper CA, direct<br>testing from isolated colonies. If<br>after initial analysis the log(score)<br>is reported at <2.00, organisms<br>may be processed by manual<br>preparation using the Extraction<br>(Ext) procedure or extended Direct<br>Transfer. | For bacteria:<br>Direct testing from isolated colonies | For bacteria:<br>Direct testing from isolated<br>colonies; If after initial analysis the<br>log(score) is reported at <2.00,<br>organisms may be processed using<br>the Extraction (Ext) procedure or<br>extended Direct Transfer (eDT,<br>70% aqueous formic acid)<br>procedure.<br>If eDT procedure still yields log<br>(score)<2.00, organisms may be<br>processed via Ext procedure. |

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Copan WASP S.r.1., Traditional 510(k)-Colibrí System

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| Differences | | | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | New Device | Primary Predicate Device | Other |
| Device Name<br>(K number) | Colibrí System<br>(K193138) | VITEK MS<br>(K181412) | MALDI Biotyper CA System<br>(DEN170081) |
| Target<br>Organism | Colibrí System has been validated<br>for direct spotting to target/slide of<br>Gram-negative and Gram-positive<br>bacteria only. | VITEK MS also includes<br>mycobacteria, nocardia, yeast and<br>mould indications for use, an<br>inactivation and extraction process<br>is required for sample prep, prior to<br>spotting the sample to the slide. | MALDI Biotyper CA also includes<br>yeast indications for use. If after<br>initial analysis the log(score) is<br>reported at <2.00, organisms may<br>be processed using the Extraction<br>(Ext) procedure or extended Direct<br>Transfer (eDT, 70% aqueous |
| | Differences | | |
| Item | New Device | Primary Predicate Device | Other |
| Device Name<br>(K number) | Colibrí System<br>(K193138) | VITEK MS<br>(K181412) | MALDI Biotyper CA System<br>(DEN170081) |
| |…