(151 days)
No reference Devices were used in this submission.
No
The document describes an automated system for specimen preparation based on operator selection from digital images, not AI/ML-driven image analysis or decision making.
No.
The device is an in vitro diagnostic specimen preparation system that aids in the diagnosis of bacterial infections by preparing samples for further analysis, not directly treating a medical condition.
Yes
The Colibri™ is described as an automated in vitro diagnostic specimen preparation system intended "to aid in the diagnosis of bacterial infections" when used by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory findings. While it does not directly provide a diagnosis, it prepares samples for diagnostic tests (MALDI-TOF MS for identification and VITEK 2 for AST) which are used in the diagnostic process.
No
The device description explicitly states that the Colibri includes an "instrument" with an "on-board pipetting system and nephelometer," as well as other physical components like "Primary Tubes," "Spreader," and "Daily Verification kit." This indicates it is a hardware system with integrated software, not a software-only device.
Based on the provided information, the Colibri™ device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Colibri™ is an "automated in vitro diagnostic specimen preparation system". It is intended for use in clinical laboratories to aid in the diagnosis of bacterial infections by preparing samples for microbial identification and antimicrobial susceptibility testing.
- Device Description: The description further clarifies its role in preparing samples for established IVD systems like the bioMérieux VITEK® MS, Bruker MALDI Biotyper® CA, and bioMérieux VITEK® 2, all of which are used for in vitro diagnostic purposes.
- Clinical Laboratory Use: The device is intended for use by trained healthcare professionals in clinical laboratories, which is a typical setting for IVD devices.
- Performance Studies: The performance studies described are designed to validate the accuracy of the device in preparing samples for downstream diagnostic tests (identification and AST).
Therefore, the Colibri™ clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Colibri™ is an automated in vitro diagnostic specimen preparation system for use with WASPLab® to prepare MALDI-TOF targets for the bioMérieux VITEK® MS or Bruker MALDI Biotyper® CA mass spectrometry systems for qualitative identification and microbial suspension for the bioMérieux VITEK® 2 Antimicrobial Susceptibility Testing (AST) system for qualitative testing of isolated colonies of gram-negative and gram-positive bacterial species grown on solid culture media.
The Colibri™ is an automated pre-analytical processor that nicks isolated colonies designated by the operator and uses a pipetting system to prepare MALDI-TOF MS (Matrix-Assisted Laser Desorption/lonization-Time of Flight Mass Spectrometry) target slides for bacterial identification and microbial suspension at known concentration for Antimicrobial Susceptibility Testing and purity assessment.
The Collori™ 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.
Bacterial suspensions for AST and purity plates are identified by barcode label.
The Colibri™ 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 Colibri™ has not been validated for use in the identification or processing of yeast species, or mycobacteria.
Product codes (comma separated list FDA assigned to the subject device)
QQV, QBN, LON
Device Description
The Colibrí is an instrument which automates the picking of selected colonies from plated media and prepares 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/Tonization Time-of Flight Mass Spectrometry (MALDI-TOF MS). The Colibrí automates the preparation of microbial suspensions at known concentration for bioMérieux VITEK 2 System that is used in clinical laboratories for AST analyses. Moreover, the Colibrí is used for Purity Plates preparation for purity assessments.
The Colibrí includes the following components:
- . Colibrí instrument and software with on-board pipetting system and nephelometer
- Colibrí Primary Tubes ●
- . Colibrí Spreader
- Colibrí Daily Verification kit. ●
Colibri is designed to be used in conjunction with the WASPLab device for culture plate incubation and image analysis. After appropriate plate incubation, the operator selects the colonies from a digital image of culture media plate streaked with microbiological human specimen, available through WebApp software, the WASPLab User Interface.
The operator assigns the automatic ID or AST tasks to the isolated colonies to be processed. Then, the operator loads the plates in the Colibri where colonies are automatically picked, spotted on the target slide and overlayed with the matrix or suspended into the dedicated solution for the preparation of the microbial suspension for AST purposes (Secondary Tube).
When used in conjunction with the bioMérieux VITEK MS, the Colibrí can prepare the 48-spot 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 Colibri 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 end of the automated colony spotting.
When used in conjunction with the bioMérieux VITEK 2, the Colibrí can prepare the microbial suspension at the proper concentration by direct colony suspension method. The onboard nephelometer allows the preparation of Secondary Tubes (AST suspensions) at the correct concentration and the Colibrí Spreader is used for Purity Plates preparation.
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.
The traceability of prepared Secondary Tube and Purity Plates is maintained by dedicated labels applications.
Colibrí requires four different calibrations, one on the nephelometer, three on the cameras. 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. The Set-up calibration of nephelometer and camera units are performed during the device initial setup. Autocalibration is performed at the end of the initial set-up and periodically during the preventive maintenance to check that all the mechanical references can be found inside the positioning tolerances, that the I/Os are responsive. Run-time calibration is performed during the normal usage to automatically check the proper functioning of the Colibrí.
Colibrí requires a daily nephelometer verification to check the proper reading of suspensions at different turbidity values.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals in clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Sample Size:
For VITEK MS identification, 292 spots were prepared.
For AST, total of 1315 on-scale MIC results were evaluated.
For AST, total of 2720 total categorical results were included.
Data Source:
Organisms tested for identification included strains from Enterobacterales (n=4), Staphylococcus (n=2), Streptococcus (n=1), Enterococcus (n=2), and non-fermenters (n=1).
Organisms for AST were selected to have a range of on-scale MIC values towards at least 4 antibiotics representative of major drug classes in VITEK 2 cards.
Annotation Protocol:
For microbial identification, performance was calculated as percentage of spotted colonies matching the expected identity.
For AST, the MICs obtained by bioMérieux VITEK 2 using Colibrí were compared to MICs obtained by bioMérieux VITEK 2 using manual sample preparation. The SIR category was reported according to the FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Full workflow validation. This study aims to demonstrate the accuracy of Colibri in picking designated colonies of different microbial species, selected by the laboratory technologist using WASPLab WebApp, for the preparation of target slides for MALDI-TOF identification and of microbial suspensions for AST.
Sample Size:
- Identification: 292 spots prepared for VITEK MS.
- AST: 1315 on-scale MIC results for Essential Agreement (EA), 2720 categorical results for Category Agreement (CA).
Key Results: - Colony Picking Accuracy: 100% of colonies designated by the operator were correctly picked.
- VITEK MS Identification Accuracy: 98.6% of designated colonies were identified correctly with high confidence. No incorrect identifications occurred.
- AST Accuracy:
- Essential Agreement (EA) of MICs: >98% for each antimicrobial agent/organism group tested. Overall, 100% (1315/1315) of on-scale MIC results were in EA.
- Category Agreement (CA): >98% for each antimicrobial agent/organism group tested. Overall, 99.4% (2703/2720) were in CA.
- Errors: No very major or major categorical errors occurred.
Standalone Performance:
The study aimed to demonstrate the performance of the Colibrí system itself in preparing samples, which are then analyzed by other IVD systems (bioMérieux VITEK MS or Bruker MALDI Biotyper CA for ID, and bioMérieux VITEK 2 for AST). The performance metrics provided (ID agreement, EA, and CA) reflect the accuracy of the sample preparation by Colibrí as it impacts the downstream analysis by these other systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Identification:
- % Agreement (Good Confidence): 98.6% overall for VITEK MS identification.
- Gram-negative species: 100% agreement.
- Gram-positive species: 98.0% agreement (range 95.0% to 100%).
AST:
- Essential Agreement (EA):
- Overall: 100.0% (1315/1315) of on-scale MIC results.
- Per Organism Group (Total Evaluable % EA): Enterobacterales (100.0%), Non-fermenters (100.0%), Staphylococci (100.0%), Enterococci (100.0%), Streptococci (100.0%).
- Category Agreement (CA):
- Overall: 99.4% (2703/2720).
- Per Organism Group (% CA): Enterobacterales (98.9%), Non-fermenters (99.5%), Staphylococci (100.0%), Enterococci (100.0%), Streptococci (100.0%).
- Major Category Errors: 0
- Very Major Category Errors: 0
- Minor Category Errors: 16 total (16 for Enterobacterales, 1 for Non-fermenters)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference Devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3378 Clinical mass spectrometry microorganism identification and differentiation system.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image shows 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 letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 20, 2023
Copan WASP Srl Chiara Congiu Regulatory Affairs Via A. Grandi, 32 Brescia, Brescia 25125 Italy
Re: K223245
Trade/Device Name: Colibrí Regulation Number: 21 CFR 866.3378 Regulation Name: Clinical Mass Spectrometry Microorganism Identification And Differentiation System Regulatory Class: Class II Product Code: QQV, QBN, LON Dated: December 21, 2022 Received: December 21, 2022
Dear Chiara Congiu:
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Branch Chief, General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K223245
Device Name Colibrí
Indications for Use (Describe)
The Colibri™ is an automated in vitro diagnostic specimen preparation system for use with WASPLab® to prepare MALDI-TOF targets for the bioMérieux VITEK® MS or Bruker MALDI Biotyper® CA mass spectrometry systems for qualitative identification and microbial suspension for the bioMérieux VITEK® 2 Antimicrobial Susceptibility Testing (AST) system for qualitative testing of isolated colonies of gram-negative and gram-positive bacterial species grown on solid culture media.
The Colibri™ is an automated pre-analytical processor that nicks isolated colonies designated by the operator and uses a pipetting system to prepare MALDI-TOF MS (Matrix-Assisted Laser Desorption/lonization-Time of Flight Mass Spectrometry) target slides for bacterial identification and microbial suspension at known concentration for Antimicrobial Susceptibility Testing and purity assessment.
The Collori™ 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.
Bacterial suspensions for AST and purity plates are identified by barcode label.
The Colibri™ 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 Colibri™ has not been validated for use in the identification or processing of yeast species, or mycobacteria.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
I. Submitter
| Applicant Name: | Copan WASP Srl
Via A. Grandi 32
25125 Brescia, Italy
+39 030 2687211
copan.regulatory@copangroup.com |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Chiara Congiu
Copan WASP Srl
Via A. Grandi 32
25125 Brescia, Italy
+39 338 6904942
copan.regulatory@copangroup.com |
| Establishment Registration Number: | 3009288740 |
Date Prepared:
February 18, 2022
II. Device Name
| Proprietary Name | Colibrí |
|---|---|
| Common/Usual Name | Colibrí |
| Classification Name | Clinical mass spectrometry microorganism |
| identification and differentiation system (21 CFR 866.3378) | |
| Fully automated short-term incubation cycle | |
| antimicrobial susceptibility system (21 CFR 866.1645) | |
| Device Class | II |
| Product Code | QQV, QBN, LON |
| Panel | Microbiology |
4
III. Legally Marketed Predicate Device
| Device Name | Colibrí System |
|---|---|
| 510(K) Number | K220546 |
No reference Devices were used in this submission.
Device Description IV.
The Colibrí is an instrument which automates the picking of selected colonies from plated media and prepares 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/Tonization Time-of Flight Mass Spectrometry (MALDI-TOF MS). The Colibrí automates the preparation of microbial suspensions at known concentration for bioMérieux VITEK 2 System that is used in clinical laboratories for AST analyses. Moreover, the Colibrí is used for Purity Plates preparation for purity assessments.
The Colibrí includes the following components:
- . Colibrí instrument and software with on-board pipetting system and nephelometer
- Colibrí Primary Tubes ●
- . Colibrí Spreader
- Colibrí Daily Verification kit. ●
Colibri is designed to be used in conjunction with the WASPLab device for culture plate incubation and image analysis. After appropriate plate incubation, the operator selects the colonies from a digital image of culture media plate streaked with microbiological human specimen, available through WebApp software, the WASPLab User Interface.
The operator assigns the automatic ID or AST tasks to the isolated colonies to be processed. Then, the operator loads the plates in the Colibri where colonies are automatically picked, spotted on the target slide and overlayed with the matrix or suspended into the dedicated solution for the preparation of the microbial suspension for AST purposes (Secondary Tube).
When used in conjunction with the bioMérieux VITEK MS, the Colibrí can prepare the 48-spot target slides by performing the direct spotting of colonies. The calibrator used for quality control
5
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 Colibri 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 end of the automated colony spotting.
When used in conjunction with the bioMérieux VITEK 2, the Colibrí can prepare the microbial suspension at the proper concentration by direct colony suspension method. The onboard nephelometer allows the preparation of Secondary Tubes (AST suspensions) at the correct concentration and the Colibrí Spreader is used for Purity Plates preparation.
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.
The traceability of prepared Secondary Tube and Purity Plates is maintained by dedicated labels applications.
Colibrí requires four different calibrations, one on the nephelometer, three on the cameras. 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. The Set-up calibration of nephelometer and camera units are performed during the device initial setup. Autocalibration is performed at the end of the initial set-up and periodically during the preventive maintenance to check that all the mechanical references can be found inside the positioning tolerances, that the I/Os are responsive. Run-time calibration is performed during the normal usage to automatically check the proper functioning of the Colibrí.
Colibrí requires a daily nephelometer verification to check the proper reading of suspensions at different turbidity values.
V. Intended Use / Indications For Use
The Colibri is an automated in vitro diagnostic specimen preparation system for use with WASPLab to prepare MALDI-TOF targets for the bioMérieux VITEK MS or Bruker MALDI Biotyper CA mass spectrometry systems for qualitative identification and microbial suspension for the bioMérieux VITEK 2 Antimicrobial Susceptibility Testing (AST) system for qualitative testing of isolated colonies of gram-negative and gram-positive bacterial species grown on solid culture media.
The Colibrí is an 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/lonization-Time of Flight Mass Spectrometry) target slides for bacterial identification and microbial suspension at known concentration for Antimicrobial Susceptibility Testing and purity assessment.
6
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.
Bacterial suspensions for AST and purity plates are identified by barcode label.
The Colibrí 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 has not been validated for use in the identification or processing of yeast species, molds, Nocardia, or mycobacteria.
VI. Comparison to Predicate
According to its intended use, Colibrí supports the performance of the connected IVD Analyzers by facilitating sample preparation for Gram-Negative and Gram-Positive bacteria ID or AST according to their intended use.
The conjunction of Colibrí device with WASPLab device does not change, expand or limit the intended use of the Predicate Device and does not affect the safety and effectiveness of the predicate.
Both the Colibrí in conjunction with WASPLab device and the Predicate Device are intended for the preparation of target ID and AST microbial suspensions of colonies grown on culture media plates streaked with human specimens indicated as an aid in the diagnosis and treatment definition for the bacterial infections.
| Similarities | ||
|---|---|---|
| Item | New Device | Predicate Device |
| Device Name | ||
| (K number) | Colibrí | Colibrí System (K220546) |
| Device Classification | Class II (special controls) | Class II (special controls) |
| Regulation Number | 21 CFR 866.3378 and 21 CFR 866.1645 | 21 CFR 866.3378 and 21 CFR 866.1645 |
| Product Code | QQV, Automated System For Sample | |
| Preparation And Identification Of | ||
| Microorganisms From Cultured Isolates By | ||
| Mass Spectrometry | ||
| QBN, Mass Spectrometry, Maldi Tof, | ||
| Microorganism Identification, Cultured Isolates | ||
| LON, System, Test, Automated, Antimicrobial | ||
| Susceptibility, Short Incubation | QQV, Automated System For Sample | |
| Preparation And Identification Of | ||
| Microorganisms From Cultured Isolates By | ||
| Mass Spectrometry | ||
| QBN, Mass Spectrometry, Maldi Tof, | ||
| Microorganism Identification, Cultured Isolates | ||
| LON, System, Test, Automated, Antimicrobial | ||
| Susceptibility, Short Incubation | ||
| Indications for Use | The Colibrí is an automated in vitro diagnostic | |
| specimen preparation system for use with | ||
| WASPLab to prepare MALDI-TOF targets for | ||
| the bioMérieux VITEK MS or Bruker MALDI | ||
| Biotyper CA mass spectrometry systems for | ||
| qualitative identification and microbial | ||
| suspensions for the bioMérieux VITEK 2 | 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 and with the | ||
| bioMérieux VITEK® 2 Antimicrobial | ||
| Similarities | ||
| Item | New Device | Predicate Device |
| Device Name | ||
| (K number) | Colibrí | Colibrí System (K220546) |
| Antimicrobial Susceptibility Testing (AST) system for qualitative testing of isolated colonies of gram-negative and gram-positive bacterial species grown on solid culture media. | ||
| The Colibrí is an 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 for bacterial identification and microbial suspension at known concentration for Antimicrobial Susceptibility Testing and purity assessment. | ||
| 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. | ||
| Bacterial suspensions for AST and purity plates are identified by barcode label. | ||
| The Colibrí 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 has not been validated for use in the identification or processing of yeast species, molds, Nocardia, or mycobacteria. | Susceptibility Testing (AST) system for qualitative testing 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 for bacterial identification and microbial suspension at known concentration for Antimicrobial Susceptibility Testing and purity assessment. | ||
| 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. | ||
| Bacterial suspensions for AST and purity plates are identified by barcode label. | ||
| 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 the identification or processing of yeast species, molds, Nocardia, or mycobacteria. | ||
| Method of testing | Direct testing from isolated colonies for ID purposes in conjunction with bioMérieux VITEK MS or Bruker MALDI Biotyper CA System. | |
| Direct testing from isolated colonies for AST purposes in conjunction with bioMérieux VITEK 2. | Same | |
| Sample/Media Type | Isolated bacterial colonies from any patient source grown on plates included in K193138 and K220546. | Same |
| Plate management | Automatic image capturing management and manual loading into instrument for picking activities. | Same |
| Colonies selection | The colony to be picked is selected by an operator on a digital plate using a Graphical User Interface on a dedicated workstation. | Same |
| Method of Colony Picking | Automatic picking of colonies using pipette tips. | Same |
| ID Target preparation | When connected with VITEK MS, a portion of microbial colony from an agar plate is automatically spotted on a Vitek MS-DS target slide (VITEK MS DS Target Slides, 48 positions disposable plastic targets) by using the pipetting system. 1µL of matrix is automatically applied to the spot using the pipetting system. The dried target slide is then manually loaded into the VITEK MS. | Same |
| Similarities | ||
| Item | New Device | Predicate Device |
| Device Name | ||
| (K number) | Colibrí | Colibrí System (K220546) |
| AST Suspension | ||
| Preparation | Using a pipetting system, a predefined number of morphologically similar colonies are transferred into Primary Tube containing saline solution (0.45% NaCl Saline Solution pH 4.5 to 7.0). A homogenous heavy suspension of organisms is prepared and checked by using on-board Colibrí nephelometer. In the Secondary Tube containing 3.0mL of the same saline solution, a variable aliquot of the heavy suspension is automatically transferred to obtain the final microbial concentration according to IVD package insert indications. The suspensions prepared by Colibrí must be tested in MANUAL MODE on the VITEK 2. | Same |
| Calibration | Colibrí requires four different calibrations, one on the nephelometer, three on the cameras. None of these calibration activities require user intervention. | Same |
| Preparatory activities | Nephelometer verification by check using Daily verification Kit. | Same |
| Quality control | Completely dependent on next-step IVD analyzers. | Same |
7
8
| Differences | ||
|---|---|---|
| Item | New Device | Predicate Device |
| Device Name | ||
| (K number) | Colibrí | Colibrí System (K220546) |
| Plate management | Automatic plate loading for image capturing that is performed according to set image protocol. | Manual loading for image capturing and selection by the operator of media plate type. |
| Plate incubation | Automatic and managed by the WASPLab. | Manual. |
These differences do not affect substantial equivalence of Colibrí and the Predicate Device.
9
VII. Performance Data
Colibrí uses equally designed and developed hardware and software modules as the Colibrí System. Therefore, the performance of the predicate device represents the performance of the new device. The results of the analytical studies were submitted to support the 510(k) Premarket Notifications K193138 and K220546 and showed that Colibrí technology allow the preparation of target slides for MALDI-TOF identifications and microbial suspension for AST with good performance regarding the:
- Accuracy of colony picking from culture plates -
- Reproducibility of identification results -
- Inclusivity of species and genera with different colony morphologies and characteristics and at various incubation times
- -Absence of positional effect on the target slides
- -Stability of the spots with and without the matrix
- -Accuracy of the on-board nephelometer
- -Accuracy of microbial content of the suspensions for AST
- Accuracy of AST results, including between-instruments and operators' reproducibility -
- -On-board reagent stability
- -Absence of carry-over
The following performance data were provided in support of the substantial equivalence determination.
Full workflow validation
This study aims to demonstrate the accuracy of Colibri in picking designated colonies of different microbial species, selected by the laboratory technologist using WASPLab WebApp, for the preparation of target slides for MALDI-TOF identification and of microbial suspensions for AST.
Three Colibrí interfaced with three WASPLab were used to pick isolated colonies from mixed cultures prepared with gram-positive and gram-negative strains, to prepare target slides for microbial identification and microbial suspensions for AST. Strains were selected to be representative of different species of Enterobacterales (n=4), Staphylococcus (n=2), Streptococcus (n=1), Enterococcus (n=2) and non-fermenters (n=1), including "on-panel" species for VITEK MS exhibiting a range of on-scale MIC values toward at least 4 antibiotics representative for the major classes of drugs in VITEK 2 cards.
After the automatic preparation, the target slides were analysed by the mass spectrometer and microbial suspensions were associated to the appropriate card of antibiotics to perform susceptibility testing. Furthermore, processed plates were visually inspected by the operator in comparison to the colonies designated on the plate image in WASPLab WebApp to verify that were successfully picked by the Colibri. For microbial identification, performance was calculated as percentage of spotted colonies matching the expected identity; for AST, the MICs obtained by bioMérieux VITEK 2 using Colibrí were compared to the MICs obtained by bioMérieux VITEK 2 using manual sample preparation and the SIR category was reported according to the FDA-
10
Recognized Antimicrobial Susceptibility Test Interpretive Criteria. Essential Agreement (EA) of the MICs and Category Agreement (CA) were calculated. The discrepant SIR results were categorized as Very Major Category Error, Major Category Error and Minor Category Error.
Colonies designated by the operator were 100% correctly picked without any event in which a wrong colony was picked, providing evidence that the picking coordinates defined by WASPLab software are correct and are successfully interpreted by Colibri. For the VITEK MS, a total of 292 spots were prepared and 98.6% of designated colonies has been identified correctly with high confidence in comparison to the expected strain identity. Data show that no incorrect identification occurred on spots prepared by the Colibrí and that it was always able to accurately pick designated colonies.
The results are summarized in the tables below. Due to the high degree of agreement between MICs determined from samples prepared manually and samples prepared by the Colibrí with WASPLab (with both EA and CA >98% for each antimicrobial agent/organism group tested), the AST accuracy was deemed acceptable. In addition, and since this is a method-to-method comparison, the cumulative results for all antimicrobial agents and species combined were evaluated. For all species and antimicrobial agents, 100% (1315/1315) of on-scale MIC results were in EA and 99.4% (2703/2720) were in CA with the comparator result. No very major or major errors occurred.
| Expected
Organism
Identity | Culture
Medium | Strains
Tested | Colonies
Picked | VITEK MS Identification Result | | | % Agreement* | |
|----------------------------------|-------------------|-------------------|--------------------|--------------------------------|-----------------------|-----------|-------------------|----------------|
| | | | | Good
Confidence | Low
Discrimination | No ID | Culture
Medium | Species/ Group |
| Citrobacter
koseri | TSA | 1 | 10 | 10 | -- | -- | 100% | 100% |
| Citrobacter
koseri | MAC | 1 | 11 | 11 | -- | -- | 100% | |
| Escherichia
coli | TSA | 1 | 14 | 14 | -- | -- | 100% | 100% |
| Escherichia
coli | MAC | 1 | 9 | 9 | -- | -- | 100% | |
| Klebsiella
pneumoniae | TSA | 1 | 7 | 7 | -- | -- | 100% | |
| Klebsiella
pneumoniae | MAC | 1 | 9 | 9 | -- | -- | 100% | 100% |
| Proteus
mirabiliis | TSA | 1 | 7 | 7 | -- | -- | 100% | |
| Proteus
mirabiliis | MAC | 1 | 8 | 8 | -- | -- | 100% | 100% |
| Pseudomonas
aeruginosa | TSA | 1 | 8 | 8 | -- | -- | 100% | |
| Pseudomonas
aeruginosa | MAC | 1 | 9 | 9 | -- | -- | 100% | 100% |
| TOTAL | 2 | 5 | 92 | 92 | -- | -- | 100% | 100% |
Identification results of the Colibrí obtained with the bioMérieux VITEK MS stratified per gram-negative species.
11
Identification results of the Colibrí obtained with the bioMérieux VITEK MS stratified per gram-positive species.
| Expected Organism
Identity | Strains
Tested | Colonies
Picked | VITEK MS Identification Result | | No ID | % Agreement* |
|---------------------------------|-------------------|--------------------|--------------------------------|-----------------------|----------|--------------|
| | | | Good
Confidence | Low
Discrimination | | |
| Enterococcus faecalis | 1 | 40 | 39 | -- | 1 | 97.5% |
| Enterococcus faecium | 1 | 40 | 38 | -- | 2 | 95.0% |
| Staphylococcus aureus | 1 | 40 | 40 | -- | 0 | 100% |
| Staphylococcus
saprophyticus | 1 | 40 | 40 | -- | 0 | 100% |
| Streptococcus agalactiae | 1 | 40 | 39 | -- | 1 | 97.5% |
| TOTAL | 5 | 200 | 196 | -- | 4 | 98.0% |
*Calculated as Agreement(%) = = No. of correct results with Good Confidence value (≥60%) x100 Total number of picked colonies
12
| Agent | Organism group | Total
tested | #
EA | % EA | Total
Evaluable | # EA of
Evaluable | % EA of
Evaluable | Total
cat. | # CA | % CA | # S | # R | #
vmj | #
maj | #
min |
|------------------------------------|------------------|-----------------|---------|--------|--------------------|----------------------|----------------------|---------------|------|--------|-----|-----|----------|----------|----------|
| Amikacin | Enterobacterales | 80 | 80 | 100.0% | 80 | 80 | 100.0% | 80 | 80 | 100.0% | 80 | 0 | 0 | 0 | 0 |
| Amikacin | Non-fermenters | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Ampicillin | Enterococcus | 40 | 40 | 100.0% | 20 | 20 | 100.0% | 40 | 40 | 100.0% | 20 | 20 | 0 | 0 | 0 |
| Ampicillin | Streptococcus | 20 | 20 | 100.0% | 0 | 0 | N/A | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Ampicillin /
Sulbactam | Enterobacterales | 60 | 60 | 100.0% | 20 | 20 | 100.0% | 60 | 59 | 98.3% | 20 | 40 | 0 | 0 | 1 |
| Aztreonam | Enterobacterales | 80 | 80 | 100.0% | 40 | 40 | 100.0% | 80 | 80 | 100.0% | 20 | 60 | 0 | 0 | 0 |
| Cefazolin | Enterobacterales | 60 | 60 | 100.0% | 0 | 0 | N/A | 60 | 60 | 100.0% | 0 | 60 | 0 | 0 | 0 |
| Cefepime | Enterobacterales | 80 | 80 | 100.0% | 80 | 80 | 100.0% | 80 | 76 | 95.0% | 40 | 0 | 0 | 0 | 4 |
| Cefepime | Non-fermenters | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Cefotaxime | Streptococcus | 20 | 20 | 100.0% | 0 | 0 | N/A | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Cefoxitin | Enterobacterales | 80 | 80 | 100.0% | 38 | 38 | 100.0% | 80 | 80 | 100.0% | 20 | 60 | 0 | 0 | 0 |
| Ceftazidime | Enterobacterales | 80 | 80 | 100.0% | 80 | 80 | 100.0% | 80 | 76 | 95.0% | 0 | 40 | 0 | 0 | 4 |
| Ceftazidime | Non-fermenters | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Ceftriaxone | Enterobacterales | 80 | 80 | 100.0% | 20 | 20 | 100.0% | 80 | 80 | 100.0% | 0 | 80 | 0 | 0 | 0 |
| Ceftriaxone | Streptococcus | 20 | 20 | 100.0% | 0 | 0 | N/A | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Ciprofloxacin | Non-fermenters | 20 | 20 | 100.0% | 0 | 0 | N/A | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Ciprofloxacin | Staphylococcus | 40 | 40 | 100.0% | 20 | 20 | 100.0% | 40 | 40 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Clindamycin | Enterococcus | 40 | 40 | 100.0% | 40 | 40 | 100.0% | 40 | 40 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Clindamycin | Staphylococcus | 40 | 40 | 100.0% | 0 | 0 | N/A | 40 | 40 | 100.0% | 20 | 20 | 0 | 0 | 0 |
| Clindamycin | Streptococcus | 20 | 20 | 100.0% | 0 | 0 | N/A | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Ertapenem | Enterobacterales | 80 | 80 | 100.0% | 0 | 0 | N/A | 80 | 80 | 100.0% | 60 | 20 | 0 | 0 | 0 |
| Erythromycin | Staphylococcus | 40 | 40 | 100.0% | 0 | 0 | N/A | 40 | 40 | 100.0% | 20 | 20 | 0 | 0 | 0 |
| Erythromycin | Enterococcus | 40 | 40 | 100.0% | 20 | 20 | 100.0% | 40 | 40 | 100.0% | 0 | 20 | 0 | 0 | 0 |
| Erythromycin | Streptococcus | 20 | 20 | 100.0% | 19 | 19 | 100.0% | 20 | 20 | 100.0% | 0 | 20 | 0 | 0 | 0 |
| Agent | Organism group | Total
tested | #
EA | % EA | Total
Evaluable | # EA of
Evaluable | % EA of
Evaluable | Total
cat. | # CA | % CA | # S | # R | #
vmj | #
maj | #
min |
| Gentamicin | Enterobacterales | 80 | 80 | 100.0% | 20 | 20 | 100.0% | 80 | 80 | 100.0% | 60 | 20 | 0 | 0 | 0 |
| Gentamicin | Non-fermenters | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Imipenem | Staphylococcus | 40 | 40 | 100.0% | 0 | 0 | N/A | 40 | 40 | 100.0% | 20 | 20 | 0 | 0 | 0 |
| Imipenem | Non-fermenters | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Levofloxacin | Enterobacterales | 80 | 80 | 100.0% | 20 | 20 | 100.0% | 80 | 80 | 100.0% | 0 | 60 | 0 | 0 | 0 |
| Levofloxacin | Non-fermenters | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 19 | 95.0% | 20 | 0 | 0 | 0 | 1 |
| Levofloxacin | Staphylococcus | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Linezolid | Enterococcus | 40 | 40 | 100.0% | 40 | 40 | 100.0% | 40 | 40 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Linezolid | Streptococcus | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Linezolid | Staphylococcus | 40 | 40 | 100.0% | 40 | 40 | 100.0% | 40 | 40 | 100.0% | 40 | 0 | 0 | 0 | 0 |
| Linezolid | Enterococcus | 40 | 40 | 100.0% | 40 | 40 | 100.0% | 40 | 40 | 100.0% | 40 | 0 | 0 | 0 | 0 |
| Meropenem | Streptococcus | 20 | 20 | 100.0% | 0 | 0 | N/A | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Meropenem | Enterobacterales | 80 | 80 | 100.0% | 20 | 20 | 100.0% | 80 | 80 | 100.0% | 60 | 20 | 0 | 0 | 0 |
| Meropenem | Non-fermenters | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Moxifloxacin | Staphylococcus | 40 | 40 | 100.0% | 0 | 0 | N/A | 40 | 40 | 100.0% | 40 | 0 | 0 | 0 | 0 |
| Nitrofurantoin | Enterobacterales | 80 | 80 | 100.0% | 80 | 80 | 100.0% | 80 | 77 | 96.3% | 0 | 40 | 0 | 0 | 3 |
| Nitrofurantoin | Staphylococcus | 40 | 40 | 100.0% | 0 | 0 | N/A | 40 | 40 | 100.0% | 40 | 0 | 0 | 0 | 0 |
| Oxacillin | Enterococcus | 40 | 40 | 100.0% | 20 | 20 | 100.0% | 40 | 40 | 100.0% | 20 | 20 | 0 | 0 | 0 |
| Oxacillin | Staphylococcus | 40 | 40 | 100.0% | 20 | 20 | 100.0% | 40 | 40 | 100.0% | 0 | 40 | 0 | 0 | 0 |
| Penicillin (Benzyl-penicillin) | Enterococcus | 40 | 40 | 100.0% | 39 | 39 | 100.0% | 40 | 40 | 100.0% | 20 | 20 | 0 | 0 | 0 |
| Penicillin (Benzyl-penicillin) | Streptococcus | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Penicillin (Benzyl-penicillin) | Staphylococcus | 40 | 40 | 100.0% | 19 | 19 | 100.0% | 40 | 40 | 100.0% | 0 | 40 | 0 | 0 | 0 |
| Piperacillin /
Tazobactam | Enterobacterales | 80 | 80 | 100.0% | 40 | 40 | 100.0% | 80 | 76 | 95.0% | 60 | 20 | 0 | 0 | 4 |
| Piperacillin /
Tazobactam | Non-fermenters | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Quinupristin /
Dalfopristin | Staphylococcus | 40 | 40 | 100.0% | 40 | 40 | 100.0% | 40 | 40 | 100.0% | 40 | 0 | 0 | 0 | 0 |
| Tetracycline | Enterobacterales | 80 | 80 | 100.0% | 40 | 40 | 100.0% | 80 | 80 | 100.0% | 40 | 40 | 0 | 0 | 0 |
| Agent | Organism group | Total
tested | #
EA | % EA | Total
Evaluable | # EA of
Evaluable | % EA of
Evaluable | Total
cat. | # CA | % CA | # S | # R | #
vmj | #
maj | #
min |
| | Staphylococcus | 40 | 40 | 100.0% | 0 | 0 | N/A | 40 | 40 | 100.0% | 20 | 20 | 0 | 0 | 0 |
| | Enterococcus | 40 | 40 | 100.0% | 0 | 0 | N/A | 40 | 40 | 100.0% | 0 | 40 | 0 | 0 | 0 |
| | Streptococcus | 20 | 20 | 100.0% | 0 | 0 | N/A | 20 | 20 | 100.0% | 0 | 20 | 0 | 0 | 0 |
| Tigecycline | Enterobacterales | 80 | 80 | 100.0% | 40 | 40 | 100.0% | 80 | 80 | 100.0% | 60 | 20 | 0 | 0 | 0 |
| | Staphylococcus | 20 | 20 | 100.0% | 0 | 0 | N/A | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| | Enterococcus | 20 | 20 | 100.0% | 0 | 0 | N/A | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| | Streptococcus | 20 | 20 | 100.0% | 0 | 0 | N/A | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Tobramycin | Enterobacterales | 80 | 80 | 100.0% | 20 | 20 | 100.0% | 80 | 80 | 100.0% | 0 | 60 | 0 | 0 | 0 |
| | Non-fermenters | 20 | 20 | 100.0% | 0 | 0 | N/A | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
| Trimethoprim /
Sulfamethoxazole | Enterobacterales | 80 | 80 | 100.0% | 0 | 0 | N/A | 80 | 80 | 100.0% | 0 | 80 | 0 | 0 | 0 |
| Vancomycin | Staphylococcus | 40 | 40 | 100.0% | 20 | 20 | 100.0% | 40 | 40 | 100.0% | 40 | 0 | 0 | 0 | 0 |
| | Enterococcus | 40 | 40 | 100.0% | 40 | 40 | 100.0% | 40 | 40 | 100.0% | 40 | 0 | 0 | 0 | 0 |
| | Streptococcus | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 20 | 100.0% | 20 | 0 | 0 | 0 | 0 |
AST summary of results, antimicrobial agent
Copan WASP S.r.l., Traditional 510(k)- Colibrí
CONFIDENTIAL Page 10
13
Copan WASP S.r.l., Traditional 510(k)- Colibrí
CONFIDENTIAL Page 11
14
AST summary of results, organism group
| Group | Total
tested | # EA | % EA | Total
Evaluable | # EA of
Evaluable | % EA of
Evaluable | Total
categ. | # CA | % CA | # S | # R | #
vmj | #
maj | #
min |
|------------------|-----------------|------|--------|--------------------|----------------------|----------------------|-----------------|------|--------|-----|-----|----------|----------|----------|
| Enterobacterales | 1400 | 1400 | 100.0% | 638 | 638 | 100.0% | 1400 | 1384 | 98.9% | 520 | 720 | 0 | 0 | 16 |
| Non-fermenters | 200 | 200 | 100.0% | 160 | 160 | 100.0% | 200 | 199 | 99.5% | 200 | 0 | 0 | 0 | 1 |
| Staphylococci | 520 | 520 | 100.0% | 179 | 179 | 100.0% | 520 | 520 | 100.0% | 340 | 160 | 0 | 0 | 0 |
| Enterococci | 380 | 380 | 100.0% | 259 | 259 | 100.0% | 380 | 380 | 100.0% | 200 | 120 | 0 | 0 | 0 |
CONFIDENTIAL Page 12
15
| Group | Total
tested | # EA | % EA | Total
Evaluable | # EA of
Evaluable | % EA of
Evaluable | Total
categ. | # CA | % CA | # S | # R | #
vmj | #
maj | #
min |
|--------------|-----------------|------|--------|--------------------|----------------------|----------------------|-----------------|------|--------|-----|-----|----------|----------|----------|
| Streptococci | 220 | 220 | 100.0% | 79 | 79 | 100.0% | 220 | 220 | 100.0% | 180 | 40 | 0 | 0 | 0 |
16
VIII. Non-Clinical and/or Clinical Tests Summary & Conclusions
Conclusions:
The predicate device, Colibrí System and the new device, Colibrí both utilize the same technology for the preparation of the MALDI-TOF targets and the AST microbial suspensions. The minor differences between the devices do not adversely affect safety and effectiveness. The submitted documentation demonstrates that the subject device is substantially equivalent to the predicate device.