Colibrí

K232756 · Copan Wasp Srl · LON · Dec 27, 2023 · Microbiology

Device Facts

• Record ID: K232756
• Device Name: Colibrí
• Applicant: Copan Wasp Srl
• Product Code: LON · Microbiology
• Decision Date: Dec 27, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

Intended 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 systems or Bruker MALDI Biotyper CA mass spectrometry systems for qualitative identification and microbial suspension for the bioMérieux VITEK 2 systems or Beckman Coulter MicroScan WalkAway Antimicrobial Susceptibility Testing (AST) systems 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. 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.

Device Story

Colibrí is an automated pre-analytical processor integrated with WASPLab; it automates colony picking, MALDI-TOF target slide preparation, and microbial suspension preparation for AST. Input: isolated bacterial colonies from solid agar plates identified via WASPLab barcode and digital imaging. Operation: operator selects colonies on a GUI; instrument uses a pipetting system to pick colonies and transfer them to target slides (for ID) or primary/secondary tubes (for AST). Nephelometer on-board ensures correct microbial concentration for AST suspensions. Output: prepared MALDI-TOF targets and AST microbial suspensions. Used in clinical microbiology laboratories by trained personnel. Output affects clinical decision-making by providing standardized, automated sample preparation for downstream ID and AST analyzers, reducing manual variability and potential for human error. Benefits include increased laboratory workflow efficiency and standardized sample quality for diagnostic testing.

Clinical Evidence

Bench testing only. Reproducibility study (n=2,619 MIC results) demonstrated combined best-case reproducibility ≥95% and worst-case ≥89%. Accuracy study compared Colibrí-prepared samples to manual preparation across 110 clinical isolates (Enterobacterales, Staphylococci, Streptococci, Enterococci, non-fermenters) using 29 antimicrobial agents. Results showed 100% Essential Agreement (1232/1232) and 98.4% Category Agreement (4187/4254) with no major or very major errors. Microbial suspension concentration accuracy was 98.5% (130/132) within expected ranges.

Technological Characteristics

Automated robotic pipetting system; on-board nephelometer for turbidity measurement; integrated camera units for positioning. Connectivity: Electronic communication with MALDI-TOF MS analyzers. Software-controlled workflow. Calibration: Auto-calibration of nephelometer and cameras; daily nephelometer verification. Materials: Pipette tips, primary/secondary tubes, spreader. Sterilization: On-board incinerator for spreader.

Indications for Use

Indicated for trained healthcare professionals in clinical laboratories to prepare MALDI-TOF targets for bacterial identification and microbial suspensions for AST (using bioMérieux VITEK 2 or Beckman Coulter MicroScan WalkAway systems) from isolated colonies of gram-negative and gram-positive bacteria grown on solid culture media. Not indicated for yeast, molds, Nocardia, or mycobacteria.

Regulatory Classification

Identification

A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”

Predicate Devices

• Colibrí (K223245)

Submission Summary (Full Text)

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December 27, 2023

Copan WASP S.r.l. Chiara Congiu Regulatory Affairs Manager Via A. Grandi, 32 Brescia, Brescia 25125 Italy

### Re: K232756

Trade/Device Name: Colibrí Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON, QQV, QBN Dated: September 8, 2023 Received: September 8, 2023

### 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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 -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

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## Indications for Use

510(k) Number (if known) K232756

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 systems or Bruker MALDI Biotyper CA mass spectrometry systems for qualitative identification and microbial suspension for the bioMérieux VITEK 2 systems or Beckman Coulter MicroScan WalkAway Antimicrobial Susceptibility Testing (AST) systems for qualitative testing of gramnegative and gram-positive bacterial species grown on solid culture media.

The Colibri is an automated 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 Antimiorobial 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
| CONTINUE ON A SEPARATE PAGE IF NEEDED | |

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#### Submitter I.

| Applicant Name: | Copan WASP Srl |
|------------------------------------|---------------------------------|
| | Via A. Grandi 32 |
| | 25125 Brescia, Italy |
| | [phone] |
| | [e-mail] |
| | |
| Contact Person | Chiara Congiu |
| | Copan WASP Srl |
| | Via A. Grandi 32 |
| | 25125 Brescia, Italy |
| | [phone] |
| | [e-mail] |
| | |
| Establishment Registration Number: | 3009288740 |
| | |
| Date Prepared: | September 08, 2023 |

#### II. Device Name

| Proprietary Name | Colibrí |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name | Colibrí |
| Classification Name | Clinical mass spectrometry microorganism identifica-<br>tion and differentiation system (21 CFR 866.3378)<br>Fully automated short-term incubation cycle antimicro-<br>bial susceptibility system (21 CFR 866.1645) |
| Device Class | II |
| Product Code | QQV, QBN, LON |
| Panel | Microbiology |

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#### III. Legally Marketed Predicate Device

| Device Name | Colibrí |
|---------------|---------|
| 510(K) Number | K223245 |

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 systems or the Bruker MALDI Biotyper CA systems that are used in clinical laboratories for identification and differentiation of organisms grown on plated media by Matrix-Assisted Laser Desorption/Jonization Time-of Flight Mass Spectrometry (MALDI-TOF MS). The Colibri automates the preparation of microbial suspensions at known concentration for bioMérieux VITEK 2 systems and Beckman Coulter MicroScan WalkAway systems that are 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 Collbri 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 systems, the Colibri 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

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the Bruker MALDI Biotyper CA systems, 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 systems or the Beckman Coulter MicroScan WalkAway systems, the Colibri 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 Colibri 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. Auto-calibration 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. Runtime 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 Colibrí is an automated in vitro diagnostic specimen preparation system for use with WASPLab to prepare MALDI-TOF targets for the bioMérieux VITEK MS systems or Bruker MALDI Biotyper CA mass spectrometry systems for qualitative identification and microbial suspension for the bioMérieux VITEK 2 systems or Beckman Coulter MicroScan WalkAway Antimicrobial Susceptibility Testing (AST) systems 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.

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.

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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.

This submission aims to demonstrate the suitability of AST microbial suspensions prepared by Colibrí for processing with MicroScan WalkAway analyzers.

| Similarities | | | |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Item | New Device | Predicate Device | |
| Device Name<br>(K number) | Colibrí | Colibrí (K223245) | |
| 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<br>From Cultured Isolates By Mass Spectrometry<br>QBN, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates<br>LON, System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | QQV, Automated System For Sample Preparation And Identification Of Microorganisms<br>From Cultured Isolates By Mass Spectrometry<br>QBN, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates<br>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 systems or Bruker MALDI Biotyper CA mass spectrometry systems for qualitative identification and microbial suspension for the bioMérieux VITEK 2 systems or Beckman Coulter MicroScan WalkAway Antimicrobial Susceptibility Testing (AST) systems for qualitative testing of isolated colonies of gram-negative and gram-positive bacterial species grown on solid culture media.<br>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.<br>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.<br>Bacterial suspensions for AST and purity plates are identified by barcode label.<br>The Colibrí is intended for use by trained healthcare professionals in clinical laboratories | 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 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.<br>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.<br>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.<br>Bacterial suspensions for AST and purity plates are identified by barcode label.<br>The Colibrí™ is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory | |
| | Similarities | | |
| Item | New Device<br>Colibrí | Predicate Device<br>Colibrí (K223245) | |
| Device Name<br>(K number) | in conjunction with other clinical and labora-<br>tory findings, including Gram staining, to aid in<br>the diagnosis of bacterial infections.<br>The Colibrí has not been validated for use in the<br>identification or processing of yeast species,<br>molds, Nocardia, or mycobacteria. | findings, including Gram staining, to aid in the<br>diagnosis of bacterial infections.<br>The Colibrí™ has not been validated for use in<br>the identification or processing of yeast species,<br>molds, Nocardia, or mycobacteria. | |
| Method of testing | Direct testing from isolated colonies for ID<br>purposes in conjunction with bioMérieux<br>VITEK MS systems or Bruker MALDI Bio-<br>typer CA systems.<br>Direct testing from isolated colonies for AST<br>purposes in conjunction with bioMérieux<br>VITEK 2 systems or Beckman Coulter Mi-<br>croScan WalkAway systems. | Direct testing from isolated colonies for ID<br>purposes in conjunction with bioMérieux<br>VITEK MS systems or Bruker MALDI Bio-<br>typer CA systems.<br>Direct testing from isolated colonies for AST<br>purposes in conjunction with bioMérieux<br>VITEK 2 systems. | |
| Sample/Media Type | Isolated bacterial colonies from any patient<br>source grown on plates included in K193138,<br>K220546 and K223245. | Same | |
| Plate management | Automatic image capturing management and<br>manual loading into instrument for picking ac-<br>tivities. | Same | |
| Colonies selection | The colony to be picked is selected by an oper-<br>ator on a digital plate using a Graphical User<br>Interface on a dedicated workstation. | Same | |
| Method of Colony Picking | Automatic picking of colonies using pipette<br>tips. | Same | |
| ID Target preparation | When connected with VITEK MS systems, a<br>portion of microbial colony from an agar plate<br>is automatically spotted on a VITEK MS-DS<br>target slide (VITEK MS DS Target Slides, 48<br>positions disposable plastic targets) by using<br>the pipetting system. 1µL of matrix is automat-<br>ically applied to the spot using the pipetting<br>system. The dried target slide is then manually<br>loaded into the VITEK MS system.<br>When connected with MALDI Biotyper CA<br>systems, a portion of microbial colony from an<br>agar plate is automatically spotted on a Bruker<br>Target Plate (IVD 48 Spot Target plate or<br>MBT Biotarget 96 US IVD) by using the pi-<br>petting system. 1µL of matrix is automatically<br>applied to the spot using the pipetting system.<br>The dried target slide is then manually loaded<br>into the MALDI Biotyper CA systems. | Same | |
| AST Suspension Preparation for VITEK 2 | Using a pipetting system, a predefined number<br>of morphologically similar colonies are trans-<br>ferred into Primary Tube containing saline so-<br>lution (0.45% NaCl Saline Solution pH 4.5 to<br>7.0). A homogenous heavy suspension of or-<br>ganisms is prepared and checked by using on-<br>board Colibrí nephelometer. In the Secondary<br>Tube containing 3.0mL of the same saline solu-<br>tion, a variable aliquot of the heavy suspension<br>is automatically transferred to obtain the final<br>microbial concentration according to IVD<br>package insert indications. The suspensions<br>prepared by Colibrí must be tested in<br>MANUAL MODE on the VITEK 2 systems. | Same | |
| Calibration | Colibrí requires four different calibrations, one<br>on the nephelometer, three on the cameras. | Same | |
| Similarities | | | |
| Item | New Device | Predicate Device | |
| Device Name<br>(K number) | Colibrí | Colibrí (K223245) | |
| Preparatory activities | None of these calibration activities require<br>user intervention.<br>Nephelometer verification by check using<br>Daily verification Kit. | Same | |
| Quality control | Completely dependent on next-step IVD analyzers. | Same…