BD Kiestra IdentifA

K191964 · Becton, Dickinson and Company · QQV · Nov 3, 2021 · Microbiology

Device Facts

• Record ID: K191964
• Device Name: BD Kiestra IdentifA
• Applicant: Becton, Dickinson and Company
• Product Code: QQV · Microbiology
• Decision Date: Nov 3, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3378
• Device Class: Class 2

Intended Use

The BD Kiestra IdentifA module is an automated in vitro diagnostic specimen preparation system for use with the BD Kiestra Laboratory Automation Solution to prepare MALDI targets for the Bruker MALDI Biotyper CA System for the qualitative identification and differentiation of microorganisms using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) analysis of colonies grown on plated culture media from human specimens. The BD Kiestra IdentifA is indicated for use in the clinical laboratory with the ReadA Compact and Bruker MALDI Biotyper CA System to aid in the diagnosis of bacterial and fungal infections.

Device Story

BD Kiestra IdentifA is an automated specimen preparation system for MALDI-TOF MS analysis. It integrates with the BD Kiestra Laboratory Automation Solution and BD Kiestra ReadA Compact. Input: digital images of plated media from ReadA Compact; technologist-selected colony coordinates. Operation: robotic x-y-z platform picks colonies, suspends them in deionized water, and uses onboard nephelometry to measure McFarland turbidity. The system applies the suspension to Bruker MALDI targets using the extended Direct Transfer method, overlaying formic acid and matrix. Output: prepared MALDI target slide for manual loading into the Bruker MALDI Biotyper CA System. The device automates sample preparation, reducing manual labor. It aids clinicians by providing standardized, reproducible sample preparation for microbial identification, facilitating faster and more consistent diagnostic results for bacterial and fungal infections.

Clinical Evidence

Bench testing only. Evaluated precision/reproducibility of nephelometers (R²=0.994) and identification results across 464 isolates (Gram-positive, Gram-negative, yeast). Accuracy of colony picking was 100% (1200/1200). Identification agreement with manual eDT method was high for bacteria (93.8% Gram-negative, 81.5% Gram-positive concordant ≥2.00 Log score). Yeast identification showed lower concordance, consistent with predicate limitations; labeling instructs manual extraction for low-confidence results. Cross-contamination studies confirmed software control architecture (immediate tip retraction) maintains acceptable performance.

Technological Characteristics

Robotic x-y-z platform; onboard nephelometers for turbidity measurement (McFarland standards); automated pipetting system. Materials: pipette tips, cuvette arrays, reusable/disposable MALDI targets. Energy: electrical. Connectivity: networked via Synapsys Informatics and BeA data interface hub. Software: automated image analysis for colony selection, nephelometry-based suspension adjustment, and robotic spotting. Sterilization: N/A (consumables are sterile/disposable). Standards: IEC 61010-1, 61010-2-010, 61010-2-081, 61010-2-101, IEC 61326-1, 61326-2-6.

Indications for Use

Indicated for use in clinical laboratories to aid in the diagnosis of bacterial and fungal infections by preparing MALDI targets from colonies grown on plated culture media derived from human specimens. For prescription use.

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

• Bruker MALDI Biotyper CA System (DEN170081)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 3, 2021

Becton, Dickinson and Company Laura Stewart Senior Manager Regulatory Affairs 7 Loveton Circle, MC 964 Sparks, Maryland 21152

# Re: K191964

Trade/Device Name: BD Kiestra IdentifA 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: March 13, 2020 Received: March 16, 2020

# Dear Laura Stewart:

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 ([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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K191964

Device Name BD Kiestra™ IdentifA

#### Indications for Use (Describe)

The BD Kiestra IdentifA module is an automated in vitro diagnostic specimen preparation system for use with the BD Kiestra Laboratory Automation Solution to prepare MALDI targets for the Bruker MALDI Biotyper CA System for the qualitative identification and differentiation of microorganisms using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) analysis of colonies grown on plated culture media from human specimens.

The BD Kiestra IdentifA is indicated for use in the clinical laboratory with the BD Kiestra Read Compact and Bruker MALDI Biotyper CA System to aid in the diagnosis of bacterial and fungal infections.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

BD Kiestra™ IdentifA

### Summary Preparation Date:

10/21/2021

Submitted by:

BD Diagnostic Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152

Contact: Laura Stewart Senior Manager Regulatory Affairs Tel: [phone] Fax: [phone] Email: laura.stewart(@bd.com

Proprietary Names: BD Kiestra™ IdentifA

Common Names: BD Kiestra IdentifA

### Regulatory Information

Regulation section: 21 CFR 866.3378 - Clinical mass spectrometry microorganism identification and differentiation device

Classification: Class II

Review Panel: Microbiology

Product Code: QQV, QBN

# Predicate Device

Bruker MALDI Biotyper CA

Similarities and Differences of BD Kiestra™ IdentifA to Predicate

{4}------------------------------------------------

| Becton, Dickinson and Company | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Item | Device:<br>BD Kiestra™ IdentifA | Predicate:<br>Bruker MALDI Biotyper CA System |
| Sample Type | Bacterial colonies isolated from culture on<br>plated media. | Same |
| Method of MALDI<br>target preparation | Extended Direct Transfer Sample<br>Preparation Procedure | Same |
| Amount of organism on<br>target | Meets Bruker Limit of Detection | Same |
| Quality Controls | US IVD Bacterial Test Standard (BTS) | Same |
| Matrix | US IVD HCCA matrix | Same |
| Targets | MBT Biotarget 96 US IVD (96-spot<br>disposable) and US IVD 48 Spot (48-spot<br>reusable) targets | Same |
| Loading of target on<br>Bruker instrument | Manual | Same |
| Differences | | |
| Item | Device:<br>BD Kiestra™ IdentifA | Predicate:<br>Bruker MALDI Biotyper CA System |
| Intended Use | The BD Kiestra IdentifA module is an<br>automated <i>in vitro</i> diagnostic specimen<br>preparation system for use with the BD<br>Kiestra Laboratory Automation Solution to<br>prepare MALDI targets for the Bruker<br>MALDI Biotyper CA System for the<br>qualitative identification and differentiation<br>of microorganisms using matrix-assisted<br>laser desorption/ionization - time of flight<br>mass spectrometry (MALDI-TOF MS)<br>analysis of colonies grown on plated<br>culture media from human specimens.<br>The BD Kiestra IdentifA is indicated for<br>use in the clinical laboratory with the BD<br>Kiestra ReadA Compact and Bruker<br>MALDI Biotyper CA System to aid in in<br>the diagnosis of bacterial and fungal<br>infections. | The MALDI Biotyper CA System is a<br>mass spectrometer system using matrix-<br>assisted laser desorption/ionization - time<br>of flight (MALDI-TOF) for the<br>identification and differentiation of<br>microorganisms cultured from human<br>specimens. The MALDI Biotyper CA<br>System is a qualitative <i>in vitro</i> diagnostic<br>device indicated for use in conjunction<br>with other clinical and laboratory findings<br>to aid in the diagnosis of bacterial and<br>fungal infections. |
| Colony Visualization | Digital image from the BD ReadA<br>Compact | Direct |
| Organism preparation | Suspension in deionized water from<br>organism picked by way of a pipettor | Organism placed directly to target by way<br>of stick. |
| Number of Colonies | Up to 9 per suspension or per spot | One per target spot |
| Alternative methods of<br>MALDI target<br>preparation | None | Direct Transfer (DT) and Extraction (Ext)<br>Sample Preparation Procedure |
| Sample and reagent<br>application | Automated | Manual |
| Drying of targets | 35°C ± 2°C | Ambient temperature |
| Results Achieved | Prepared MALDI target | Identification of the organism |
| Result Reported | None | Identification of the organism |
| Technology | Robotic x-y-z platform using pipettors and<br>onboard nephelometry | Mass spectrometer using matrix-assisted<br>laser desorption/ionization - time of flight<br>(MALDI-TOF) |

{5}------------------------------------------------

### Device Establishment

Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152 Registration Number: 1119779

# Performance Standards

N/A

# Intended Use

The BD Kiestra IdentifA module is an automated in vitro diagnostic specimen preparation system for use with the BD Kiestra Laboratory Automation Solution to prepare MALDI targets for the Bruker MALDI Biotyper CA System for the qualitative identification and differentiation of microorganisms using matrixassisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) analysis of colonies grown on plated culture media from human specimens.

The BD Kiestra Identif A is indicated for use in the clinical laboratory with the BD Kiestra Read A Compact and Bruker MALDI Biotyper CA System to aid in the diagnosis of bacterial and fungal infections.

Special Conditions for Use Statement: For in vitro diagnostic use. For prescription use.

### Special Instrument Requirements:

Standalone or integrated into the BD Kiestra™ Laboratory Automation System

BD Kiestra™ ReadA Compact, v 1.1

MALDI Biotyper CA (Bruker)

# Device Description

The BD Kiestra™ IdentifA is an instrument which automates picking of technologist-selected colonies from plated media and prepares a Bruker MALDI target for identification and differentiation of organisms. The BD Kiestra IdentifA includes the following components (Note: Bruker MALDI targets, Matrix and Bacterial Test Standard (BTS) are required, however, they are obtained directly from Bruker Daltonik GmbH):

- . BD Kiestra IdentifA instrument and software with onboard pipetting and nephelometry.
- . BD formic acid, deionized water, pipet tips, Matrix and BTS transfer vials.
- . BD Kiestra IdentifA nephelometer calibration standards (0.2, 0.5, 1.0 and 3.0 McFarland).
- BD Kiestra IdentifA cuvette array.

When a MALDI identification is ordered by a technologist selects the colonies from an image of a plated medium obtained using the BD Kiestra™ ReadA Compact. The coordinates of the colonies and the plated medium are transferred to BD Kiestra IdentifA where the colonies are picked. The colonies are suspended in deionized water and the onboard nephelometer determines the McFarland turbidity. Based on the McFarland, BD Kiestra IdentifA pipets the organism suspension onto a Bruker MALDI target. The BD Kiestra IdentifA uses the Bruker extended Direct Transfer method for preparation

{6}------------------------------------------------

of the MALDI target by overlaying formic acid and Bruker Matrix onto the target spot. In addition, BTS spots are prepared on the target slide for quality control. Once dried, the technologist manually removes the target and loads onto the Bruker MALDI Biotyper CA System. The BD Kiestra IdentifA transfers the location of sample and BTS spots to the MALDI Biotyper CA. If requested by the technologist, BD Kiestra IdentifA will also dilute the organism suspension to a target of 0.5 McFarland.

The BD Kiestra IdentifA can be used as a standalone instrument or integrated into the BD Kiestra Laboratory Automation System. The standalone instrument utilizes an input/output module for manual plate loading, which handles de-stacking and stacking of plates. When physically integrated into the BD Kiestra Laboratory Automation System, BD Kiestra IdentifA is connected to a track by way of a connection module for automatic plate transfer. BD Kiestra IdentifA software is responsible for the instrument functionality and a touchscreen is mounted on the instrument for user interface.

### Device Comparison

The BD Kiestra™ IdentifA demonstrated substantially equivalent performance when compared with the FDA cleared Bruker MALDI Biotyper CA with manual extended Direct Transfer method. This premarket notification provides data supporting the use of the BD Kiestra™ IdentifA for automated preparation of a MALDI target.

### Summary of Substantial Equivalence1 Testing

The BD Kiestra™ IdentifA has demonstrated substantially equivalent performance when compared to the Bruker MALDI Biotyper CA.

### Analytical Performance

Internal analytical testing confirmed the performance of BD Kiestra IdentifA automated sample processing compared to the FDA cleared Bruker MALDI manual sample processing using the extended Direct Transfer (eDT) method.

### Accuracy of the BD Kiestra IdentifA:

### Colony Picking

The ability of the BD Kiestra IdentifA to pick colonies designated by the operator in the digital image obtained by the BD Kiestra ReadA Compact was evaluated. Two organisms, Escherichia coli and Streptococcus pyogenes, were inoculated on 200 mixed culture plates. Colonies from both isolates on each plate were selected by a technologist and picked by BD Kiestra IdentifA. Picking of each colony was confirmed visually, and prepared target spots were identified on Bruker MALDI Biotyper CA. One thousand two hundred (1,200) colonies (100%) were successfully selected and picked by the BD Kiestra IdentifA, and 400 target spots (100%) provided the expected identification, with Log(score) values ≥ 2.00.

### Organism Identification

Accuracy of organism identification with samples prepared by the BD Kiestra IdentifA was evaluated in the Identification Equivalency Study. A total of 464 isolates of Gram-positive bacteria, Gram-negative bacteria and yeasts were tested using 3 BD Kiestra IdentifA instruments and compared to results by manual sample preparation, i.e. performing the extended Direct Transfer (eDT) Procedure and spotting on

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under which a device can be marketed without pre-market approval or reclassification of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infingement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission aganst interest under the US Patent Laws on the courts.

{7}------------------------------------------------

a MALDI target according to the previously FDA-cleared Bruker MALDI Biotyper CA user manual. Results from both methods of preparation were compared in the table below.

| BD Kiestra IdentifA performance compared to the expected result compared to manual sample preparation: |
|--------------------------------------------------------------------------------------------------------|
| Log(score) |

| | Log(score) | | | | | |
|------------------------|------------|-----------|------------|-------------------|----------|----------|
| Method | Concordant | | Discordant | No Identification | | |
| | ≥2.00 | 1.70-1.99 | ≥2.00 | 1.70-1.99 | <1.70 | No Peaks |
| BD Kiestra<br>IdentifA | 388 (83.6) | 25 (5.4) | 9 (1.9) | 2 (0.4) | 22 (4.7) | 18 (3.9) |
| Manual | 387 (83.4) | 28 (6.0) | 10 (2.2) | 0 (0.0) | 21 (4.5) | 18 (3.9) |

Of the 397 samples with positive organism identification (Log(score) ≥ 2.00), BD Kiestra IdentifA processing yielded 388 (97.7%) of the isolates matching the expected identification. Sample processing with the Bruker manual eDT method yielded 387 (97.5%) of the isolates matching the expected identification. This demonstrates that the BD Kiestra IdentifA performs equivalently to manually prepared samples to provide accurate results on the Bruker MALDI Biotyper CA.

Results from the BD Kiestra IdentifA were compared to the expected result for each isolate to determine agreement in the tables below.

BD Kiestra IdentifA performance compared to the expected result, by species:

{8}------------------------------------------------

#### BD Kiestra™ IdentifA K191964 BD Dia gnostic Systems

BD Kiestra IdentifA agreement in comparison to expected identity for Gram-negative bacteria

| | N | Log(Score) | | | | | |
|-----------------------------------------------|-----|-----------------------------------------------------------------------------------------------------------|---------------|------------|------------|-------------------|-------------|
| Expected Identity | | Concordant | | Discordant | | No Identification | |
| | | ≥2.00 | 1.70-1.99 | ≥2.00 | 1.70-1.99 | <1.70 | No<br>Peaks |
| Acinetobacter baumannii/nosocomialis group | 10 | 10 | 0 | 0 | 0 | 0 | 0 |
| Bacteroides fragilis | 2 | 2 | 0 | 0 | 0 | 0 | 0 |
| Campylobacter coli | 3 | 3 | 0 | 0 | 0 | 0 | 0 |
| Campylobacter jejuni | 3 | 3 | 0 | 0 | 0 | 0 | 0 |
| Campylobacter lari | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Citrobacter amalonaticus complex | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Citrobacter freundii complex | 4 | 4 | 0 | 0 | 0 | 0 | 0 |
| Citrobacter koseri | 9 | 9 | 0 | 0 | 0 | 0 | 0 |
| Eikenella corrodens | 2 | 2 | 0 | 0 | 0 | 0 | 0 |
| Enterobacter aerogenes | 9 | 9 | 0 | 0 | 0 | 0 | 0 |
| Enterobacter cloacae complex | 7 | 7 | 0 | 0 | 0 | 0 | 0 |
| Escherichia coli | 37 | 37 | 0 | 0 | 0 | 0 | 0 |
| Gardnerella vaginalis | 2 | 0 | 1 | $1^2$ | 0 | 0 | 0 |
| Haemophilus influenzae | 4 | 4 | 0 | 0 | 0 | 0 | 0 |
| Haemophilus parainfluenzae | 2 | 2 | 0 | 0 | 0 | 0 | 0 |
| Hafnia alvei | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Klebsiella oxytoca/Raoultella ornithinolytica | 13 | 12 | 0 | 0 | 0 | 0 | 1 |
| Klebsiella pneumoniae | 20 | 19 | 0 | 0 | 0 | 0 | 1 |
| Moraxella sg Branhamella catarrhalis | 2 | 2 | 0 | 0 | 0 | 0 | 0 |
| Morganella morganii | 12 | 12 | 0 | 0 | 0 | 0 | 0 |
| Neisseria gonorrhoeae | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Pantoea agglomerans | 1 | 0 | 0 | 0 | $1^6$ | 0 | 0 |
| Porphyromonas gingivalis | 1 | 0 | 0 | $1^3$ | 0 | 0 | 0 |
| Prevotella oralis | 1 | 0 | 0 | 0 | $1^7$ | 0 | 0 |
| Proteus mirabilis | 9 | 9 | 0 | 0 | 0 | 0 | 0 |
| Proteus vulgaris group | 14 | 11 | 0 | 0 | 0 | 0 | 3 |
| Providencia stuartii | 10 | 8 | 0 | $1^4$ | 0 | 0 | 1 |
| Pseudomonas aeruginosa | 15 | 15 | 0 | 0 | 0 | 0 | 0 |
| Salmonella sp. | 4 | 4 | 0 | 0 | 0 | 0 | 0 |
| Serratia liquefaciens | 2 | 2 | 0 | 0 | 0 | 0 | 0 |
| Serratia marcescens | 14 | 13 | 0 | $1^5$ | 0 | 0 | 0 |
| Shigella sonnei | 3 | 3 | 0 | 0 | 0 | 0 | 0 |
| Stenotrophomonas maltophilia | 5 | 5 | 0 | 0 | 0 | 0 | 0 |
| Total (%) | 224 | 210<br>(93.8) | 1<br>(0.4) | 4<br>(1.8) | 2<br>(0.9) | 1<br>(0.4) | 6<br>(2.7) |
| | | 211<br>(94.2) | | 6<br>(2.7) | | 7<br>(3.1) | |
| | | BD Kiestra IdentifA agreement in comparison to expected identity for Gram-positive bacteria<br>Log(Score) | | | | | |
| Expected Identity | N | Concordant | | Discordant | | No Identification | |
| | | ≥2.00 | 1.70-1.99 | ≥2.00 | 1.70-1.99 | <1.70 | No Peaks |
| Corynebacterium jeikeium | 3 | 3 | 0 | 0 | 0 | 0 | 0 |
| Corynebacterium urealyticum | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Enterococcus avium | 2 | 2 | 0 | 0 | 0 | 0 | 0 |
| Enterococcus casseliflavus | 3 | 3 | 0 | 0 | 0 | 0 | 0 |
| Enterococcus faecalis | 12 | 11 | 0 | 0 | 0 | 0 | 1 |
| Enterococcus faecium | 19 | 17 | 1 | 12 | 0 | 0 | 0 |
| Enterococcus gallinarum | 5 | 5 | 0 | 0 | 0 | 0 | 0 |
| Propionibacterium acnes | 2 | 0 | 1 | 0 | 0 | 1 | 0 |
| Rothia dentocariosa | 3 | 1 | 0 | 0 | 0 | 0 | 2 |
| Staphylococcus aureus | 21 | 20 | 0 | 0 | 0 | 0 | 1 |
| Staphylococcus cohnii | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Staphylococcus epidermidis | 16 | 15 | 0 | 0 | 0 | 1 | 0 |
| Staphylococcus haemolyticus | 6 | 1 | 4 | 0 | 0 | 1 | 0 |
| Staphylococcus hominis | 3 | 3 | 0 | 0 | 0 | 0 | 0 |
| Staphylococcus lugdunensis | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Staphylococcus saprophyticus | 3 | 3 | 0 | 0 | 0 | 0 | 0 |
| Staphylococcus sciuri | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Staphylococcus simulans | 2 | 2 | 0 | 0 | 0 | 0 | 0 |
| Staphylococcus warneri | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Staphylococcus xylosus | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Streptococcus agalactiae | 25 | 24 | 0 | 13 | 0 | 0 | 0 |
| Streptococcus anginosus | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Streptococcus dysgalactiae | 8 | 8 | 0 | 0 | 0 | 0 | 0 |
| Streptococcus gordonii | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Streptococcus infantarius | 1 | 11 | 0 | 0 | 0 | 0 | 0 |
| Streptococcus mitis/oralis group | 4 | 2 | 1 | 0 | 0 | 1 | 0 |
| Streptococcus parasanguinis | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Streptococcus pneumoniae | 32 | 19 | 6 | 14 | 0 | 3 | 3 |
| Streptococcus pyogenes | 10 | 9 | 0 | 15 | 0 | 0 | 0 |
| Total (%) | 189 | 154<br>(81.5) | 15<br>(7.9) | 4<br>(2.1) | 0<br>(0.0) | 9<br>(4.8) | 7<br>(3.7) |
| | | | 169<br>(89.4) | | 4<br>(2.1) | | 16<br>(8.5) |
| | N | Log(Score) | | | | | |
| Expected Identity | | Concordant | | Discordant | | No Identification | |
| | | ≥2.00 | 1.70-1.99 | ≥2.00 | 1.70-1.99 | <1.70 | No Peaks |
| Candida albicans | 8 | 6 | 2 | 0 | 0 | 0 | 0 |
| Candida dubliniensis | 2 | 2 | 0 | 0 | 0 | 0 | 0 |
| Candida glabrata | 5 | 3 | 0 | 0 | 0 | 2 | 0 |
| Candida guilliermondii | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Candida kefyr | 2 | 0 | 2 | 0 | 0 | 0 | 0 |
| Candida parapsilosis | 3 | 1 | 2 | 0 | 0 | 0 | 0 |
| Candida pelliculosa | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Candida sphaerica | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Cryptococcus gattii | 3 | 3 | 0 | 0 | 0 | 0 | 0 |
| Cryptococcus neoformans var. grubii | 2 | 1 | 0 | 0 | 0 | 0 | 1 |
| Cryptococcus neoformans var. neoformans | 3 | 0 | 0 | 12 | 0 | 1 | 1 |
| Cryptococcus neoformans var. Not Known | 1 | 11 | 0 | 0 | 0 | 0 | 0 |
| Geotrichum candidum | 3 | 0 | 1 | 0 | 0 | 2 | 0 |
| Magnusiomyces capitatus | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Pichia angusta | 2 | 0 | 0 | 0 | 0 | 1 | 1 |
| Saccharomyces cerevisiae | 2 | 1 | 1 | 0 | 0 | 0 | 0 |
| Trichosporon aquatile | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Trichosporon asahii | 4 | 3 | 0 | 0 | 0 | 1 | 0 |
| Trichosporon inkin | 2 | 2 | 0 | 0 | 0 | 0 | 0 |
| Trichosporon mucoides group | 2 | 0 | 0 | 0 | 0 | 1 | 1 |
| Ttrichosporon ovoides | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Trichosporon pullulans | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Total (%) | 51 | 24 | 9 | 1 | 0 | 12 | 5 |
| | | (47.1) | (17.6) | (2.0) | (0) | (23.5) | (9.8) |
| | | (64.7) | | (2.0) | | (33.3) | |

Identified as Escherichia coli in accordance with a known Limitation of the Bruker MALDI Biotyper CA

2 Identified as Lactobacillus rhamnosus; concordant with the result obtained with manual sample preparation

3 Identified as Veillonella parvula; concordant with the result obtained with manual sample preparation

4 Identified as Citrobacter freundii complex; concordant with the result obtained with manual sample preparation

5 Identified as Enterobacter cloacae complex; concordant with the result obtained with manual sample preparation

6 Identified as Escherichia species; manual result provided Escherichia vulneris (log score of 2.03)

7 Identified as Bacteroides species; manual result provided unspecified (log score of 1.6)

{9}------------------------------------------------

# BD Kiestra Identif A agreement in comparison to expected identity for Gram-positive bacteria

1 Identified as Streptococcus lutetiensis in accordance with a known Limitation of the Bruker MALDI Biotyper CA

2 Identified as Enterococcus faecalis; concordant with the result obtained with manual sample preparation

3 Identified as Streptococcus pyogenes; concordant with the result obtained with manual sample preparation

4 Identified as Streptococcus mitis/oralis group; concordant with the result obtained with manual sample preparation

5 Identified as Streptococcus agalactiae; concordant with the result obtained with manual sample preparation

{10}------------------------------------------------

### October21,2021

#### BD Kiestra™ IdentifA K191964 BD Dia gnostic Systems

Becton, Dickinson and Company

BD Kiestra IdentifA agreement in comparison to expected identity for yeast

1 Identified as Cryptococcus neoformans var. grubii

2 Identified as Candida lusitaniae; concordant with the result obtained with manual sample preparation

A substantially lower proportion of concordant results for yeast species than for either Gram-positive or Gram-negative bacteria was noted. Consistent with the original Bruker's system, the BD Kiestra IdentifA User's Manual will recommend that yeast species or any samples that produce a Low Confidence Identification or No Identification Result should be manually prepared using the Bruker's Extraction (Ext) Test Procedure and/or an alternative method of organism identification.

Twenty-five (25) isolates included in the study represented species that were not listed in the Bruker MALDI Biotyper CA Reference Library. Both the BD Kiestra IdentifA and Bruker manual eDT method processing accurately yielded no peaks/no identification for these strains not in the Bruker US IVD database on the Bruker MALDI Biotyper CA.

The results of the accuracy study demonstrate that the BD Kiestra IdentifA performs acceptably compared to manually prepared samples to provide accurate results on the Bruker MALDI Biotyper CA.

{11}------------------------------------------------

### Reproducibility of the BD Kiestra IdentifA

Reproducibility of organism identification when performed using the BD Kiestra IdentifA for preparation of samples was evaluated. Strains with known identifications were processed on three BD Kiestra Identif A modules by three groups of technologists using three lots of reagents in triplicate for three days (3 days × 3 replicates × 3 instruments = 27 data points per strain). The inoculated MALDI targets were loaded onto the Bruker MALDI Biotyper CA System for identification. The table below provides the reproducibility data by organism.

| Organism Name | Strain# | No. Tests<br>Performed | No. Log<br>Score<br>≥2.00 | % Agreement |
|----------------------------------------|---------|------------------------|---------------------------|-------------|
| Escherichia coli | 25922 | 27 | 27 | 100% |
| Escherichia coli | 35218 | 27 | 27 | 100% |
| Enterobacter (Klebsiella)<br>aerogenes | 13048 | 27 | 27 | 100% |
| Pseudomonas aeruginosa | 27853 | 27 | 27 | 100% |
| Proteus mirabilis | 10070 | 27 | 27 | 100% |
| Alcaligenes faecalis | 9139 | 27 | 26 | 96% |
| Staphylococcus aureus | 29213 | 27 | 27 | 100% |
| Staphylococcus aureus (MRSA) | 43300 | 27 | 27 | 100% |
| Staphylococcus epidermidis | 274 | 27 | 27 | 100% |
| Enterococcus faecalis | 29212 | 27 | 27 | 100% |
| Streptococcus agalactiae | 9812 | 27 | 27 | 100% |
| Streptococcus pyogenes | 2979 | 27 | 26 | 96% |
| Bacillus cereus | 1059 | 27 | 27 | 100% |
| Corynebacterium jeikeium | 11246 | 27 | 10 | 37% |
| Candida albicans | 18804 | 27 | 20 | 74% |

### BD Kiestra IdentifA Reproducibility by Organism

All except two strains had a Log(score) ≥ 2.00 > 95% of the time between BD Kiestra IdentifA modules, replicates, groups, and lots. Corynebacterium jeikeium and Candida albicans reproducibility were evaluated by manual preparation using the eDT method and also did not meet the acceptance criteria of > 95%. Due to the results of the Bruker manual eDT method, the failure to meet acceptance criteria was not attributed to performance of the BD Kiestra Identif A because this low confidence identification is a property of the original Bruker's system and not the BD Kiestra IdentifA.

The results of the reproducibility study demonstrate that the BD Kiestra Identif A performs equivalently to manually prepared samples to provide reproducible results on the Bruker MALDI Biotyper CA. The results of the Reproducibility Study were determined to be acceptable.

# Limit of Detection of the BD Kiestra IdentifA

The ability of the BD Kiestra IdentifA to obtain the expected organism identification with microbial suspensions at or above the limit of detection as defined for the BD Kiestra IdentifA (0.2 McFarland) was evaluated. Organism suspensions of at least 0.2 McFarland (0.2 - 0.3 McFarland) were inoculated onto eight MALDI target spots and processed on BD Kiestra IdentifA. The MALDI targets were analyzed by the Bruker MALDI Biotyper CA to obtain a log(score).

{12}------------------------------------------------

#### BD Kiestra IdentifA Limit of Detection

| MALDI Identification Performance | | | | |
|-----------------------------------|--------------------------------|--------|--|--|
| | | Result | | |
| | Staphylococcus aureus 25923 | 8/8 | | |
| ram positiy | Enterococcus faecium 19434 | 8/8 | | |
| | Enterococcus faecalis 29212 | 8/8 | | |
| ram negativ | Enterobacter cloacae 13047 | 8/8 | | |
| | Klebsiella pneumoniae 13883 | 8/8 | | |
| | Proteus vulgaris 13315 | 8/8 | | |
| | Pseudomonas aeruginosa 27853 | 8/8 | | |
| | Escherichia coli 25922 | 8/8 | | |
| | Acinetobacter baumannii 19606 | 8/8 | | |
| east | Saccharomyces cerevisiae 1125A | 3/8 | | |

For each organism, 6/8 replicates should result in a correct identification. All of the organisms obtained 8/8 acceptable MALDI identifications except Saccharomyces cerevisiae. For S. cerevisiae, 3/8 replicates produced the expected result and 5/8 were reported as "No Peaks." There were no incorrect identifications for any organism. The inability to obtain a High Confidence Identification when the concentration of yeast in a sample is at the low end of the specified range for turbidity is noted. Consistent with the original Bruker's system, the BD Kiestra IdentifA User's Manual recommends that yeast species or any samples that produce a Low Confidence Identification or No Identification Result should be manually prepared using the Bruker's Extraction (Ext) Test Procedure and/or use an alternative method of organism identification. The concentration of organisms present near the LoD for the BD Kiestra IdentifA (0.2 to 0.3 McFarland) was shown to be equivalent to the claimed LoD for the manual extended Direct Transfer (eDT) method of sample preparation for the Bruker MALDI Biotyper CA (CFU/target spot).

### Cross-contamination of BD Kiestra IdentifA

A cross-contamination study was performed in support of the original 510(k) submission. Since the original submission, multiple software updates were made including a modification to remove a delay in pipette tip retraction during target spotting, and further validations were performed. A final crosscontamination study was performed on the most updated software version for the candidate device and is described below.

A cross-contamination study was conducted to evaluate the potential for cross-contamination using the BD Kiestra IdentifA within and between culture plates and between spots o…