VITEK® MS PRIME is a mass spectrometry system using matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens.

The VITEK® MS PRIME system is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.

Device Description

This 510(k) submission introduces the VITEK®MS PRIME System. The VITEK® MS PRIME is intended for laboratory use by professional users who are trained in microbiology and good laboratory practices.

The VITEK® MS PRIME makes microorganism identifications via matrix-assisted laser desorption/ionization - time of flight mass spectrometry (MALDI-TOF MS) technology, which includes the three basic principles of ionization, separation, and detection,

As a first step, a VITEK® MS-DS Target Slide is prepared in accordance with the instructions for use.

NOTE: Depending on the culture, the analyte sample (i.e. microorganism from cultured media) may be directly spotted to a target slide, or for Mycobacterium. Nocardia and mould it must be processed/inactivated before adding to the target slide.

Once the specimen (cultured from the appropriate media) is spotted to the target slide, a matrix is added for the purpose of easy sublimation and strong absorbance in the laser wavelength employed by theinstrument.

NOTE: The VITEK® MS PRIME is a Class 1 laser product, containing a Class 4 Neodymium-doped yttrium lithium fluoride (Nd:YLF) laser – the laser operates at a wavelength of 349 nm.

The prepared slide is then loaded onto the VITEK®MS PRIME instrument. where a laser targets the sample spot and pulses the isolate spot, resulting in vibrational excitation of matrix and analyte molecules. The matrix transfer protons to the analyte resulting in a positive charge. So as part of the first basic principle, the ionized molecules are then accelerated in an electromagnetic field and a grid electrode in the ionization chamber.

The acceleration in the electromagnetic field is the beginning of the second basic principle (i.e. the separation process that is based of the time-of-flight principle). The velocity of the molecules depends on the mass-to-charge (m/z) ratio of the analyte, with heavier molecules having a higher moment of inertia resulting in a lower velocity.

As a final step in the basic principle of MALDI-ToF technology (i.e. detection) the time of flight is measured precisely by the ions arrival at a particle detector. This speed of the ions in flight depends on their mass - with heavier molecules having a higher moment of inertia resulting in a lower velocity. The time of transit is measured precisely by the ions' arrival at a particle detector. Based on the time of flight, the m/z ratio of each particle can be determined, and a mass spectrum of the analyte sample mixture is generated. The recorded signal is processed and presented as a spectrum of intensity versus mass in Daltons (Da). The mass spectrum displays results as a series of peaks (spectrum) which correspond to the ionized proteins derived from the analyte sample. And for identification of an unknown organism, the resulting mass spectra are sufficiently distinctive to allow taxonomic characterization at the genus and species when compared against the VITEK® MS Knowledge Base.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VITEK® MS PRIME, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Minimum Agreement)	Reported Device Performance (VITEK® MS PRIME)
Biological Equivalency	95% Agreement (compared to reference method)	99.7% Agreement (1456/1461, excluding discordant IDs and No IDs)
Correct single choice ID or low discrimination to correct genus (Gram-positive)	Not explicitly stated, but within overall 95%	99.0%
Correct single choice ID or low discrimination to correct genus (Gram-negative)	Not explicitly stated, but within overall 95%	97.2%
Correct single choice ID or low discrimination to correct genus (Yeast)	Not explicitly stated, but within overall 95%	100%
Correct single choice ID or low discrimination to correct genus (Mycobacteria - solid culture)	Not explicitly stated, but within overall 95%	100%
Correct single choice ID or low discrimination to correct genus (Mycobacteria - liquid culture)	Not explicitly stated, but within overall 95%	97.62%
Correct single choice ID or low discrimination to correct genus (Moulds)	Not explicitly stated, but within overall 95%	97.4%
Correct single choice ID or low discrimination to correct genus (Nocardia)	Not explicitly stated, but within overall 95%	100%
Discordant Identification Rate (Biological Equivalency)	Not explicitly stated, but implied to be low	0.3% (5/1461)
No Identification Rate (Biological Equivalency)	Not explicitly stated, but implied to be low	1.6% (23/1461)
Clinical Performance Evaluation (Overall, including/excluding No IDs)	95% Agreement (compared to reference method)	98.4% (492/500)
Clinical Performance (Overall, excluding No ID results)	95% Agreement (compared to reference method)	99.6% (492/494)
Correct single choice ID or low discrimination to correct genus (Gram-positive)	Not explicitly stated, but within overall 95%	99.3%
Correct single choice ID or low discrimination to correct genus (Gram-negative)	Not explicitly stated, but within overall 95%	98.8%
Correct single choice ID or low discrimination to correct genus (Yeast)	Not explicitly stated, but within overall 95%	95.3%
Correct single choice ID or low discrimination to correct genus (Mycobacteria)	Not explicitly stated, but within overall 95%	100%
Correct single choice ID or low discrimination to correct genus (Moulds)	Not explicitly stated, but within overall 95%	98.0%
Correct single choice ID or low discrimination to correct genus (Nocardia)	Not explicitly stated, but within overall 95%	100%
Discordant Identification Rate (Clinical Performance)	Not explicitly stated, but implied to be low	0.4% (2/500)
No Identification Rate (Clinical Performance)	Not explicitly stated, but implied to be low	1.2% (6/500)
Challenge Isolate Results	Not explicitly stated, but implied to be high agreement, no misidentifications/no IDs	100.0% (100/100) agreement, no No IDs, no discrepant results
Quality Control Results	Not explicitly stated, but implied to be high agreement	98.3% agreement
Reproducibility Results	Not explicitly stated, but implied to be high agreement	99.5% agreement

2. Sample Sizes Used for the Test Set and Data Provenance:

Biological Equivalency Study:
- Sample Size: 1461 samples (representing 487 unique tests in triplicate).
- Data Provenance: Not explicitly stated, but the strains tested included "critical pathogens" for the 479 claimed species. It is likely a combination of well-characterized laboratory strains and potentially some clinical isolates, given the reference to "clinically validated isolates." retrospective or prospective is not mentioned.
Clinical Performance Evaluation:
- Sample Size: 500 clinical isolates (from 100 species with five strains each).
- Data Provenance: "clinical isolates tested from all sites combined." The specific countries of origin are not specified, but the data is explicitly from "clinical isolates," suggesting data from human specimens. The study design of using "clinical isolates" usually implies retrospective or prospectively collected samples from clinical settings. It refers to "reference identification obtained during previous clinical studies," suggesting a retrospective use of previously characterized clinical data.
Challenge Isolate Results:
- Sample Size: 100 challenge strains.
- Data Provenance: Not specified, but "challenge strains" often refers to a curated set of difficult-to-identify or representative strains used for rigorous testing.
Quality Control Results:
- Sample Size: Not explicitly stated, but refers to "all quality control strains tested at all sites."
Reproducibility Results:
- Sample Size: Not explicitly stated, but refers to "Reproducibility strains."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not directly state the number of experts or their qualifications.
For the Clinical Performance Evaluation, the ground truth was established by "a one choice or multiple choice (more than one species) reference identification obtained during previous clinical studies." This implies that the reference identifications were well-established and accepted, likely through conventional microbiological methods and expert interpretation from those previous studies. The nature of these "previous clinical studies" (e.g., whether they involved expert consensus or a gold standard method) is not detailed.

4. Adjudication Method for the Test Set:

The document does not explicitly describe an adjudication method for the test set results. The ground truth for the clinical performance evaluation was "reference identification obtained during previous clinical studies," implying that disagreements with a single reference standard were likely noted as discordant results rather than undergoing a separate adjudication process within this specific study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. This device (VITEK® MS PRIME) is an automated system for microorganism identification using MALDI-TOF MS technology, which does not involve human readers interpreting results in the same way an imaging AI algorithm would. Its performance is compared to a reference method, not to human readers' performance with and without AI assistance.

6. Standalone Performance:

Yes, a standalone performance study was done. Both the "Biological Equivalency study" and "Clinical Performance Evaluation" describe the performance of the VITEK® MS PRIME system alone (algorithm only) in identifying microorganisms, comparing its results to a ground truth or reference identification. The stated agreement rates (e.g., 98.4% clinical agreement) are measures of this standalone performance. The device is described as "a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings," but the performance metrics provided are for the device's identification capability itself.

7. Type of Ground Truth Used:

The ground truth used appears to be reference identification by accepted microbiological methods (which implicitly includes expert consensus in their establishment).
- For the Biological Equivalency study, performance was measured "in comparison with the reference method."
- For the Clinical Performance Evaluation, performance was determined by comparing the VITEK® MS PRIME identification to "a one choice or multiple choice (more than one species) reference identification obtained during previous clinical studies." This "reference identification" would be established through a combination of traditional culture-based methods, molecular methods, and expert interpretation/consensus over time, serving as the gold standard for organism identification. "Outcomes data" or "pathology" as the direct ground truth are not mentioned for identifying the microorganisms themselves, though the device aids in diagnosis of infections.

8. Sample Size for the Training Set:

The document does not explicitly state the sample size for the training set. It refers to a "VITEK® MS Knowledge Base" (KB v3.2) against which the mass spectra are compared. This knowledge base is the "training set" or reference library. The complexity and size of this knowledge base are not detailed in terms of number of samples/isolates used to build it.

9. How the Ground Truth for the Training Set Was Established:

The document states that identifications are made "when compared against the VITEK® MS Knowledge Base." While it doesn't describe the exact process for building this KB, such knowledge bases for MALDI-TOF MS systems are typically built by:
- Acquisition of mass spectra from a large collection of well-characterized and phenotypically/genetically confirmed (often by sequencing, biochemical tests, or other gold-standard methods) reference strains across various species.
- Each reference strain's identity is verified by expert microbiologists using established methods before being added to the database.
- The collection process ensures reproducibility and representation of intra-species variability.
- Thus, the ground truth for the training set (Knowledge Base) is established through a rigorous process of expert-validated identification using traditional and molecular microbiological gold standards.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

bioMerieux, Inc. Nathan Hardesty Sr. Manager, Regulatory Affairs Microbiology 595 Anglum Rd. Hazelwood, Missouri 63042

March 15, 2022

Re: K212461

Trade/Device Name: Vitek MS Prime Regulation Number: 21 CFR 866.3378 Regulation Name: Clinical Mass Spectrometry Microorganism Identification And Differentiation System Regulatory Class: Class II Product Code: QBN Dated: August 3, 2021 Received: August 6, 2021

Dear Nathan Hardesty:

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

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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 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 (OS) 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,

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) To be assigned

Device Name VITEK® MS PRIME

Indications for Use (Describe)

(See Attached for 'List of Claimed Organisms')

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Indications for Use Attachment

List of Claimed Organisms

Gram Negative / Positive Bacteria & Yeast

Abiotrophia defectiva Achromobacter denitrificans Achromobacter xylosoxidans Acinetobacter baumannii Acinetobacter calcoaceticus Acinetobacter haemolyticus Acinetobacter johnsonii Acinetobacter junii Acinetobacter lwoffii Acinetobacter nosocomialis Acinetobacter pittii Actinomyces bovis Actinomyces israelii Actinomyces meyeri Actinomyces naeslundii Actinomyces neuii Actinomyces odontolyticus Actinotignum schaalii Aerococcus viridans Aeromonas hydrophila Aeromonas jandaei Aeromonas punctata (caviae) Aeromonas sobria Aggregatibacter actinomycetemcomitans Aggregatibacter aphrophilus Aggregatibacter segnis Alcaligenes faecalis ssp faecalis Bacteroides caccae Bacteroides eggerthii Bacteroides fragilis Bacteroides ovatus / xylanisolvens Bacteroides pyogenes Bacteroides stercoris Bacteroides thetaiotaomicron Bacteroides uniformis Bacteroides vulgatus Bifidobacterium spp Bilophila wadsworthia Bordetella avium Bordetella bronchiseptica Bordetella parapertussis Bordetella pertussis Brevundimonas diminuta Brevundimonas vesicularis Brucella spp

Burkholderia cenocepacia Burkholderia cepacia Burkholderia contaminans Burkholderia gladioli Burkholderia multivorans Burkholderia vietnamiensis Campylobacter coli Campylobacter jejuni Campylobacter rectus Candida albicans Candida auris Candida dubliniensis Candida duobushaemulonii Candida famata Candida glabrata Candida guilliermondii Candida haemulonii Candida inconspicua Candida intermedia Candida kefyr Candida krusei Candida lambica Candida lipolytica Candida lusitaniae Candida metapsilosis Candida norvegensis Candida orthopsilosis Candida parapsilosis Candida pelliculosa Candida rugosa Candida tropicalis Candida utilis Candida zeylanoides Cedecea davisae Cedecea lapagei Cedecea neteri Chryseobacterium gleum Chryseobacterium indologenes Citrobacter amalonaticus Citrobacter braakii Citrobacter farmeri Citrobacter freundii Citrobacter koseri Citrobacter youngae Clostridium baratii Clostridium beijerinckii Clostridium butyricum Clostridium cadaveris

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Clostridium clostridioforme Clostridium difficile Clostridium innocuum Clostridium novyi Clostridium perfringens Clostridium ramosum Clostridium septicum Clostridium sporogenes Clostridium tertium Clostridium tetani Comamonas testosteroni Corynebacterium jeikeium Cronobacter muytjensii Cronobacter sakazakii Cronobacter turicensis Cryptococcus gattii Cryptococcus neoformans Curtobacterium flaccumfaciens Delftia acidovorans Edwardsiella hoshinae Edwardsiella tarda Eikenella corrodens Elizabethkingia anophelis Elizabethkingia meningoseptica Elizabethkingia miricola Enterobacter aerogenes Enterobacter cloacae Enterobacter asburiae Enterobacter cancerogenus Enterobacter hormaechei Enterobacter kobei Enterobacter ludwigii Enterococcus avium Enterococcus casseliflavus Enterococcus durans Enterococcus faecalis Enterococcus faecium Enterococcus gallinarum Enterococcus hirae Escherichia coli Escherichia fergusonii Escherichia hermannii Escherichia vulneris Ewingella americana Finegoldia magna Fusobacterium mortiferum Fusobacterium necrophorum Fusobacterium nucleatum Fusobacterium periodonticum Gardnerella vaginalis

Gemella haemolysans Gemella morbillorum Granulicatella adiacens Haemophilus influenzae Haemophilus parahaemolyticus Haemophilus parainfluenzae Hafnia alvei Hathewaya histolytica Kingella denitrificans Kingella kingae Klebsiella oxytoca Klebsiella pneumoniae Kluyvera ascorbata Kluyvera cryocrescens Kluyvera intermedia Kocuria rhizophila Kodamaea ohmeri Lactococcus garvieae Lactococcus lactis Leclercia adecarboxylata Legionella pneumophila Lelliottia amnigena Leuconostoc mesenteroides Leuconostoc pseudomesenteroides Listeria monocytogenes Malassezia furfur Malassezia pachydermatis Mannheimia haemolytica Micrococcus luteus Mobiluncus curtisii Moraxella catarrhalis Moraxella lacunata Moraxella nonliquefaciens Moraxella osloensis Morganella morganii Myroides spp Neisseria cinerea Neisseria gonorrhoeae Neisseria meningitidis Neisseria mucosa / sicca Ochrobactrum anthropi Oligella ureolytica Oligella urethralis Paeniclostridium sordellii Pantoea agglomerans Pantoea dispersa

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Paraclostridium bifermentans Parvimonas micra Pasteurella aerogenes Pasteurella multocida Pediococcus acidilactici Peptoniphilus asaccharolyticus Peptostreptococcus anaerobius Plesiomonas shigelloides Pluralibacter gergoviae Porphyromonas asaccharolytica / uenonis Porphyromonas gingivalis Prevotella bivia Prevotella buccae Prevotella denticola Prevotella intermedia Prevotella loescheii Prevotella melaninogenica Prevotella oralis Prevotella oris Propionibacterium acidipropionici Propionibacterium acnes Propionibacterium avidum Propionibacterium granulosum Propionibacterium propionicum Proteus mirabilis Proteus penneri Proteus vulgaris Providencia alcalifaciens Providencia rettgeri Providencia rustigianii Providencia stuartii Pseudomonas aeruginosa Pseudomonas alcaligenes Pseudomonas fluorescens Pseudomonas luteola Pseudomonas mendocina Pseudomonas oryzihabitans Pseudomonas putida Pseudomonas stutzeri Ralstonia pickettii Raoultella ornithinolytica Raoultella planticola Raoultella terrigena Rhizobium radiobacter Rhodotorula mucilaginosa Rothia mucilaginosa Saccharomyces cerevisiae Salmonella enterica ssp enterica Saprochaete capitata Serratia ficaria

Serratia fonticola Serratia grimesii Serratia liquefaciens Serratia marcescens Serratia odorifera Serratia plymuthica Serratia proteamaculans Serratia quinivorans Serratia rubidaea Shewanella putrefaciens Sphingobacterium multivorum Sphingobacterium spiritivorum Sphingomonas paucimobilis Staphylococcus aureus Staphylococcus auricularis Staphylococcus capitis Staphylococcus chromogenes Staphylococcus cohnii ssp cohnii Staphylococcus cohnii ssp urealyticus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus hyicus Staphylococcus intermedius Staphylococcus kloosii Staphylococcus lentus Staphylococcus lugdunensis Staphylococcus pseudintermedius Staphylococcus saprophyticus Staphylococcus schleiferi Staphylococcus sciuri Staphylococcus simulans Staphylococcus warneri Staphylococcus xylosus Stenotrophomonas maltophilia Streptococcus agalactiae Streptococcus alactolyticus Streptococcus anginosus Streptococcus canis Streptococcus constellatus Streptococcus cristatus Streptococcus dysgalactiae ssp dysgalactiae Streptococcus dysgalactiae ssp equisimilis Streptococcus equi ssp equi Streptococcus equi ssp zooepidemicus Streptococcus equinus Streptococcus gallolyticus ssp gallolyticus Streptococcus gallolyticus ssp pasteurianus Streptococcus gordonii

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Streptococcus infantarius ssp coli (Str.lutetiensis) Streptococcus infantarius ssp infantarius Streptococcus intermedius Streptococcus mitis / Streptococcus oralis Streptococcus mutans Streptococcus parasanguinis Streptococcus pneumoniae Streptococcus pseudoporcinus Streptococcus pyogenes Streptococcus salivarius ssp salivarius Streptococcus sanguinis Streptococcus sobrinus Streptococcus suis Streptococcus uberis Streptococcus vestibularis Tannerella forsythia Veillonella dispar Vibrio alginolyticus Vibrio cholerae Vibrio fluvialis Vibrio metschnikovii Vibrio mimicus Vibrio parahaemolyticus Vibrio vulnificus Yersinia aldovae Yersinia enterocolitica Yersinia frederiksenii Yersinia intermedia Yersinia kristensenii Yersinia pseudotuberculosis Yersinia ruckeri

Mycobacterium

Mycobacterium abscessus Mycobacterium avium Mycobacterium chelonae Mycobacterium fortuitum group Mycobacterium gordonae Mycobacterium haemophilum Mycobacterium immunogenum Mycobacterium intracellulare Mycobacterium kansasii Mycobacterium lentiflavum Mycobacterium malmoense Mycobacterium marinum Mycobacterium mucogenicum Mycobacterium scrofulaceum Mycobacterium simiae

Mycobacterium smegmatis Mycobacterium szulgai Mycobacterium tuberculosis complex Mycobacterium xenopi

Nocardia

Nocardia abscessus Nocardia africana / nova Nocardia asteroides Nocardia brasiliensis Nocardia cyriacigeorgica Nocardia farcinica Nocardia otitidiscaviarum Nocardia paucivorans Nocardia pseudobrasiliensis Nocardia transvalensis Nocardia veterana Nocardia wallacei

Mould

Acremonium sclerotigenum Alternaria alternata Aspergillus brasiliensis Aspergillus calidoustus / ustus Aspergillus flavus / oryzae Aspergillus fumigatus Aspergillus lentulus Aspergillus nidulans Aspergillus niger complex Aspergillus sydowii Aspergillus terreus complex Aspergillus versicolor Blastomyces dermatitidis Cladophialophora bantiana Coccidioides immitis / posadasii Curvularia hawaiiensis Curvularia spicifera Epidermophyton floccosum Exophiala dermatitidis Exophiala xenobiotica Exserohilum rostratum Fusarium oxysporum complex Fusarium proliferatum Fusarium solani complex Histoplasma capsulatum Lecythophora hoffmannii Lichtheimia corymbifera Microsporum audouinii

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Microsporum canis Microsporum gypseum Mucor racemosus complex Paecilomyces variotii complex Penicillium chrysogenum Pseudallescheria boydii Purpureocillium lilacinum Rasamsonia argillacea complex Rhizopus arrhizus complex Rhizopus microsporus complex Sarocladium kiliense Scedosporium apiospermum

Scedosporium prolificans Sporothrix schenckii complex Trichophyton interdigitale Trichophyton rubrum Trichophyton tonsurans Trichophyton verrucosum Trichophyton violaceum Trichosporon asahii Trichosporon dermatis / mucoides Trichosporon inkin

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Image /page/8/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue circle on top of a yellow and green semi-circle. The word "BIOMÉRIEUX" is written in white letters inside the blue circle.

510(k) SUMMARY

VITEK®MS PRIME

A. 510(k) Submission Information:

Submitter's Name:	bioMerieux, Inc. on behalf of bioMérieux SA
ManufacturerAddress:	3 Route de Port MichaudLa Balme les Grottes, 38390 (France)
Contact Person:	Nathan HardestyAssociate Director, Regulatory Affairs Microbiology
Phone Number:	314-731-8666
Fax Number:	314-731-8689
Date of Preparation:	March 2, 2022

B. Device Name and Classification:

Formal/Trade Name:	VITEK® MS PRIME
Regulation:	21 CFR 866.3378
Classification Name:	Clinical Mass Spectrometry MicroorganismIdentification and Differentiation System
Common Name:	VITEK MS PRIME

C. Predicate Device:

VITEK®MS (K181412)

Item	Device:VITEK® MS PRIME	Predicate:VITEK® MS(K181412)
Similarities
Intended Use	VITEK® MS PRIME is a massspectrometry system using matrix-assisted laser desorption /ionization time of flight massspectrometry (MALDI-TOF MS)for the identification ofmicroorganisms cultured fromhuman specimens.	VITEK® MS is a massspectrometry system using matrix-assisted laser desorption /ionization time of flight massspectrometry (MALDI-TOF MS) forthe identification ofmicroorganisms cultured fromhuman specimens.
Same – the onlydifference is that forthe VITEK® MSPRIME the referenceto yeast and mouldwas simplified (i.e.combined to indicate“fungal.”)	The VITEK® MS PRIME system isa qualitative in vitro diagnosticdevice indicated for use in	The VITEK® MS PRIME system isa qualitative in vitro diagnosticdevice indicated for use in

595 Anglum Rd., Hazelwood, MO 63042 United States

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Item	Device:VITEK® MS PRIME	Predicate:VITEK® MS(K181412)
Similarities
	conjunction with other clinical andlaboratory findings to aid in thediagnosis of bacterial and fungalinfections.	conjunction with other clinical andlaboratory findings to aid in thediagnosis of bacterial, yeast andmould infections.
Where Used	Clinical laboratories (used bytrained clinicians)	Same
Test Methodology	Use of MALDI-TOF MStechnology for microorganismidentification, as a qualitative invitro diagnostic device to be usedin conjunction with other clinicaland laboratory findings to aid inthe diagnosis of bacterial andfungal infections	Same
Analyte Tested	Microorganisms cultured fromhuman specimens. The bacterialand fungal cultures are from solidmedia, or in the case ofMycobacteria may be isolatedfrom either solid or liquid media.	Same
PreparationReagents /Components / Set UpMethods	CHCA Matrx FA Reagent VITEK® MS DS Target Slides Myco. / Nocardia Preparation Kit (and liquid media components for Mycobacteria) Mould Preparation Kit	Same
Knowledge Base	KB v3.2.	Same

Item	Device:VITEK® MS PRIME	Predicate:VITEK® MS(K181412)
	Differences
Instrument	1. Benchtop model – with shorter flight tube2. Laser - neodymium-doped yttrium fluoride lasing (YFL) laser3. Multichannel plate detector in a photomultiplier tube4. Optics are on access for irradiation5. Load and go approach for loading slides onto the system - system can load up to 16 slides with the option for slide prioritization.	1. Floor standing model – with longer flight tube2. Nitrogen based3. Multiple dynode detector4. Optics used for irradiation are asymmetrical of deflectors5. Maximum of four slides can be loaded onto the instrument (slides must be read in the order that they were loaded).
Accelerated ions	Cations	Cations and anions
Rastering Pattern	Continuous raster path across the	Rastering is accomplished by firing

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Item	Device:VITEK® MS PRIME	Predicate:VITEK® MS(K181412)
Differences
	slide spot. The “profile” for thesample is defined as an averageof 50 spectra obtained by asmany consecutive laser shots.	the laser at the first raster point (fiveshots are made to obtain oneprofile). If the profile is good, thenthe laser will re-shoot the same spotto acquire a new profile. If there aretwo consecutive failed profiles thenthe laser moves to the next rasterpoint. The acquisition processstops when the target of 100 goodprofiles is achieved, or when allraster points have been visited.

D. 510(k) Summary:

Intended Use:

List of Claimed Organisms

Gram Negative / Positive Bacteria & Yeast

Abiotrophia defectiva Achromobacter denitrificans Achromobacter xylosoxidans Acinetobacter baumannii Acinetobacter calcoaceticus Acinetobacter haemolvticus Acinetobacter johnsonii Acinetobacter junii Acinetobacter Iwoffii Acinetobacter nosocomialis Acinetobacter pittii Actinomyces bovis Actinomyces israelii Actinomyces meyeri Actinomyces naeslundii Actinomyces neuii Actinomyces odontolyticus Actinotignum schaalii Aerococcus viridans Aeromonas hydrophila Aeromonas jandaei

Aeromonas punctata (caviae) Aeromonas sobria Aggregatibacter actinomycetemcomitans Aggregatibacter aphrophilus Aggregatibacter segnis Alcaligenes faecalis ssp faecalis Bacteroides caccae Bacteroides eqgerthii Bacteroides fragilis Bacteroides ovatus / xylanisolvens Bacteroides pyogenes Bacteroides stercoris Bacteroides thetaiotaomicron Bacteroides uniformis Bacteroides vulgatus Bifidobacterium spp Bilophila wadsworthia Bordetella avium Bordetella bronchiseptica Bordetella parapertussis Bordetella pertussis Brevundimonas diminuta Brevundimonas vesicularis Brucella spp

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Burkholderia cenocepacia Burkholderia cepacia Burkholderia contaminans Burkholderia qladioli Burkholderia multivorans Burkholderia vietnamiensis Campylobacter coli Campylobacter jejuni Campylobacter rectus Candida albicans Candida auris Candida dubliniensis Candida duobushaemulonii Candida famata Candida glabrata Candida quilliermondii Candida haemulonii Candida inconspicua Candida intermedia Candida kefyr Candida krusei Candida lambica Candida lipolytica Candida lusitaniae Candida metapsilosis Candida norvegensis Candida orthopsilosis Candida parapsilosis Candida pelliculosa Candida rugosa Candida tropicalis Candida utilis Candida zeylanoides Cedecea davisae Cedecea lapagei Cedecea neteri Chryseobacterium qleum Chryseobacterium indologenes Citrobacter amalonaticus Citrobacter braakii Citrobacter farmeri Citrobacter freundii Citrobacter koseri Citrobacter youngae Clostridium baratii Clostridium beijerinckii Clostridium butyricum Clostridium cadaveris Clostridium clostridioforme Clostridium difficile Clostridium innocuum Clostridium novyi Clostridium perfringens Clostridium ramosum Clostridium septicum Clostridium sporogenes

Clostridium tertium Clostridium tetani Comamonas testosteroni Corynebacterium jeikeium Cronobacter muytjensii Cronobacter sakazakii Cronobacter turicensis Cryptococcus qattii Cryptococcus neoformans Curtobacterium flaccumfaciens Delftia acidovorans Edwardsiella hoshinae Edwardsiella tarda Eikenella corrodens Elizabethkingia anophelis Elizabethkinqia meninqoseptica Elizabethkinqia miricola Enterobacter aerogenes Enterobacter cloacae Enterobacter asburiae Enterobacter cancerogenus Enterobacter hormaechei Enterobacter kobei Enterobacter ludwigii Enterococcus avium Enterococcus casseliflavus Enterococcus durans Enterococcus faecalis Enterococcus faecium Enterococcus gallinarum Enterococcus hirae Escherichia coli Escherichia fergusonii Escherichia hermannii Escherichia vulneris Ewingella americana Finegoldia magna Fusobacterium mortiferum Fusobacterium necrophorum Fusobacterium nucleatum Fusobacterium periodonticum Gardnerella vaginalis Gemella haemolysans Gemella morbillorum Granulicatella adiacens Haemophilus influenzae Haemophilus parahaemolyticus Haemophilus parainfluenzae Hafnia alvei Hathewaya histolytica Kingella denitrificans Kingella kingae Klebsiella oxvtoca Klebsiella pneumoniae Kluyvera ascorbata Kluyvera cryocrescens

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Kluyvera intermedia Kocuria rhizophila Kodamaea ohmeri Lactococcus qarvieae Lactococcus lactis Leclercia adecarboxvlata Legionella pneumophila Lelliottia amnigena Leuconostoc mesenteroides Leuconostoc pseudomesenteroides Listeria monocytogenes Malassezia furfur Malassezia pachydermatis Mannheimia haemolytica Micrococcus luteus Mobiluncus curtisii Moraxella catarrhalis Moraxella lacunata Moraxella nonliquefaciens Moraxella osloensis Morganella morganii Myroides spp Neisseria cinerea Neisseria gonorrhoeae Neisseria meningitidis Neisseria mucosa / sicca Ochrobactrum anthropi Oligella ureolvtica Oligella urethralis Paeniclostridium sordellii Pantoea aqqlomerans Pantoea dispersa Paraclostridium bifermentans Parvimonas micra Pasteurella aerogenes Pasteurella multocida Pediococcus acidilactici Peptoniphilus asaccharolyticus Peptostreptococcus anaerobius Plesiomonas shigelloides Pluralibacter gergoviae Porphyromonas asaccharolytica / uenonis Porphyromonas gingivalis Prevotella bivia Prevotella buccae Prevotella denticola Prevotella intermedia Prevotella loescheii Prevotella melaninogenica Prevotella oralis Prevotella oris Propionibacterium acidipropionici Propionibacterium acnes Propionibacterium avidum Propionibacterium granulosum

Propionibacterium propionicum Proteus mirabilis Proteus penneri Proteus vulgaris Providencia alcalifaciens Providencia rettgeri Providencia rustigianii Providencia stuartii Pseudomonas aeruginosa Pseudomonas alcaligenes Pseudomonas fluorescens Pseudomonas luteola Pseudomonas mendocina Pseudomonas oryzihabitans Pseudomonas putida Pseudomonas stutzeri Ralstonia pickettii Raoultella ornithinolytica Raoultella planticola Raoultella terrigena Rhizobium radiobacter Rhodotorula mucilaginosa Rothia mucilaqinosa Saccharomyces cerevisiae Salmonella enterica ssp enterica Saprochaete capitata Serratia ficaria Serratia fonticola Serratia grimesii Serratia liquefaciens Serratia marcescens Serratia odorifera Serratia plymuthica Serratia proteamaculans Serratia quinivorans Serratia rubidaea Shewanella putrefaciens Sphinqobacterium multivorum Sphingobacterium spiritivorum Sphingomonas paucimobilis Staphylococcus aureus Staphylococcus auricularis Staphylococcus capitis Staphylococcus chromogenes Staphylococcus cohnii ssp cohnii Staphylococcus cohnii ssp urealyticus Staphylococcus epidermidis Staphylococcus haemolvticus Staphylococcus hominis Staphylococcus hyicus Staphylococcus intermedius Staphylococcus kloosii Staphylococcus lentus Staphylococcus lugdunensis Staphylococcus pseudintermedius Staphylococcus saprophyticus

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Staphylococcus schleiferi Staphylococcus sciuri Staphylococcus simulans Staphylococcus warneri Staphylococcus xylosus Stenotrophomonas maltophilia Streptococcus aqalactiae Streptococcus alactolyticus Streptococcus anginosus Streptococcus canis Streptococcus constellatus Streptococcus cristatus Streptococcus dysqalactiae ssp dysgalactiae Streptococcus dysgalactiae ssp equisimilis Streptococcus equi ssp equi Streptococcus equi ssp zooepidemicus Streptococcus equinus Streptococcus gallolyticus ssp gallolyticus Streptococcus gallolyticus ssp pasteurianus Streptococcus gordonii Streptococcus infantarius ssp coli (Str.lutetiensis) Streptococcus infantarius ssp infantarius Streptococcus intermedius Streptococcus mitis / Streptococcus oralis Streptococcus mutans Streptococcus parasanguinis Streptococcus pneumoniae Streptococcus pseudoporcinus Streptococcus pyogenes Streptococcus salivarius ssp salivarius Streptococcus sanquinis Streptococcus sobrinus Streptococcus suis Streptococcus uberis Streptococcus vestibularis Tannerella forsythia Veillonella dispar Vibrio alginolyticus Vibrio cholerae Vibrio fluvialis Vibrio metschnikovii Vibrio mimicus Vibrio parahaemolyticus Vibrio vulnificus Yersinia aldovae Yersinia enterocolitica Yersinia frederiksenii Yersinia intermedia Yersinia kristensenii Yersinia pseudotuberculosis Yersinia ruckeri

Mycobacterium

Mvcobacterium abscessus Mycobacterium avium Mycobacterium chelonae Mycobacterium fortuitum group Mycobacterium qordonae Mycobacterium haemophilum Mycobacterium immunogenum Mycobacterium intracellulare Mycobacterium kansasii Mycobacterium lentiflavum Mycobacterium malmoense Mycobacterium marinum Mycobacterium mucogenicum Mycobacterium scrofulaceum Mycobacterium simiae Mycobacterium smegmatis Mycobacterium szulgai Mycobacterium tuberculosis complex Mycobacterium xenopi

Nocardia

Nocardia abscessus Nocardia africana / nova Nocardia asteroides Nocardia brasiliensis Nocardia cyriacigeorgica Nocardia farcinica Nocardia otitidiscaviarum Nocardia paucivorans Nocardia pseudobrasiliensis Nocardia transvalensis Nocardia veterana Nocardia wallacei

Mould

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Epidermophyton floccosum Exophiala dermatitidis Exophiala xenobiotica Exserohilum rostratum Fusarium oxysporum complex Fusarium proliferatum Fusarium solani complex Histoplasma capsulatum Lecythophora hoffmannii Lichtheimia corymbifera Microsporum audouinii Microsporum canis Microsporum qypseum Mucor racemosus complex Paecilomyces variotii complex Penicillium chrysogenum Pseudallescheria boydii

Purpureocillium lilacinum Rasamsonia arqillacea complex Rhizopus arrhizus complex Rhizopus microsporus complex Sarocladium kiliense Scedosporium apiospermum Scedosporium prolificans Sporothrix schenckii complex Trichophyton interdigitale Trichophyton rubrum Trichophyton tonsurans Trichophyton verrucosum Trichophyton violaceum Trichosporon asahii Trichosporon dermatis / mucoides Trichosporon inkin

Device Description:

This 510(k) submission introduces the VITEK®MS PRIME System. The VITEK® MS PRIME is intended for laboratory use by professional users who are trained in microbiology and good laboratory practices.

As a first step, a VITEK® MS-DS Target Slide is prepared in accordance with the instructions for use.

NOTE: The VITEK® MS PRIME is a Class 1 laser product, containing a Class 4 Neodymium-doped yttrium lithium fluoride (Nd:YLF) laser – the laser operates at a wavelength of 349 nm.

As a final step in the basic principle of MALDI-ToF technology (i.e. detection) the time of flight is

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measured precisely by the ions arrival at a particle detector. This speed of the ions in flight depends on their mass - with heavier molecules having a higher moment of inertia resulting in a lower velocity. The time of transit is measured precisely by the ions' arrival at a particle detector. Based on the time of flight, the m/z ratio of each particle can be determined, and a mass spectrum of the analyte sample mixture is generated. The recorded signal is processed and presented as a spectrum of intensity versus mass in Daltons (Da). The mass spectrum displays results as a series of peaks (spectrum) which correspond to the ionized proteins derived from the analyte sample. And for identification of an unknown organism, the resulting mass spectra are sufficiently distinctive to allow taxonomic characterization at the genus and species when compared against the VITEK® MS Knowledge Base.

VITEK® MS PRIME Performance Summary:

Biological equivalency:

As part of the VITEK® MS PRIME verification activities, a biological equivalency study was performed to test the clinically validated species as included in the current VITEK® MS Knowledge Base. The biological equivalency study corresponds to the 479 claimed species, and the strains tested during the study included critical pathogens, from all microorganism groups combined: i.e. Gram-positive aerobic and anaerobic bacteria, Gram negative aerobic and anaerobic bacteria (including Brucella), yeasts, moulds, Mycobacterium (from both solid and liquid culture media), and Nocardia.

The biological equivalency performance is calculated from 1461 samples (487 unique tests in triplicate) and is presented below.

NOTE: Two species from the 479 claimed species (Coccidioides immitis and C. posadasii) were not tested due to lack of available strains

Biological equivalency performance of each organism group tested on the VITEK® MS PRIME is highlighted below,

Gram positive organisms (99.0% for correct single choice ID or low discrimination to the ● correct genus)
Gram negative organisms (97.2% for correct single choice ID or low discrimination to the correct genus)
Yeast (100% for correct single choice ID or low discrimination to the correct genus)
Mycobacteria from solid culture media (100% for correct single choice ID or low ● discrimination to the correct genus)
. Mvcobacteria from liquid culture media (97,62% for correct single choice ID or low discrimination to the correct genus)
Moulds (97.4% for correct single choice ID or low discrimination to the correct genus)
Nocardia (100% for correct single choice ID or low discrimination to the correct genus).

The VITEK® MS PRIME biological equivalency performance demonstrated an error (i.e. a Discordant Identification) rate of 0.3% (5/1461) with the clinically validated isolates tested. In addition, the combined no identification rate for the VITEK® MS PRIME was 1.6% (23/1461).

In summary a minimum 95% agreement (in comparison with the reference method) was met during the biological equivalency study.

Clinical Performance Evaluation:

The clinical performance evaluation for the VITEK®MS PRIME used an equivalency approach

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with the VITEK® MS - 100 species (with five strains each) from the list of FDA Indications for use for Knowledge Base (KB) v3.2. Performance was determined by comparing the VITEK® MS PRIME identification to a one choice or multiple choice (more than one species) reference identification obtained during previous clinical studies.

When tested on the VITEK®MS PRIME, clinical isolates tested from all sites combined (for correct single choice identification, or a low discrimination correct genus result) showed an agreement rate of 98.4% (492/500). Clinical Performance of each organism group tested on the VITEK® MS PRIME is highlighted below,

Gram positive organisms (99.3% for correct single choice ID or low discrimination to the ● correct genus)
Gram negative organisms (98.8% for correct single choice ID or low discrimination to the ● correct genus)
. Yeast (95.3% for correct single choice ID or low discrimination to the correct genus)
Mycobacteria (100% for correct single choice ID or low discrimination to the correct genus) ●
Moulds (98.0% for correct single choice ID or low discrimination to the correct genus) ●
. Nocardia (100% for correct single choice ID or low discrimination to the correct genus).

The VITEK® MS PRIME clinical performance evaluation demonstrated an error (Discordant Identification) rate of 0.4% (2/500) with the clinical isolates tested that were tested. In addition, the combined no identification rate for the VITEK® MS PRIME was 1.2% (6/500).

In summary a minimum 95% agreement (in comparison with the reference method) was met for the following:

Overall performance for all species combined from all sites, including and excluding A No ID results
A Overall performance for the following organism groups: Gram positive, Gram negative, Mycobacteria, Nocardia, moulds, and yeasts from all sites combined, including and excluding No ID results
A Overall performance for each organism classification (aerobic Gram positive, anaerobic Gram positive, aerobic Gram negative and anaerobic Gram negative) from all sites combined, including and excluding No ID results.

Challenge Isolate Results:

100.0% (100/100) agreement was obtained for the 100 challenge strains tested - identification results were received for all isolates (i.e. there were no No ID results), and there were no discrepant results (i.e. misidentifications).

Quality Control Results:

98.3% agreement was obtained with all quality control strains tested at all sites.

Reproducibility Results:

For Reproducibility testing a 99.5% agreement was achieved for Reproducibility strains tested on the VITEK®MS PRIME.

Conclusion:

The clinical performance data as presented in this submission supports a substantial equivalence decision for the VITEK® MS PRIME. The VITEK® MS PRIME shows 98.4% (492/500) agreement for clinical isolates tested, with two discordant results (0.4%) and six no identification (1.2%) results. When excluding No ID results, performance is 99.6% (492/494) agreement with the same discordant rate of 0.4%.

Regulation Number and Section

§ 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.