ApodictaShow me on my files

Microbiology · De Novo · 2013

VITEK MS

BIOMERIEUX, INC.. Granted by FDA on 21 August 2013 under submission DEN130013, product code PEX (system, mass spectrometry, maldi tof, microorganism identification, cultured isolates). What FDA's record says, in FDA's words.

Device record · DEN130013

  1. Device. VITEK MSDEVICE
  2. Company. BIOMERIEUX, INC.COMPANY
  3. Decision. 21 August 2013, De NovoDECISION
  4. Panel. MicrobiologyPANEL
  5. Product code. PEX, System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured IsolatesCODE
  6. Regulation. 21 CFR 866.3361, Class IIREG
  7. Source. FDA database entrySOURCE

Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.

What FDA granted it for

The Indications for Use statement could not be read from a public decision document for this submission on the retrieval date (the document is absent, scanned without text, or filed under another number). FDA's database entry is the place to read it.

The product code's definition, from FDA's classification record. A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.

Adverse-event reports in MAUDE, by product code

As of , MAUDE held 431 reports filed against devices carrying product code PEX. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:

12 May 2021 · Malfunction · VITEK MS INSTRUMENT · BIOMERIEUX, SA · report 9615754-2021-00161

INTENDED USE: THE VITEK MS SYSTEM, REFERENCE 410895, IS A MASS SPECTROMETER USING MALDI-TOF (MATRIX-ASSISTED LASER DESORPTION/IONIZATION-TIME OF FLIGHT) TECHNOLOGY FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM CLINICAL SPECIMENS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF STAPHYLOCOCCUS SAPROPHYTICUS AS STAPHYLOCOCCUS XYLOSUS WHEN USING THE VITEK MS SYSTEM, REFERENCE 410895, SERIAL NUMBER (B)(4). A POSITIVE GRAM COCCUS […]

10 May 2021 · Malfunction · VITEK MS MYCOB/NOCARDIA KIT · BIOMERIEUX, SA · report 9615754-2021-00157

INTENDED USE: THE VITEK MS SYSTEM, REFERENCE 410895, IS A MASS SPECTROMETER USING MALDI-TOF (MATRIX-ASSISTED LASER DESORPTION/IONIZATION-TIME OF FLIGHT) TECHNOLOGY FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM CLINICAL SPECIMENS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF MB. INTRACELLULARE AS N. AFRICANA WHEN USING THE VITEK MS SYSTEM (REFERENCE 410895, SERIAL NUMBER #(B)(4)), AS COMPARED TO PCR TEST. WHEN TESTING WITH THE […]

10 May 2021 · Malfunction · VITEK MS MYCOB/NOCARDIA KIT · BIOMERIEUX, SA · report 9615754-2021-00158

INTENDED USE: THE VITEK MS MYCOBACTERIUM/NOCARDIA KIT PROVIDES THE REAGENTS AND CONSUMABLES NEEDED TO PROCESS SAMPLES BY PROTEIN EXTRACTION AND INACTIVATION FOR MYCOBACTERIUM AND NOCARDIA IDENTIFICATION USING THE VITEK MS SYSTEM. THE VITEK MS SYSTEM IS A MASS SPECTROMETER USING MALDI-TOF (MATRIX-ASSISTED LASER DESORPTION/IONIZATION-TIME OF FLIGHT) TECHNOLOGY FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM CLINICAL SPECIMENS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN (B)(6) NOTIFIED […]

7 May 2021 · Malfunction · VITEK MS INSTRUMENT · BIOMERIEUX, SA · report 9615754-2021-00146

AN INDUSTRY CUSTOMER ((B)(6)) FROM (B)(6) REPORTED THAT HE OBTAINED A POTENTIAL ORGANISM MISIDENTIFICATION OF ESCHERICHIA VULNERIS AS SALMONELLA ENTERICA SPP ENTERICA WHEN USING VITEK MS INSTRUMENT (REF. 410895) ¿ SERIAL NUMBER (B)(4). FOR ONE ISOLATE, THE CUSTOMER OBTAINED ON VITEK MS: - ONE SINGLE CHOICE TO SALMONELLA ENTERICA SPP ENTERICA - ONE NO IDENTIFICATION - TWENTY-ONE SINGLE CHOICE TO ESCHERICHIA VULNERIS - ONE LOW-DISCRIMINATION TO ESCHERICHIA VULNERIS - PLURALIBACTER GERGOVIAE THE […]

16 July 2020 · Malfunction · VITEK MS · BIOMERIEUX, SA · report 9615754-2020-00115

A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING MISIDENTIFICATION OF MORAXELLA ATLANTAE AS EIKENELLA CORRODENS WHILE TESTING A QC SAMPLE PROVIDED BY THE (B)(6) USING THE VITEK MS INSTRUMENT (REFERENCE # (B)(4). SERIAL NUMBER OF INSTRUMENT WAS NOT PROVIDED. VITEK MS RESULTS: KNOWLEDGE BASE (KB): KB VERSION : 3.0 (CLI) SINGLE CHOICE TO EIKENELLA CORRODENS VITEK MS RUO MODE - KB V4.15 : MORAXELLA ATLANTAE. THERE IS NO PATIENT ASSOCIATED WITH THIS QC SAMPLE; THEREFORE, THERE IS NO ADVERSE […]

Where this fits

This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.

More devices under product code PEX, in Microbiology, or granted in 2013. The whole record is at FDA AI-enabled medical devices.

A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.

Show me on one of my files →

This device is authorized for a stated use. See a record read against what it must prove, on your own file.

Show me on one of my filesTry the gate
Show me on my files