Microbiology · 510(k) · 2020
Accelerate Pheno System, Accelerate PhenoTest BC Kit
Accelerate Diagnostics, Inc.. Cleared by FDA on 15 September 2020 under submission K192665, product code PRH (positive blood culture identification and ast kit). What FDA's record says, in FDA's words.
Device record · K192665
- Device. Accelerate Pheno System, Accelerate PhenoTest BC KitDEVICE
- Company. Accelerate Diagnostics, Inc.COMPANY
- Decision. 15 September 2020, 510(k), substantially equivalent (traditional review); received 25 September 2019DECISION
- Panel. MicrobiologyPANEL
- Product code. PRH, Positive Blood Culture Identification And Ast KitCODE
- Regulation. 21 CFR 866.1650, Class IIREG
- Source. FDA database entry · decision document (26 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Accelerate PhenoTest BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) methods and is intended for use with the Accelerate Pheno system. The Accelerate PhenoTest BC kit is capable of simultaneous detection and identification of multiple microbial targets followed by susceptibility testing of the appropriate detected bacterial organisms. The Accelerate PhenoTest BC kit is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results. The Accelerate PhenoTest BC kit identifies the following Gram-positive and Gram-negative bacteria and yeasts utilizing FISH probes targeting organism-specific ribosomal RNA sequences: Staphylococcus aureus, Staphylococcus lugdunensis, Coagulase‐negative Staphylococcus species (i.e., Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus capitis, Staphylococcus lugdunensis, Staphylococcus warneri, not differentiated), Enterococcus faecalis, Enterococcus faecium, Streptococcus spp. (i.e., Streptococcus mitis, Streptococcus oralis, Streptococcus gallolyticus, Streptococcus agalactiae, Streptococcus pneumoniae, not differentiated), Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella spp. (i.e., Klebsiella […]
The product code's definition, from FDA's classification record. Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 4 reports filed against devices carrying product code PRH. 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:
26 April 2023 · Injury · ACCELERATE PHENOTEST BC KIT · ACCELERATE DIAGNOSTICS · report 3010671651-2023-00001
IT WAS REPORTED THAT THE ACCELERATE PHENOTEST BC KIT ALLEGEDLY HAD AN INCORRECT RESULT OF METHICILLIN-RESISTANT S. AUREUS (MRSA) AND THE PATIENT'S CENTRAL LINE WAS REMOVED AND A NEW CENTRAL LINE WAS INSERTED. THE CUSTOMER STATED THAT TESTING ON THE BD PHOENIX IDENTIFIED S. EPIDERMIDIS. THE INCORRECT RESULT HAS NOT BEEN CONFIRMED.
17 March 2020 · Malfunction · ACCELERATE PHENO SYSTEM, ACCELERATE PHENOTEST BC KIT · ACCELERATE DIAGNOSTICS, INC. · report 3010671651-2020-00001
ACCELERATE DIAGNOSTICS HAS INVESTIGATED THE PERFORMANCE CHALLENGES REPORTED BY (B)(6) MEDICAL CENTER IN MEDWATCH FORM 3500A, REPORT (B)(4). THREE PERFORMANCE CONCERNS WERE REPORTED. FOR THE ORGANISM PSEUDOMONAS AERUGINOSA, UVA REPORTED AST MINOR ERRORS WITH ACCELERATE PHENOTEST BC KIT RESULTING IN OVERCALLING OF RESISTANCE FOR THIS ORGANISM, AS COMPARED TO THEIR STANDARD OF CARE METHOD, SENSITITRE. THE ANTIMICROBIALS FOR WHICH THIS WAS OBSERVED WERE NOT SPECIFIED BY UVA. FOR THE ANTIMICROBIAL, […]
12 February 2020 · type not stated · ACCELERATE PHENO SYSTEM · ACCELERATE DIAGNOTICS · report 9699497
IN SUMMARY, WE ARE REPORTING THIS EVENT BECAUSE WE ARE CONCERNED ABOUT THE HIGH ERROR RATES WHEN COMPARING PHENO RESULTS TO THOSE OF SENSITITRE AND OTHER STANDARD METHODS IN OUR CLINICAL MICROBIOLOGY LABORATORY. WE SUSPECT WE ARE ACUTELY AWARE OF THESE ISSUES BECAUSE OUR ANTIMICROBIAL STEWARDSHIP TEAM IS HEAVILY INVOLVED IN THE DAY-TO-DAY FUNCTIONS OF THE CLINICAL MICROBIOLOGY LABORATORY. WE BELIEVE OUR PRACTICE OF ROUTINELY PERFORMING ADDITIONAL SUSCEPTIBILITY TESTING IS LIKELY PROVIDING […]
23 October 2019 · Malfunction · ACCELERATE PHENO SYSTEM, ACCELERATE PHENOTEST BC KIT · ACCELERATE DIAGNOSTICS, INC. · report 3010671651-2019-00001
THE ACCELERATE PHENO¿ SYSTEM REPORTED PSEUDOMONAS AERUGINOSA (FALSE POSITIVE). THE PATIENT RECEIVED AN ESCALATION OF ANTIBIOTICS, AN ID CONSULT, AND CT CHEST/ABDOMEN/PELVIS TO IDENTIFY THE SOURCE OF THE INFECTION. THE COMPARATOR METHOD (MALDI-TOF) IDENTIFIED ESCHERICHIA COLI. A PATIENT ADMITTED WITH ASCENDING CHOLANGITIS HAD BLOOD CULTURES TAKEN FOR IDENTIFICATION (ID)AND ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST). THE ACCELERATE PHENO¿ SYSTEM ID RESULT INDICATED THAT THE PATIENT WAS INFECTED […]
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 PRH, in Microbiology, or cleared in 2020. 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.