510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K192665Substantially Equivalent

Accelerate Pheno System, Accelerate PhenoTest BC Kit

Accelerate Diagnostics, Inc., Tucson AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192665 is the FDA 510(k) clearance record for Accelerate Pheno System, Accelerate PhenoTest BC Kit, a class II device, cleared for Accelerate Diagnostics, Inc. on under FDA product code PRH (Positive Blood Culture Identification And Ast Kit). FDA's definition for product code PRH reads: "Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets". FDA records list 2 510(k) clearances for Accelerate Diagnostics, Inc., from to . As of , FDA records show 2 recalls naming K192665.

Clearance record

Decision date
Received
(356 days to decision)
Product code
PRH Positive Blood Culture Identification And Ast Kit
Regulation
21 CFR 866.1650
Device class
Class II
Review panel
Microbiology
Applicant
Accelerate Diagnostics, Inc. 3950 S. Country Club Rd. #470, Tucson AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PRH

Trailing 12 months

FDA records hold no clearances under product code PRH in the trailing twelve months.

FDA records show no clearances under product code PRH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PRH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260