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
K160729Substantially Equivalent

Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160729 is the FDA 510(k) clearance record for Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5, a class II device, cleared for Roche Diagnostics on under FDA product code PMT (Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens). FDA's definition for product code PMT reads: "An assay used to determine the level of procalcitonin (PCT) in human serum and plasma as an aid in assessing the mortality for patients diagnosed with severe sepsis or septic shock". FDA records list 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show one recall naming K160729.

Clearance record

Decision date
Received
(89 days to decision)
Product code
PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
Regulation
21 CFR 866.3215
Device class
Class II
Review panel
Microbiology
Applicant
Roche Diagnostics 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PMT

Trailing 12 months

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

FDA records show no clearances under product code PMT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PMT, 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