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
K162297Substantially Equivalent

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

Diazyme Laboratories, Inc., Poway CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K162297 is the FDA 510(k) clearance record for Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set, a class II device, cleared for Diazyme Laboratories on under FDA product code PTF (Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission). FDA's definition for product code PTF reads: "Assay to measure procalcitonin to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock". FDA records list 52 510(k) clearances for Diazyme Laboratories, from to . As of , FDA records show no recalls naming K162297.

Clearance record

Decision date
Received
(245 days to decision)
Product code
PTF Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
Regulation
21 CFR 866.3215
Device class
Class II
Review panel
Microbiology
Applicant
Diazyme Laboratories 12889 Gregg Ct., Poway CA
510(k) summary
Statement
Third party review
No

Clearances, product code PTF

Trailing 12 months

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

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