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
K250513Substantially Equivalent

IntelliSep Test (CV-ICG-048)

Cytovale, Inc., South San Francisco CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250513 is the FDA 510(k) clearance record for IntelliSep Test (CV-ICG-048), a class II device, cleared for Cytovale, Inc. on under FDA product code QUT (Deformability Cytometry For Sepsis Risk Assessment). FDA's definition for product code QUT reads: "A semi-quantitative assay that measures cellular deformability and other physical properties of leukocytes in whole blood samples to aid the early detection of sepsis". FDA records list 3 510(k) clearances for Cytovale, Inc., from to . As of , FDA records show no recalls naming K250513.

Clearance record

Decision date
Received
(28 days to decision)
Product code
QUT Deformability Cytometry For Sepsis Risk Assessment
Regulation
21 CFR 866.3215
Device class
Class II
Review panel
Microbiology
Applicant
Cytovale, Inc. 2 Tower Pl., South San Francisco CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QUT

Trailing 12 months
1 clearance under product code QUT in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QUT, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260