510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211181Substantially Equivalent

Idylla MSI Test

Biocartis NV, Mechelen, BE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211181 is the FDA 510(k) clearance record for Idylla MSI Test, a class II device, cleared for Biocartis NV on under FDA product code PZJ (Lynch Syndrome Test System). FDA's definition for product code PZJ reads: "The Lynch syndrome test system is used to identify loss of DNA mismatch repair proteins or microsatellite instability in tumor tissue from cancer patients for the purpose of identifying patients who may benefit from additional testing for...". FDA records list one 510(k) clearance for Biocartis NV. As of , FDA records show no recalls naming K211181.

Clearance record

Decision date
Received
(678 days to decision)
Product code
PZJ Lynch Syndrome Test System
Regulation
21 CFR 864.1866
Device class
Class II
Review panel
Immunology
Applicant
Biocartis NV Generaal De Wittelaan 11 B3, Mechelen, BE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PZJ

Trailing 12 months

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

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