510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161951Substantially Equivalent

KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

Kronus, Inc., Star ID / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K161951 is the FDA 510(k) clearance record for KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay, a class II device, cleared for Kronus, Inc. on under FDA product code PNI (Aquaporin-4 Autoantibody). FDA's definition for product code PNI reads: "For the determination of autoantibodies to Aquaporin-4 in human serum and plasma. The test may be useful as an aid in the diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD). The test is not to be...". FDA records list 9 510(k) clearances for Kronus, Inc., from to . As of , FDA records show no recalls naming K161951.

Clearance record

Decision date
Received
(7 days to decision)
Product code
PNI Aquaporin-4 Autoantibody
Regulation
21 CFR 866.5665
Device class
Class II
Review panel
Immunology
Applicant
Kronus, Inc. 170 S. Seneca Springs Way, Star ID
510(k) summary
Statement
Third party review
No

Clearances, product code PNI

Trailing 12 months

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

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