510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083294Substantially Equivalent

Verigene Cftr Nucleic Acid Test and Verigene Cftr Polyt Nucleic Acid Test

Luminex Corporation, Northbrook IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K083294 is the FDA 510(k) clearance record for VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST, a class II device, cleared for Nanosphere, Inc. on under FDA product code NUA (System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection). FDA's definition for product code NUA reads: "The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected...". FDA records list 34 510(k) clearances for Luminex Corporation, from to . As of , FDA records show no recalls naming K083294.

Clearance record

Decision date
Received
(256 days to decision)
Product code
NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Regulation
21 CFR 866.5900
Device class
Class II
Review panel
Immunology
Applicant
Nanosphere, Inc. 4088 Commercial Ave., Northbrook IL
510(k) summary
Statement
Third party review
No

Clearances, product code NUA

Trailing 12 months

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

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