510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070597Substantially Equivalent

Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid Test

Luminex Corporation, Northbrook IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070597 is the FDA 510(k) clearance record for VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST, a class II device, cleared for Nanosphere, Inc. on under FDA product code NSU (Instrumentation For Clinical Multiplex Test Systems). FDA's definition for product code NSU reads: "Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured...". FDA records list 34 510(k) clearances for Luminex Corporation, from to . As of , FDA records show no recalls naming K070597.

Clearance record

Decision date
Received
(223 days to decision)
Product code
NSU Instrumentation For Clinical Multiplex Test Systems
Regulation
21 CFR 862.2570
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Nanosphere, Inc. 4088 Commercial Ave., Northbrook IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NSU

Trailing 12 months

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

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