510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193081Substantially Equivalent

Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit

Rheonix, Inc., Ithaca NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193081 is the FDA 510(k) clearance record for Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit, a class II device, cleared for Rheonix, Inc. on under FDA product code QEP (Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections). FDA's definition for product code QEP reads: "A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in...". FDA records list one 510(k) clearance for Rheonix, Inc. As of , FDA records show no recalls naming K193081.

Clearance record

Decision date
Received
(773 days to decision)
Product code
QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Regulation
21 CFR 866.3393
Device class
Class II
Review panel
Microbiology
Applicant
Rheonix, Inc. 10 Brown Rd., Suite 103, Ithaca NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEP

Trailing 12 months
3 clearances under product code QEP in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QEP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20262
June 20260
July 20261
August 20260
September 20260
October 20260