510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200070Unknown

Simple 2 Test

Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.), Dun Laoghaire, IE / Direct, Unknown
FDA source (opens on fda.gov)

DEN200070 is the FDA 510(k) clearance record for Simple 2 Test, a class II device, cleared for Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) on under FDA product code QYA (System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home). FDA's definition for product code QYA reads: "This device is an in vitro diagnostic system intended for self-collecting specimens in home settings or similar environments and testing in a clinical laboratory for detection of nucleic acids from non-viral microorganism(s) causing...". FDA records list one 510(k) clearance for Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.). As of , FDA records show no recalls naming DEN200070.

Clearance record

Decision date
Received
(1,094 days to decision)
Product code
QYA System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
Regulation
21 CFR 866.3385
Device class
Class II
Review panel
Microbiology
Applicant
Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) Unit 3, Adelphi House, George'S St. Upper, Dun Laoghaire, IE
Third party review
No

Clearances, product code QYA

Trailing 12 months

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

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