510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243410Substantially Equivalent

simpli-COLLECT STI Test

Abbott Molecular, Inc., Des Plaines IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243410 is the FDA 510(k) clearance record for simpli-COLLECT STI Test, a class II device, cleared for Abbott Molecular 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 19 510(k) clearances for Abbott Molecular, from to . As of , FDA records show no recalls naming K243410.

Clearance record

Decision date
Received
(90 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
Abbott Molecular 1300 E Touhy Ave., Des Plaines IL
510(k) summary
Summary PDF
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