510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K990377Substantially Equivalent

Ontrak Testcup M2k and Ontrak Teststik Positive Control, Model 11 18544, Ontrak Testcup M2k and Ontrak Teststick Negativ

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990377 is the FDA 510(k) clearance record for ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV, a class I device, cleared for Roche Diagnostics Corp. on under FDA product code DIF (Drug Mixture Control Materials). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K990377.

Clearance record

Decision date
Received
(18 days to decision)
Product code
DIF Drug Mixture Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., P.O. Box 50457, Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code DIF

Trailing 12 months

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

FDA records show no clearances under product code DIF in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DIF, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260