510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983388Substantially Equivalent

Ontrak Testcup-Er

Roche Diagnostic Systems, Inc., Somerville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983388 is the FDA 510(k) clearance record for ONTRAK TESTCUP-ER, a class II device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K983388.

Clearance record

Decision date
Received
(54 days to decision)
Product code
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Regulation
21 CFR 862.3250
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Roche Diagnostic Systems, Inc. Branchburg Township, Somerville NJ
510(k) summary
Summary
Third party review
No

Clearances, product code DIO

Trailing 12 months

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

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