Cleared Traditional

RAPIDEC COLI (K890626) - FDA 510(k) Clearance

Class I Microbiology device.

K890626 · Dms Products, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1989
Decision
115d
Days
Class 1
Risk

K890626 is an FDA 510(k) clearance for the RAPIDEC COLI. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Dms Products, Inc. (Flemington, US). The FDA issued a Cleared decision on June 2, 1989 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dms Products, Inc. devices

Submission Details

510(k) Number K890626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1989
Decision Date June 02, 1989
Days to Decision 115 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 102d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSS Kit, Identification, Enterobacteriaceae
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JSS Kit, Identification, Enterobacteriaceae

All 48
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K890626.
ROCHE ENTEROTUBE II
K922588 · Roche Diagnostic Systems, Inc. · Sep 1992
GI MOTILITY TEST MEDIUM W/TTC
K863603 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
K853009 · Roche Diagnostic Systems, Inc. · Mar 1986
QUANTUM II BACTERIAL IDENT. SYSTEM
K830698 · Abbott Laboratories · Apr 1983
MINITECK ENTERIC BROTH & ENTEROBACTER
K812286 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1981
SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS
K811434 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1981