Cleared Traditional

TITERTEK ENTEROBAC* (K834090) - FDA 510(k) Clearance

Class I Microbiology device.

K834090 · Flow Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1984
Decision
46d
Days
Class 1
Risk

K834090 is an FDA 510(k) clearance for the TITERTEK ENTEROBAC*. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 13, 1984 after a review of 46 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Flow Laboratories, Inc. devices

Submission Details

510(k) Number K834090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1983
Decision Date January 13, 1984
Days to Decision 46 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 102d · This submission: 46d
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 K834090.
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