Cleared Traditional

K811434 - SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS

K811434 is the FDA 510(k) clearance for SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 1 Microbiology device (product code JSS) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K811434 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Jun 1981
Decision
35d
Days
Class 1
Risk

K811434 is an FDA 510(k) clearance for the SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on June 26, 1981 after a review of 35 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K811434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1981
Decision Date June 26, 1981
Days to Decision 35 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 102d · This submission: 35d
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 23
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K811434.
SYSTEK #1 EIKEN
K813164 · Syn-Kit, Inc. · Dec 1981
MINITECK ENTERIC BROTH & ENTEROBACTER
K812286 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1981
SENSITITIRE AP60
K811765 · Gibco Laboratories Life Technologies, Inc. · Aug 1981
ENTERIC-TEK
K792058 · Flow Laboratories, Inc. · Jan 1980
3M MICROBIAL PROFILE SYSTEM GRAM
K791789 · 3M Company · Nov 1979
AMS ENTEROBACTERIACEASE CARE
K791932 · Vitek Systems, Inc. · Nov 1979