Cleared Traditional

K883907 - SCEPTORPETTE SYSTEM

K883907 is the FDA 510(k) clearance for SCEPTORPETTE SYSTEM by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Microbiology device (product code LRG) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K883907 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Oct 1988
Decision
42d
Days
Class 2
Risk

K883907 is an FDA 510(k) clearance for the SCEPTORPETTE SYSTEM. Classified as Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (product code LRG), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on October 27, 1988 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 K883907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1988
Decision Date October 27, 1988
Days to Decision 42 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
60d faster than avg
Panel avg: 102d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

All 37
Devices cleared under the same product code (LRG) and FDA review panel - the closest regulatory comparables to K883907.
WALKAWAY TM 40
K911400 · Baxter Healthcare Corp · Nov 1991
AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING
K900821 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990
AUTOSCEPTOR
K896447 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1990
ALADIN (TM)
K865062 · Analytical Products, Inc. · Mar 1987