Cleared Traditional

AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING (K900821) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K900821 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Mar 1990
Decision
22d
Days
Class 2
Risk

K900821 is an FDA 510(k) clearance for the AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING. 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 March 15, 1990 after a review of 22 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 K900821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1990
Decision Date March 15, 1990
Days to Decision 22 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
80d faster than avg
Panel avg: 102d · This submission: 22d
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 31
Devices cleared under the same product code (LRG) and FDA review panel - the closest regulatory comparables to K900821.
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
K033948 · Dade Behring, Inc. · Mar 2004
SYNERGY SCREEN TEST, MODIFICATION
K921977 · Baxter Healthcare Corp · Oct 1993
WALKAWAY TM 40
K911400 · Baxter Healthcare Corp · Nov 1991
AUTOSCEPTOR
K896447 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1990
SCEPTORPETTE SYSTEM
K883907 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988