Cleared Traditional

SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL (K854097) - FDA 510(k) Clearance

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

K854097 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Nov 1985
Decision
38d
Days
Class 2
Risk

K854097 is an FDA 510(k) clearance for the SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on November 14, 1985 after a review of 38 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 K854097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1985
Decision Date November 14, 1985
Days to Decision 38 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
64d faster than avg
Panel avg: 102d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWY Manual Antimicrobial Susceptibility Test 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 - JWY Manual Antimicrobial Susceptibility Test Systems

All 121
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K854097.
SCEPTOR GRAM POSITIVE BREAKPOINT/ID PANEL
K861186 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986
FOX FASTIDIOUS TEST PANEL
K854525 · Beckman Instruments, Inc. · Apr 1986
MICRO-MEDIA MICRODILUTION TEST PANELS
K853805 · Beckman Instruments, Inc. · Mar 1986
SCEPTOR PSEUDOMONAS PLUS MIC PANEL
K854098 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1985
SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL
K854099 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1985
SCEPTOR GRAM POSITIVE MIC/ID PANEL
K854100 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1985