Cleared Traditional

GRAM NEGATIVE MIC/COMBO PANELS (K880430) - FDA 510(k) Clearance

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

K880430 · Baxter Healthcare Corp · Microbiology device
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Apr 1988
Decision
71d
Days
Class 2
Risk

K880430 is an FDA 510(k) clearance for the GRAM NEGATIVE MIC/COMBO PANELS. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (West Sacramento, US). The FDA issued a Cleared decision on April 12, 1988 after a review of 71 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K880430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1988
Decision Date April 12, 1988
Days to Decision 71 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
31d faster than avg
Panel avg: 102d · This submission: 71d
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 K880430.
SCEPTOR ENTERIC MIC PANEL (REVISED 4/88)
K882300 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1988
SCEPTOR ENTERIC MIC/ID PANEL (REVISED 4/88)
K882301 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1988
SCEPTOR- NEW ANTIMICROBIAL AGENT: NORFLOXACIN
K881846 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1988
GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL
K874876 · Baxter Healthcare Corp · Jan 1988
NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO
K874426 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1987
SENSIR SYSTEM
K870719 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1987