Cleared Traditional

K874876 - GRAM - & GRAM + MIC/COMBO & BREAKPOINT/...

K874876 is the FDA 510(k) clearance for GRAM - & GRAM + MIC/COMBO & BREAKPOINT/... by Baxter Healthcare Corp. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K874876 · Baxter Healthcare Corp · Microbiology device
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Jan 1988
Decision
42d
Days
Class 2
Risk

K874876 is an FDA 510(k) clearance for the GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL. 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 January 11, 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K874876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1987
Decision Date January 11, 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 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 364
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K874876.
MODIFICATIONS TO API UNISCEPT (R) KB
K880598 · Analytical Products, Inc. · Mar 1988
ADDITION OF AMPICILLIN/SULBACTAM & CIPROFLOXACIN
K880617 · Pasco Laboratories, Inc. · Mar 1988
PRECEPT(TM) CIPROFLOXACIN
K874727 · Austin Biological Laboratories · Feb 1988
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC
K874466 · Analytical Products, Inc. · Dec 1987
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