Cleared Traditional

K861584 - GRAM NEGATIVE COMBO PANEL TYPE 3

K861584 is the FDA 510(k) clearance for GRAM NEGATIVE COMBO PANEL TYPE 3 by American Micro Scan. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K861584 · American Micro Scan · Microbiology device
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Jun 1986
Decision
49d
Days
Class 2
Risk

K861584 is an FDA 510(k) clearance for the GRAM NEGATIVE COMBO PANEL TYPE 3. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by American Micro Scan (West Sacramento, US). The FDA issued a Cleared decision on June 17, 1986 after a review of 49 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 American Micro Scan devices

Submission Details

510(k) Number K861584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date June 17, 1986
Days to Decision 49 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 102d · This submission: 49d
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 365
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K861584.
RESISTANT 6 MIC PANEL
K862978 · Pasco Laboratories, Inc. · Sep 1986
PRECEPT CEFTAZIDIME
K862446 · Austin Biological Laboratories · Jul 1986
PRECEPT CEFTIZOXIME
K862560 · Austin Biological Laboratories · Jul 1986
SCEPTOR GRAM NEGATIVE BREAKPOINT /ID PANEL
K861187 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986
SCEPTOR GRAM POSITIVE BREAKPOINT/ID PANEL
K861186 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986
SENSITITRE SUSCEPTIBILITY PLATES
K860753 · Gibco Laboratories Life Technologies, Inc. · May 1986