Cleared Traditional

K854278 - NEG COMBO BREAKPOINT PANEL POS COMBO

K854278 is the FDA 510(k) clearance for NEG COMBO BREAKPOINT PANEL POS COMBO by American Micro Scan. It is a Class 1 Microbiology device (product code JWX) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K854278 · American Micro Scan · Microbiology device
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Mar 1986
Decision
131d
Days
Class 1
Risk

K854278 is an FDA 510(k) clearance for the NEG COMBO BREAKPOINT PANEL POS COMBO. Classified as Kit, Screening, Staphylococcus Aureus (product code JWX), Class I - General Controls.

Submitted by American Micro Scan (Sacramento, US). The FDA issued a Cleared decision on March 4, 1986 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Micro Scan devices

Submission Details

510(k) Number K854278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1985
Decision Date March 04, 1986
Days to Decision 131 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 102d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JWX Kit, Screening, Staphylococcus Aureus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JWX Kit, Screening, Staphylococcus Aureus

All 7
Devices cleared under the same product code (JWX) and FDA review panel - the closest regulatory comparables to K854278.
STAPH-A-LEX(TM) SYSTEM
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SLIDEX STAPH-KIT
K923212 · Biomerieux Vitek, Inc. · Sep 1992
AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT
K902259 · Orthomet, Inc. · Jun 1990
BACTO STAPHYLOCOCCUS LATEX TEST
K843560 · Difco Laboratories, Inc. · Oct 1984
LSM AGAR
K822558 · Granite Diagnostics, Inc. · Sep 1982
BBL STAPHYSLIDE TEST
K821962 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1982