Cleared Traditional

K854278 - NEG COMBO BREAKPOINT PANEL POS COMBO (FDA 510(k) Clearance)

Class I Microbiology device.

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.