Cleared Traditional

K854278 - NEG COMBO BREAKPOINT PANEL POS COMBO

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

K854278 · American Micro Scan · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K854278

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 102d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

JWX Device Classification - Class 1, General Controls

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 12
Devices cleared under the same product code (JWX) and FDA review panel - the closest regulatory comparables to K854278.
STAPH-A-LEX(TM) SYSTEM
K926173 · Trinity Laboratories, Inc. · Aug 1993
SLIDEX STAPH-KIT
K923212 · Biomerieux Vitek, Inc. · Sep 1992
AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT
K902259 · Orthomet, Inc. · Jun 1990
V-TREND KIT STAPH LATEX TEST
K855220 · Texas Immunology, Inc. · Mar 1986
BACTO STAPHYLOCOCCUS LATEX TEST
K843560 · Difco Laboratories, Inc. · Oct 1984
LA-STAPH IDENTIFICATION SYSTEM
K831918 · Immuno-Mycologics, Inc. · Jun 1983