Cleared Traditional

K945538 - STAPHAUREX PLUS(TM)

K945538 is an FDA 510(k) clearance for STAPHAUREX PLUS(TM), manufactured by Murex Diagnostics Limitd. The device is a Class 1 Microbiology device with product code JWX cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K945538 · Murex Diagnostics Limitd · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
199d
Days
Class 1
Risk

K945538 is an FDA 510(k) clearance for the STAPHAUREX PLUS(TM). Classified as Kit, Screening, Staphylococcus Aureus (product code JWX), Class I - General Controls.

Submitted by Murex Diagnostics Limitd (England, DE). The FDA issued a Cleared decision on June 1, 1995 after a review of 199 days - an extended review cycle.

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 Murex Diagnostics Limitd devices

FDA 510(k) Submission Details - K945538

510(k) Number K945538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1994
Decision Date June 01, 1995
Days to Decision 199 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 102d · This submission: 199d
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 13
Devices cleared under the same product code (JWX) and FDA review panel - the closest regulatory comparables to K945538.
BINAXNOX STAPHYLOCOCCUS AUREUS TEST
K090964 · Binax, Inc. · Dec 2009
STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
K972030 · Oxoid , Ltd. · Sep 1997
REMEL STAPH LATEX KIT
K964315 · Remel, L.P. · Feb 1997
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