Cleared Traditional

K926173 - STAPH-A-LEX(TM) SYSTEM

K926173 is an FDA 510(k) clearance for STAPH-A-LEX(TM) SYSTEM, manufactured by Trinity Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JWX cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K926173 · Trinity Laboratories, Inc. · Microbiology device
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Aug 1993
Decision
245d
Days
Class 1
Risk

K926173 is an FDA 510(k) clearance for the STAPH-A-LEX(TM) SYSTEM. Classified as Kit, Screening, Staphylococcus Aureus (product code JWX), Class I - General Controls.

Submitted by Trinity Laboratories, Inc. (Raleigh, US). The FDA issued a Cleared decision on August 10, 1993 after a review of 245 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 Trinity Laboratories, Inc. devices

FDA 510(k) Submission Details - K926173

510(k) Number K926173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1992
Decision Date August 10, 1993
Days to Decision 245 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 102d · This submission: 245d
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 11
Devices cleared under the same product code (JWX) and FDA review panel - the closest regulatory comparables to K926173.
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K854278 · American Micro Scan · Mar 1986
V-TREND KIT STAPH LATEX TEST
K855220 · Texas Immunology, Inc. · Mar 1986