Cleared Traditional

K926173 - STAPH-A-LEX(TM) SYSTEM (FDA 510(k) Clearance)

Class I Microbiology device.

K926173 · Trinity Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 102d · This submission: 245d
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.