Cleared Traditional

K923212 - SLIDEX STAPH-KIT

K923212 is an FDA 510(k) clearance for SLIDEX STAPH-KIT, manufactured by Biomerieux Vitek, Inc.. The device is a Class 1 Microbiology device with product code JWX cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K923212 · Biomerieux Vitek, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
89d
Days
Class 1
Risk

K923212 is an FDA 510(k) clearance for the SLIDEX STAPH-KIT. Classified as Kit, Screening, Staphylococcus Aureus (product code JWX), Class I - General Controls.

Submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on September 28, 1992 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K923212

510(k) Number K923212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1992
Decision Date September 28, 1992
Days to Decision 89 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 102d · This submission: 89d
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 19
Devices cleared under the same product code (JWX) and FDA review panel - the closest regulatory comparables to K923212.
REMEL STAPH LATEX KIT
K964315 · Remel, L.P. · Feb 1997
STAPHAUREX PLUS(TM)
K945538 · Murex Diagnostics Limitd · Jun 1995
STAPH-A-LEX(TM) SYSTEM
K926173 · Trinity Laboratories, Inc. · Aug 1993
VISI-STAPH
K905617 · Connecticut Diagnostics, Ltd. · Mar 1991
AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT
K902259 · Orthomet, Inc. · Jun 1990
STAPHSLIDE
K874019 · Ncs Diagnostics, Inc. · Oct 1987
K923212 · SLIDEX STAPH-KIT
Download PDF FDA Summary Biomerieux Vitek, Inc.