Cleared Traditional

K905617 - VISI-STAPH

K905617 is the FDA 510(k) clearance for VISI-STAPH by Connecticut Diagnostics, Ltd.. It is a Class 1 Microbiology device (product code JWX) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K905617 · Connecticut Diagnostics, Ltd. · Microbiology device
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Mar 1991
Decision
105d
Days
Class 1
Risk

K905617 is an FDA 510(k) clearance for the VISI-STAPH. Classified as Kit, Screening, Staphylococcus Aureus (product code JWX), Class I - General Controls.

Submitted by Connecticut Diagnostics, Ltd. (Danielson, US). The FDA issued a Cleared decision on March 29, 1991 after a review of 105 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 Connecticut Diagnostics, Ltd. devices

Submission Details

510(k) Number K905617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1990
Decision Date March 29, 1991
Days to Decision 105 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 102d · This submission: 105d
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.

Regulatory Peers - JWX Kit, Screening, Staphylococcus Aureus

All 8
Devices cleared under the same product code (JWX) and FDA review panel - the closest regulatory comparables to K905617.
STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
K972030 · Oxoid , Ltd. · Sep 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
BACTO STAPHYLOCOCCUS LATEX TEST
K843560 · Difco Laboratories, Inc. · Oct 1984
LSM AGAR
K822558 · Granite Diagnostics, Inc. · Sep 1982