Cleared Traditional

K943499 - KULTSURE STARSWAB(M240)

K943499 is the FDA 510(k) clearance for KULTSURE STARSWAB(M240) by Ncs Diagnostics, Inc.. It is a Class 1 Microbiology device (product code JSM) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K943499 · Ncs Diagnostics, Inc. · Microbiology device
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Nov 1994
Decision
170d
Days
Class 1
Risk

K943499 is an FDA 510(k) clearance for the KULTSURE STARSWAB(M240), MODIFICATION. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Ncs Diagnostics, Inc. (Etobicoke, Ontario, CA). The FDA issued a Cleared decision on November 30, 1994 after a review of 170 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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 Ncs Diagnostics, Inc. devices

Submission Details

510(k) Number K943499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1994
Decision Date November 30, 1994
Days to Decision 170 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
68d slower than avg
Panel avg: 102d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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 - JSM Culture Media, Non-propagating Transport

All 53
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K943499.
A.C.T. III
K965151 · Remel Co. · Jan 1997
A.C.T. II
K965152 · Remel Co. · Jan 1997
CVM TRANSPORT
K955451 · Hardy Diagnostics · Jul 1996
FLEXTRANS
K935987 · Baxter Diagnostics, Inc. · Aug 1994
AEROBIC FOAM SWAB CULTURETTE(R)
K913789 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
BACTI-SWAB
K910180 · Remel Co. · May 1991