Cleared Traditional

K962843 - MULTITRANS CULTURE COLLECTION AND TRANS...

K962843 is the FDA 510(k) clearance for MULTITRANS CULTURE COLLECTION AND TRANS... by Starplex Scientific, Inc.. It is a Class 1 Microbiology device (product code JSM) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K962843 · Starplex Scientific, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
58d
Days
Class 1
Risk

K962843 is an FDA 510(k) clearance for the MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Starplex Scientific, Inc. (Etobicoke, Ontario, CA). The FDA issued a Cleared decision on September 18, 1996 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Starplex Scientific, Inc. devices

Submission Details

510(k) Number K962843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1996
Decision Date September 18, 1996
Days to Decision 58 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
44d faster than avg
Panel avg: 102d · This submission: 58d
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 50
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K962843.
A.C.T. IV
K965150 · Remel Co. · Jan 1997
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