Cleared Traditional

K965150 - A.C.T. IV

K965150 is the FDA 510(k) clearance for A.C.T. IV by Remel Co.. It is a Class 1 Microbiology device (product code JSM) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K965150 · Remel Co. · Microbiology device
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Jan 1997
Decision
30d
Days
Class 1
Risk

K965150 is an FDA 510(k) clearance for the A.C.T. IV. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 30 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 Remel Co. devices

Submission Details

510(k) Number K965150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date January 22, 1997
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 102d · This submission: 30d
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 49
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K965150.
UriSwab-Urine Collection, Transport and Preservation System
K180052 · Copan Italia Spa · Mar 2018
CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K
K993812 · Hardy Diagnostics · Dec 1999
A.C.T. I
K965149 · 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