Cleared Traditional

K853686 - PRECEPT TM AMIKACIN

K853686 is the FDA 510(k) clearance for PRECEPT TM AMIKACIN by Austin Biological Laboratories. It is a Class 2 Microbiology device (product code LTW) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K853686 · Austin Biological Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
175d
Days
Class 2
Risk

K853686 is an FDA 510(k) clearance for the PRECEPT TM AMIKACIN. Classified as Susceptibility Test Cards, Antimicrobial (product code LTW), Class II - Special Controls.

Submitted by Austin Biological Laboratories (Austin, US). The FDA issued a Cleared decision on September 13, 1985 after a review of 175 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Austin Biological Laboratories devices

Submission Details

510(k) Number K853686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1985
Decision Date September 13, 1985
Days to Decision 175 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 102d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LTW Susceptibility Test Cards, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LTW Susceptibility Test Cards, Antimicrobial

All 14
Devices cleared under the same product code (LTW) and FDA review panel - the closest regulatory comparables to K853686.
PRECEPT TM CARBENICILLIN
K853685 · Austin Biological Laboratories · Sep 1985
PRECEPT METHICILLIN
K853772 · Austin Biological Laboratories · Sep 1985
PRECEPT KANAMYCIN
K853684 · Austin Biological Laboratories · Sep 1985
PRECEPT NETILMICIN 32-13
K853687 · Austin Biological Laboratories · Sep 1985
PRECEPT TM TOBRAMYCIN
K853688 · Austin Biological Laboratories · Sep 1985
PRECEPT TM MOXALACTAM
K853689 · Austin Biological Laboratories · Sep 1985