Cleared Traditional

K853263 - PRECEPT AVGMENTIN

K853263 is the FDA 510(k) clearance for PRECEPT AVGMENTIN by Austin Biological Laboratories. It is a Class 2 Microbiology device (product code LTW) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K853263 · Austin Biological Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1985
Decision
24d
Days
Class 2
Risk

K853263 is an FDA 510(k) clearance for the PRECEPT AVGMENTIN. 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 August 29, 1985 after a review of 24 days - a notably fast clearance 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: 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 Austin Biological Laboratories devices

Submission Details

510(k) Number K853263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1985
Decision Date August 29, 1985
Days to Decision 24 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
78d faster than avg
Panel avg: 102d · This submission: 24d
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 K853263.
PRECEPT TM TOBRAMYCIN
K853688 · Austin Biological Laboratories · Sep 1985
PRECEPT TM MOXALACTAM
K853689 · Austin Biological Laboratories · Sep 1985
PRECEPT ERYTHROMYCIN
K853053 · Austin Biological Laboratories · Aug 1985
API UNISCEPT KB
K850347 · Analytical Products, Inc. · Mar 1985
API UNISCEPT MIC 100UL
K844159 · Analytical Products, Inc. · Dec 1984
SCEPTOR BETA-LACTAM PLUS MIC PANEL
K844231 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1984