Cleared Traditional

K853689 - PRECEPT TM MOXALACTAM

K853689 is an FDA 510(k) clearance for PRECEPT TM MOXALACTAM, manufactured by Austin Biological Laboratories. The device is a Class 2 Microbiology device with product code LTW cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K853689 · Austin Biological Laboratories · Microbiology device
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Sep 1985
Decision
196d
Days
Class 2
Risk

K853689 is an FDA 510(k) clearance for the PRECEPT TM MOXALACTAM. 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 196 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

FDA 510(k) Submission Details - K853689

510(k) Number K853689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1985
Decision Date September 13, 1985
Days to Decision 196 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
94d slower than avg
Panel avg: 102d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LTW Device Classification - Class 2, Special Controls

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 K853689.
PRECEPT TM AMIKACIN
K853686 · 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 ERYTHROMYCIN
K853053 · Austin Biological Laboratories · Aug 1985
PRECEPT AVGMENTIN
K853263 · Austin Biological Laboratories · Aug 1985
API UNISCEPT KB
K850347 · Analytical Products, Inc. · Mar 1985