Cleared Traditional

K853685 - PRECEPT TM CARBENICILLIN

K853685 is an FDA 510(k) clearance for PRECEPT TM CARBENICILLIN, 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 178-day FDA review.

K853685 · Austin Biological Laboratories · Microbiology device
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Sep 1985
Decision
178d
Days
Class 2
Risk

K853685 is an FDA 510(k) clearance for the PRECEPT TM CARBENICILLIN. 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 16, 1985 after a review of 178 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 - K853685

510(k) Number K853685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1985
Decision Date September 16, 1985
Days to Decision 178 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
76d slower than avg
Panel avg: 102d · This submission: 178d
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 K853685.
PRECEPT CEFTRIAXONE
K853273 · Austin Biological Laboratories · Sep 1985
PRECEPT CEFOPERAZONE
K853596 · Austin Biological Laboratories · Sep 1985
PRECEPT METHICILLIN
K853772 · Austin Biological Laboratories · Sep 1985
PRECEPT KANAMYCIN
K853684 · Austin Biological Laboratories · Sep 1985
PRECEPT TM AMIKACIN
K853686 · Austin Biological Laboratories · Sep 1985
PRECEPT NETILMICIN 32-13
K853687 · Austin Biological Laboratories · Sep 1985