Cleared Traditional

K860195 - PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE

K860195 is the FDA 510(k) clearance for PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE by Austin Biological Laboratories. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K860195 · Austin Biological Laboratories · Microbiology device
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Feb 1986
Decision
29d
Days
Class 2
Risk

K860195 is an FDA 510(k) clearance for the PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Austin Biological Laboratories (Austin, US). The FDA issued a Cleared decision on February 20, 1986 after a review of 29 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 K860195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1986
Decision Date February 20, 1986
Days to Decision 29 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 faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
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 - JWY Manual Antimicrobial Susceptibility Test Systems

All 364
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K860195.
FOX FASTIDIOUS TEST PANEL
K854525 · Beckman Instruments, Inc. · Apr 1986
MICRO-MEDIA MICRODILUTION TEST PANELS
K853805 · Beckman Instruments, Inc. · Mar 1986
API UNISCEPT MICRO-MIC CEFTRIAXONE/UNISCEPT MIC
K860369 · Analytical Products, Inc. · Mar 1986
PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN)
K854577 · Austin Biological Laboratories · Feb 1986
PASCO RESISTANT 5 PANEL
K853862 · Pasco Laboratories, Inc. · Jan 1986
SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL
K854097 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1985