Cleared Traditional

K850833 - PRECEPT TM MEZLOCILLIN

K850833 is the FDA 510(k) clearance for PRECEPT TM MEZLOCILLIN by Austin Biological Laboratories. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K850833 · Austin Biological Laboratories · Microbiology device
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Sep 1985
Decision
196d
Days
Class 2
Risk

K850833 is an FDA 510(k) clearance for the PRECEPT TM MEZLOCILLIN. 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 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

Submission Details

510(k) Number K850833 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.

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 K850833.
SCEPTOR GRAM POSITIVE MIC PANEL
K854101 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1985
SCEPTOR ENTERIC MIC PANEL
K854102 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1985
SCEPTOR ENTERIC MIC/ID PANEL
K854103 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1985
MIC-BIO-PLATE
K844903 · Pasco Laboratories, Inc. · Dec 1984
METRONIDAZOLE DISCS
K801805 · G.D. Searle and Co. · Feb 1981