Cleared Traditional

K850833 - PRECEPT TM MEZLOCILLIN

K850833 is an FDA 510(k) clearance for PRECEPT TM MEZLOCILLIN, manufactured by Austin Biological Laboratories. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K850833

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.

JWY Device Classification - Class 2, Special Controls

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 406
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