Cleared Traditional

K874727 - PRECEPT(TM) CIPROFLOXACIN

K874727 is the FDA 510(k) clearance for PRECEPT(TM) CIPROFLOXACIN by Austin Biological Laboratories. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K874727 · Austin Biological Laboratories · Microbiology device
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Feb 1988
Decision
92d
Days
Class 2
Risk

K874727 is an FDA 510(k) clearance for the PRECEPT(TM) CIPROFLOXACIN. 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 18, 1988 after a review of 92 days - within the typical 510(k) review window.

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 K874727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1987
Decision Date February 18, 1988
Days to Decision 92 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
10d faster than avg
Panel avg: 102d · This submission: 92d
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 K874727.
GRAM NEGATIVE MIC/COMBO PANELS
K880430 · Baxter Healthcare Corp · Apr 1988
MODIFICATIONS TO API UNISCEPT (R) KB
K880598 · Analytical Products, Inc. · Mar 1988
ADDITION OF AMPICILLIN/SULBACTAM & CIPROFLOXACIN
K880617 · Pasco Laboratories, Inc. · Mar 1988
GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL
K874876 · Baxter Healthcare Corp · Jan 1988
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC
K874466 · Analytical Products, Inc. · Dec 1987
NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO
K874426 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1987