Cleared Traditional

K854525 - FOX FASTIDIOUS TEST PANEL

K854525 is an FDA 510(k) clearance for FOX FASTIDIOUS TEST PANEL, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K854525 · Beckman Instruments, Inc. · Microbiology device
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Apr 1986
Decision
149d
Days
Class 2
Risk

K854525 is an FDA 510(k) clearance for the FOX FASTIDIOUS TEST PANEL. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 11, 1986 after a review of 149 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K854525

510(k) Number K854525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1985
Decision Date April 11, 1986
Days to Decision 149 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
47d slower than avg
Panel avg: 102d · This submission: 149d
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 366
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K854525.
SCEPTOR GRAM NEGATIVE BREAKPOINT /ID PANEL
K861187 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986
SCEPTOR GRAM POSITIVE BREAKPOINT/ID PANEL
K861186 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986
SENSITITRE SUSCEPTIBILITY PLATES
K860753 · Gibco Laboratories Life Technologies, Inc. · May 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 TRIMETHOPRIM/SULFAMETHOXAZOLE
K860195 · Austin Biological Laboratories · Feb 1986