Cleared Traditional

K860753 - SENSITITRE SUSCEPTIBILITY PLATES

K860753 is the FDA 510(k) clearance for SENSITITRE SUSCEPTIBILITY PLATES by Gibco Laboratories Life Technologies, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K860753 · Gibco Laboratories Life Technologies, Inc. · Microbiology device
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May 1986
Decision
68d
Days
Class 2
Risk

K860753 is an FDA 510(k) clearance for the SENSITITRE SUSCEPTIBILITY PLATES. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Gibco Laboratories Life Technologies, Inc. (Andover, US). The FDA issued a Cleared decision on May 6, 1986 after a review of 68 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 Gibco Laboratories Life Technologies, Inc. devices

Submission Details

510(k) Number K860753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1986
Decision Date May 06, 1986
Days to Decision 68 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
34d faster than avg
Panel avg: 102d · This submission: 68d
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 K860753.
PRECEPT CEFTIZOXIME
K862560 · Austin Biological Laboratories · Jul 1986
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
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