Cleared Traditional

K860868 - TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTA...

K860868 is the FDA 510(k) clearance for TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTA... by Technicon Instruments Corp.. It is a Class 2 Chemistry device (product code LCD) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K860868 · Technicon Instruments Corp. · Chemistry device
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Apr 1986
Decision
27d
Days
Class 2
Risk

K860868 is an FDA 510(k) clearance for the TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN. Classified as Enzyme Immunoassay, Gentamicin (product code LCD), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on April 3, 1986 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3450 - the FDA in vitro diagnostics and chemistry 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K860868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1986
Decision Date April 03, 1986
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCD Enzyme Immunoassay, Gentamicin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3450
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 Chemistry devices follow this clearance model.

Regulatory Peers - LCD Enzyme Immunoassay, Gentamicin

All 30
Devices cleared under the same product code (LCD) and FDA review panel - the closest regulatory comparables to K860868.
EMIT GENTAMICIN ASSAY
K873854 · Syva Co. · Oct 1987
EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640
K871329 · Em Diagnostic Systems, Inc. · May 1987
EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS
K862260 · Syva Co. · Nov 1986
DETERMINATION OF GENTAMICIN
K860045 · Clinical Data, Inc. · Jan 1986
ACA GENTAMICIN TEST PACK
K852672 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1985
DU PONT GENTAMICIN ASSAY REAGENTS
K850060 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1985