Cleared Traditional

K871329 - EASY-TEST EMIT GENTAMICIN (GENT) ITEM N...

K871329 is the FDA 510(k) clearance for EASY-TEST EMIT GENTAMICIN (GENT) ITEM N... by Em Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code LCD) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K871329 · Em Diagnostic Systems, Inc. · Toxicology device
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May 1987
Decision
39d
Days
Class 2
Risk

K871329 is an FDA 510(k) clearance for the EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640. Classified as Enzyme Immunoassay, Gentamicin (product code LCD), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on May 12, 1987 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3450 - the FDA toxicology 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K871329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1987
Decision Date May 12, 1987
Days to Decision 39 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 87d · This submission: 39d
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 Toxicology 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 K871329.
EMIT CONVENIENCE PACK: GENTAMICIN ASSAY
K874703 · Syva Co. · Dec 1987
EMIT QST GENTAMICIN ASSAY
K873855 · Syva Co. · Oct 1987
EMIT GENTAMICIN ASSAY
K873854 · Syva Co. · Oct 1987
EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS
K862260 · Syva Co. · Nov 1986
TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN
K860868 · Technicon Instruments Corp. · Apr 1986
DETERMINATION OF GENTAMICIN
K860045 · Clinical Data, Inc. · Jan 1986