Cleared Traditional

K821698 - TDX NETILMICIN

K821698 is an FDA 510(k) clearance for TDX NETILMICIN, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code LCE cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K821698 · Abbott Laboratories · Chemistry device
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Jun 1982
Decision
14d
Days
Class 2
Risk

K821698 is an FDA 510(k) clearance for the TDX NETILMICIN. Classified as Radioimmunoassay, Netilmicin (i-125) (product code LCE), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 22, 1982 after a review of 14 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K821698

510(k) Number K821698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1982
Decision Date June 22, 1982
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCE Device Classification - Class 2, Special Controls

Product Code LCE Radioimmunoassay, Netilmicin (i-125)
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 - LCE Radioimmunoassay, Netilmicin (i-125)

Devices cleared under the same product code (LCE) and FDA review panel - the closest regulatory comparables to K821698.
EMIT NETILMICIN ASSAY
K833715 · Syva Co. · Dec 1983
AMES TDA NETILMICIN TEST & SERUM
K832088 · Miles Laboratories, Inc. · Oct 1983
NETILMICIN FLUORESCENT IMMUNOASSAY
K822941 · American Diagnostic Corp. · Oct 1982
MACRO-VUE CARD TEST, NETILMICIN
K821399 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1982
EMIT AND NETILMICIN ASSAY
K820324 · Syva Co. · Feb 1982