Cleared Traditional

K832088 - AMES TDA NETILMICIN TEST & SERUM

K832088 is the FDA 510(k) clearance for AMES TDA NETILMICIN TEST & SERUM by Miles Laboratories, Inc.. It is a Class 2 Chemistry device (product code LCE) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K832088 · Miles Laboratories, Inc. · Chemistry device
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Oct 1983
Decision
122d
Days
Class 2
Risk

K832088 is an FDA 510(k) clearance for the AMES TDA NETILMICIN TEST & SERUM. Classified as Radioimmunoassay, Netilmicin (i-125) (product code LCE), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on October 28, 1983 after a review of 122 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Miles Laboratories, Inc. devices

Submission Details

510(k) Number K832088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1983
Decision Date October 28, 1983
Days to Decision 122 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
34d slower than avg
Panel avg: 88d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K832088.
EMIT NETILMICIN ASSAY
K833715 · Syva Co. · Dec 1983
NETILMICIN FLUORESCENT IMMUNOASSAY
K822941 · American Diagnostic Corp. · Oct 1982
TDX NETILMICIN
K821698 · Abbott Laboratories · Jun 1982
MACRO-VUE CARD TEST, NETILMICIN
K821399 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1982
EMIT AND NETILMICIN ASSAY
K820324 · Syva Co. · Feb 1982