Cleared Traditional

K832088 - AMES TDA NETILMICIN TEST & SERUM

K832088 is an FDA 510(k) clearance for AMES TDA NETILMICIN TEST & SERUM, manufactured by Miles Laboratories, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K832088

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.

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 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