Cleared Traditional

AMINOGLYCOSIDE TEST SYSTEM (K772116) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K772116 · Nichols Institute Diagnostics · Immunology device
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Apr 1978
Decision
172d
Days
Class 2
Risk

K772116 is an FDA 510(k) clearance for the AMINOGLYCOSIDE TEST SYSTEM. Classified as Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (product code DJB), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (Mchenry, US). The FDA issued a Cleared decision on April 28, 1978 after a review of 172 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3450 - the FDA immunology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nichols Institute Diagnostics devices

Submission Details

510(k) Number K772116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1977
Decision Date April 28, 1978
Days to Decision 172 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 104d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJB Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep.
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 Immunology devices follow this clearance model.

Regulatory Peers - DJB Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep.

All 18
Devices cleared under the same product code (DJB) and FDA review panel - the closest regulatory comparables to K772116.
GENTAMICIN TEST PACK-ACA
K831210 · E.I. Dupont DE Nemours & Co., Inc. · May 1983
COAT-A-COUNT GENTAMICIN RIA KIT
K811844 · Diagnostic Products Corp. · Jul 1981
QUANTIMUNE GENTAMICIN RIA GENTAMICIN
K791770 · Bio-Rad · Oct 1979
FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY
K791547 · Bio-Rad · Oct 1979
BIOASSAY SYSTEM, MS-2 SERUM
K782049 · Abbott Laboratories · Aug 1979
EMIT GENTAMICIN ASSAY
K790829 · Syva Co. · May 1979