Cleared Traditional

K772116 - AMINOGLYCOSIDE TEST SYSTEM

K772116 is an FDA 510(k) clearance for AMINOGLYCOSIDE TEST SYSTEM, manufactured by Nichols Institute Diagnostics. The device is a Class 2 Immunology device with product code DJB cleared through the Traditional 510(k) pathway after a 172-day FDA review.

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

FDA 510(k) Submission Details - K772116

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 105d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJB Device Classification - Class 2, Special Controls

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 15
Devices cleared under the same product code (DJB) and FDA review panel - the closest regulatory comparables to K772116.
EMIT GENTAMICIN ASSAY
K790829 · Syva Co. · May 1979
RIA KIT, SISOMICIN
K782126 · Diagnostic Products Corp. · Feb 1979
MACRO-VUE TEST, GENTAMICIN
K781674 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1978
QUANTITOPE 125-I GENTAMICIN RIA KIT
K780323 · Kallestad Laboratories, Inc. · Mar 1978
RIANEN GENTAMICIN RIA KIT
K772425 · New England Nuclear · Jan 1978
AMINOGLYCOSIDE (125I) RIA KIT
K761157 · Diagnostic Products Corp. · Mar 1977