Cleared Traditional

K761157 - AMINOGLYCOSIDE (125I) RIA KIT

K761157 is an FDA 510(k) clearance for AMINOGLYCOSIDE (125I) RIA KIT, manufactured by Diagnostic Products Corp.. The device is a Class 2 Immunology device with product code DJB cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K761157 · Diagnostic Products Corp. · Immunology device
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Mar 1977
Decision
92d
Days
Class 2
Risk

K761157 is an FDA 510(k) clearance for the AMINOGLYCOSIDE (125I) RIA KIT. Classified as Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (product code DJB), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1977 after a review of 92 days - within the typical 510(k) review window.

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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K761157

510(k) Number K761157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1976
Decision Date March 01, 1977
Days to Decision 92 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
13d faster than avg
Panel avg: 105d · This submission: 92d
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 K761157.
AMINOGLYCOSIDE TEST SYSTEM
K772116 · Nichols Institute Diagnostics · Apr 1978
QUANTITOPE 125-I GENTAMICIN RIA KIT
K780323 · Kallestad Laboratories, Inc. · Mar 1978
RIANEN GENTAMICIN RIA KIT
K772425 · New England Nuclear · Jan 1978
KIT, RIA, GENTAMICIN SULF.
K760068 · New England Nuclear · Jul 1976