Cleared Traditional

K781495 - RIANEN ASSAY SYSTEM

K781495 is the FDA 510(k) clearance for RIANEN ASSAY SYSTEM by New England Nuclear. It is a Class 2 Immunology device (product code DNL) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K781495 · New England Nuclear · Immunology device
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Sep 1978
Decision
15d
Days
Class 2
Risk

K781495 is an FDA 510(k) clearance for the RIANEN ASSAY SYSTEM, 125I KIT. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep. (product code DNL), Class II - Special Controls.

Submitted by New England Nuclear (Mchenry, US). The FDA issued a Cleared decision on September 14, 1978 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3320 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all New England Nuclear devices

Submission Details

510(k) Number K781495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1978
Decision Date September 14, 1978
Days to Decision 15 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 104d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DNL Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
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.