Cleared Traditional

K772098 - DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS (FDA 510(k) Clearance)

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

K772098 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Immunology device
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Dec 1977
Decision
43d
Days
Class 2
Risk

K772098 is an FDA 510(k) clearance for the DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. (product code DON), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 20, 1977 after a review of 43 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K772098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1977
Decision Date December 20, 1977
Days to Decision 43 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 104d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DON Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase 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.