Cleared Traditional

K821811 - 125I DIGOXIN RADIOIMMUNOASSAY KIT

K821811 is the FDA 510(k) clearance for 125I DIGOXIN RADIOIMMUNOASSAY KIT by Cambridge Medical Technology. It is a Class 2 Chemistry device (product code DPB) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K821811 · Cambridge Medical Technology · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1982
Decision
14d
Days
Class 2
Risk

K821811 is an FDA 510(k) clearance for the 125I DIGOXIN RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep. (product code DPB), Class II - Special Controls.

Submitted by Cambridge Medical Technology (Mchenry, US). The FDA issued a Cleared decision on July 2, 1982 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - the FDA in vitro diagnostics and chemistry 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 Cambridge Medical Technology devices

Submission Details

510(k) Number K821811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1982
Decision Date July 02, 1982
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPB Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal 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 Chemistry devices follow this clearance model.

Regulatory Peers - DPB Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep.

Devices cleared under the same product code (DPB) and FDA review panel - the closest regulatory comparables to K821811.
OPTIMATE DIGOXIN TEST
K853021 · Miles Laboratories, Inc. · Aug 1985
DIGOXIN RADIOIMMUNOASSAY
K820274 · American Diagnostic Corp. · Feb 1982
RIA TEST KIT, CENTRIA DIGOXIN
K790540 · Ventrex Laboratories, Inc. · Apr 1979
125 I DIGOXIN RIA KIT
K771525 · Diagnostic Products Corp. · Oct 1977