Cleared Traditional

OPUS DIGITOXIN (K935229) - FDA 510(k) Clearance

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

K935229 · Pb Diagnostic Systems, Inc. · Toxicology device
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Dec 1993
Decision
51d
Days
Class 2
Risk

K935229 is an FDA 510(k) clearance for the OPUS DIGITOXIN. Classified as Radioimmunoassay, Digitoxin (125-i), Rabbit Antibody, Coated Tube Sep. (product code DPG), Class II - Special Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on December 22, 1993 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3300 - the FDA toxicology 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 Pb Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K935229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1993
Decision Date December 22, 1993
Days to Decision 51 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 87d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPG Radioimmunoassay, Digitoxin (125-i), Rabbit Antibody, Coated Tube Sep.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3300
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 Toxicology devices follow this clearance model.