Cleared Traditional

K770069 - DIGOXIN CLASP TM RIA KIT

K770069 is the FDA 510(k) clearance for DIGOXIN CLASP TM RIA KIT by E. R. Squibb & Sons, Inc.. It is a Class 2 Toxicology device (product code DPO) cleared through the Traditional 510(k) pathway after a 5-day FDA review.

K770069 · E. R. Squibb & Sons, Inc. · Toxicology device
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Jan 1977
Decision
5d
Days
Class 2
Risk

K770069 is an FDA 510(k) clearance for the DIGOXIN CLASP TM RIA KIT. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. (product code DPO), Class II - Special Controls.

Submitted by E. R. Squibb & Sons, Inc. (New York, US). The FDA issued a Cleared decision on January 18, 1977 after a review of 5 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - 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 E. R. Squibb & Sons, Inc. devices

Submission Details

510(k) Number K770069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1977
Decision Date January 18, 1977
Days to Decision 5 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 87d · This submission: 5d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPO Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube 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 Toxicology devices follow this clearance model.