Cleared Traditional

K760709 - EMIT DIGOKIN ASSAY

K760709 is an FDA 510(k) clearance for EMIT DIGOKIN ASSAY, manufactured by Syva Co.. The device is a Class 2 Toxicology device with product code DOG cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K760709 · Syva Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1976
Decision
27d
Days
Class 2
Risk

K760709 is an FDA 510(k) clearance for the EMIT DIGOKIN ASSAY. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Polyethylene Glycol (product code DOG), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on October 21, 1976 after a review of 27 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.

FDA 510(k) Submission Details - K760709

510(k) Number K760709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1976
Decision Date October 21, 1976
Days to Decision 27 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
60d faster than avg
Panel avg: 87d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DOG Device Classification - Class 2, Special Controls

Product Code DOG Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Polyethylene Glycol
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.

Regulatory Peers - DOG Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Polyethylene Glycol

Devices cleared under the same product code (DOG) and FDA review panel - the closest regulatory comparables to K760709.
DCA DIGOX-SYN RIA TEST
K810477 · Diagnostic Corp. of America · Mar 1981
IMMU-TRACE DIGOXIN (125I) RADIOIMMUN.
K803045 · American Dade · Dec 1980
DIGOXIN RIA (PEG) KIT
K781335 · Ortho Diagnostics, Inc. · Aug 1978
DATA-TOPE SYSTEM DIGOXIN RIA
K760416 · Dade, Baxter Travenol Diagnostics, Inc. · Aug 1976
K760709 · EMIT DIGOKIN ASSAY
Download PDF Syva Co.