Cleared Traditional

K812749 - ULTRA-DIG

K812749 is the FDA 510(k) clearance for ULTRA-DIG by Antibodies, Inc.. It is a Class 2 Toxicology device (product code LCS) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K812749 · Antibodies, Inc. · Toxicology device

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Oct 1981

Decision

20d

Days

Class 2

Risk

K812749 is an FDA 510(k) clearance for the ULTRA-DIG. Classified as Radioimmunoassay, Digoxin (125-i) (product code LCS), Class II - Special Controls.

Submitted by Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 19, 1981 after a review of 20 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 Antibodies, Inc. devices

Submission Details

510(k) Number	K812749 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 29, 1981
Decision Date	October 19, 1981
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

67d faster than avg

Panel avg: 87d · This submission: 20d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	LCS Radioimmunoassay, Digoxin (125-i)
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 - LCS Radioimmunoassay, Digoxin (125-i)

Devices cleared under the same product code (LCS) and FDA review panel - the closest regulatory comparables to K812749.

IMMPULSE DIGOXIN ASSAY REAGENTS

K874748 · Sclavo, Inc. · Feb 1988

DART DIGOXIN ASSAY

K864802 · Coulter Electronics, Inc. · Feb 1987

TDX DIGOXIN

K820154 · Abbott Laboratories · Feb 1982

AMERLEX DIGOXIN RIA KIT

K801413 · Amersham Corp. · Jul 1980

DIGOXIN CLASP RIA KIT

K800997 · E. R. Squibb & Sons, Inc. · May 1980

PHALDEBAS DIGOXIN RIA

K770322 · Pharmacia, Inc. · Apr 1977

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K812749

Antibodies, Inc.

Mchenry, IL · US

Regulatory profile

16 submissions 16 cleared

100% clearance rate · Active in Toxicology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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