Cleared Traditional

K874748 - IMMPULSE DIGOXIN ASSAY REAGENTS

K874748 is an FDA 510(k) clearance for IMMPULSE DIGOXIN ASSAY REAGENTS, manufactured by Sclavo, Inc.. The device is a Class 2 Toxicology device with product code LCS cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K874748 · Sclavo, Inc. · Toxicology device
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Feb 1988
Decision
93d
Days
Class 2
Risk

K874748 is an FDA 510(k) clearance for the IMMPULSE DIGOXIN ASSAY REAGENTS. Classified as Radioimmunoassay, Digoxin (125-i) (product code LCS), Class II - Special Controls.

Submitted by Sclavo, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 19, 1988 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sclavo, Inc. devices

FDA 510(k) Submission Details - K874748

510(k) Number K874748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1987
Decision Date February 19, 1988
Days to Decision 93 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
6d slower than avg
Panel avg: 87d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCS Device Classification - Class 2, Special Controls

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)

All 11
Devices cleared under the same product code (LCS) and FDA review panel - the closest regulatory comparables to K874748.
QMS - DIGOXIN
K913562 · Seradyn, Inc. · Aug 1991
INNOFLUOR DIGOXIN REAGENT SET
K895828 · Innotron of Oregon, Inc. · Oct 1989
FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT
K884707 · Cyberfluor, Inc. · Jan 1989
DART DIGOXIN ASSAY
K864802 · Coulter Electronics, Inc. · Feb 1987
TDX DIGOXIN
K820154 · Abbott Laboratories · Feb 1982
I-125 LABELED DIGOXIN
K803047 · Pcl-Ria, Inc. · Dec 1980