Cleared Traditional

K895828 - INNOFLUOR DIGOXIN REAGENT SET

K895828 is an FDA 510(k) clearance for INNOFLUOR DIGOXIN REAGENT SET, manufactured by Innotron of Oregon, Inc.. The device is a Class 2 Toxicology device with product code LCS cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K895828 · Innotron of Oregon, Inc. · Toxicology device
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Oct 1989
Decision
28d
Days
Class 2
Risk

K895828 is an FDA 510(k) clearance for the INNOFLUOR DIGOXIN REAGENT SET. Classified as Radioimmunoassay, Digoxin (125-i) (product code LCS), Class II - Special Controls.

Submitted by Innotron of Oregon, Inc. (Portland, US). The FDA issued a Cleared decision on October 30, 1989 after a review of 28 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 Innotron of Oregon, Inc. devices

FDA 510(k) Submission Details - K895828

510(k) Number K895828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1989
Decision Date October 30, 1989
Days to Decision 28 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
59d faster than avg
Panel avg: 87d · This submission: 28d
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 K895828.
DIGOXIN COATED TUBE RIA
K922353 · Monobind · Aug 1992
QMS - DIGOXIN
K913562 · Seradyn, Inc. · Aug 1991
FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT
K884707 · Cyberfluor, Inc. · Jan 1989
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