Cleared Traditional

K861195 - DELFIA DIGOXIN

K861195 is an FDA 510(k) clearance for DELFIA DIGOXIN, manufactured by Lkb Instruments, Inc.. The device is a Class 2 Toxicology device with product code KXT cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K861195 · Lkb Instruments, Inc. · Toxicology device
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Jul 1986
Decision
102d
Days
Class 2
Risk

K861195 is an FDA 510(k) clearance for the DELFIA DIGOXIN. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Lkb Instruments, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on July 11, 1986 after a review of 102 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 Lkb Instruments, Inc. devices

FDA 510(k) Submission Details - K861195

510(k) Number K861195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1986
Decision Date July 11, 1986
Days to Decision 102 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
15d slower than avg
Panel avg: 87d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXT Device Classification - Class 2, Special Controls

Product Code KXT Enzyme Immunoassay, Digoxin
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 - KXT Enzyme Immunoassay, Digoxin

All 78
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K861195.
AFFINITY DIGOXIN IMMUNIT
K870552 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
DIGOXIN FPIA REAGENT SET
K870951 · Sigma Diagnostics, Inc. · Apr 1987
DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY
K864333 · Windsor Laboratories, Inc. · Jan 1987
EMIT COLUMN DIGOXIN ASSAY
K861393 · Syva Co. · May 1986
EMIT DIGOXIN MOBILE PHASE SOLUTION
K861394 · Syva Co. · May 1986
CEDIA DIGOXIN ASSAY
K854638 · Microgenics Corp. · Mar 1986