Cleared Traditional

K861395 - EMIT COLUMN DIGOXIN CALIBRATORS

K861395 is the FDA 510(k) clearance for EMIT COLUMN DIGOXIN CALIBRATORS by Syva Co.. It is a Class 2 Chemistry device (product code DLJ) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K861395 · Syva Co. · Chemistry device
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May 1986
Decision
23d
Days
Class 2
Risk

K861395 is an FDA 510(k) clearance for the EMIT COLUMN DIGOXIN CALIBRATORS. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on May 7, 1986 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3200 - the FDA in vitro diagnostics and chemistry 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 Syva Co. devices

Submission Details

510(k) Number K861395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1986
Decision Date May 07, 1986
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 Chemistry devices follow this clearance model.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 93
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K861395.
EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95
K871330 · Em Diagnostic Systems, Inc. · Apr 1987
EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93
K870247 · Em Diagnostic Systems, Inc. · Feb 1987
ANTIASTHMATIC CALIBRATORS
K862964 · American Monitor Corp. · Aug 1986
DU PONT DIGOXIN ASSAY CALIBRATOR
K850457 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1985
DU PONT TOBRAMYCIN ASSAY CALIBRATOR
K850057 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1985
DU PONT GENTAMICIN ASSAY CALIBRATOR
K850059 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1985