Cleared Traditional

K902614 - ELVI 828 DIGICLOT MULTISCAN

K902614 is an FDA 510(k) clearance for ELVI 828 DIGICLOT MULTISCAN, manufactured by Logos Scientific, Inc.. The device is a Class 2 Hematology device with product code KQG cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K902614 · Logos Scientific, Inc. · Hematology device
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Nov 1990
Decision
148d
Days
Class 2
Risk

K902614 is an FDA 510(k) clearance for the ELVI 828 DIGICLOT MULTISCAN. Classified as Instrument, Coagulation (product code KQG), Class II - Special Controls.

Submitted by Logos Scientific, Inc. (Henderson, US). The FDA issued a Cleared decision on November 8, 1990 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Logos Scientific, Inc. devices

FDA 510(k) Submission Details - K902614

510(k) Number K902614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1990
Decision Date November 08, 1990
Days to Decision 148 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 113d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KQG Device Classification - Class 2, Special Controls

Product Code KQG Instrument, Coagulation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5400
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 Hematology devices follow this clearance model.

Regulatory Peers - KQG Instrument, Coagulation

All 8
Devices cleared under the same product code (KQG) and FDA review panel - the closest regulatory comparables to K902614.
PACIFIC HEMOSTASIS THROMBOSCREEN 400C
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PACIFIC HEMOSTASIS THROMBOSCREEN 200
K991321 · Pacific Hemostasis · Jun 1999
HEMOCHRON RESPONSE
K983475 · International Technidyne Corp. · May 1999
ELECTRA 800 AUTOMATIC COAGULATION TIMER
K851169 · Medical Laboratory Automation Systems, Inc. · Jun 1985
KOAGULAB 40-A AUTOMATED COAGULATION SYS
K823131 · Ortho Diagnostic Systems, Inc. · Dec 1982
ELVI BICLOT 816
K812906 · Volu Sol Medical Industries · Jul 1982