Cleared Traditional

K944227 - ELECTRA 1400C AUTOMATIC COAGULATION ANA...

K944227 is the FDA 510(k) clearance for ELECTRA 1400C AUTOMATIC COAGULATION ANA... by Medical Laboratory Automation Systems, Inc.. It is a Class 2 Hematology device (product code GKP) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K944227 · Medical Laboratory Automation Systems, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Feb 1995
Decision
155d
Days
Class 2
Risk

K944227 is an FDA 510(k) clearance for the ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Medical Laboratory Automation Systems, Inc. (Pleasantville, US). The FDA issued a Cleared decision on February 3, 1995 after a review of 155 days - an extended review cycle.

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 Medical Laboratory Automation Systems, Inc. devices

Submission Details

510(k) Number K944227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1994
Decision Date February 03, 1995
Days to Decision 155 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 113d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKP Instrument, Coagulation, Automated
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 - GKP Instrument, Coagulation, Automated

All 37
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K944227.
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
K961579 · American Bioproducts Co. · Jul 1996
PROTIME MICROCOAGULATION SYSTEM
K951072 · International Technidyne Corp. · Oct 1995
MICROSAMPLE COAGULATION ANALYZER
K943153 · Bio/Data Corp. · Mar 1995
STA AUTOMATED MULTI-PARAMETRIC ANALYZER
K942117 · American Bioproducts Co. · Feb 1995
HEMOLAB
K931992 · Biomerieux Vitek, Inc. · Dec 1994
CASCADE M, CAT. NO. 1710
K931956 · Helena Laboratories · Aug 1993