Cleared Traditional

K854938 - COASCREENER/DIASCREENERBLOOD PLASMA TIM...

K854938 is the FDA 510(k) clearance for COASCREENER/DIASCREENERBLOOD PLASMA TIM... by Diatech, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K854938 · Diatech, Inc. · Hematology device
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Mar 1986
Decision
92d
Days
Class 2
Risk

K854938 is an FDA 510(k) clearance for the COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Diatech, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on March 12, 1986 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 Diatech, Inc. devices

Submission Details

510(k) Number K854938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1985
Decision Date March 12, 1986
Days to Decision 92 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 113d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 119
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K854938.
COAG-A-MATE(R) XC
K870960 · Organon Teknika Corp. · Mar 1987
IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA
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KOAGULAB* M COAGULATION SYSTEM
K862537 · Ortho Diagnostic Systems, Inc. · Jul 1986
MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP
K860342 · Bio/Data Corp. · Mar 1986
MICROSAMPLE COAGULATION ANALYSER MODEL 110P
K854546 · Bio/Data Corp. · Jan 1986
THROMBOPLASTIN-R REAGENT
K853986 · American Dade · Nov 1985