Cleared Traditional

K854938 - COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.

K854938 is an FDA 510(k) clearance for COASCREENER/DIASCREENERBLOOD PLASMA TIM..., manufactured by Diatech, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K854938

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
Combination Product No
PCCP Authorized No
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.

JPA Device Classification - Class 2, Special Controls

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 158
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K854938.
ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER
K864534 · Medical Laboratory Automation Systems, Inc. · Feb 1987
IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA
K864271 · Instrumentation Laboratory CO · Nov 1986
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
DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT
K854089 · Diatech, Inc. · Jan 1986