Cleared Traditional

K854546 - MICROSAMPLE COAGULATION ANALYSER MODEL 110P

K854546 is an FDA 510(k) clearance for MICROSAMPLE COAGULATION ANALYSER MODEL 110P, manufactured by Bio/Data Corp.. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K854546 · Bio/Data Corp. · Hematology device
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Jan 1986
Decision
55d
Days
Class 2
Risk

K854546 is an FDA 510(k) clearance for the MICROSAMPLE COAGULATION ANALYSER MODEL 110P. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Bio/Data Corp. (Hatboro, US). The FDA issued a Cleared decision on January 7, 1986 after a review of 55 days - a notably fast clearance cycle.

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: 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 Bio/Data Corp. devices

FDA 510(k) Submission Details - K854546

510(k) Number K854546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1985
Decision Date January 07, 1986
Days to Decision 55 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
58d faster than avg
Panel avg: 113d · This submission: 55d
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 K854546.
KOAGULAB* M COAGULATION SYSTEM
K862537 · Ortho Diagnostic Systems, Inc. · Jul 1986
COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.
K854938 · Diatech, Inc. · Mar 1986
MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP
K860342 · Bio/Data Corp. · Mar 1986
DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT
K854089 · Diatech, Inc. · Jan 1986
DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT
K854090 · Diatech, Inc. · Jan 1986
THROMBOPLASTIN-R REAGENT
K853986 · American Dade · Nov 1985