Cleared Traditional

K860342 - MICROSAMPLE COAGULATION ANALYSER

K860342 is the FDA 510(k) clearance for MICROSAMPLE COAGULATION ANALYSER by Bio/Data Corp.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K860342 · Bio/Data Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
34d
Days
Class 2
Risk

K860342 is an FDA 510(k) clearance for the MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP. 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 March 4, 1986 after a review of 34 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

Submission Details

510(k) Number K860342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1986
Decision Date March 04, 1986
Days to Decision 34 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
79d faster than avg
Panel avg: 113d · This submission: 34d
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 116
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K860342.
COAG-A-MATE(R) XC
K870960 · Organon Teknika Corp. · Mar 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 110P
K854546 · Bio/Data Corp. · Jan 1986
THROMBOPLASTIN-R REAGENT
K853986 · American Dade · Nov 1985
KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS
K853328 · Ortho Diagnostic Systems, Inc. · Nov 1985