Cleared Traditional

K853328 - KOAGULAB 16-S SEMI-AUTOMATED COAGULATIO...

K853328 is the FDA 510(k) clearance for KOAGULAB 16-S SEMI-AUTOMATED COAGULATIO... by Ortho Diagnostic Systems, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K853328 · Ortho Diagnostic Systems, Inc. · Hematology device
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Nov 1985
Decision
89d
Days
Class 2
Risk

K853328 is an FDA 510(k) clearance for the KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on November 5, 1985 after a review of 89 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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K853328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1985
Decision Date November 05, 1985
Days to Decision 89 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
24d faster than avg
Panel avg: 113d · This submission: 89d
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 K853328.
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
CALCIUM CHLORIDE
K853246 · Bio/Data Corp. · Aug 1985
CITREX I
K853076 · Bio/Data Corp. · Aug 1985
CITREX II
K853077 · Bio/Data Corp. · Aug 1985