Cleared Traditional

K083896 - DESTINY MAX COAGULATION ANALYZER

K083896 is the FDA 510(k) clearance for DESTINY MAX COAGULATION ANALYZER by Trinity Biotech. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K083896 · Trinity Biotech · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
185d
Days
Class 2
Risk

K083896 is an FDA 510(k) clearance for the DESTINY MAX COAGULATION ANALYZER. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Trinity Biotech (Jamestown, US). The FDA issued a Cleared decision on July 2, 2009 after a review of 185 days - an extended review 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: 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 Trinity Biotech devices

Submission Details

510(k) Number K083896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2008
Decision Date July 02, 2009
Days to Decision 185 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 113d · This submission: 185d
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 117
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K083896.
TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
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ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS
K083518 · Instrumentation Laboratory CO · Mar 2009
BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2
K083159 · Siemens Healthcare Diagnostics · Jan 2009
BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2
K083175 · Siemens Healthcare Diagnostics · Jan 2009