Cleared Traditional

K050265 - CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700

K050265 is an FDA 510(k) clearance for CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, manufactured by Chrono-Log Corp.. The device is a Class 2 Hematology device with product code JOZ cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K050265 · Chrono-Log Corp. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
252d
Days
Class 2
Risk

K050265 is an FDA 510(k) clearance for the CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700. Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Chrono-Log Corp. (Havertown, US). The FDA issued a Cleared decision on October 14, 2005 after a review of 252 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5700 - 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.

FDA 510(k) Submission Details - K050265

510(k) Number K050265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2005
Decision Date October 14, 2005
Days to Decision 252 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 113d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOZ Device Classification - Class 2, Special Controls

Product Code JOZ System, Automated Platelet Aggregation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5700
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 - JOZ System, Automated Platelet Aggregation

All 34
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K050265.
AGGREGUIDE
K122162 · Aggredyne, Inc. · Dec 2013
MULTIPLATE 5.0 AGGREGOMETER
K103555 · Verum Diagnostica GmbH · Jul 2012
DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
K060489 · Dade Behring, Inc. · Jul 2006
VERIFYNOW-P2Y12 ASSAY
K051231 · Accumetrics, Inc. · Aug 2005
VERIFYNOW-ASPIRIN ASSAY
K042423 · Accumetrics, Inc. · Oct 2004
THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
K041502 · Haemoscope Corp. · Sep 2004
K050265 · CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700
Download PDF FDA Summary Chrono-Log Corp.