Cleared Traditional

K050265 - CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050265 · Chrono-Log Corp. · Hematology device
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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.

View all Chrono-Log Corp. devices

Submission Details

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
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.

Device Classification

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.