Cleared Traditional

K060489 - DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS

K060489 is an FDA 510(k) clearance for DADE PFA-100 PLATELET FUNCTION ANALYZER..., manufactured by Dade Behring, Inc.. The device is a Class 2 Hematology device with product code JOZ cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K060489 · Dade Behring, Inc. · Hematology device
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Jul 2006
Decision
147d
Days
Class 2
Risk

K060489 is an FDA 510(k) clearance for the DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS. Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on July 21, 2006 after a review of 147 days - within the typical 510(k) review window.

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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K060489

510(k) Number K060489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2006
Decision Date July 21, 2006
Days to Decision 147 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
34d slower than avg
Panel avg: 113d · This submission: 147d
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 24
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K060489.
Chrono-log Platelet Aggregometer, 4 channel
K161329 · Chrono-Log Corp. · Dec 2016
AGGREGUIDE
K122162 · Aggredyne, Inc. · Dec 2013
MULTIPLATE 5.0 AGGREGOMETER
K103555 · Verum Diagnostica GmbH · Jul 2012
CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700
K050265 · Chrono-Log Corp. · Oct 2005
CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A
K032951 · Chrono-Log Corp. · Apr 2004
PLATELETWORKS, MODELS PW-A, PW-C
K023761 · Helena Laboratories · Feb 2003