Cleared Traditional

K002885 - DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP

K002885 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 279-day FDA review.

K002885 · Dade Behring, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
279d
Days
Class 2
Risk

K002885 is an FDA 510(k) clearance for the DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHR.... Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on June 21, 2001 after a review of 279 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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K002885

510(k) Number K002885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2000
Decision Date June 21, 2001
Days to Decision 279 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
166d slower than avg
Panel avg: 113d · This submission: 279d
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 K002885.
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
PLATELETWORKS
K012723 · Helena Laboratories · Sep 2001
ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM
K992531 · Accumetrics, Inc. · Dec 1999
PLATELETWORKS
K990398 · Array Medical, Inc. · Dec 1999
DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/
K970505 · Dade Intl., Inc. · Nov 1997