Cleared Traditional

K984501 - DADE BEHRING BFTII

K984501 is an FDA 510(k) clearance for DADE BEHRING BFTII, manufactured by Dade Behring, Inc.. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K984501 · Dade Behring, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
222d
Days
Class 2
Risk

K984501 is an FDA 510(k) clearance for the DADE BEHRING BFTII. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on July 28, 1999 after a review of 222 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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K984501

510(k) Number K984501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1998
Decision Date July 28, 1999
Days to Decision 222 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
109d slower than avg
Panel avg: 113d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPA Device Classification - Class 2, Special Controls

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 152
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K984501.
THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES
K993678 · Haemoscope Corp. · May 2000
ACL 9000 SYSTEM
K000053 · Instrumentation Laboratory CO · Mar 2000
BEHRING COAGULATION SYSTEM (BCS)
K992959 · Dade Behring, Inc. · Jan 2000
TAS ANALYZER, MODEL 1009
K990566 · Cardiovascular Diagnostics, Inc. · May 1999
COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P
K983892 · Roche Diagnostics/Boehringer Mannheim GmbH · Apr 1999
HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
K990449 · International Technidyne Corp. · Apr 1999