Cleared Traditional

K992959 - BEHRING COAGULATION SYSTEM (BCS)

K992959 is the FDA 510(k) clearance for BEHRING COAGULATION SYSTEM (BCS) by Dade Behring, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K992959 · Dade Behring, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
131d
Days
Class 2
Risk

K992959 is an FDA 510(k) clearance for the BEHRING COAGULATION SYSTEM (BCS). Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on January 11, 2000 after a review of 131 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K992959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1999
Decision Date January 11, 2000
Days to Decision 131 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
18d slower than avg
Panel avg: 113d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 95
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K992959.
DADE BEHRING COAGULATION ANALYZER (BCT)
K001067 · Dade Behring, Inc. · Jun 2000
BEHRING COAGULATION SYSTEM (BCS)
K000973 · Dade Behring, Inc. · May 2000
ACL 9000 SYSTEM
K000053 · Instrumentation Laboratory CO · Mar 2000
DADE BEHRING BFTII
K984501 · Dade Behring, Inc. · Jul 1999
HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
K990449 · International Technidyne Corp. · Apr 1999
STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
K983460 · American Bioproducts Co. · Nov 1998