Cleared Traditional

K926551 - BEHRING FIBRINTIMER A

K926551 is the FDA 510(k) clearance for BEHRING FIBRINTIMER A by Behring Diagnostics, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 838-day FDA review.

K926551 · Behring Diagnostics, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Apr 1995
Decision
838d
Days
Class 2
Risk

K926551 is an FDA 510(k) clearance for the BEHRING FIBRINTIMER A. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on April 18, 1995 after a review of 838 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K926551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1992
Decision Date April 18, 1995
Days to Decision 838 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
725d slower than avg
Panel avg: 113d · This submission: 838d
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 116
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K926551.
COAGUCHEK SYSTEM
K952625 · Boehringer Mannheim Corp. · Nov 1995
ACL FUTURA COAGULATION SYSTEM
K951891 · Instrumentation Laboratory CO · Nov 1995
CASCASE 480 SNSLYZER
K951497 · Helena Laboratories · Sep 1995
HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM
K940957 · International Technidyne Corp. · Oct 1994
ACT CONTROL SET
K940840 · Sigma Diagnostics, Inc. · Jul 1994
JR. MICROCOAGULATION SYSTEM
K940401 · International Technidyne Corp. · May 1994