FDA Product Code DAP: Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Under FDA product code DAP, fibrinogen and fibrin split product antigen/antibody detection systems are cleared for the evaluation of coagulation disorders.
These tests measure fibrin degradation products and D-dimer in plasma to detect excessive fibrinolysis, disseminated intravascular coagulation, and venous thromboembolism. Elevated FDP and D-dimer indicate ongoing coagulation and fibrinolysis activity.
DAP devices are Class II medical devices, regulated under 21 CFR 864.7320 and reviewed by the FDA Hematology panel.
Leading manufacturers include Instrumentation Laboratory CO, Dade Behring, Inc. and Organon Teknika Corp..
58
Total
58
Cleared
139d
Avg days
1986
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
242d
recently vs 137d historically
FDA 510(k) Cleared Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Devices (Product Code DAP)
58 devices
Cleared
Aug 11, 2026
INNOVANCE® D-Dimer 2.0 (SMN 10873803)
Siemens Healthcare Diagnostic Products GmbH
Hematology
242d
Cleared
Nov 22, 2017
HemosIL D-Dimer HS 500
Instrumentation Laboratory CO
Hematology
61d
Cleared
Dec 10, 2016
STA® - Liatest® D-Di
Diagnostica-Stago
Hematology
124d
Cleared
Oct 27, 2016
HemosIL D-Dimer HS
Instrumentation Laboratory CO
Hematology
210d
Cleared
Jul 06, 2015
HemosIL D-Dimer HS
Instrumentation Laboratory CO
Hematology
28d
Cleared
Sep 03, 2014
STA LIATEST D-DI
Diagnostica-Stago
Hematology
124d
Cleared
Jul 31, 2012
VIDAS D-DIMER EXCLUSION II (DEX2)
bioMerieux, Inc.
Hematology
307d
Cleared
May 16, 2011
STRATUS CS ACUTE CARE D-DIMER
Siemens Healthcare Diagnostics
Hematology
104d
Cleared
Nov 29, 2010
INNOVANCE D-DIMER, MODEL OPBP09
Siemens Healthcare Diagnostics
Hematology
370d
Cleared
Feb 05, 2010
HEMOSIL D-DIMER HS 500, CONTROLS
Instrumentation Laboratory CO
Hematology
367d
Cleared
Oct 29, 2009
INNOVANCE D-DIMER, MODEL OPBP09
Siemens Healthcare Diagnostics
Hematology
121d
Cleared
Oct 24, 2008
INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS
Siemens Healthcare Diagnostics
Hematology
127d
Cleared
Sep 17, 2007
HEMOSIL D-DIMER HS
Instrumentation Laboratory CO
Hematology
167d
Cleared
Mar 23, 2007
STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK
Dade Behring, Inc.
Hematology
136d
Cleared
Aug 17, 2005
STRATUS CS D-DIMER
Dade Behring, Inc.
Hematology
62d
Cleared
Apr 26, 2005
HEMOSIL D-DIMER HS
Instrumentation Laboratory CO
Hematology
55d
Cleared
Mar 10, 2005
HEMOSIL D-DIMER
Instrumentation Laboratory CO
Hematology
31d
Cleared
Dec 07, 2004
TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300
Biosite Incorporated
Chemistry
67d
Cleared
Sep 01, 2004
ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY
Roche Diagnostics Corp.
Hematology
302d
Cleared
Aug 11, 2004
ADVANCED D-DIMER ASSAY
Dade Behring, Inc.
Hematology
71d
Cleared
Jun 25, 2004
TRIAGE PROFILER S.O.B. PANEL
Biosite Incorporated
Chemistry
127d
Cleared
Jun 10, 2004
VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442
bioMerieux, Inc.
Hematology
66d
Cleared
Oct 24, 2003
QUANTEX D-DIMER
Instrumentation Laboratory CO
Hematology
80d
Cleared
Sep 02, 2003
VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
bioMerieux, Inc.
Hematology
214d
About Product Code DAP - Regulatory Context
510(k) Submission Activity
58 total 510(k) submissions under product code DAP since 1986, with 58 receiving FDA clearance (average review time: 139 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - DAP Product Code
Recent submissions under DAP have taken an average of 242 days to reach a decision - up from 137 days historically. Manufacturers should account for longer review timelines in current project planning.
DAP devices are reviewed by the Hematology panel. Browse all Hematology devices →