Fibrin Split Products
FDA product code GHH · Class II (moderate risk) · 21 CFR 864.7320 · Hematology
28510(k) clearances
0PMA approvals
7recalls
Manufacturers
- American Bioproducts Co. 3
- Roche Diagnostics Corp. 3
- Agen Biomedical , Ltd. 3
- E.I. Dupont DE Nemours & Co., Inc. 2
- Abbott Laboratories 2
- Diazyme Laboratories 1
- Calbiochem-Behring Corp. 1
- Mitsubishi Kagaku Iatron 1
- Olympus Life & Material Science Europa GmbH (Irish 1
- Biosite Incorporated 1
- Biomerieux Inc 1
- Behring Diagnostics, Inc. 1
- Biomerieux Vitek, Inc. 1
- Biopool AB 1
- Organon Teknika Corp. 1
- American Dade 1
- Pacific Hemostasis 1
- Mabco, Inc. 1
- Syn-Kit, Inc. 1
- American Hospital Supply Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K112120 | Diazyme D-Dimer Assay Kit,Calibrator Setand Control SetGHH · Traditional | Diazyme Laboratories | 01/24/2013SE |
| K072288 | Pathfast D-DimerGHH · Traditional | Mitsubishi Kagaku Iatron | 05/06/2009SE |
| K070453 | Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model ODR3033…GHH · Traditional | Olympus Life & Material Science Europa GmbH (Irish | 06/11/2007SE |
| K062203 | Tina-Quant D-Dimer Test SystemGHH · Traditional | Roche Diagnostics Corp. | 03/14/2007SE |
| K042890 | Triage D-Dimer Test, Model 98100GHH · Traditional | Biosite Incorporated | 11/29/2004SE |
| K030740 | Modification to Tina-Quant D-Dimer Test SystemGHH · Special | Roche Diagnostics Corp. | 04/01/2003SE |
| K021877 | Mda D-DimerGHH · Traditional | bioMerieux, Inc. | 08/07/2002SE |
| K011143 | Tina-Quant D-Dimer Test SystemGHH · Special | Roche Diagnostics Corp. | 05/29/2001SE |
| K993276 | Simplify D-Dimer, Model DCGK1GHH · Traditional | Agen Biomedical , Ltd. | 12/14/1999SE |
| K972316 | Opus D-DimerGHH · Traditional | Behring Diagnostics, Inc. | 09/09/1997SE |
| K945642 | Agen Dimertest Gold EiaGHH · Traditional | Agen Biomedical , Ltd. | 10/25/1995SE |
| K921989 | FDP - Slidex DirectGHH · Traditional | Biomerieux Vitek, Inc. | 11/03/1993SE |
| K920668 | Minutex D-Dimer Latex TestGHH · Traditional | Biopool AB | 10/16/1992SE |
| K905643 | Bed Red D-Dimer Whole Blood Agglutination AssayGHH · Traditional | Agen Biomedical , Ltd. | 04/12/1991SE |
| K893961 | Abbott Imx(Tm) D-DimerGHH · Traditional | Abbott Laboratories | 08/03/1989SE |
| K890422 | Abbott Testpack(Tm) D-DimerGHH · Traditional | Abbott Laboratories | 03/27/1989SE |
| K890399 | Modified D-Di-Test KitGHH · Traditional | American Bioproducts Co. | 02/07/1989SE |
| K880077 | FibrinosticonGHH · Traditional | Organon Teknika Corp. | 02/09/1988SE |
| K872360 | Data-Fi Fibrin(Ogen) Degradation Prod.(Fdp)Det SetGHH · Traditional | American Dade | 07/06/1987SE |
| K861973 | D-Di Test KitGHH · Traditional | American Bioproducts Co. | 09/04/1986SE |
| K852848 | FDP ASSAY-20 Test KitGHH · Traditional | American Bioproducts Co. | 10/10/1985SE |
| K852520 | Aca Fibrin Degradation Prod Analytical Test PackGHH · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 10/04/1985SE |
| K852512 | Thrombo Screeen Fibrin Degradation Product KitGHH · Traditional | Pacific Hemostasis | 09/17/1985SE |
| K852176 | Dupont Aca Fibrin Ogen Degrad-Products CalibratorGHH · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 08/12/1985SE |
| K842277 | Dimertest LatexGHH · Traditional | Mabco, Inc. | 04/03/1985SE |
| K812298 | Fibrogen(Fibrin Split Product) AntigenGHH · Traditional | Syn-Kit, Inc. | 12/17/1981SE |
| K801841 | Fibrin(Ogen) Degradation Products(Fdp)GHH · Traditional | American Hospital Supply Corp. | 10/10/1980SE |
| K791358 | Fibro-Tec Test KitGHH · Traditional | Calbiochem-Behring Corp. | 09/04/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0352-2024 Class II | Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material…Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples. | Roche Diagnostics Operations, Inc. | 10/03/2023Open, Classified |
| Z-0646-2017 Class II | Pathfast D-Dimer, Reference number: PF1051-KUSTwo complaints were received about decrease in sensitivity (control value and/or calibration value) of the… | Lsi Medience Corporation | 08/16/2016Terminated |
| Z-0314-2017 Class II | SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid…A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an… | Bbi Solutions Oem Ltd | 06/01/2016Terminated |
| Z-1727-2014 Class II | Alere Triage D-Dimer Test PN 98100, Lot W53884B. The Alere Triage D-Dimer Test is a…Alere initiated this recall because a limited number of Alere Triage D-Dimer devices from PN 98100 Lot… | Alere San Diego, Inc. | 05/02/2014Terminated |
| Z-1932-2012 Class I | Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients…Certain lots of the affected products may have significantly decreased precision relative to the package… | Alere San Diego, Inc. | 05/22/2012Terminated |
| Z-0030-2012 | Minutex D-Dimer ; Trinity Biotech plc, Bray, Co. Wicklow, Ireland. Tel: (353) 1 276…There is a performance issue with Minutex D-Dimer Kit which may cause false negative results for patient… | Tcoag Us, Incorporated | 06/13/2011Terminated |
| Z-0594-2007 | Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in…Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off. | Inverness Medical Professional Diagnostics | 02/15/2007Terminated |