Instrument, Coagulation, Automated
FDA product code GKP · Class II (moderate risk) · 21 CFR 864.5400 · Hematology
49510(k) clearances
0PMA approvals
29recalls
Manufacturers
- Instrumentation Laboratory CO 9
- Dade Behring, Inc. 9
- Medical Laboratory Automation Systems, Inc. 5
- Helena Laboratories 5
- Organon Teknika Corp. 3
- Haemoscope Corp. 3
- American Bioproducts Co. 3
- Ortho Diagnostic Systems, Inc. 2
- Bio/Data Corp. 2
- Instrumentation Laboratory (IL) Co. 1
- General Diagnostics 1
- Fisher Diagnostics 1
- Cardiovascular Diagnostics, Inc. 1
- Dade Intl., Inc. 1
- International Technidyne Corp. 1
- Biomerieux Vitek, Inc. 1
- Cardiovascular Diagnostic Services 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242127 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550…GKP · Special | Instrumentation Laboratory (IL) Co. | 08/16/2024SE |
| K231031 | ACL TOP Family 70 SeriesGKP · Traditional | Instrumentation Laboratory Company | 06/21/2023SE |
| K160276 | Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS)GKP · Special | Instrumentation Laboratory CO | 03/03/2016SE |
| K150877 | Acl Top Family 50 Series: Acl Top 350 CTS; Acl Top 550 CTS; Acl Top 750; Acl Top 750…GKP · Traditional | Instrumentation Laboratory CO | 12/13/2015SE |
| K091980 | Acl Top 700 LasGKP · Special | Instrumentation Laboratory CO | 09/22/2009SE |
| K073377 | Acl Top (with System Software V3.0.0)GKP · Traditional | Instrumentation Laboratory CO | 05/04/2008SE |
| K063679 | Acl TopGKP · Special | Instrumentation Laboratory CO | 01/12/2007SE |
| K033414 | Acl Top Model, TopGKP · Abbreviated | Instrumentation Laboratory CO | 01/12/2004SE |
| K031377 | Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and…GKP · Traditional | Dade Behring, Inc. | 09/08/2003SE |
| K023362 | Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus KaolinGKP · Traditional | Fisher Diagnostics | 12/09/2002SE |
| K020979 | Sysmex Automated Coagulation Analyzer, Model #CA-7000GKP · Traditional | Dade Behring, Inc. | 06/27/2002SE |
| K001645 | Sysmex Automated Coagulation Analyzer, Model CA-1500GKP · Traditional | Dade Behring, Inc. | 08/04/2000SE |
| K001891 | Microsample Coagulation Analyzer, Model Mca 310-CGKP · Special | Bio/Data Corp. | 07/12/2000SE |
| K001145 | Sysmex Automated Coagulation Analyzer, Model CA-6000GKP · Traditional | Dade Behring, Inc. | 05/11/2000SE |
| K993299 | Sysmex Automated Coagulation Analyzer, Model CA-1500GKP · Traditional | Dade Behring, Inc. | 12/07/1999SE |
| K993174 | Sysmex Automated Coagulation Analyzer, Model CA-6000GKP · Traditional | Dade Behring, Inc. | 11/09/1999SE |
| K992763 | Sysmex Automated Coagulation Analyzer, Model CA-500GKP · Traditional | Dade Behring, Inc. | 09/21/1999SE |
| K992423 | Sysmex Automated Coagulation Analyzer, Model CA-500GKP · Traditional | Dade Behring, Inc. | 09/21/1999SE |
| K992321 | Sysmex Automated Coagulation Analyzer, Model CA-6000GKP · Traditional | Dade Behring, Inc. | 09/17/1999SE |
| K991101 | Coag-A-Mate MaxGKP · Traditional | Organon Teknika Corp. | 06/01/1999SE |
| K981206 | Tas Results Data Acquisition System (Traqs)GKP · Traditional | Cardiovascular Diagnostics, Inc. | 05/26/1998SE |
| K964139 | Sysmex CA-6000GKP · Traditional | Dade Intl., Inc. | 02/06/1997SE |
| K962857 | Coag-A-Mate MTXGKP · Traditional | Organon Teknika Corp. | 01/22/1997SE |
| K962664 | Electra 1800C Automatic Coagulation AnalyzerGKP · Traditional | Medical Laboratory Automation Systems, Inc. | 09/10/1996SE |
| K961991 | Acl 6000 System (Acl 6000)GKP · Traditional | Instrumentation Laboratory CO | 09/04/1996SE |
| K961579 | Sta Compact Automated Multi-Parametric AnalyzerGKP · Traditional | American Bioproducts Co. | 07/10/1996SE |
| K954437 | Thrombelastograph Coagulation Analyzer 3000SGKP · Traditional | Haemoscope Corp. | 01/30/1996SE |
| K951072 | Protime Microcoagulation SystemGKP · Traditional | International Technidyne Corp. | 10/27/1995SE |
| K943153 | Microsample Coagulation AnalyzerGKP · Traditional | Bio/Data Corp. | 03/24/1995SE |
| K944227 | Electra 1400C Automatic Coagulation AnalyzerGKP · Traditional | Medical Laboratory Automation Systems, Inc. | 02/03/1995SE |
| K942117 | Sta Automated Multi-Parametric AnalyzerGKP · Traditional | American Bioproducts Co. | 02/01/1995SE |
| K931992 | HemolabGKP · Traditional | Biomerieux Vitek, Inc. | 12/22/1994SE |
| K933092 | Tas AnalyzerGKP · Traditional | Cardiovascular Diagnostic Services | 11/15/1993SE |
| K931956 | Cascade M, Cat. No. 1710GKP · Traditional | Helena Laboratories | 08/23/1993SE |
| K931206 | Electra 1600C Automatic Coagulation TimerGKP · Traditional | Medical Laboratory Automation Systems, Inc. | 08/23/1993SE |
| K924098 | Il MCL-2 Coagulation AnalyzerGKP · Traditional | Instrumentation Laboratory CO | 06/18/1993SE |
| K921465 | Cat. No. 1471 (110V) & Cat. No. 1472 (220V)GKP · Traditional | Helena Laboratories | 06/29/1992SE |
| K921363 | Cascade 480GKP · Traditional | Helena Laboratories | 06/09/1992SE |
| K914946 | Cascade 480(TM) Auto Coag Analyzer, ModificationGKP · Traditional | Helena Laboratories | 01/13/1992SE |
| K904297 | ST-4 Coagulation InstrumentGKP · Traditional | American Bioproducts Co. | 11/13/1990SE |
| K904204 | ThrombelastographGKP · Traditional | Haemoscope Corp. | 11/01/1990SE |
| K901380 | Cascade 480(TM) Automated Coagulation Analy. 1430GKP · Traditional | Helena Laboratories | 05/25/1990SE |
| K901120 | Koagulab 60-S Coagulation SystemGKP · Traditional | Ortho Diagnostic Systems, Inc. | 05/22/1990SE |
| K895844 | Thrombelastograph(R)GKP · Traditional | Haemoscope Corp. | 10/24/1989SE |
| K894052 | Electra 1000C Automatic Coagulation TimerGKP · Traditional | Medical Laboratory Automation Systems, Inc. | 07/27/1989SE |
| K885035 | Koagulab* 32-S Coagulation SystemGKP · Traditional | Ortho Diagnostic Systems, Inc. | 02/03/1989SE |
| K884863 | Electra 900C Automatic Coagulation TimerGKP · Traditional | Medical Laboratory Automation Systems, Inc. | 02/03/1989SE |
| K881281 | Coag-A-Mate(R) XMGKP · Traditional | Organon Teknika Corp. | 05/18/1988SE |
| K813564 | Coag-A-Mate X2GKP · Traditional | General Diagnostics | 01/28/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2578-2023 Class II | ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the…Sample misidentification could occur under specific conditions and patient management altered based on an… | Instrumentation Laboratory | 07/13/2023Open, Classified |
| Z-1014-2022 Class II | ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS…Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality… | Instrumentation Laboratory | 02/22/2022Open, Classified |
| Z-2066-2014 Class II | ACL TOP 300 CTS, automated coagulation laboratory instrument.Potential for sample misidentification. | Instrumentation Laboratory Co. | 06/03/2014Terminated |
| Z-2065-2014 Class II | ACL TOP 700 CTS, automated coagulation laboratory instrument.Potential for sample misidentification. | Instrumentation Laboratory Co. | 06/03/2014Terminated |
| Z-2064-2014 Class II | ACL TOP 500 CTS, automated coagulation laboratory instrument.Potential for sample misidentification. | Instrumentation Laboratory Co. | 06/03/2014Terminated |
| Z-2063-2014 Class II | ACL TOP 700 LAS, automated coagulation laboratory instrument.Potential for sample misidentification. | Instrumentation Laboratory Co. | 06/03/2014Terminated |
| Z-2062-2014 Class II | ACL TOP CTS, automated coagulation laboratory instrument.Potential for sample misidentification. | Instrumentation Laboratory Co. | 06/03/2014Terminated |
| Z-2061-2014 Class II | ACL TOP 700, automated coagulation laboratory instrument.Potential for sample misidentification. | Instrumentation Laboratory Co. | 06/03/2014Terminated |
| Z-2060-2014 Class II | ACL TOP (Base), automated coagulation laboratory instrument.Potential for sample misidentification. | Instrumentation Laboratory Co. | 06/03/2014Terminated |
| Z-2250-2013 Class II | ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | Instrumentation Laboratory Co. | 07/19/2013Terminated |
| Z-2249-2013 Class II | ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | Instrumentation Laboratory Co. | 07/19/2013Terminated |
| Z-2248-2013 Class II | ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | Instrumentation Laboratory Co. | 07/19/2013Terminated |
| Z-2247-2013 Class II | ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | Instrumentation Laboratory Co. | 07/19/2013Terminated |
| Z-2246-2013 Class II | ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | Instrumentation Laboratory Co. | 07/19/2013Terminated |
| Z-2245-2013 Class II | ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | Instrumentation Laboratory Co. | 07/19/2013Terminated |
| Z-2244-2013 Class II | ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | Instrumentation Laboratory Co. | 07/19/2013Terminated |
| Z-2392-2012 Class II | Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully…Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Instrumentation Laboratory Co. | 08/03/2012Terminated |
| Z-2391-2012 Class II | Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully…Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Instrumentation Laboratory Co. | 08/03/2012Terminated |
| Z-2390-2012 Class II | Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully…Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Instrumentation Laboratory Co. | 08/03/2012Terminated |
| Z-2389-2012 Class II | Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully…Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Instrumentation Laboratory Co. | 08/03/2012Terminated |
| Z-2388-2012 Class II | Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully…Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Instrumentation Laboratory Co. | 08/03/2012Terminated |
| Z-2387-2012 Class II | Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully…Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | Instrumentation Laboratory Co. | 08/03/2012Terminated |
| Z-0138-2011 | ACL TOP CTS PN 000280020 Bench top, fully automated, random access analyzer designed…Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot… | Instrumentation Laboratory Co. | 08/13/2010Terminated |
| Z-0137-2011 | ACL TOP 700 LAS PN 000280030 Bench top, fully automated, random access analyzer designed…Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot… | Instrumentation Laboratory Co. | 08/13/2010Terminated |
| Z-0136-2011 | ACL TOP 500 CTS PN 000280040 Bench top, fully automated, random access analyzer designed…Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot… | Instrumentation Laboratory Co. | 08/13/2010Terminated |
| Z-0135-2011 | ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed…Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot… | Instrumentation Laboratory Co. | 08/13/2010Terminated |
| Z-0039-2008 | STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.Incorrect results. Internal investigation determined the presence of a defective measurement head which can… | Diagnostica Stago, Inc. | 07/30/2007Terminated |
| Z-1127-2007 | Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood…ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube. | Instrumentation Laboratory Co. | 06/19/2007Terminated |
| Z-0812-2007 | STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro diagnostic…Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of… | Diagnostica Stago, Inc. | 01/18/2007Terminated |