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CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. CRYOcheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations.

CRYOcheck Hex LA is comprised of three reagents supplied in a frozen format as follows: LA Start: Pooled normal plasma with buffer and a heparin neutralizer. LA Correct: Pooled normal plasma with buffer, a heparin neutralizer, and inverted hexagonal phase phospholipid. LA APTT: Silica-based lupus sensitive APTT reagent with stabilizer.

The Sysmex® Automated Blood Coagulation Analyzer CS-2500 is a fully automated blood coagulation analyzer intended for in vitro diagnostic use using plasma collected from venous blood samples in 3.2% sodium citrate tubes to analyze clotting, chromogenic and immunoassay methods in the clinical laboratory. For determination of: - . Prothrombin Time (PT) seconds and PT INR with Dade® Innovin® - . Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL - . Fibrinogen (Fbg) with Dade® Thrombin Reagent - . Coagulation Factor V with Dade® Innovin® - . Coagulation Factor VII with Dade® Innovin® - . Coagulation Factor VIII with Dade® Actin® FSL - . Coagulation Factor IX with Dade® Actin® FSL - . Lupus Anticoagulant with LA1 Screening / LA2 Confirmation Reagent - . Factor V Leiden with Factor V Leiden Assay - . Protein C with Protein C Reagent - . Antithrombin (AT) with INNOVANCE® Antithrombin - Protein C with Berichrom® Protein C - D-dimer with INNOVANCE® D-Dimer The performance of this device has not been established in neonate and pediatric patient populations. Intended Use for Factor V Leiden Assay: The Siemens Healthcare Diagnostics Factor V Leiden Assay is a simple functional clotting test system intended for screening of resistance to Activated Protein C (APC) in plasma from individuals with Factor V (Leiden) defect. For in vitro diagnostic use. Intended Use for Coagulation Factor VIII Deficient Plasma: In vitro diagnostic reagents for the determination of the activity of coagulation factor VIII, IX, XI and XII in human plasma by coagulation methods. Intended Use for Coagulation Factor IX Deficient Plasma: In vitro diagnostic reagents for the determination of the activity of coagulation factor VIII, IX, XI and XII in human plasma by coagulation methods. Intended Use for LA1 Screening / LA2 Confirmation Reagents: LA1 Screening Reagent / LA2 Confirmation Reagent are simplified DRVVT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests. LA1 Screening Reagent: Simplified DRVV reagent to the presence of Lupus Anticoagulants. LA2 Confirmation Reagent: Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants.

The Sysmex® CS-2500 is an automated blood coagulation instrument which can analyze samples using clotting, chromogenic and immunoassay methods. Analysis results are displayed on the Information Processing Unit (IPU) screen. They can be printed on external printers or transmitted to a host computer. Sold separately from the instrument are the associated Reagents, Controls, Calibrators, and Consumable materials. The subject of this 510(k) notification are reagent applications which perform the coagulation tests Factor V Leiden with Factor V Leiden Assay, Coagulation Factor VIII with Dade® Actin FSL®, Coagulation Factor IX with Dade® Actin FSL®, Lupus Anticoagulant with LA 1 Screening Reagent / LA 2 Confirmation Reagent. The analysis principles used on the instrument are reflected by the reagent application testing provided in this 510(k) notification and is described in the below table. The instrument is capable of measuring in Normal mode and Micro-sample mode. Options and accessories include a waste tank and a 2D barcode reader.

The Sysmex® Automated Blood Coagulation Analyzer CS-5100 is a fully automated blood coagulation analyzer intended for in vitro diagnostic use using plasma collected from venous blood samples in 3.2% sodium citrate tubes to analyze clotting, chromogenic and immunoassay methods in the clinical laboratory. For determination of: - . Prothrombin Time (PT) seconds and PT INR with Dade® Innovin® - . Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL - . Fibrinogen (Fbg) with Dade® Thrombin Reagent - . Coagulation Factor V with Dade® Innovin® - . Coagulation Factor VII with Dade® Innovin® - . Coagulation Factor VIII with Dade® Actin® FSL - . Coagulation Factor IX with Dade® Actin® FSL - . Lupus Anticoagulant with LA1 Screening and LA2 Confirmation Reagent - . Factor V Leiden with Factor V Leiden Assay - . Protein C with Protein C Reagent - . Antithrombin (AT) with INNOVANCE® Antithrombin - Protein C with Berichrom® Protein C - D-dimer with INNOVANCE® D-Dimer The performance of this device has not been established in neonate and pediatric patient populations. Intended Use for Factor V Leiden Assay: The Siemens Healthcare Diagnostics Factor V Leiden Assay is a simple functional clotting test system intended for screening of resistance to Activated Protein C (APC) in plasma from individuals with Factor V (Leiden) defect. For in vitro diagnostic use. Intended Use for Coagulation Factor VIII Deficient Plasma: In vitro diagnostic reagents for the determination of the activity of coagulation factors VIII, IX, XI and XII in human plasma by coagulation methods. Intended Use for Coagulation Factor IX Deficient Plasma: In vitro diagnostic reagents for the determination of the activity of coagulation factor VIII, IX, XI and XII in human plasma by coagulation methods. Intended Use for LA1 Screening and LA2 Confirmation Reagents: LA1 Screening Reagent and LA2 Confirmation Reagent are simplified DRVVT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests. LA1 Screening Reagent: Simplified DRVV reagent to the presence of Lupus Anticoagulants. LA2 Confirmation Reagent: Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants.

The Sysmex® CS-5100 is an automated blood coagulation instrument which can analyze samples using clotting, chromogenic and immunoassay methods. Analysis results are displayed on the Information Processing Unit (IPU) screen. They can be printed on external printers or transmitted to a host computer. Sold separately from the instrument are the associated Reagents, Controls, Calibrators, and Consumable materials. The subject of this 510(k) notification are reagent applications which perform the coagulation tests Factor V Leiden with Factor V Leiden Assay, Coagulation Factor VIII with Dade® Actin FSL®, Coagulation Factor IX with Dade® Actin FSL®, Lupus Anticoagulant with LA 1 Screening Reagent and LA 2 Confirmation Reagent. The analysis principles used on the instrument are reflected by the reagent application testing provided in this 510(k) notification and is described in the below table.

HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies. For in vitro diagnostic use.

The HemoIL SCT assay, consisting of SCT Screen and SCT Confirm, is intended to simplify and standardize the detection of Lupus Anticoagulants (LA) in clinical evaluations. SCT Screen is poor in phospholipid making it sensitive to LA. The additional amount of phospholipid in SCT Confirm neutralizes LA to give shorter clotting times. Silica Clotting Time in the presence of calcium, directly activates the intrinsic pathway of coagulation. SCT Screen and SCT Confirm are therefore unaffected by factor VII deficiencies or inhibitors.

HEMOCLOT Quanti VL is an in vitro diagnostic test for the quantitative determination of Factor V Leiden (FVL) activity in human citrated plasma, using automated or manual methods, by its resistance to the action of Activated Protein C ( APC). Patients with the Factor V-L (mutalion R506Q), are exposed to an increased thrombotic risk. Biophen V-L CAL (undiluted), at defined Factor V-Leiden (FV-L) concentrations, for the callibration of Factor V-Leiden aclivity on human plasma, using the Hemoclot Quanti V-L kit. Factor V-L Cafibrator, pre diluted (1:20) human plasmas. at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-L activity on human plasma using Hemoclot Quanti V-L Kit. Biophen Act PC-r Control Plasma contains human plasma, presenting an Activated Protein C Resistance (APC-R) is used as quality control plasma for the testing of Activated Protein C resistance (APC-R) on human plasma using Hemoclot Quarti V-L Kit. (Updated) BIOPHEN Normal Control Plasma is a set of 12 vials of normal citrated human plasma for the quality control of some coagulation factors. The following table shows parameters, which are measured using assays from HYPHEN BioMed or from other manufacturers, and according to the package inserts: | Assays | Reagents | Manufacturers | Reference | |-------------------------------|----------------------|-------------------------|---------------| | ATIII | Biophen ATIII | Hyphen Biomed | 221102/221105 | | Protein C | Biophen Protein C | Hyphen Biomed | 221202/221205 | | aPC resistance<br>(FV Leiden) | Hemoclot Quanti V-L | Hyphen Biomed | CK065K | | Lupus<br>Anticoagulant | DVVtest®/DVVconfirm® | American<br>Diagnostica | 810/815/815L | DVVtest, DVVconfirm are registered trademarks from American Diagnostica, Inc. The BIOPHEN Normal Control Plasma is tested for the absence of Lupus Anticoagulant and can be used as a negative control for this investigation. This control plasma is also tested for the absence of Activated Protein C resistance (Act PC-7). When the APTT is performed with or without Activated Protein C (APC) the ratio obtained (APTT + APC/APTT) is ≥2.00.

- 1. HEMOCLOT Quanti V-L is an in vitro diagnostic test kit containing 3 vials of each of the following 2 lyophilized reagents: R1: Reagent 1: Clotting mixture containing human Fibrinogen, human prothrombin, Protein S at a constant concentration, optimized for the assay, and human Activated Protein C, lyophilized. It also contains a heparin neutralizing substance. Each vial is to be reconstituted with exactly 2 ml of distilled water. R2: Reagent 2: Purified Human Factor Xa, containing rabbit brain phospholipds (cephalin), lyophilized. Each vial is to be reconstituted with exactly 1 ml of distilled water. Calibrators and controls to be used with the test kit are supplied separately. The following calibrators and control are included in this submission: - 2. Factor V-L Calibrator is a calibrator kit containing 3 vials each of 1.0 ml prediluted human plasma (1:20), freeze dried, at 4 different concentrations of FV-L, to cover the assay range, from 10% to 100%. Each vial is restored with 1.0 ml Owren Koller type buffer. - 3. BIOPHEN V-L CAL (Undiluted) is a calibrator kit containing 3 vials each of 0.5 ml undiluted human plasma, freeze dried, at 3 different concentrations of FV-L, to cover the assay range, from about 10% to 100%. Each vial is restored with 0.5 ml distilled water. - BIOPHEN Act PC-r Control Plasma is a controls kit containing 12 vials of 0.5 ml human 4. plasma, presenting an Activated Protein C Resistance (APC-R), citrated and Iyophilized. Each vial is to be reconstituted with exactly 0.5 ml of distilled water. - BIOPHEN Normal Control Plasma manufactured by Hyphen-Biomed, is also used with the test kit and is currently marketed in the US under 510(k) # K043451, It is a controls kit containing 12 vials of 1.0 ml of normal citrated human plasma, lyophilized. Each vial is to be reconstituted with exactly 1.0 ml of distilled water.

Wortham Laboratories Stasis 1 Coagulation Control (Normal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT, and Fibrinogen values in the normal range. Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the moderate abnormal range. Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the strongly abnormal range. Wortham Laboratories Serathan-B PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-B is a moderately sensitive thromboplastin reagent. Wortham Laboratories Serathan-A PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-A is a highly sensitive thromboplastin reagent. Wortham Laboratories Intrin-EA APTT is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-EA reagent is sensitive to mild coagulopathies. Wortham Laboratories Intrin-SI is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-SI reagent is sensitive to heparin and lupus anticoagulant plasmas. Wortham Laboratories Fibrinogen Control Low, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays. Wortham Laboratories Fibrinogen Control Normal, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays. Wortham Laboratories Thrombin Reagent is intended for thrombin to convert fibrinogen in the quantitative determination of fibrinogen in plasma samples. Wortham Laboratories Fibrinogen Assay Set, containing a complete set of Normal Fibrinogen Control (200-400 mg/dl), Thrombin Reagent (100 IU/ml), and Fibrinogen Buffer, is intend for use in the quantitative determination of fibrinogen in plasma samples. Wortham Laboratories Heparin Control Level 1, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring. Wortham Laboratories Heparin Control Level 2, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring. Wortham Laboratories Calcium Chloride Solution 0.02 M (CaCl2) is intended for quantitative use with ellagic acid (Intrin-EA) or silicon particulate activators (Intrin-SI) in performing the activated partial thromboplastin time (APTT) on citrated plasma. Wortham Laboratories Fibrinogen Buffer is designed as a diluent for fibrinogen studies.

Wortham Laboratories Stasis 1 Coagulation Control (Normal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBsAg and negative for antibodies to HIV and HCV. Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBSAg and negative for antibodies to HIV and HCV. Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBsAg and negative for antibodies to HIV and HCV. Wortham Laboratories Serathan-B PT Reagent is a liquid stable extract of rabbit thromboplastin containing calcium, stabilizer and buffer. Serathan-B is an in-vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays for Factors II, V. VII and X. Wortham Laboratories Scrathan-A PT Reagent is a liquid stable extract of rabbit thromboplastin containing calcium, stabilizer and buffer. Serathan-A is an in-vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays for Factors II, V. VII and X. Wortham Laboratories Intrin-EA APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic hemostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit cephalin with the surface activator ellagic acid. Wortham Laboratories Intrin-SI APTT Reagent is a liquid stable extract of rabbit brain thromboplastin, containing stabilizers and buffers. Intrin-SI is an in-vitro diagnostic reagent intended for use for the performance of a citrated Partial Thromboplastin Time (APTT) testing and quantitative PTT-based factor assays for Factors XII, XI, IX and VIII. Wortham Laboratories Fibrinogen Low Control is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV. Wortham Laboratories Fibrinogen Normal Control is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV. Wortham Laboratories Thrombin Reagent is a liquid stable preparation of activated bovine proteins (Factor IIa). Wortham Laboratories Fibrinogen Assay Set contains a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers, buffers, and a bovine reagent and buffer solution which are also provided in the set. Each unit of source material used in the preparation of the control has been tested by an EDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV. Wortham Laboratories Heparin Control Level 1 is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV. Wortham Laboratories Heparin Control Level 2 is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodics to HIV and HCV. Wortham Laboratories Calcium Chloride Solution 0.02 M (CaCl2) is intended for quantitative use with ellagic acid (Intrin-EA) or silicon particulate activators (Intrin-SI) in performing the activated partial thromboplastin time (APTT) on citrated plasma. Fibrinogen Buffer : 1.3% TAPSO Buffer. 0.9% sodium chloride, 0.1% sodium azide and stabilizers; pH 7.35 ± 0.05.

cryocheck Clot APCR is a clotting assay intended to screen for resistance to activated protein C in citrated human plasma from individuals with the factor V Leiden mutation.

cryocheck Clot APCR consists of: - 5 x 2.0 mL Activator Reagent (APC-AR) . - 5 x 4.0 mL Russell's Viper Venom Reagent (APC-RV)

The STA® - Cephascreen® kits provide reagents for the determination of the activated partial thromboplastin time (APTT) in citrated plasma on the STA® line of analyzers suitable to these reagents.

The STA®-Cephascreen kits provide reagents for the determination of the activated partial thromboplastin time (APTT) according to Langdell R.D. et al. (1) and Larrieu M. J., Weilland C. (2) by analyzers of the STA® line suitable to these reagents. STA®-Cephascreen ®: reagent containing cephalin (platelet substitute), prepared from rabbit cerebral tissues (2) and a polyphenolic activator (patent pending) in a buffered medium. The STA®-Cephascreen ® is available in two different kit sizes: - STA®-Cephascreen®©(REF00308) containing 12x4 mL vials ready for . use reagent - STA®-Cephascreen®쓰(REF 00310) containing 12x10 mL vials of ready . for use reagent The STA®-Cephascreen® reagents are provided in liquid form, ready for use after stabilization and mixing when a vial is opened.

HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems. The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems. The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies. For in vitro diagnostic use.

HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies.