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The STA® - Coag Control (N + ABN) PLUS is a kit containing a normal plasma and an abnormal plasma intended for the quality control of the following tests on STA-R® and STA Compact analyzers: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, thrombin time (TT), and antithrombin (AT).

The STA® - Coag Control (N + ABN) PLUS kit is a set of two control levels. Each kit provides: 12 x 2-ml vials of Reagent 1 (STA® - Coag Control N PLUS), citrated normal human plasma, lyophilized. 12 x 2-ml vials of Reagent 2 (STA® - Coag Control ABN PLUS), citrated abnormal human plasma, lyophilized. STA® - Coag Control (N+ ABN) PLUS Reagents are used as controls for clotting assays (PT, APTT, fibrinogen, and TT) and chromogenic assays (AT) performed on analyzers of the STA® line. Analyzers of the STA® line utilize the chronometric principle (viscosity based detection system) for clotting tests while the chromogenic assays are based on the photometric method (measurement of absorbance of monochromatic light).

The STA® - Liquid Anti-Xa kits are intended for use with STA-R®, STA Compact® and STA Satellite® analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate. The STA® - Multi Hep Calibrator is a set of calibrator plasmas intended for use with STA-R®, STA Compact®, and STA Satellite® analyzers, for the calibration of heparin (UFH and LMWH) activity assay by measuring the anti-Xa activity. The STA® - Quality HNF/UFH kit is a set of two plasmas intended for the quality control of unfractionated heparin (UFH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact®, and STA Satellite® analyzers. The STA® - Quality HBPM/LMWH kit is a set of two plasmas intended for the quality control of low molecular weight heparin (LMWH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact, and STA Satellite® analyzers.

The STA® - Liquid Anti-Xa is a chromogenic assay technique used for determination of the level of UFH and LMWH that have high affinity for antithrombin by measuring their anti-Xa activity. The method is a one-step reaction based on a similar principle: as soon as factor Xa is added to the plasma-substrate mixture, two reactions take place simultaneously, namely, hydrolysis of the substrate by factor Xa and inhibition of factor Xa by the heparin-antithrombin complex. After the necessary period of time for the competitive reaction to reach equilibrium, the quantity of paranitroaniline that is released is inversely proportional to the concentration of heparin present in the test medium. The STA® - Multi Hep Calibrator reagents are lyophilized human plasmas at five different heparin concentrations. They are used to create the calibration curve on STA-R®, STA Compact®, and STA Satellite® analyzers performing the chromogenic method for heparin (UFH and LMWH) using STA® - Liquid Anti-Xa. The STA® - Quality HNF/UFH reagents are lyophilized human plasmas at two different UFH concentrations. They are used for the quality control of UFH activity assay by measuring the anti-Xa activity using the chromogenic method STA® - Liquid Anti-Xa performed on STA-R®, STA Compact®, and STA Satellite® analyzers. The STA® - Quality HBPM/LMWH reagents are lyophilized human plasmas at two different LMWH concentrations. They are used for the quality control of LMWH activity assay by measuring the anti-Xa activity using the chromogenic methods, STA® - Liquid Anti-Xa and STA® - Rotachrom® Heparin, performed on STA-R®, STA Compact, and STA Satellite® analyzers.

The STA® - Hybrid Hep Calibrator is a set of calibrator plasmas intended for use with analyzers of the STA® line suitable to these reagents, for the calibration of heparin (UFH and LMWH) activity assay by measuring the anti-Xa activity using the chromogenic method, STA® - Rotachrom® Heparin.

The STA® Hybrid Hep Calibrator is a set of lyophilized human plasmas used to create the calibration curve on the STA® line of IVD instruments performing the chromogenic method for heparin (UFH and LMWH) assays. Each STA® Hybrid Hep Calibrator available contains: 4 x 1-ml vials of Reagent 1: STA® Hybrid Hep Calibrator O lyophilized human plasma free of heparin. 4 x 1-ml vials of Reagent 2: STA® Hybrid Hep Calibrator 3 lyophilized human plasma containing a well-defined quantity of UFH. 4 x 1-ml vials of Reagent 3: STA® Hybrid Hep Calibrator 6 lyophilized human plasma containing a well-defined quantity of UFH that is greater than that of Reagent 2. 4 x 1-ml vials of Reagent 4: STA® - Hybrid Hep Calibrator 9 lyophilized human plasma containing a well-defined quantity of LMWH. 4 x 1-ml vials of Reagent 5: STA® Hybrid Hep Calibrator 18 lyophilized human plasma containing a well-defined quantity of LMWH that is greater than that of Reagent 4.

The STA® - Liatest® Free PS kits are intended for use with analyzers of the STA® line suitable with these reagents for the antigenic assay of free Protein S in plasma by the immuno-turbidimetric method.

The STA® - Liatest® Free PS test kit is comprised of a suspension of latex microparticles coated with two (2) different mouse monoclonal anti-human free protein S antibodies stabilized with bovine albumin. Also in the test kit is an HEPES buffer. Testing is carried out in citrated human plasma via the immunoturbidimetric method utilizing external calibrator plasmas for the STA® - Liatest Free PS (the predicate device is pre-calibrated, not utilizing external calibrator plasmas).

The STA Compact® Automated Multi-Parametric Analyzer is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

The STA Compact Automated Multi-Parametric Analyzer is designed as a fully automatic system. Samples and test reagents are loaded into the instrument where sample handling, reagent delivery, analysis, and reporting of results are performed automatically. A central processing unit controls instrument functions such as, management of patient results, quality control, support for instrument maintenance, and work load optimization. The instrument utilizes Diagnostica Stago reagents in addition to open adaptation of other currently available reagents. Barcoding of test reagents, calibrators, and controls facilitate their use on the system and permits reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents. The instrument performs multiple test methodologies in random access as selected by the user. These include clotting time or clot-based tests (i.e. chronometric) measurements and photometric assays (at specific wavelengths) on plasma samples. The STA Compact® is the modified version of the Company's STA Compact® (K961579), legally marketed Predicate Device. The modification of the device involves replacement of components for reliability of operation or obsolescence reasons, change in the device application software to provide operator/user use enhancements and modification of the data post-processing to increase results reliability.

STA® - Free PS Calibrator kit is a set of calibrator plasmas intended for use with analyzers of the STA® line suitable to these reagents for the calibration of free protein S assays by the immuno-turbidimetric method, STA® - Liatest® Free PS.

The STA® - Free PS Calibrator kit is a set of lyophilized human plasmas used to create the calibration curve on an IVD instrument performing the immunoturbidimetric method for free protein S assays, STA® - Liatest® Free PS. Such IVD instruments being the STA® product line of medical device analyzers such as STA-R® and STA Compact®. In the lyophilized state and uncompromised primary packaging, the product calibrator plasmas remain stable for a period of 18 months from the date of manufacture when stored at 2 - 8°C. In the reconstituted state, STA® - Free PS Calibrator have demonstrated to be stable for 4 hours on board STA-R® and STA Compact®.

The STA Satellite™ Automated Multi-Parametric AnalyzerSatellite® Automated Multi-Parametric Analyzer is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

The STA Satellite® Automated Multi-Parametric Analyzer is designed as a fully automatic bench-top system. Samples and test reagents are loaded into the instrument where sample handling, reagent delivery, analysis, and reporting of results are performed automatically. A central processing unit controls instrument functions such as, management of patient results, quality control, system supervision, support for instrument maintenance, and work load optimization. The STA Satellite® is the bench-top version of the company's STA-R®, legally marketed predicate device. The instrument utilizes Diagnostica Stago reagents in addition to open adaptation of other currently available reagents. Barcoding of test reagents, calibrators, and controls facilitate their use on the system and permits reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents. The instrument performs multiple test methodologies in random access as selected by the user. These include clotting time or clot-based tests (i.e. Chronometricchronometric) measurements and photometric assays (at specific wave lengths) on plasma samples. The principle of the chronometric method consists in measuring the variation of the oscillation amplitude of the ball (in the cuvette). A decrease in oscillation amplitude corresponds to an increase in the viscosity of the media (i.e. ., coagulation). The principle of the photometric measurements on the instrument is based on measured absorbance (also referred to as Optical Density, or OD) of monochromatic light of predetermined wavelength passing through the cuvette as a (clotting) reaction takes place.

The STA-R® Evolution (or STA-R®) Automated Multi-Parametric Analyzer is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

The STA-R® Automated Multi-Parametric Analyzer is designed as a fully automatic system. Samples and test reagents are loaded into the instrument where sample handling, reagent delivery, analysis, and reporting of results are performed automatically. A central processing unit controls instrument functions such as, management of patient results, quality control, system supervision, support for instrument maintenance, and work load optimization. The STA-R® Evolution is the modified or updated version of the company's STA-R®, legally marketed predicate device. The modification of the device involves the upgrade of the instrument's operating system from Windows NT to the Windows XP platform. Slight modifications to the application software were made to accommodate the new operating system along with operator/user enhancements but without logic configuration changes. The instrument utilizes Diagnostica Stago reagents in addition to open adaptation of other currently available reagents. Barcoding of test reagents, calibrators, and controls facilitate their use on the system and permits reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents. The instrument performs multiple test methodologies in random access as selected by the user. These include clotting time or clot-based tests (i.e. chronometric) measurements and photometric assays (at specific wave lengths) on plasma samples. The Technological Characteristics and Principles of Operation for the aforementioned analyses are the same between the subject submission device and the predicate device.

The STA®-Staclot® dRVV Screen and STA®-Staclot® dRVV Confirm kits are intended for the detection of lupus anticoagulants (LA) in plasma by the dilute Russell's viper venom method (1) performed with analyzers of the STA® line suitable to these reagents.

The in vitro diagnostic device presented in this 510K submission, STA® -Staclote dRVV Screen and STA® -Staclot® dRVV Confirm, is substantially equivalent to the IL Test LAC Screen and Confirm manufactured by Instrumentation Laboratories.

The STA® - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of the tendsma for LA detection carried out with the following tests: STA® -Staclor® dRVV Screen (#00339 & #00333) STA® -Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594)

The STA® - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of LA testing using the following kits: STA® - Staclot® dRVV Screen (#00339 & 00333) STA® - Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594)