Automated Blood Coagulation Analyzer CS-2500

K172286 · Siemens Healthcare Diagnostic Products GmbH · JPA · Dec 18, 2017 · Hematology

Device Facts

• Record ID: K172286
• Device Name: Automated Blood Coagulation Analyzer CS-2500
• Applicant: Siemens Healthcare Diagnostic Products GmbH
• Product Code: JPA · Hematology
• Decision Date: Dec 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

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. The performance of this device has not been established in neonate and pediatric patient populations.

Device Story

Sysmex CS-2500 is a fully automated blood coagulation analyzer for clinical/hospital laboratories. It processes venous plasma samples collected in 3.2% sodium citrate tubes. The device uses clotting, chromogenic, and immunoassay methods to analyze coagulation parameters. It features an Information Processing Unit (IPU) with a touch panel, keyboard, and mouse for operator control. The system includes an automated sampler, reagent section, and cuvette handling. It performs automatic pipetting, dilution, and analysis. Results are displayed on the IPU, printed, or transmitted to a host computer. The device supports normal and micro-sample modes. It aids clinicians in diagnosing coagulation disorders and monitoring therapy by providing quantitative and qualitative results for factors and anticoagulants. Benefits include high-throughput, automated testing, and reduced manual labor for laboratory staff.

Clinical Evidence

Method comparison studies (N=347-494 per application) across four sites compared CS-2500 to CA-1500 using Passing-Bablok regression, showing high correlation (r=0.902-0.996). Reproducibility studies (20-day, 3-site) followed CLSI EP05-A2, with Total CVs ranging from 0.72% to 10.54%. Detection capability (LoQ) and linearity studies confirmed performance within clinically reportable ranges. Factor V Leiden cut-off study (N=381) showed 100% positive agreement and 99.4% negative agreement against PCR genotype. No clinical data for neonate/pediatric populations.

Technological Characteristics

Automated coagulation analyzer; uses transmitted light detection (absorbance) at 340, 405, 575, 660, 800 nm. Halogen lamp light source. Temperature control: detector 37±0.5°C, reagent probe 37.5±0.5°C. Reagent cooling: 4-15°C. Connectivity: host computer interface, 2D barcode reader. Software-controlled automated pipetting and dilution. Sample types: citrated human plasma. Dimensions/form factor: floor-standing/benchtop main unit with separate IPU.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories to analyze clotting, chromogenic, and immunoassay parameters in citrated human plasma. Specific tests include PT, APTT, Fibrinogen, Factor V, VII, VIII, IX, Lupus Anticoagulant, Factor V Leiden, Protein C, Antithrombin, and D-dimer. Not established for neonate or pediatric populations.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Sysmex® CA-1500 (K011235)

Submission Summary (Full Text)

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December 18, 2017

Siemens Healthcare Diagnostic Products GmbH Nils Neumann Regulatory Affairs Manager Emil-von-Behring Strasse 76 35041 Marburg, Germany

Re: K172286

Trade/Device Name: Sysmex® Automated Blood Coagulation Analyzer CS-2500 Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: JPA, GGW, GJT, GIR Dated: December 8, 2017 Received: December 12, 2017

Dear Nils Neumann:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 809), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Leonthena R. Carrington -S

Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K172286

### Device Name

Sysmex® Automated Blood Coagulation Analyzer CS-2500, Factor V Leiden Assay, Coagulation Factor VIII, IX, XI and XII Deficient Plasmas, LA1 Screening / LA2 Confirmation Reagents

### Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92 and follows the FDA guidance 'The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]', issued July 28, 2014.

#### 1 Submitter

Siemens Healthcare Diagnostics Products GmbH

Emil-von-Behring-Str. 76

35041 Marburg, Germany

| Contact Person: | Nils Neumann |
|-----------------|---------------------------------------|
| Email: | [e-mail] |
| Phone: | + (49) 6421 39 7133 |
| Facsimile: | + (49) 6421 39 4977 |
| Date Prepared: | December 12, 2017 |

#### 2 Device

| Name of Device: | Sysmex® Automated Blood Coagulation Analyzer<br>CS-2500 |
|-----------------------|---------------------------------------------------------------------------|
| Common or Usual Name: | Automated Coagulation Instrument |
| Classification Name: | Multipurpose system for in vitro coagulation studies<br>(21 CFR 864.5425) |
| Regulatory Class: | 2 |
| Product Code: | JPA |
| 510(k) Review Panel | Hematology |

#### 3 Predicate Device

| Name of Device: | Sysmex® CA-1500 (K011235) |
|-----------------------|---------------------------------------------------------------------------|
| Common or Usual Name: | Automated Coagulation Instrument |
| Classification Name: | Multipurpose system for in vitro coagulation studies<br>(21 CFR 864.5425) |
| Regulatory Class: | 2 |
| Product Code: | JPA |
| 510(k) Review Panel | Hematology |

The predicate has not been subject to a design-related recall for any of the applications associated with this premarket notification. No reference devices were used in this submission. Siemens Healthcare Diagnostics Products, GmbH Page 1 of 22

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| Reagent Applications that are the subject of this 510(k) notification | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|----------------------|---------------------|-----------------|------------|
| Application<br>Intended Use | 510(k) Number<br>related to<br>application on<br>predicate device | Regulation<br>Number | Regulatory<br>Class | Product<br>Code | Panel |
| Factor V Leiden Assay<br>The Siemens Healthcare<br>Diagnostics Factor V Leiden<br>Assay is a simple functional<br>clotting test system intended for<br>screening of resistance to<br>Activated Protein C (APC) in<br>plasma from individuals with the<br>Factor V (Leiden) defect. For in<br>vitro diagnostic use. | K992456 | 864.7925 | Class II | GGW | Hematology |
| Coagulation Factor VIII<br>Deficient Plasma<br>In vitro diagnostic reagents for<br>the determination of the activity<br>of coagulation factors VIII, IX,<br>XI and XII in human plasma by<br>coagulometric methods. | K924396 | 864.7290 | Class II | GJT | Hematology |
| Coagulation Factor IX<br>Deficient Plasma<br>In vitro diagnostic reagents for<br>the determination of the activity<br>of coagulation factors VIII, IX,<br>XI and XII in human plasma by<br>coagulometric methods. | K924396 | 864.7290 | Class II | GJT | Hematology |
| LA 1 Screening Reagent /<br>LA 2 Confirmation Reagent,<br>and LA Ratio<br>LA 1 Screening Reagent / LA 2<br>Confirmation Reagent are<br>simplified DRVVT reagents for<br>detection of Lupus<br>Anticoagulants (LA) in one-<br>stage clotting tests. LA 1<br>Screening Reagent: Simplified<br>DRVV reagent to screen for the<br>presence of Lupus<br>Anticoagulants. LA 2<br>Confirmation Reagent:<br>Phospholipid-rich DRVV<br>reagent for the specific<br>correction of Lupus<br>Anticoagulants. | K993299 | 864.8950 | Class I | GIR | Hematology |

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#### Device Description / Test Principle 4

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 ●
- 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.

| Table of Sysmex® CS-2500 Analysis Principles | | |
|------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------|
| Reagent | Application | Methodology |
| Factor V Leiden Assay | Factor V Leiden with<br>Factor V Leiden Assay | Clotting<br>(extrinsic pathway);<br>Calculated |
| Coagulation Factor VIII<br>Deficient Plasma | Coagulation Factor VIII<br>with Dade® Actin FSL® | Clotting<br>(intrinsic pathway) |
| Coagulation Factor IX<br>Deficient Plasma | Coagulation Factor IX<br>with Dade® Actin FSL® | Clotting<br>(intrinsic pathway) |
| LA 1 Screening Reagent | Lupus Anticoagulant with<br>LA 1 Screening Reagent | Clotting |
| LA 2 Confirmation<br>Reagent | Lupus Anticoagulant with<br>LA 2 Confirmation<br>Reagent | Clotting |
| LA 1 Screening Reagent<br>and LA 2 Confirmation<br>Reagent | LA Ratio with LA 1<br>Screening Reagent / LA 2<br>Confirmation Reagent | Clotting;<br>Calculated |

### Table of Sysmex® CS-2500 Analysis Principles

The intended Environment of Use is a clinical central/hospital laboratory.

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### Instrument (main unit)

Image /page/7/Figure/2 description: This image shows a diagram of a machine with labels pointing to different parts. The labels include numbers 1 through 8, each pointing to a specific component of the machine. The diagram appears to be a technical illustration, possibly from a user manual or product guide, intended to identify and explain the various parts of the machine.

#### Front View of the Sysmex CS-2500 (main unit) Figure 1:

- (1) Light shield lid: Open this cover to set reagents, perform maintenance, etc.
- (2) Sampler: Automatically transports samples that are set in the sample rack to the aspiration position.
- (3) Reagent section lid: Open this cover to set reagents.
- (4) Cuvette hopper: Cuvettes placed here are automatically supplied to the interior of the instrument.
- (5) Alarm indicator LED: Indicates the instrument status.
- (6) Mechanical stop switch:
- (7) Start button: This button is the same as the [Start] button on the IPU toolbar.
- (8) Cuvette trash box: Used cuvettes are discarded here.

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### Figure 2: Informational Processing Unit (IPU) Sysmex CS-2500

Image /page/8/Figure/2 description: The image shows a desktop computer setup with four labeled components. The monitor, labeled (1), sits atop the computer case, labeled (2). Below the case is the keyboard, labeled (3), and to the right of the keyboard is the mouse, labeled (4). The image is a black and white line drawing.

- (1) Touch panel display: Displays the IPU screen. It can also be used as a touch panel.
- (2) IPU Main Unit: This is the Main Unit of IPU.
- (3) Keyboard: Used to operate the IPU together with the touch panel.
- (4) Mouse: Used to operate the IPU together with the touch panel.

The instrument is capable of measuring in the following analysis modes:

(1) Normal mode: Samples for all the analyses including re-analyses are taken into the instrument at the same time and analyzed. Automatic re-analysis can also be performed.

(2) Micro-sample mode: The sample volume from samples set in the sampler or STAT holder is taken into the instrument for each analysis through dispensing sample probe and analyzed. This analysis mode can also be performed with less sample volume than normal mode; however, automatic re-analysis cannot be performed.

Options and accessories that can be used for this instrument are as follows:

(1) Waste tank (with float switch for waste tank): Waste fluids discharged from the Main Unit enter this tank.

(2) 2D barcode reader: Reads barcodes to input calibrator's or reagent's assay sheet values, normal values and ISI values, and control's targets/limits. It also reads barcodes to input sample numbers, rack numbers and reagent IDs.

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#### 5 Similarities between Sysmex CS-2500 and Sysmex CA-1500

| Similarities between Sysmex CS-2500 and Sysmex CA-1500 | | |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyzer Component | Proposed Device<br>Sysmex® CS-2500 | Predicate Device<br>Sysmex® CA-1500 |
| Regulatory Classification | JPA, Class 2<br>System, Multipurpose for in<br>vitro coagulation studies | Same |
| Intended Use | The Sysmex® CS-2500 is a fully<br>automated blood coagulation analyzer<br>intended for in vitro diagnostic use using<br>plasma collected from venous blood<br>samples in 3.2% sodium citrate tubes to<br>analyze clotting, chromogenic and<br>immunoassay methods in the clinical<br>laboratory.<br>For determination of:<br>• Prothrombin Time (PT) seconds and<br>PT INR with Dade® Innovin®<br>• Activated Partial Thromboplastin Time<br>(APTT) with Dade® Actin® FSL<br>• Fibrinogen (Fbg) with Dade®<br>Thrombin Reagent<br>• Coagulation Factor V with Dade®<br>Innovin®<br>• Coagulation Factor VII with Dade®<br>Innovin®<br>• Coagulation Factor VIII with Dade®<br>Actin® FSL<br>• Coagulation Factor IX with Dade®<br>Actin® FSL<br>• Lupus Anticoagulant with LA1<br>Screening / LA2 Confirmation Reagent<br>• Factor V Leiden with Factor V Leiden<br>Assay<br>• Protein C with Protein C Reagent<br>• Antithrombin (AT) with<br>INNOVANCE® Antithrombin<br>• Protein C with Berichrom® Protein C<br>• D-dimer with INNOVANCE® D-<br>Dimer<br>The performance of this device has not<br>been established in neonate and<br>pediatric patient populations. | The intended use of the Sysmex®<br>CA-1500 is as a fully automated,<br>computerized blood plasma<br>coagulation analyzer for in vitro<br>diagnostic use in clinical<br>laboratories.<br>The instrument uses citrated<br>human plasma to perform the<br>following parameters and<br>calculated parameters:<br>Clotting Analysis Parameters:<br>Prothrombin Time (PT); Activated<br>Partial Thromboplastin Time<br>(APTT); Fibrinogen (Clauss);<br>Batroxobin Time; Extrinsic Factors<br>(II, V, VII, X); Intrinsic Factors<br>(VIII, IX, XI, XII); Protein C.<br>Chromogenic Analysis<br>Parameters: Antithrombin III;<br>Factor VIII; Plasminogen;<br>Heparin; Protein C; a2-<br>Antiplasmin.<br>Immunologic Analysis Parameters:<br>D-dimer.<br>Calculated Parameters: PT Ratio;<br>PT INR; PT %; Derived<br>Fibrinogen; Factor Assays %<br>Activity. |
| Sample Type | Human plasma<br>3.2% sodium citrate | Same |
| Similarities between Sysmex CS-2500 and Sysmex CA-1500 | | |
| Analyzer Component | Proposed Device<br>Sysmex® CS-2500 | Predicate Device<br>Sysmex® CA-1500 |
| Application type | Clotting Applications:<br>Prothrombin Time (PT) with<br>Dade® Innovin®;<br>Activated Partial Thromboplastin<br>Time (APTT) with<br>Dade® Actin® FSL;<br>Fibrinogen (Clauss) with<br>Dade® Thrombin Reagent;<br>Coagulation Factor V with<br>Dade® Innovin®<br>Coagulation Factor VII with<br>Dade® Innovin®<br>Coagulation Factor VIII with Dade®<br>Actin® FSL<br>Coagulation Factor IX with Dade®<br>Actin® FSL<br>Lupus Anticoagulant with LA 1<br>Screening / LA 2 Confirmation<br>Reagents<br>Factor V Leiden with Factor V Leiden<br>Assay<br>Protein C with Protein C Reagent | Same |
| | Chromogenic Application:<br>Antithrombin with<br>INNOVANCE® Antithrombin;<br>Protein C with<br>Berichrom® Protein C | Same |
| | Immuno-Chemical Application:<br>D-dimer with<br>INNOVANCE® D-Dimer | Same |
| | Calculated Application:<br>PT INR with Dade® Innovin® | Same |
| Similarities between Sysmex CS-2500 and Sysmex CA-1500 | | |
| Analyzer Component | Proposed Device<br>Sysmex® CS-2500 | Predicate Device<br>Sysmex® CA-1500 |
| Clinical Reportable Range | Coagulation Factor VIII with Dade®<br>Actin® FSL: 3.0 – 182.0% of norm;<br>Coagulation Factor IX with Dade®<br>Actin® FSL: 3.0 – 145.5%;<br>Factor V Leiden with Factor V Leiden<br>Assay: 0.72 – 5.91 ratio;<br>LA 1 with LA 1 Screening Reagent:<br>24.9 – 158.8 sec. | Same |
| Specimen Processing | Automatic Pipetting and Dilution | Same |
| Random Access | Yes | Same |
| Liquid Level Sensing | Yes - reagent and sample | Same |
| Bar Code Reader | Sample and reagent | Same |
| STAT Testing | Yes | Same |
| Sampling Capabilities | Normal and Micro Mode | Same |

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| Similarities between Sysmex CS-2500 and Sysmex CA-1500 | | |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Analyzer Component | Proposed Device<br>Sysmex® CS-2500 | Predicate Device<br>Sysmex® CA-1500 |
| Sample Volumes (Plasma) | PT with Dade® Innovin® (50 µL)<br>APTT with Dade® Actin® FSL<br>(50 µL)<br>Fibrinogen with Dade® Thrombin<br>Reagent (10 µL)<br>Coagulation Factor V with Dade®<br>Innovin® (5 µL)<br>Coagulation Factor VII with Dade®<br>Innovin® (5 µL)<br>Protein C with Protein C Reagent<br>(5 µL)<br>Protein C with Berichrom® Protein C<br>(15 µL)<br>Coagulation Factor VIII with Dade®<br>Actin FSL® (2 µL)<br>Coagulation Factor IX with Dade®<br>Actin FSL® (2 µL)<br>Lupus Anticoagulant with LA1<br>Screening Reagent (100 µL)<br>Lupus Anticoagulant with LA2<br>Confirmation Reagent (100 µL)<br>Factor V Leiden with Factor V | Same |
| Similarities between Sysmex CS-2500 and Sysmex CA-1500 | | |
| Analyzer Component | Proposed Device<br>Sysmex® CS-2500 | Predicate Device<br>Sysmex® CA-1500 |
| Sample Volumes in Micro<br>Mode (Plasma) | PT with Dade® Innovin® (50 µL)<br>APTT with Dade® Actin® FSL<br>(50 µL)<br>Fibrinogen with Dade® Thrombin<br>Reagent (10 µL)<br>Coagulation Factor V with Dade®<br>Innovin® (5 µL)<br>Coagulation Factor VII with Dade®<br>Innovin® (5 µL)<br>Protein C with Protein C Reagent<br>(5 µL)<br>Protein C with Berichrom®<br>Protein C (15 µL)<br>Coagulation Factor VIII with Dade®<br>Actin FSL® (2 µL)<br>Coagulation Factor IX with Dade®<br>Actin FSL® (2 µL)<br>Lupus Anticoagulant with LA1<br>Screening Reagent (100 µL)<br>Lupus Anticoagulant with LA2<br>Confirmation Reagent (100 µL)<br>Factor V Leiden with Factor<br>V Leiden Assay (50 µL) | Same |
| Rinse & Buffer Solutions<br>On-board | CA-CLEAN I<br>CA-CLEAN II<br>Dade® Owren's Buffer | Same |
| External | Water | |
| Light Source | | |
| Chromogenic | Halogen Lamp | Same |
| Immuno-chemical | Halogen Lamp | Same |
| Probes | 1 Sample probe;<br>1 Reagent probe | Same |
| Similarities between Sysmex CS-2500 and Sysmex CA-1500 | | |
| Analyzer Component | Proposed Device<br>Sysmex® CS-2500 | Predicate Device<br>Sysmex® CA-1500 |
| Wavelengths used in Analysis | Coagulation Factor VIII with Dade®<br>Actin FSL®<br>(Default = 660 nm; Sub-wavelength=none)<br>Coagulation Factor IX with Dade®<br>Actin FSL®<br>(Default = 660 nm; Sub-wavelength=none)<br>Lupus Anticoagulant with LA1<br>Screening Reagent<br>(Default = 660 nm; Sub-wavelength=none)<br>Lupus Anticoagulant with LA2<br>Confirmation Reagent<br>(Default = 660 nm; Sub-wavelength=none)<br>Factor V Leiden with Factor V Leiden<br>Assay (Default = 660 nm; Sub-wavelength=none) | Same |
| Temperature Control | Sample incubation well:<br>37 °C ± 1.0 °C | Same |

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#### Differences between Sysmex CS-2500 and CA-1500 6.

| Differences between Sysmex CS-2500 and Sysmex CA-1500 | | |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Analyzer Component | Proposed Device<br>Sysmex® CS-2500 | Predicate Device<br>Sysmex® CA-1500 |
| Operating Principle | Clotting:<br>Transmitted Light Detection<br>(Absorbance) at 340, 405, 575, 660 or<br>800 nm. Wavelengths 340, 405 and<br>575 are technically available but not<br>validated in combination with the<br>intended applications. | Scattered Light Detection at 660<br>nm |
| | Chromogenic:<br>Transmitted Light Detection<br>(Absorbance) at 340, 405, 575, 660,<br>800 nm. Wavelengths 340, 575, 660,<br>and 800 are technically available but not<br>validated in combination with the<br>intended applications. | Transmitted Light Detection<br>(Absorbance) at 405, 575, 800 nm |
| | Immunochemical:<br>Transmitted Light Detection<br>(Absorbance) at 340, 405, 575, 660 or<br>800 nm. Wavelengths 340, 405, 575,<br>and 800 are technically available but not<br>validated in combination with the<br>intended applications. | Transmitted Light Detection<br>(Absorbance) at 405, 575, or 800<br>nm |
| Light Source<br>Clotting | Halogen Lamp | Light Emitting Diode |
| Cap Piercing | Cap Piercer only | Both Cap Piercer model and Non-<br>Cap Piercer models are available |
| Temperature Control | Detector: 37 ± 0.5 °C<br>Reagent probe: 37.5 ± 0.5 °C | Detector: 37 ± 1.0 °C Reagent<br>probe: 37 ± 1.0 °C |
| Reagent…