Sysmex Automated Blood Coagulation Analyzer CS-5100

K162420 · Siemens Healthcare Diagnostics Products GmbH · JPA · Dec 12, 2016 · Hematology

Device Facts

• Record ID: K162420
• Device Name: Sysmex Automated Blood Coagulation Analyzer CS-5100
• Applicant: Siemens Healthcare Diagnostics Products GmbH
• Product Code: JPA · Hematology
• Decision Date: Dec 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The Sysmex® 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® - . 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.

Device Story

Sysmex® CS-5100 is a fully automated, standalone blood coagulation analyzer for clinical laboratories. It processes citrated venous plasma samples via automated pipetting and dilution. The device performs clotting-based assays (Factor V, Factor VII, Protein C) and chromogenic assays (Berichrom® Protein C). Clotting assays measure time to fibrin clot formation; chromogenic assays measure kinetic absorbance changes at 405 nm. Results are displayed on an Information Processing Unit (IPU) screen, printable, or transmittable to a host computer. The system supports STAT testing and uses barcode-based specimen identification. Healthcare providers use these quantitative results to aid in diagnosing inherited and acquired coagulation factor deficiencies. The device benefits patients by providing rapid, automated, and precise coagulation testing, reducing manual labor and potential for human error in clinical decision-making.

Clinical Evidence

Method comparison studies (N=505-624 per application) conducted at four US sites using CLSI EP09-A3 guidelines showed equivalence to predicate (r=0.974-0.996). Reproducibility studies (20-day, 3 sites) per CLSI EP05-A2 showed Total CVs ranging from 3.22% to 7.92%. Detection capability (CLSI EP17-A2) and linearity (CLSI EP6-A) met acceptance criteria. Reference intervals established per CLSI EP28-A3c. No clinical data for neonates/pediatrics.

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: Bidirectional interface (CA, ASTM, CS protocols). Sample/reagent liquid level sensing. Cap piercing. Dimensions/form factor: Floor-standing/benchtop with external IPU.

Indications for Use

Indicated for use in clinical laboratories for automated in vitro diagnostic coagulation testing (clotting, chromogenic, immunoassay) using citrated human plasma. 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 12, 2016

Siemens Healthcare Diagnostics Products GmbH Petra M. Dissmann, Ph.D. Regulatory Affairs Manager Emil-von-Behring Strasse 76 35041 Marburg, Germany

Re: K162420 Trade/Device Name: Sysmex® CS-5100 Coagulation Factor V Deficient Plasma Coagulation Factor II. VII and X Deficient Plasmas Protein C Reagent Berichrom® Protein C Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: JPA, GGP, GJT Dated: September 12, 2016 Received: September 13, 2016

Dear Dr. Dissmann:

We have reviewed your 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. Isting 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.

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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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 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

Leonthena R. Carrington, MS. MBA. MT(ASCP) 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) K162420

### Device Name

Sysmex® CS-5100, Coagulation Factor V Deficient Plasma, Coagulation Factor II, VII and X Deficient Plasmas, Protein C Reagent, Berichrom® Protein C

### Indications for Use (Describe)

Sysmex® CS-5100:

The Sysmex® 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®
- . 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.

Coagulation Factor V Deficient Plasma:

In vitro diagnostic reagent for the determination of the activity of coagulation factor V in human plasma.

Coagulation Factor II, VII and X Deficient Plasmas:

In vitro diagnostic reagents for the determination of the activity of coagulation factor II (prothrombin), coagulation factor VII and coagulation factor X in human plasma by coagulometric methods.

Protein C Reagent:

Protein C Reagent is a coagulation test for the quantitative determination of protein C activity in human plasma.

Berichrom® Protein C:

For the quantitative determination of functionally active protein C using a chromogenic substrate as an aid in the diagnosis of inherited and acquired deficiencies.

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 8807.92 and follows the FDA guidance 'The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]', issued July 28, 2014.

#### Submitter 1

Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76 35041 Marburg, Germany Contact Person: Dr. Petra M. Dissmann Email: [e-mail] Phone: + 49 6421 39 2009 Facsimile: + 49 6421 39 4977 Date Prepared: August 29, 2016 2 Device Name of Device: Sysmex® CS-5100 Common or Usual Name: Automated Coagulation Instrument Classification Name: Multipurpose system for in vitro coagulation studies (21 CFR 864.5425) Regulatory Class: Class II 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 (21 CFR 864.5425) Regulatory Class: Class II 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.

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| Reagent Applications that are the subject of this 510(k) notification | | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------|---------------------|-----------------|------------|
| Application<br>Intended Use | 510(k)<br>Number<br>related to<br>application on<br>predicate device | Regulation<br>Number | Regulatory<br>Class | Product<br>Code | Panel |
| Coagulation Factor V<br>with Dade® Innovin®<br>In vitro diagnostic<br>reagent for the<br>determination of the<br>activity of coagulation<br>factor V in human<br>plasma. | K993299 | 864.7290 | Class II | GJT | Hematology |
| Coagulation Factor VII<br>with Dade® Innovin®<br>In vitro diagnostic<br>reagents for the<br>determination of the<br>activity of coagulation<br>factor II (prothrombin),<br>coagulation factor VII<br>and coagulation factor X<br>in human plasma by<br>coagulometric methods. | K993299 | 864.7290 | Class II | GJT | Hematology |
| Protein C with<br>Protein C Reagent<br>Protein C Reagent is a<br>coagulation test for the<br>quantitative<br>determination of protein<br>C activity in human<br>plasma. | K000649 | 864.7290 | Class II | GGP | Hematology |
| Protein C with<br>Berichrom® Protein C<br>For the quantitative<br>determination of<br>functionally active<br>protein C using a<br>chromogenic substrate as<br>an aid in the diagnosis of<br>inherited and acquired<br>deficiencies. | K001645 | 864.7290 | Class II | GGP | Hematology |

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#### Device Description / Test Principle 4

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 ●
- Consumable materials ●

The subject of this 510(k) notification are reagent applications which perform the coagulation tests Coagulation Factor V with Dade® Innovin®, Coagulation Factor VII with Dade® Innovin®, Protein C with Protein C Reagent and Protein C with Berichrom® Protein C.

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-5100 Analysis Principles | | | |
|-------------------------------------------------------------------|-----------------------------------------------|---------------------------------|--|
| Reagent | Application | Methodology | |
| Dade® Innovin® with<br>Coagulation Factor V<br>Deficient Plasma | Coagulation Factor V with<br>Dade® Innovin® | Clotting<br>(extrinsic pathway) | |
| Dade® Innovin® with<br>Coagulation Factor<br>VII Deficient Plasma | Coagulation Factor VII with<br>Dade® Innovin® | Clotting<br>(extrinsic pathway) | |
| Protein C Reagent | Protein C with<br>Protein C Reagent | Clotting | |
| Berichrom® Protein C | Protein C with<br>Berichrom® Protein C | Chromogenic | |

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

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### Front View of the Instrument

Image /page/7/Figure/2 description: This image is a line drawing of a machine with several components labeled with numbers. The top section of the machine is labeled (1), and below it, a small component is labeled (2). The left cabinet door is labeled (3), while the top right corner features labels (4), (5), and (6). The middle section is labeled (7), and the right cabinet door is labeled (8).

- (1) Light shield lid: Open this cover to set reagents, perform maintenance, etc.
- (2) Power switch: Turns the power ON/OFF.
- (3) Left door: Holds the Pneumatic Unit inside. Open this door to adjust the positive pressure (0.22 MPa).
- (4) Alarm indicator LED: Indicates the instrument status.
- (5) Mechanical stop switch: Press this switch to immediately stop the instrument's mechanical movement.
- (6) Start button: Press this button to immediately start an analysis. This button is the same as the [Start] button on the IPU toolbar.
- (7) Sampler: Automatically transports samples that are set in the sample rack to the aspiration position.
- (8) Right door: Open the door for maintenance or to discard cuvettes.

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### Informational Processing Unit

Image /page/8/Figure/2 description: This image shows a computer setup with four labeled parts. The labels point to the monitor (1), the computer tower (2), the keyboard (3), and the mouse (4). The computer is a desktop model with a separate monitor, keyboard, and mouse.

- (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.
- Keyboard: Used to operate the IPU together with the touch panel. (3)
- (4) Mouse: Used to operate the IPU together with the touch panel.

### Options and Accessories

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) Wand barcode reader: Reads barcodes to input sample numbers, rack numbers and reagent IDs.
- (3) 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.
- (4) IPU cart: The IPU (which includes the keyboard, PC and touch panel display), and the tanks for waste, rinse and CA Clean II can be placed on this cart.
- (5) External indicator light: The status of the instrument is indicated with a red, yellow or green light that can be seen when the operator is not directly in front of the instrument.
- (6) IPU holder: This is an optional holder for the IPU which includes the keyboard, PC and touch panel display which can be installed on the right side of the instrument to minimize the instrument footprint.

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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. In a normal mode, a capped sample tube analysis can be performed. Automatic re-analysis can also be performed.
- (2) Micro-sample mode: Samples set in the sampler or STAT holder are taken into the instrument for each analysis through a secondary dispensing sample probe. When measurements are to be performed in Micro mode, sample tubes must be uncapped. The instrument detects capped tubes automatically and displays an error message. This analysis mode can be performed with less sample volume than normal mode (consult instruction manual for further information). However, automatic re-analysis cannot be performed.

#### 5 Intended Use / Indications for Use

The Sysmex® 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® ●
- 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.

#### 6 Comparison of Technological Characteristics with the Predicate Device

Both the subject and predicate instruments employ the same technological characteristics in that they automatically analyze various clotting tests using reagents, calibrators and controls previously cleared for automated coagulation analyzers. The reagents perform at least equally well on both the subject and predicate instruments. At a high level, the devices have the following same technological elements:

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## Similarities between CS-5100 and CA-1500

There are no technological differences between the subject and predicate devices. However the following minor changes exist between the subject and predicate devices:

| Similarities between CS-5100 and CA-1500 | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyzer Component | Proposed Device<br>Sysmex® CS-5100 | Predicate Device<br>Sysmex® CA-1500 |
| Regulatory Classification | JPA, Class II<br>System, Multipurpose for in<br>vitro coagulation studies | Same |
| Intended Use Statement | The Sysmex® CS-5100 is a fully<br>automated blood coagulation<br>analyzer intended for in vitro<br>diagnostic use using plasma<br>collected from venous blood<br>samples in 3.2% sodium citrate<br>tubes to analyze clotting,<br>chromogenic and immunoassay<br>methods in the clinical laboratory.<br>For determination of:<br>• Prothrombin Time (PT) seconds<br>and PT INR with Dade®<br>Innovin®<br>• Activated Partial Thromboplastin<br>Time (APTT) with Dade®<br>Actin® FSL<br>• Fibrinogen (Fbg) with Dade®<br>Thrombin Reagent<br>• Coagulation Factor V with<br>Dade® Innovin®<br>• Coagulation Factor VII with<br>Dade® Innovin®<br>• Protein C with Protein C Reagent<br>• Antithrombin (AT) with<br>INNOVANCE® Antithrombin<br>• Protein C with Berichrom®<br>Protein C<br>• D-dimer with INNOVANCE®<br>D-Dimer<br>The performance of this device has<br>not 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<br>Factors (II, V, VII, X); Intrinsic<br>Factors (VIII, IX, XI, XII);<br>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 |
| Analyzer Component | Proposed Device<br>Sysmex® CS-5100 | 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>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 |
| Specimen Processing | Automatic Pipetting and Dilution | Same |
| Random Access | Yes | Same |
| Liquid Level Sensing | Yes - reagent and sample | Same |
| Bar Code Reader | Sample + reagent | Same |
| STAT Testing | Yes | Same |
| Sampling Capabilities | Normal and Micro Mode | Same |
| Similarities between CS-5100 and CA-1500 | | |
| Analyzer Component | Proposed Device<br>Sysmex® CS-5100 | 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) | Same |
| | Coagulation Factor V with<br>Dade® Innovin® (5 µL) | |
| | Coagulation Factor VII with<br>Dade® Innovin® (5 µL) | |
| | Protein C with Protein C Reagent<br>(5 μL)<br>Protein C with Berichrom®<br>Protein C (15 µL) | |
| Sample Volumes in Micro Mode<br>(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<br>Dade® Innovin® (5 µL)<br>Coagulation Factor VII with<br>Dade® Innovin® (5 µL)<br>Protein C with Protein C Reagent<br>(5 uL)<br>Protein C with Berichrom®<br>Protein C (15 µL) | Same |
| Rinse & Buffer Solutions | | |
| | On-board<br>External | CA-CLEAN I<br>CA-CLEAN II<br>Dade® Owren's Buffer<br>Water |
| Light Source | | |
| | Chromogenic<br>Immuno-chemical | Halogen Lamp<br>Halogen Lamp |
| Similarities between CS-5100 and CA-1500 | | |
| Analyzer Component | Proposed Device<br>Sysmex® CS-5100…