Sysmex CS-2100i

K162688 · Siemens Healthcare Diagnostics Products GmbH · JPA · Dec 26, 2016 · Hematology

Device Facts

• Record ID: K162688
• Device Name: Sysmex CS-2100i
• Applicant: Siemens Healthcare Diagnostics Products GmbH
• Product Code: JPA · Hematology
• Decision Date: Dec 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The Sysmex® CS-2100i 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-2100i is a standalone, fully automated blood coagulation analyzer for clinical laboratories; processes venous plasma samples collected in 3.2% sodium citrate. Device uses clotting, chromogenic, and immunoassay methods; inputs include patient plasma samples and specific reagents (e.g., Dade Innovin, Protein C Reagent, Berichrom Protein C). Instrument performs automatic pipetting, dilution, and liquid level sensing; utilizes transmitted light detection (absorbance) at 660 nm for clotting and 405 nm for chromogenic assays. Results displayed on Information Processing Unit (IPU) screen; can be printed or transmitted to host computer. System supports normal and micro-sample modes; includes cap piercing for normal mode. Healthcare providers use quantitative results to aid in diagnosis of inherited and acquired deficiencies. Benefits include standardized, high-throughput coagulation testing with automated dilution and re-analysis capabilities.

Clinical Evidence

Method comparison study (N=492-589 per application) against predicate device using Passing-Bablok regression showed high correlation (r=0.977-0.994). Reproducibility studies (20-day, 3 sites) demonstrated total CVs ranging from 2.19% to 10.43% across applications. Linearity and limit of quantitation studies confirmed performance within clinically reportable ranges. Reference intervals established with 191-193 subjects.

Technological Characteristics

Automated coagulation analyzer; uses transmitted light detection (absorbance) at 660 nm (clotting) and 405 nm (chromogenic). Halogen lamp light source. Sample/reagent liquid level sensing; barcode reader for identification. Supports normal (cap-piercing) and micro-sample modes. Connectivity via CA-, ASTM-, and CS-protocols. Reagent cooling (4-15°C). Software-controlled automated pipetting and dilution. Sterilization not applicable (instrument).

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories to analyze clotting, chromogenic, and immunoassay coagulation parameters in human plasma collected in 3.2% sodium citrate tubes. Performance not established for neonates 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® Automated Coagulation Analyzer 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 26, 2016

Siemens Healthcare Diagnostics Products GmbH Ms. Donna Noeh Regulatory Affairs Manager Emil-von-Behring Strasse 76 35041 Marburg, Germany

Re: K162688 Trade/Device Name: Sysmex® CS-2100i 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 26, 2016 Received: September 27, 2016

Dear Ms. Noeh:

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/Resourcesfor You/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) K162688

### Device Name

Sysmex® CS-2100i, Coagulation Factor V Deficient Plasma, Coagulation Factor II, VII, and X Deficient Plasmas, Protein C Reagent, Berichrom® Protein C

### Indications for Use (Describe)

For Sysmex® CS-2100i:

The Sysmex CS-2100i 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.

For Coagulation Factor V Deficient Plasma:

Intended Use

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

For Coagulation Factor VII Deficient Plasma:

Intended Use

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.

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

For Berichrom® Protein C:

Intended Use

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 §807.92 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: | Donna Noeh |
|-----------------|------------------------|
| Email: | [e-mail] |
| Phone: | + (49) 6421 39 5107 |
| Facsimile: | + (49) 6421 39 4977 |
| Date Prepared: | November 18, 2016 |

#### 2 Device

3

| Name of Device: | Sysmex® Automated Blood Coagulation Analyzer CS-2100 |
|-----------------------|---------------------------------------------------------------------------|
| Common or Usual Name: | Sysmex® CS-2100i; CS-2100i |
| Classification Name: | Multipurpose system for in vitro coagulation studies<br>(21 CFR 864.5425) |
| Regulatory Class: | II |
| Product Code: | JPA |
| 510(k) Review Panel | Hematology |
| Predicate Device | |
| Name of Device: | Sysmex® Automated Blood Coagulation Analyzer CA-1500<br>(K011235) |
| Common or Usual Name: | Sysmex® CA-1500 |
| Classification Name: | Multipurpose system for in vitro coagulation studies<br>(21 CFR 864.5425) |
| Regulatory 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 Name | K number | Regulation<br>Number | Regulatory<br>Class | Product Code | Panel |
|-------------------------------------------|----------|----------------------|---------------------|--------------|------------|
| Factor V with<br>Dade®<br>Innovin® | K993299 | 864.7290 | 2 | GJT | Hematology |
| Factor VII with<br>Dade®<br>Innovin® | K993299 | 864.7290 | 2 | GJT | Hematology |
| Protein C with<br>Protein C<br>Reagent | K000649 | 864.7290 | 2 | GGP | Hematology |
| Protein C with<br>Berichrom®<br>Protein C | K001645 | 864.7290 | 2 | GGP | Hematology |

Reagent Applications that are the subject of this 510(k) notification:

#### Device Description / Test Principle 4

The Sysmex® CS-2100i 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-2100i 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) |

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| Dade® Innovin® with<br>Coagulation Factor VII<br>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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### Instrument (main unit)

#### Front View of the Sysmex CS-2100i (main unit) Figure 1:

Image /page/7/Figure/3 description: This image is a line drawing of a piece of equipment with multiple labeled parts. The parts are labeled with the numbers 1 through 9. The equipment has a boxy shape with multiple compartments and openings.

(1) Power connector: Connected to the power cable.

- (2) Power Switch: Turns the power ON and OFF.
- (3) Light shield lid: Open this cover to set reagents and perform maintenance.
- (4) Alarm indicator LED: This displays alarms affecting the instrument.
- (5) Cuvette hopper: Holds cuvettes and automatically supplies them to the instrument.
- (6) Start button: This is the same as the Start button on the IPU screen.

(7) Mechanical stop switch: Press this switch to immediately stop the instrument's mechanical movement.

(8) Cuvette trash tray: Used cuvettes are discarded here.

(9) Sampler: The sampler automatically transports samples that are set in the sample rack to the aspiration position.

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### Figure 2: Informational Processing Unit (IPU) Sysmex CS-2100i

Image /page/8/Figure/2 description: The 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 monitor is placed on top of the computer tower, and the keyboard is in front of the tower. The mouse is located to the right of the keyboard.

- (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.

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#### 5 Intended Use / Indications for Use

The Sysmex® CS-2100i 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 with Dade® Innovin®

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

### Coagulation Factor VII with Dade® Innovin® Plasma

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

### Protein C with Protein C Reagent

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

### Protein C with 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.

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

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-2100i and CA-1500 | | |
|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyzer Component | Proposed Device<br>Sysmex® CS-2100i | 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-2100i is a fully<br>automated blood coagulation<br>analyzer intended for in vitro<br>diagnostic use using plasma collected<br>from venous blood samples in 3.2%<br>sodium citrate tubes to analyze<br>clotting, chromogenic and<br>immunoassay methods in the clinical<br>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® D-<br>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 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; α2-<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 CS-2100i and CA-1500 | | |
| Analyzer Component | Proposed Device<br>Sysmex® CS-2100i | Predicate Device<br>Sysmex® CA-1500 |
| Application type | Clotting Applications: | Same |
| | Prothrombin Time (PT) with<br>Dade® Innovin®; | |
| | Activated Partial Thromboplastin<br>Time (APTT) with<br>Dade® Actin® FSL; | |
| | Fibrinogen (Clauss) with<br>Dade® Thrombin Reagent; | |
| | Coagulation Factor V with<br>Dade® Innovin® | |
| | Coagulation Factor VII with<br>Dade® Innovin® | |
| | Protein C with Protein C Reagent | |
| | Chromogenic Application: | |
| | Antithrombin with<br>INNOVANCE® Antithrombin;<br>Protein C with<br>Berichrom® Protein C | Same |
| | Immuno-Chemical Application: | |
| | D-dimer with<br>INNOVANCE® D-Dimer | Same |
| | Calculated Application: | |
| | PT INR with Dade® Innovin® | Same |
| Clinical Reportable Range | Fibrinogen with Dade® Thrombin<br>Reagent 50 to 860 mg/dL; | Same |
| | Antithrombin with INNOVANCE®<br>Antithrombin 9.0 to 128% of norm; | |
| | D-dimer with INNOVANCE® D-<br>dimer 0.19 to 35.2 mg/L FEU; | |
| | Coagulation Factor V with Dade®<br>Innovin® 6.0 to 149.0% of norm; | |
| | Coagulation Factor VII with Dade®<br>Innovin® 6.0 to 149.0% of norm; | |
| | Protein C with Protein C Reagent<br>10.1 to 131.0% of norm | |
| Specimen Processing | Automatic Pipetting and Dilution | Same |
| Similarities between CS-2100i and CA-1500 | | |
| Analyzer Component | Proposed Device<br>Sysmex® CS-2100i | Predicate Device<br>Sysmex® CA-1500 |
| Random Access | Yes | Same |
| Liquid Level Sensing | Yes - reagent and sample | Same |
| Bar Code Reader | Sample and reagent | Same |
| STAT Testing…