Sysmex Automated Blood Coagulation Analyzer CS-2100i

K151259 · Siemens Healthcare Diagnostics Products GmbH · JPA · Jan 26, 2016 · Hematology

Device Facts

• Record ID: K151259
• Device Name: Sysmex Automated Blood Coagulation Analyzer CS-2100i
• Applicant: Siemens Healthcare Diagnostics Products GmbH
• Product Code: JPA · Hematology
• Decision Date: Jan 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 - Antithrombin (AT) with INNOVANCE® Antithrombin - D-dimer with INNOVANCE® D-Dimer. The performance of this device has not been established in neonate and pediatric patient populations.

Device Story

Fully automated blood coagulation analyzer for clinical/hospital laboratories. Inputs: venous plasma samples in 3.2% sodium citrate tubes. Operation: automated pipetting/dilution; analysis via clotting (transmitted light detection), chromogenic, and immunochemical methods. Instrument includes sampler, cuvette hopper, and IPU (Information Processing Unit) for display/data management. Output: quantitative results for PT, APTT, Fibrinogen, Antithrombin, and D-dimer. Healthcare providers use results to assess coagulation status and aid in clinical decision-making, such as pulmonary embolism exclusion. Benefits: standardized, high-throughput automated testing; reduced manual labor; improved diagnostic efficiency.

Clinical Evidence

Multi-center study (n=1467) evaluated D-dimer PE exclusion performance. Sensitivity 97.0% (95% LCL 91.6%), Specificity 54.5% (95% LCL 51.9%), NPV 99.6% (95% LCL 98.8%). Method comparison (n=349-460 per assay) against predicate showed high correlation (r=0.994-0.999). Reproducibility studies (20-day, 3 sites) showed total CVs generally <7.24%.

Technological Characteristics

Automated coagulation analyzer; uses transmitted light detection (absorbance) at 340, 405, 575, 660, or 800 nm. Sample/reagent probes with liquid level sensing. Temperature control: detector 37°C ± 0.5°C; reagent probe 37.5°C ± 0.5°C. Connectivity: bidirectional interface (CA, ASTM, CS protocols). Power: 100-240V. Includes cap piercer, barcode readers, and IPU with touch panel.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories to analyze clotting, chromogenic, and immunoassay methods using venous plasma (3.2% sodium citrate). Parameters: PT (seconds/INR), APTT, Fibrinogen, 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® 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

January 26, 2016

Siemens Healthcare Diagnostics Products GmbH Mr. Nils Neumann Regulatory Manager, US Affairs Emil-von-Behring-Str. 76 35041 Marburg, Germany

Re: K151259

Trade/Device Name: Sysmex CS-2100i Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: JPA Dated: December 24, 2015 Received: December 28, 2015

Dear Mr. Neumann:

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, 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

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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 vours.

## 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K151259

Device Name Sysmex CS-2100i

Indications for Use (Describe)

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
- Antithrombin (AT) with INNOVANCE® Antithrombin
- · D-dimer with INNOVANCE® D-Dimer.

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

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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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: January 14, 2016 2. Device

| Name of Device: | Sysmex CS-2100i |
|-----------------------|---------------------------------------------------------------------------|
| Common or Usual Name: | Automated Coagulation Instrument |
| Classification Name: | Multipurpose system for in vitro coagulation studies (21 CFR<br>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 (21 CFR<br>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.

#### 4. Device Description / Test Principle

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:

510(k) Summary K151259 Sysmex CS-2100i

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- Reagents I
- Controls
- 트 Calibrators
- 트 Consumable materials

The subject of this 510(k) notification are reagent applications which perform the coagulation tests 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; Antithrombin (AT) with INNOVANCE® Antithrombin; and D-dimer with INNOVANCE® D-Dimer. 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® | PT, Prothrombin Time (seconds) | Clotting (extrinsic pathway) |
| Dade® Innovin® | PT, Prothrombin Time (INR) | Clotting, calculated |
| Dade® Actin® FSL | APTT, Activated Partial Thromboplastin Time | Clotting (intrinsic pathway) |
| Dade® Thrombin Reagent | Fibrinogen quantitation | Clotting (common pathway) |
| INNOVANCE® Antithrombin | Antithrombin quantitation | Chromogenic |
| INNOVANCE® D-Dimer | D-dimer quantitation | Immunochemical |

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

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### Instrument (main unit)

Image /page/6/Figure/2 description: This image is a line drawing of a piece of equipment with multiple labeled parts. The labels are numbers 1 through 9 and point to different parts of the machine. The machine 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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Informational Processing Unit (IPU)

Image /page/7/Figure/2 description: The image shows a desktop computer setup with four labeled components. Label (1) points to the computer monitor, which is rectangular and sits atop a stand. Label (2) points to the computer case, which is a rectangular box that sits below the monitor. Label (3) points to the keyboard, which is a standard QWERTY keyboard. Label (4) points to the computer mouse, which is a standard two-button 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.

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

(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.

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: Sampler or STAT holder are taken into the instrument for each analysis through a secondary dispensing sample probe. When measurements are to be

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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-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:

- I Prothrombin Time (PT) seconds and PT INR with Dade® Innovin®
- 트 Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL
- Fibrinogen (Fbq) with Dade® Thrombin Reagent l
- Antithrombin (AT) with INNOVANCE® Antithrombin
- 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:

| Similarities between Sysmex CS-2100i and Sysmex CA-1500 | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyzer Component | Proposed Device<br>Sysmex CS-2100i | Predicate Device<br>Sysmex CA-1500 |
| Regulatory<br>Classification | JPA Class 2<br>System, Multipurpose for in vitro<br>coagulation studies | Same |
| Sample Type | Human plasma,<br>3.2% sodium citrate | Same |
| Applications | Clotting Applications:<br>Prothrombin Time (PT) with Dade®<br>Innovin®;<br>Activated Partial Thromboplastin<br>Time (APTT) with Dade® Actin®<br>FSL | Same |
| Similarities between Sysmex CS-2100i and Sysmex CA-1500 | | |
| Analyzer Component | Proposed Device<br>Sysmex CS-2100i | Predicate Device<br>Sysmex CA-1500 |
| | Fibrinogen (Clauss) with Dade®<br>Thrombin Reagent | |
| | Chromogenic Application:<br>Antithrombin with INNOVANCE®<br>Antithrombin | Same |
| | Immuno-chemical Application:<br>D-dimer<br>with INNOVANCE® D-Dimer | Same |
| | Calculated Application:<br>PT INR with Dade® Innovin® | Same |
| Clinical Reportable<br>Range | Fibrinogen with Dade®<br>Thrombin Reagent<br>50 to 860 mg/dL | Same |
| | Antithrombin with<br>INNOVANCE®<br>Antithrombin<br>9.0 to 128 % of norm | Same |
| | D-dimer with<br>INNOVANCE® D-Dimer<br>0.19 to 35.2 mg/L FEU | 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 |
| Sample Volumes in<br>Normal Mode | PT with Dade® Innovin® 50 μL<br>APTT with Dade® Actin® FSL 50 μL<br>Fibrinogen with Dade® Thrombin | Same |
| Similarities between Sysmex CS-2100i and Sysmex CA-1500 | | |
| Analyzer Component | Proposed Device<br>Sysmex CS-2100i | Predicate Device<br>Sysmex CA-1500 |
| | Reagent 10 μL | |
| | Antithrombin with INNOVANCE®<br>Antithrombin 10 µL | |
| | D-dimer with INNOVANCE® D-<br>Dimer 13 µL | |
| | PT with Dade® Innovin® 50 μL | |
| Sample Volumes in<br>Micro Mode (Plasma) | APTT with Dade® Actin® FSL 50 μL | Same |
| | Fibrinogen with Dade® Thrombin<br>Reagent 10 μL | |
| Rinse & Buffer<br>Solutions | | |
| • On-board | • CA-CLEAN I<br>• CA-CLEAN II<br>• Dade Owren's Buffer | • Same<br>• Same<br>• Same |
| • External | • Water | • Same |
| Light Source<br>Chromogenic | Halogen Lamp | Same |
| Immuno-chemical | Halogen Lamp…