Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard automated blood coagulation analyzer and its performance characteristics for specific assays. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The analysis relies on established laboratory methods and cut-off values.

Therapeutic

No
This device is an in vitro diagnostic (IVD) device used to analyze blood coagulation, not a therapeutic device that treats or prevents diseases.

Diagnostic

Yes

The device is explicitly stated to be an "in vitro diagnostic use" device, and its purpose is to analyze various blood coagulation parameters to aid in the diagnosis of conditions like Deep Vein Thrombosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "automated blood coagulation instrument" and mentions hardware components like an "Information Processing Unit (IPU) screen" and the ability to print on "external printers". It also mentions associated reagents, controls, calibrators, and consumable materials, which are physical components.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "The Sysmex CS-2100i is a fully automated blood coagulation analyzer intended for in vitro diagnostic use using plasma collected from venous blood samples..."

This statement directly identifies the device as being for in vitro diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

Product codes (comma separated list FDA assigned to the subject device)

JPA

Device Description

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 is to expand the use of the INNOVANCE® D-Dimer for the exclusion of Deep Vein Thrombosis on Sysmex CS-2100i. All other established indications, performance and technology characteristics as cleared under K151259 remain unchanged.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

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

For the exclusion of deep vein thrombosis (DVT) the diagnostic performance was assessed in a population of patients with the suspicion of a first event of DVT. For other patient populations (e. g. with recurrent or chronic DVT) the effectiveness of the device to exclude DVT has not been verified.

Intended User / Care Setting

Clinical laboratory

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

The INNOVANCE® D-Dimer assay was evaluated on the Sysmex CS-2100i System in a multicenter study to validate the exclusion of a first event of Deep Vein Thrombosis (DVT) using frozen specimens collected prospectively from 1907 consecutive outpatients presenting to the emergency or ambulatory department with suspected DVT. Of these 1907 patients, 368 were excluded from analysis (including 213 patients reported to have a previously documented or chronic DVT) resulting in a total of 1539 patients. All potentially eligible patients were evaluated using the Wells' rules to estimate their pre-test probability (PTP) with regard to DVT, and then categorized into likely or unlikely, or alternatively as high, intermediate or low PTP. Patients with a high PTP score were excluded from enrollment. Patients with no or a positive D-dimer result with the D-dimer assay used at the respective study center were evaluated by imaging methods, e.g. ultrasound. Patients with a negative D-dimer result with the D-dimer assay used at the respective study center underwent imaging at the physician's discretion. All patients with a negative clinical diagnosis of DVT at presentation were followed up after three months to evaluate potential development of DVT. Patients with unobtainable follow-up data were excluded from analysis resulting in n= 1317 patients available for final analysis. The overall prevalence of DVT in the 1317 patients was 6.1 % (80 of 1317) with 7.0 % in the US population and 4.7 % in the European population.

The specimens were tested with the INNOVANCE® D-Dimer assay and results were compared to a cut-off value of 0.50 mg/L FEU. A D-dimer result

Regulation Number and Section

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
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.(b)
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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 01, 2016

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

Re: K161312

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: July 28, 2016 Received: August 1, 2016

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Kelly Oliner S

For.

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) K161312

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:	neumann.nils@siemens.com
Phone:	+ 49 6421 39 7133
Facsimile:	+ 49 6421 39 4977
Date Prepared:	August 26, 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
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
864.5425)
Regulatory Class:	2
Product Code:	JPA

The predicate has not been subject to a design-related recall for any of the applications associated with this Premarket Notification.

Hematology

No reference devices were used in this submission.

510(k) Review Panel:

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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:

Reagents ■
. Controls
트 Calibrators
I Consumable materials

The subject of this 510(k) notification is to expand the use of the INNOVANCE® D-Dimer for the exclusion of Deep Vein Thrombosis on Sysmex CS-2100i. All other established indications, performance and technology characteristics as cleared under K151259 remain unchanged.

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 (Fbq) 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.

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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Device Comparison Table

Similarities to the Predicate Device

Similarities between Sysmex CS-2100i and Sysmex CA®-1500
Analyzer Component	Proposed Device
Predicate Device
	Sysmex CS-2100i	Sysmex CA®-1500
Regulatory
Classification	JPA Class 2
System, Multipurpose for in vitro
coagulation studies	Same
Intended Use
Statement	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. | The intended use of the
Sysmex CA®-1500 is as
a fully automated,
computerized blood
plasma coagulation
analyzer for in vitro
diagnostic use in clinical
laboratories.

The instrument uses
citrated human plasma
to perform the following
parameters and
calculated parameters:

Clotting Analysis
Prameters: Prothrombin
Time (PT); Activated
Partial Thromboplastin
Time (APTT); Fibrinogen
(Clauss); Batroxobin
Time; Extrinsic Factors
(II, V, VII, X); Intrinsic
Factors (VIII, IX, XI, XII);
Protein C.

Chromogenic Analysis
Parameters:
Antithrombin III; Factor
VIII; Plasminogen;
Heparin; Protein C; α2-
Antiplasmin. | |
| Similarities between Sysmex CS-2100i and Sysmex CA®-1500 | | | |
| Analyzer Component | Proposed Device
Sysmex CS-2100i | Predicate Device
Sysmex CA®-1500 | |
| | | Parameters: D-dimer.
Calculated Parameters:
PT Ratio; PT INR; PT %;
Derived Fibrinogen;
Factor Assays % Activity | |
| Application | Immuno-chemical Application:

-Reagent incubation probe :
37.5 °C ± 0.5 °C | -Detector: 37°C ± 1.0°C

Sample probe:
4 – 270 μL | Reagent probe:
3 – 200 μL

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8

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

9

The above described differences do not raise new questions as to safety and effectiveness of the new device.

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7. Performance Data

Performance Data: Extended indication for the exclusion of deep vein thrombosis (DVT). See original submission (K151259) for previously conducted analytical and clinical studies:

-Method comparison
-Reproducibility
-Detection Capability
Linearity & Measuring Range
-Reference Interval
-D-dimer PE exclusion validation

7.1 D-Dimer DVT Exclusion Validation Study

The INNOVANCE® D-Dimer assay was evaluated on the Sysmex CS-2100i System in a multicenter study to validate the exclusion of a first event of Deep Vein Thrombosis (DVT) using frozen specimens collected prospectively from 1907 consecutive outpatients presenting to the emergency or ambulatory department with suspected DVT. Of these 1907 patients, 368 were excluded from analysis (including 213 patients reported to have a previously documented or chronic DVT) resulting in a total of 1539 patients. All potentially eligible patients were evaluated using the Wells' rules to estimate their pre-test probability (PTP) with regard to DVT, and then categorized into likely or unlikely, or alternatively as high, intermediate or low PTP. Patients with a high PTP score were excluded from enrollment. Patients with no or a positive D-dimer result with the D-dimer assay used at the respective study center were evaluated by imaging methods, e.g. ultrasound. Patients with a negative D-dimer result with the D-dimer assay used at the respective study center underwent imaging at the physician's discretion. All patients with a negative clinical diagnosis of DVT at presentation were followed up after three months to evaluate potential development of DVT. Patients with unobtainable follow-up data were excluded from analysis resulting in n= 1317 patients available for final analysis. The overall prevalence of DVT in the 1317 patients was 6.1 % (80 of 1317) with 7.0 % in the US population and 4.7 % in the European population.

The specimens were tested with the INNOVANCE® D-Dimer assay and results were compared to a cut-off value of 0.50 mg/L FEU. A D-dimer result