K Number

Device Name

Sysmex CS-5100

Manufacturer

Siemens Healthcare Diagnostics Products GmbH

Date Cleared

2017-10-31

(90 days)

Product Code

JPA GGW GIR GJT

Regulation Number

864.5425

Intended Use

The Sysmex® Automated Blood Coagulation Analyzer 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® - . Coagulation Factor VIII with Dade® Actin® FSL - . Coagulation Factor IX with Dade® Actin® FSL - . Lupus Anticoagulant with LA1 Screening and 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 factors 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 and LA2 Confirmation Reagents: LA1 Screening Reagent and 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.

Device Description

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, and 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 and 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Sysmex® CA-1500 (K011235)

Reference Devices

K992456, K924396, K993299

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard automated blood coagulation analyzer and its associated reagents. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis methods are based on established clotting, chromogenic, and immunoassay principles.

Therapeutic

No
This device is an in vitro diagnostic (IVD) device used to analyze blood coagulation parameters. It provides information for diagnosis and monitoring, but it does not directly treat or prevent a disease, nor does it affect the structure or function of the body.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use." It also details various analyses performed on blood samples to determine specific medical conditions and factors, which is the definition of a diagnostic device.

SaMD (Software as a Medical Device)

The device description clearly 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". While it includes software for analysis, it is fundamentally a hardware device with integrated software.

IVD (In Vitro Diagnostic)

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

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Sysmex® Automated Blood Coagulation Analyzer CS-5100 is a fully automated blood coagulation analyzer intended for in vitro diagnostic use..." and "For in vitro diagnostic use." for the Factor V Leiden Assay and the Coagulation Factor Deficient Plasmas.
Purpose: The device is used to analyze plasma collected from venous blood samples to determine various coagulation parameters (PT, APTT, Fibrinogen, Coagulation Factors, Lupus Anticoagulant, Factor V Leiden, Protein C, Antithrombin, D-dimer). These analyses are performed in vitro (outside the body) on biological specimens to provide information for the diagnosis, treatment, or prevention of disease.
Clinical Laboratory Setting: The intended environment of use is a clinical central/hospital laboratory, which is a typical setting for IVD devices.

The entire description and intended use clearly align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

. 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 and 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 factors 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 and LA2 Confirmation Reagents:

LA1 Screening Reagent and 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.

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

JPA, GGW, GJT, GIR

Device Description

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.

Intended User / Care Setting

The intended Environment of Use is a clinical central/hospital 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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Method Comparison: Studies designed according to EP09-A3 CLSI Guideline 'Measurement Procedure Comparison and Bias Estimation Using Patient Samples' were conducted at four external sites (3 in the United States, 1 in Germany). Samples were measured on both the predicate device (Sysmex® CA-1500) and the new device (Sysmex® CS-5100) in random order. Results were compared by Passing-Bablok regression analysis and Bland-Altman plots. Results from each application met the predetermined acceptance criteria.
- Factor V Leiden with Factor V Leiden Assay (Ratio): N = 495 (Sites Combined), y = 0.976 x + 0.058, r = 0.983 (r2 = 0.967)
- Coagulation Factor VIII with Dade® Actin® FSL (% of norm): N = 432 (Sites Combined), y = 1.054 x - 2.558, r = 0.966 (r2 = 0.933)
- Coagulation Factor IX with Dade® Actin® FSL (% of norm): N = 475 (Sites Combined), y = 1.014 x - 1.227, r = 0.985 (r2 = 0.970)
- Lupus Anticoagulant with LA 1 Screening Reagent (seconds): N = 369 (Sites Combined), y = 0.952 x + 1.523, r = 0.993 (r2 = 0.986)
- Lupus Anticoagulant with LA 2 Confirmation Reagent (seconds): N = 353 (Sites Combined), y = 0.964 x + 1.219, r = 0.989 (r2 = 0.978)
- Lupus Anticoagulant with LA1/ LA2 Ratio (Ratio): N = 306 (Sites Combined), y = 0.942 x + 0.054, r = 0.990 (r2 = 0.980)
Reproducibility Studies: Twenty-day precision studies were performed at one external site in Germany and two external sites in the United States, following CLSI EP05-A2.
- Within Run (%CV) - Sites Combined (Range):
  - Factor V Leiden with Factor V Leiden Assay: 0.82 - 3.08
  - Coagulation Factor VIII with Dade® Actin® FSL: 2.15 - 4.46
  - Coagulation Factor IX with Dade® Actin® FSL: 2.12 - 4.49
  - Lupus Anticoagulant with LA 1 Screening Reagent (seconds): 0.60 - 2.75
  - Lupus Anticoagulant with LA 2 Confirmation Reagent (seconds): 0.27 - 1.18
  - Lupus Anticoagulant with LA1/LA2 Ratio (Ratio): 0.59 - 1.14
- Total CV (Within Site and Sites Combined) (%CV) - Sites Combined (Range):
  - Factor V Leiden with Factor V Leiden Assay: 2.15 - 5.91
  - Coagulation Factor VIII with Dade® Actin® FSL: 4.02 - 7.12
  - Coagulation Factor IX with Dade® Actin® FSL: 4.34 - 7.26
  - Lupus Anticoagulant with LA 1 Screening Reagent (seconds): 1.38 - 3.34
  - Lupus Anticoagulant with LA 2 Confirmation Reagent (seconds): 0.90 - 1.91
  - Lupus Anticoagulant with LA1/LA2 Ratio (Ratio): 1.16 - 3.45
Detection Capability Studies: Measured for Coagulation Factor VIII with Dade® Actin® FSL and Coagulation Factor IX with Dade® Actin® FSL, following CLSI document EP17-A2. All data met predetermined acceptance criteria.
- Coagulation Factor VIII with Dade® Actin® FSL: Lower Limit of Clinically Reportable Range = 3.0% of norm, Measured Limit of Quantitation = 2.52% of norm, Maximum Total Error = 0.50% of norm.
- Coagulation Factor IX with Dade® Actin® FSL: Lower Limit of Clinically Reportable Range = 3.0% of norm, Measured Limit of Quantitation = 2.76% of norm, Maximum Total Error = 1.07% of norm.
Linearity & Measuring Range: Performed for Coagulation Factor VIII with Dade® Actin® FSL and Coagulation Factor IX with Dade® Actin® FSL, following CLSI EP6-A. All reagents met predetermined acceptance criteria.
- Coagulation Factor VIII with Dade® Actin® FSL: Measured Linear Range = 2.12 – 246.41% of Norm, Clinically Reportable Range = 3.0 – 182.0% of Norm.
- Coagulation Factor IX with Dade® Actin® FSL: Measured Linear Range = 2.38 – 193.79% of Norm, Clinically Reportable Range = 3.0 – 145.5% of Norm.
Reference Interval Studies: Conducted at three clinical study sites in the United States following CLSI document EP28-A3c. The study population did not include neonate and pediatric sample populations. Sample sizes for each application varied from 184 to 193.
Factor V Leiden Cut-off Study: A cut-off of 1.8 (ratio) was validated. Citrated plasma samples from n=381 patients (127 from US, others from Germany) submitted for thrombophilia screening were collected at three clinical sites. Samples were frozen and measured with the FV Leiden assay. Results were compared to Factor V Leiden genotype.
- Results (All sites combined):
  - Negative Reference (Factor V Leiden PCR method): 161
  - Positive Reference (Factor V Leiden PCR method): 220
  - Factor V Leiden assay on Sysmex® CS-5100 System - Negative: 161 (161 Negative Reference, 0 Positive Reference)
  - Factor V Leiden assay on Sysmex® CS-5100 System - Positive: 220 (0 Negative Reference, 220 Positive Reference)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Factor V Leiden Cut-off Study:
- Sensitivity = 100.0% (95.0% Confidence Interval = 98.3 – 100.0%)
- Specificity = 100.0% (95.0% Confidence Interval = 97.7 – 100.0%)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Sysmex® CA-1500 (K011235)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K992456, K924396, K993299

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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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October 31, 2017

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

Re: K172333

Trade/Device Name: Sysmex® Automated Blood Coagulation Analyzer CS-5100 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: July 21, 2017 Received: August 2, 2017

Dear Donna 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, 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 (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 809), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (800) 638-2041 or (301) 796-7100 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

Indications for Use

510(k) Number (if known) K172333

Device Name

Sysmex® Automated Blood Coagulation Analyzer CS-5100, Factor V Leiden Assay, Coagulation Factor VIII, IX, XI and XII Deficient Plasmas, LA1 Screening and LA2 Confirmation Reagents

Indications for Use (Describe)

. 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 and 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:

Intended Use for Coagulation Factor VIII Deficient Plasma:

In vitro diagnostic reagents for the determination of the activity of coagulation factors 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 and LA2 Confirmation Reagents:

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:	donna.noeh@siemens-healthineers.com
Phone:	+ (49) 6421 39 5107
Facsimile:	+ (49) 6421 39 4977
Date Prepared:	October 19, 2017

2 Device

| Name of Device: | Sysmex® Automated Blood Coagulation Analyzer
CS-5100 |
|-----------------------|---------------------------------------------------------------------------|
| 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 |
| 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. No reference devices were used in this submission.

Reagent Applications that are the subject of this 510(k) notification
Application
Intended Use	510(k) Number
related to
application on
predicate device	Regulation
Number	Regulatory
Class	Product
Code	Panel
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
the Factor V (Leiden) defect.
For in vitro diagnostic use.	K992456	864.7925	Class II	GGW	Hematology
Coagulation Factor VIII
Deficient Plasma
In vitro diagnostic reagents for
the determination of the activity
of coagulation factors VIII, IX,
XI and XII in human plasma by
coagulometric methods.	K924396	864.7290	Class II	GJT	Hematology
Coagulation Factor IX
Deficient Plasma
In vitro diagnostic reagents for
the determination of the activity
of coagulation factors VIII, IX,
XI and XII in human plasma by
coagulometric methods.	K924396	864.7290	Class II	GJT	Hematology
LA 1 Screening Reagent,
LA 2 Confirmation
Reagent, and LA Ratio
LA 1 Screening Reagent and LA
2 Confirmation Reagent are
simplified DRVVT reagents for
detection of Lupus
Anticoagulants (LA) in one-
stage clotting tests. LA 1
Screening Reagent: Simplified
DRVV reagent to screen for the
presence of Lupus
Anticoagulants. LA 2
Confirmation Reagent:
Phospholipid-rich DRVV
reagent for the specific
correction of Lupus
Anticoagulants.	K993299	864.8950	Class I	GIR	Hematology

4 Device Description / Test Principle

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 and 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-5100 Analysis Principles
Reagent	Application	Methodology
Factor V Leiden Assay	Factor V Leiden with
Factor V Leiden Assay	Clotting
(extrinsic pathway);
Calculated
Coagulation Factor VIII
Deficient Plasma	Coagulation Factor VIII
with Dade® Actin FSL®	Clotting
(intrinsic pathway)
Coagulation Factor IX
Deficient Plasma	Coagulation Factor IX
with Dade® Actin FSL®	Clotting
(intrinsic pathway)
LA 1 Screening Reagent	Lupus Anticoagulant with
LA 1 Screening Reagent	Clotting
LA 2 Confirmation
Reagent	Lupus Anticoagulant with
LA 2 Confirmation
Reagent	Clotting
LA 1 Screening Reagent
and LA 2 Confirmation
Reagent	LA Ratio with LA 1
Screening Reagent and LA
2 Confirmation Reagent	Clotting;
Calculated

Table of Sysmex® CS-5100 Analysis Principles

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

Instrument (main unit)

Front View of the Sysmex CS-5100 (main unit) Figure 1:

Image /page/7/Figure/3 description: The image shows a front view of a machine with several labeled parts. The top part of the machine is labeled as (1). Below that, a part is labeled as (2). The bottom left of the machine is labeled as (3), and the bottom right is labeled as (8). On the top right of the machine, there are labels for (4), (5), (6), and (7).

(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.

Image /page/8/Figure/1 description: The image shows a line drawing of a desktop computer setup. The setup includes a monitor labeled (1), a computer tower labeled (2), a keyboard labeled (3), and a mouse labeled (4). The monitor is placed on top of the computer tower, and the keyboard and mouse are positioned in front of the tower.

Figure 2: Informational Processing Unit (IPU) Sysmex CS-5100

(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) 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.

Similarities between Sysmex CS-5100 and Sysmex CA-1500
Analyzer Component	Proposed Device
Sysmex® CS-5100	Predicate Device
Sysmex® CA-1500
Regulatory Classification	JPA, Class 2
System, Multipurpose for in
vitro coagulation studies	Same
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® Coagulation Factor VIII with Dade® Actin® FSL Coagulation Factor IX with Dade® Actin® FSL Lupus Anticoagulant with LA1 Screening and 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.	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 Parameters:
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.
Immunologic Analysis Parameters:
D-dimer.
Calculated Parameters: PT Ratio;
PT INR; PT %; Derived
Fibrinogen; Factor Assays %
Activity.
Similarities between Sysmex CS-5100 and Sysmex CA-1500
Analyzer Component	Proposed Device
Sysmex® CS-5100	Predicate Device
Sysmex® CA-1500
Sample Type	Human plasma
3.2% sodium citrate	Same
Application type	Clotting Applications:
Prothrombin Time (PT) with
Dade® Innovin®;
Activated Partial Thromboplastin
Time (APTT) with
Dade® Actin® FSL;
Fibrinogen (Clauss) 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 LA 1
Screening and LA 2 Confirmation
Reagents
Factor V Leiden with Factor V Leiden
Assay
Protein C with Protein C Reagent	Same
	Chromogenic Application:
Antithrombin with
INNOVANCE® Antithrombin;
Protein C with
Berichrom® Protein C	Same
	Immuno-Chemical Application:
D-dimer with
INNOVANCE® D-Dimer	Same
	Calculated Application:
PT INR with Dade® Innovin®	Same
Similarities between Sysmex CS-5100 and Sysmex CA-1500
Analyzer Component	Proposed Device
Sysmex® CS-5100	Predicate Device
Sysmex® CA-1500
Clinical Reportable Range	Coagulation Factor VIII with Dade®
Actin® FSL: 3.0 - 182.0.0% of norm;
Coagulation Factor IX with Dade®
Actin® FSL: 3.0 - 145.5%;
Factor V Leiden with Factor V Leiden
Assay: 0.72 - 5.91 ratio;
LA 1 with LA 1 Screening Reagent:
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

5 Similarities between Sysmex CS-5100 and Sysmex CA-1500

Similarities between Sysmex CS-5100 and Sysmex CA-1500
Analyzer Component	Proposed Device
Sysmex® CS-5100	Predicate Device
Sysmex® CA-1500
Sample Volumes (Plasma)	PT with Dade® Innovin® (50 µL)	Same
	APTT with Dade® Actin® FSL (50 µL)
	Fibrinogen with Dade® Thrombin Reagent (10 µL)
	Coagulation Factor V with Dade® Innovin® (5 µL)
	Coagulation Factor VII with Dade® Innovin® (5 µL)
	Protein C with Protein C Reagent (5 µL)
	Protein C with Berichrom® Protein C (15 µL)
	Coagulation Factor VIII with Dade® Actin FSL® (2 µL)
	Coagulation Factor IX with Dade® Actin FSL® (2 µL)
	Lupus Anticoagulant with LA1 Screening Reagent (100 µL)
	Lupus Anticoagulant with LA2 Confirmation Reagent (100 µL)
	Factor V Leiden with Factor V Leiden Assay (50 µL)
Similarities between Sysmex CS-5100 and Sysmex CA-1500
Analyzer Component	Proposed Device
Sysmex® CS-5100	Predicate Device
Sysmex® CA-1500
Sample Volumes in Micro
Mode
(Plasma)	PT with Dade® Innovin® (50 μL)
APTT with Dade® Actin® FSL (50 μL)
Fibrinogen with Dade® Thrombin
Reagent (10 μL)
Coagulation Factor V with Dade®
Innovin® (5 μL)
Coagulation Factor VII with Dade®
Innovin® (5 μL)
Protein C with Protein C Reagent
(5 μL)
Protein C with Berichrom®
Protein C (15 μL)
Coagulation Factor VIII with Dade®
Actin FSL® (2 μL)
Coagulation Factor IX with Dade®
Actin FSL® (2 μL)
Lupus Anticoagulant with LA1
Screening Reagent (100 μL)
Lupus Anticoagulant with LA2
Confirmation Reagent (100 μL)
Factor V Leiden with Factor V
Leiden Assay (50 μL)	Same
Rinse & Buffer Solutions
On-board	CA-CLEAN I CA-
CLEAN II
Dade® Owren's Buffer	Same
External	Water
Light Source
Chromogenic	Halogen Lamp	Same
Immuno-chemical	Halogen Lamp	Light emitted diode
Probes	1 Sample probe;
1 Reagent probe	Same
Similarities between Sysmex CS-5100 and Sysmex CA-1500
Analyzer Component	Proposed Device
Sysmex® CS-5100	Predicate Device
Sysmex® CA-1500
Wavelengths used in
Analysis	Coagulation Factor VIII with Dade®
Actin FSL®
(Default = 660 nm; Sub-wavelength=
none)
Coagulation Factor IX with Dade®
Actin FSL®
(Default = 660 nm; Sub-wavelength=
none)
Lupus Anticoagulant with LA1
Screening Reagent
(Default = 660 nm; Sub-
wavelength=none)
Lupus Anticoagulant with LA2
Confirmation Reagent
(Default = 660 nm; Sub-
wavelength=none)
Factor V Leiden with Factor V Leiden
Assay (Default = 660 nm; Sub-
wavelength=none)	Same
Temperature Control	Sample incubation well:
37 °C ± 1.0 °C	Same

Differences between Sysmex CS-5100 and Sysmex CA-1500
Analyzer Component	Proposed Device
Sysmex® CS-5100	Predicate Device
Sysmex® CA-1500
Operating Principle	Clotting:
Transmitted Light Detection
(Absorbance) at 340, 405, 575, 660 or
800 nm. Wavelengths 340, 405 and
575 are technically available but not
validated in combination with the
intended applications.	Scattered Light Detection at 660
nm
	Chromogenic:
Transmitted Light Detection
(Absorbance) at 340, 405, 575, 660,
800 nm. Wavelengths 340, 575, 660,
and 800 are technically available but not
validated in combination with the
intended applications.	Transmitted Light Detection
(Absorbance) at 405, 575, 800 nm
	Immunochemical:
Transmitted Light Detection
(Absorbance) at 340, 405, 575, 660 or
800 nm. Wavelengths 340, 405, 575,
and 800 are technically available but not
validated in combination with the
intended applications.	Transmitted Light Detection
(Absorbance) at 405, 575, or 800
nm
	Light Source
Clotting	Halogen Lamp
Cap Piercing	Cap Piercer only	Both Cap Piercer model and Non-
Cap Piercer models are available
Temperature Control	Detector: 37 ± 0.5 °C
Reagent probe: 37.5 ± 0.5 °C	Detector: 37 ± 1.0 °C Reagent
probe: 37 ± 1.0 °C
Reagent Cooling	10 ± 2 °C, when ambient
temperature is 20 – 28 °C.
During operation 4 – 15 °C, when
ambient temperature is 15 - 30 °C	15 ± 2 °C, when ambient
temperature is 15 - 30
°C
Pipetting Capabilities	Reagent probe:
20 – 200 μL	Reagent probe:
4 – 200 μL
	Sample probe:
4 - 270 μL	Sample probe:
5 - 450 μL
Differences between Sysmex CS-5100 and Sysmex CA-1500
Analyzer Component	Proposed Device
Sysmex® CS-5100	Predicate Device
Sysmex® CA-1500
Clinical Reportable Range	LA2 with LA 2 Confirmation
Reagent: 32.2 – 80.0 sec.;
LA Ratio with LA 1 / LA 2 reagent :
0.71 – 2.60 ratio	LA2 with LA 2 Confirmation
Reagent: 32.2 – 111.2 sec.;
LA Ratio with LA 1 / LA 2
reagent : 0.71 – 2.98 ratio
Sample Volumes (Plasma)	Antithrombin with
INNOVANCE® Antithrombin
(14 μL)
D-dimer with INNOVANCE®
D-Dimer (15 μL)	Antithrombin with
INNOVANCE®
Antithrombin (10 μL)
D-dimer with
INNOVANCE® D-Dimer (13 μL)
Probes	2 Sample probes;
3 Reagent probes	1 Sample probe;
1 Reagent probe

Differences between Sysmex CS-5100 and CA-1500 6.

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

7 Performance Data

The following performance data were provided in support of the substantial equivalence determination.

7.1 Method comparison

Method comparison studies designed according to EP09-A3 CLSI Guideline 'Measurement Procedure Comparison and Bias Estimation Using Patient Samples' were conducted at four external sites; 3 in the United States and one in Germany, all sites using the same protocol.

Samples were measured on both the predicate device (Sysmex® CA-1500) as well as the new device (Sysmex® CS-5100), in random order to eliminate any inherent bias. Results were compared by Passing-Bablok regression analysis as well as Bland-Altman plots. Results from each application met the predetermined acceptance criteria. The following summary of Passing-Bablok regression shows that the proposed and predicate devices provide equivalent results when used in a clinical setting.

Sysmex® CS-5100: Method Comparison Summary Table, Passing-Bablok regression
Application	1st Site	2nd Site	3rd Site	4th Site	Sites
Combined
Factor V
Leiden with
Factor V
Leiden Assay
(Ratio)	N = 87
y = 0.965 x +
0.137
r = 0.991
(r2 = 0.983)	N = 173
y = 0.958 x +
0.052
r = 0.996
(r2 = 0.991)	N = 84
y = 1.039 x +
0.040
r = 0.979
(r2 = 0.959)	N = 151
y = 1.010 x +
0.005
r = 0.946
(r2 = 0.895)	N = 495
y = 0.976 x +
0.058
r = 0.983
(r2 = 0.967)
Coagulation
Factor VIII
with Dade®
Actin® FSL
(% of norm)	N = 83
y = 1.128 x -
7.297
r = 0.954
(r2 = 0.910)	N = 155
y = 1.010 x -
1.157
r = 0.992
(r2 = 0.985)	N = 72
y = 1.010 x +
3.199
r = 0.951
(r2 = 0.904)	N = 122
y = 1.046 x -
1.651
r = 0.920
(r2 = 0.847)	N = 432
y = 1.054 x -
2.558
r = 0.966
(r2 = 0.933)
Coagulation
Factor IX with
Dade® Actin®
FSL
(% of norm)	N = 87
y = 1.021 x -
1.607
r = 0.982
(r2 = 0.964)	N = 146
y = 1.011 x -
0.763
r = 0.991
(r2 = 0.982)	N = 73
y = 0.999 x +
1.627
r = 0.972
(r2 = 0.944)	N = 169
y = 1.003 x -
1.474
r = 0.985
(r2 = 0.971)	N = 475
y = 1.014 x -
1.227
r = 0.985
(r2 = 0.970)
Lupus
Anticoagulant
with LA 1
Screening
Reagent
(seconds)	N = 4
y = n/a
r = n/a
(r2 = n/a)	N = 112
y = 0.941 x +
3.738
r = 0.997
(r2 = 0.993)	N = 88
y = 0.965 x +
0.470
r = 0.993
(r2 = 0.986)	N = 165
y = 0.902 x +
3.043
r = 0.994
(r2 = 0.987)	N = 369
y = 0.952 x +
1.523
r = 0.993
(r2 = 0.986)

Sysmex® CS-5100: Method Comparison Summary Table, Passing-Bablok regression
Application	1st Site	2nd Site	3rd Site	4th Site	Sites
Combined
Lupus
Anticoagulant
with LA 2
Confirmation
Reagent
(seconds)	N = 17
y = n/a
r = n/a
(r2 = n/a)	N = 118
y = 0.972 x +
2.254
r = 0.996
(r2 = 0.992)	N = 79
y = 0.938 x +
2.369
r = 0.997
(r2 = 0.994)	N = 139
y = 0.928 x +
1.999
r = 0.989
(r2 = 0.979)	N = 353
y = 0.964 x +
1.219
r = 0.989
(r2 = 0.978)
Lupus
Anticoagulant
with LA1/ LA2
Ratio
(Ratio)	N = 4
y = n/a
r = n/a
(r2 = n/a)	N = 106
y = 0.933 x +
0.071
r = 0.990
(r2 = 0.979)	N = 71
y = 0.992 x -
0.012
r = 0.988
(r2 = 0.976)	N = 125
y = 0.917 x +
0.078
r = 0.992
(r2 = 0.984)	N = 306
y = 0.942 x +
0.054
r = 0.990
(r2 = 0.980)

7.2 Reproducibility Studies

Twenty-day precision studies were performed at one external site in Germany and two external sites in the United States. Testing followed the scheme of two runs per day, with two replicates per run, at each of the three sites according to CLSI EP05-A2 'Evaluation of Precision Performance of Quantitative Measurement Methods'. The order of the analysis of parameter, samples and quality control samples for each run and day varied to avoid an inherent bias to the study. One calibration curve of each calibrated application was used in the study. Within Run, Between Run, Between Day, and Total (within site) were calculated. The data for Within Run and Total (within site) is summarized in the following tables.

Sysmex® CS-5100: Reproducibility Summary Table, Within Run
Application	1st Site
Within Run
(%CV)	2nd Site
Within Run
(%CV)	3rd Site
Within Run
(%CV)	Sites Combined
(%CV)
Factor V Leiden with Factor V
Leiden Assay	0.82 - 4.82	0.70 - 1.39	0.58 – 1.98	0.82 - 3.08
Coagulation Factor VIII with
Dade® Actin® FSL	2.29 - 3.95	1.94 - 4.20	2.04 - 5.25	2.15 - 4.46
Coagulation Factor IX with
Dade® Actin® FSL	1.79 – 4.70	2.01 - 4.11	2.26 - 4.63	2.12 - 4.49
Lupus Anticoagulant with LA 1
Screening Reagent (seconds)	0.58 - 3.29	0.51 - 2.52	0.51 - 2.33	0.60 - 2.75
Lupus Anticoagulant with LA 2
Confirmation Reagent
(seconds)	0.55 - 2.58	0.26 - 1.36	0.32 - 1.52	0.27 - 1.18
Lupus Anticoagulant with LA1/
LA2 Ratio
(Ratio)	0.51 - 1.38	0.61 – 1.04	0.58 – 1.47	0.59 - 1.14

| Sysmex® CS-5100: Reproducibility Summary Table, Total CV

(Within Site and Sites Combined)
Application	1st Site
Total CV
Within Site
(%CV)	2nd Site
Total CV
Within Site
(%CV)	3rd Site
Total CV
Within Site
(%CV)	Total CV
Sites Combined
(%CV)
Factor V Leiden with Factor V
Leiden Assay	1.10 - 5.25	1.00 - 3.96	0.90 - 2.62	2.15 - 5.91
Coagulation Factor VIII with
Dade® Actin® FSL	4.45 - 6.30	2.88 - 4.80	3.78 - 6.09	4.02 - 7.12
Coagulation Factor IX with
Dade® Actin® FSL	4.58 - 9.13	2.25 - 5.12	3.96 - 6.71	4.34 - 7.26
Lupus Anticoagulant with LA 1
Screening Reagent (seconds)	0.80 - 3.90	1.09 - 2.83	1.39 - 3.29	1.38 - 3.34
Lupus Anticoagulant with LA 2
Confirmation Reagent
(seconds)	0.41 - 1.42	0.55 - 1.54	0.51 - 1.45	0.90 - 1.91
Lupus Anticoagulant with LA1/
LA2 Ratio
(Ratio)	0.93 - 2.26	0.96 - 3.45	0.96 - 2.78	1.16 - 3.45

7.3 Detection Capability Results

Detection capability studies were measured for the calibrated assays on the Sysmex® CS-5100: Coagulation Factor VIII with Dade® Actin® FSL and Coagulation Factor IX with Dade® Actin® FSL. Studies were conducted following the CLSI document EP17-A2 'Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures'. Data for all tested reagents met the predetermined acceptance criteria and support the lower limit of the clinically reportable range claim.

Sysmex® CS-5100: Summary of Limit of Quantitation Studies
Application	Lower Limit of
Clinically
Reportable
Range
(% of norm)	Measured Limit
of Quantitation
based on
predicate device
(% of norm)	Maximum Total
Error
(% of norm)
Coagulation Factor VIII with
Dade® Actin® FSL	3.0	2.52	0.50
Coagulation Factor IX with
Dade® Actin® FSL	3.0	2.76	1.07

7.4 Linearity & Measuring Range

Linearity studies were performed for the calibrated assays on the Sysmex® CS-5100: Coagulation Factor VIII with Dade® Actin® FSL and Coagulation Factor IX with Dade® Actin® FSL. All reagents met the predetermined acceptance criteria and support the clinically reportable range claim. Studies were conducted as described in CLSI EP6-A 'Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach'.

Sysmex® CS-5100: Linearity and Measuring Range Summary
Application	Measured Linear Range
(% of Norm)	Clinically Reportable Range
(% of Norm)
Coagulation Factor VIII with
Dade® Actin® FSL	2.12 – 246.41	3.0 – 182.0
Coagulation Factor IX with
Dade® Actin® FSL	2.38 – 193.79	3.0 – 145.5

7.5 Reference Interval

Reference interval studies were conducted at three clinical study sites in the United States following the guidance of CLSI document EP28-A3c 'Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory'. The summary is provided below. The study population did not include neonate and pediatric sample populations.

Application	N	Sysmex® CS-5100 Reference Interval
Factor V Leiden with Factor V Leiden
Assay	193	1.47 Ratio (2.5th Percentile)
Coagulation Factor VIII with Dade®
Actin® FSL	190	82.0% of norm (2.5th Percentile)
Coagulation Factor IX with Dade®
Actin® FSL	188	81.4% of norm (2.5th Percentile)
Lupus Anticoagulant with LA 1
Screening Reagent (fresh samples)	185	32.2 seconds (2.5th Percentile)
Lupus Anticoagulant with LA 1
Screening Reagent (frozen samples)	191	32.8 seconds (2.5th Percentile)
Lupus Anticoagulant with LA 2
Confirmation Reagent (fresh samples)	185	34.7 seconds (2.5th Percentile)
Lupus Anticoagulant with LA 2
Confirmation Reagent (frozen samples)	191	35.7 seconds (2.5th Percentile)
Lupus Anticoagulant with LA1/ LA2
Ratio (fresh samples)	184	0.89Ratio (2.5th Percentile)
Lupus Anticoagulant with LA1/ LA2
Ratio (frozen samples)	191	0.91 Ratio (2.5th Percentile)

7.6 Factor V Leiden Cut-off Study

A cut-off of 1.8 (ratio) was validated on the CS-5100 instrument in a performance evaluation study. Citrated plasma samples from patients submitted for thrombophilia screening were collected by three different clinical sites (one site in the US and two sites in Germany). The samples were frozen and measured with the FV Leiden assay on the CS-5100 instrument. The FV Leiden assay results were classified using the cut-off of 1.8: a ratio ≤1.8 is suggestive for FV Leiden variant (single point mutation G1691A) and a ratio >1.8 is considered as negative for the FV Leiden variant. The FV Leiden assay results were subsequently compared to the Factor V Leiden genotype to calculate the positive and negative percentage agreement. In total, n=381 patients of which n=127 patients came from the US were included. The results are shown in the tables below.

All sites combined (US and OUS)		Reference (Factor V Leiden PCR method)
		Negative	Positive	Total
Factor V Leiden assay
on Sysmex® CS-5100
System	Negative	161	0	161
	Positive	0	220	220
	Total	161	220	381
Sensitivity =	100.0%	95.0% Confidence Interval = 98.3 – 100.0%
Specificity =	100.0%	95.0% Confidence Interval = 97.7 – 100.0%

8 Conclusion

The predicate device was cleared based in part on the results of clinical studies; therefore clinical testing was required to support substantial equivalence.

The non-clinical and clinical data support the safety of the device.

The clinical data demonstrate that the Sysmex® CS-5100 performs comparably to the predicate device that is currently marketed for the same intended use.

The data submitted for this premarket notification demonstrates that the device raises no new concerns as to safety and effectiveness when compared to the predicate device, and is substantially equivalent to the predicate device.