(90 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Sysmex® Automated Blood Coagulation Analyzer CS-5100, based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness from scratch. Therefore, the "acceptance criteria" discussed are primarily related to showing that the new device performs comparably to the predicate for specific applications, and "ground truth" is often established by comparing to the predicate device's results.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria values in the format of a table as it pertains to specific numerical thresholds for accuracy, sensitivity, or specificity. Instead, the acceptance criteria for most studies (Method Comparison, Reproducibility, Detection Capability, Linearity) are generally described as "met the predetermined acceptance criteria." However, for the Factor V Leiden Cut-off Study, specific performance metrics (Sensitivity and Specificity) are provided and imply acceptance criteria. For the Method Comparison, the implicit acceptance criterion is that the results demonstrate equivalence to the predicate device, as confirmed by Passing-Bablok regression and Bland-Altman plots.
Here's an attempt to extract and summarize:
| Study/Application | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Method Comparison (all applications listed) | Results between proposed and predicate devices demonstrate equivalence through Passing-Bablok regression and Bland-Altman plots. | Passing-Bablok: Slope near 1, Intercept near 0 (e.g., Factor V Leiden: y = 0.976x + 0.058, r=0.983) |
| Reproducibility (all applications listed) | Met predetermined acceptance criteria for Within Run and Total %CV. | Example: Factor V Leiden Within Run %CV: 0.70 - 4.82 (Site-specific ranges); Total %CV: 0.90 - 5.25 (Site-specific ranges) |
| Detection Capability | Data met predetermined acceptance criteria supporting lower limit of clinically reportable range. | For Coagulation Factor VIII: Measured Limit of Quantitation 2.52% of norm (Clinical Reportable Range 3.0% of norm) |
| Linearity & Measuring Range | All reagents met predetermined acceptance criteria supporting clinically reportable range. | For Coagulation Factor VIII: Measured Linear Range 2.12 – 246.41% (Clinical Reportable Range 3.0 – 182.0%) |
| Factor V Leiden Cut-off Study | High sensitivity and specificity (implied 95% CI covering satisfactory performance). | Sensitivity = 100.0% (95.0% CI = 98.3 – 100.0%); Specificity = 100.0% (95.0% CI = 97.7 – 100.0%) |
2. Sample Size and Data Provenance for Test Set
- Method Comparison:
- Sample Sizes:
- Factor V Leiden: N = 495 (combined from 4 sites)
- Coagulation Factor VIII: N = 432 (combined from 4 sites)
- Coagulation Factor IX: N = 475 (combined from 4 sites)
- LA 1 Screening Reagent: N = 369 (combined from 3 sites, 1 site had N=4)
- LA 2 Confirmation Reagent: N = 353 (combined from 3 sites, 1 site had N=17)
- LA Ratio: N = 306 (combined from 3 sites, 1 site had N=4)
- Data Provenance: 4 external sites, 3 in the United States and 1 in Germany. Retrospective or prospective is not explicitly stated for individual samples, but the comparison uses "patient samples" and "were measured on both the predicate device... as well as the new device."
- Sample Sizes:
- Reproducibility Studies:
- Sample Sizes: Not explicitly stated as number of patient samples, but testing used 2 runs per day, 2 replicates per run, over 20 days. These studies typically use control materials at various levels rather than a large set of unique patient samples for performance assessment.
- Data Provenance: 1 external site in Germany, 2 external sites in the United States.
- Detection Capability Studies:
- Sample Sizes: Not specified beyond stating "calibrated assays."
- Data Provenance: Not specified beyond referring to the method.
- Linearity & Measuring Range:
- Sample Sizes: Not specified beyond stating "calibrated assays."
- Data Provenance: Not specified beyond referring to the method.
- Reference Interval Studies:
- Sample Sizes:
- Factor V Leiden: N = 193
- Coagulation Factor VIII: N = 190
- Coagulation Factor IX: N = 188
- LA 1 Screening Reagent (fresh): N = 185
- LA 1 Screening Reagent (frozen): N = 191
- LA 2 Confirmation Reagent (fresh): N = 185
- LA 2 Confirmation Reagent (frozen): N = 191
- LA1/LA2 Ratio (fresh): N = 184
- LA1/LA2 Ratio (frozen): N = 191
- Data Provenance: 3 clinical study sites in the United States.
- Sample Sizes:
- Factor V Leiden Cut-off Study:
- Sample Size: N = 381 (of which N = 127 from the US)
- Data Provenance: 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.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of "experts" in the traditional sense of clinicians or radiologists establishing ground truth. For coagulation analyzers, the "ground truth" is typically established by comparing the new device's measurements to a reference method or a predicate device's measurements that are already accepted as accurate and reliable.
- In the Method Comparison study, the predicate device (Sysmex® CA-1500) serves as the reference for comparison, meaning its results are the "ground truth" against which the new device's results are measured for equivalence.
- In the Factor V Leiden Cut-off Study, the "ground truth" for confirming the presence of the Factor V Leiden variant was established by the Factor V Leiden genotype (PCR method). The number of experts involved in performing or interpreting these PCR tests is not specified, but they would typically be laboratory professionals trained in molecular diagnostics.
4. Adjudication Method for the Test Set
No explicit adjudication method (like "2+1" or "3+1") is described, as the studies are primarily quantitative comparisons against established methods or predicate device results, rather than subjective interpretations requiring adjudication by multiple readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This type of study (comparing human reader performance with and without AI assistance) is typically relevant for interpretative diagnostic devices, such as imaging systems, where human experts make diagnoses. The Sysmex® CS-5100 is an automated blood coagulation analyzer that provides quantitative measurements, not interpretations, so an MRMC study is not applicable here.
6. Standalone Performance Study (Algorithm Only)
Yes, standalone performance studies were done. All the studies described (Method Comparison, Reproducibility, Detection Capability, Linearity, Reference Interval, Factor V Leiden Cut-off Study) assess the performance of the Sysmex® CS-5100 device itself, functioning independently, without human-in-the-loop interpretation or intervention in the measurement process. The device outputs quantitative results, and these studies evaluate the accuracy, precision, and clinical relevance of those outputs.
7. Type of Ground Truth Used
- Method Comparison: Comparison against the results obtained from the predicate device (Sysmex® CA-1500), which is itself a legally marketed device with established performance.
- Factor V Leiden Cut-off Study: Factor V Leiden genotype (PCR method). This is a definitive molecular pathology test.
- Detection Capability, Linearity, Reference Interval studies: These generally establish the device's inherent analytical characteristics against internal standards or established statistical methodologies (CLSI guidelines), rather than using an external "ground truth" from experts or a pathology panel in the same way an interpretative diagnostic device might.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning. The Sysmex® CS-5100 is a an automated laboratory instrument for performing coagulation tests, not a software algorithm that undergoes a training phase with a distinct dataset. The performance data presented are for validation/testing of the device's operational capabilities across predefined assays using various samples.
9. How Ground Truth for the Training Set Was Established
Since a "training set" in the machine learning sense is not applicable or explicitly mentioned for this device, a method for establishing its ground truth is also not provided. The development and calibration of such instruments typically involve rigorous analytical methods and the use of certified reference materials and control samples, rather than a "ground truth" established from a large dataset for algorithm training.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
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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
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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)
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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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
3
| Name of Device: | Sysmex® Automated Blood Coagulation AnalyzerCS-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 |
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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 | |||||
|---|---|---|---|---|---|
| ApplicationIntended Use | 510(k) Numberrelated toapplication onpredicate device | RegulationNumber | RegulatoryClass | ProductCode | Panel |
| Factor V Leiden AssayThe Siemens HealthcareDiagnostics Factor V LeidenAssay is a simple functionalclotting test system intended forscreening of resistance toActivated Protein C (APC) inplasma from individuals withthe Factor V (Leiden) defect.For in vitro diagnostic use. | K992456 | 864.7925 | Class II | GGW | Hematology |
| Coagulation Factor VIIIDeficient PlasmaIn vitro diagnostic reagents forthe determination of the activityof coagulation factors VIII, IX,XI and XII in human plasma bycoagulometric methods. | K924396 | 864.7290 | Class II | GJT | Hematology |
| Coagulation Factor IXDeficient PlasmaIn vitro diagnostic reagents forthe determination of the activityof coagulation factors VIII, IX,XI and XII in human plasma bycoagulometric methods. | K924396 | 864.7290 | Class II | GJT | Hematology |
| LA 1 Screening Reagent,LA 2 ConfirmationReagent, and LA RatioLA 1 Screening Reagent and LA2 Confirmation Reagent aresimplified DRVVT reagents fordetection of LupusAnticoagulants (LA) in one-stage clotting tests. LA 1Screening Reagent: SimplifiedDRVV reagent to screen for thepresence of LupusAnticoagulants. LA 2Confirmation Reagent:Phospholipid-rich DRVVreagent for the specificcorrection of LupusAnticoagulants. | K993299 | 864.8950 | Class I | GIR | Hematology |
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4 Device Description / Test Principle
The Sysmex® CS-5100 is an automated blood coagulation instrument which can analyze samples using clotting, chromogenic and immunoassay methods. Analysis results are displayed on the Information Processing Unit (IPU) screen. They can be printed on external printers or transmitted to a host computer. Sold separately from the instrument are the associated
- Reagents
- Controls
- Calibrators ●
- . Consumable materials
The subject of this 510(k) notification are reagent applications which perform the coagulation tests 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 withFactor V Leiden Assay | Clotting(extrinsic pathway);Calculated |
| Coagulation Factor VIIIDeficient Plasma | Coagulation Factor VIIIwith Dade® Actin FSL® | Clotting(intrinsic pathway) |
| Coagulation Factor IXDeficient Plasma | Coagulation Factor IXwith Dade® Actin FSL® | Clotting(intrinsic pathway) |
| LA 1 Screening Reagent | Lupus Anticoagulant withLA 1 Screening Reagent | Clotting |
| LA 2 ConfirmationReagent | Lupus Anticoagulant withLA 2 ConfirmationReagent | Clotting |
| LA 1 Screening Reagentand LA 2 ConfirmationReagent | LA Ratio with LA 1Screening Reagent and LA2 Confirmation Reagent | Clotting;Calculated |
Table of Sysmex® CS-5100 Analysis Principles
The intended Environment of Use is a clinical central/hospital laboratory.
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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.
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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.
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(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 DeviceSysmex® CS-5100 | Predicate DeviceSysmex® CA-1500 |
| Regulatory Classification | JPA, Class 2System, Multipurpose for invitro coagulation studies | Same |
| Intended Use | The Sysmex® CS-5100 is a fullyautomated blood coagulation analyzerintended for in vitro diagnostic use usingplasma collected from venous bloodsamples in 3.2% sodium citrate tubes toanalyze clotting, chromogenic andimmunoassay methods in the clinicallaboratory.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 notbeen established in neonate and pediatricpatient populations. | The intended use of the Sysmex®CA-1500 is as a fully automated,computerized blood plasmacoagulation analyzer for in vitrodiagnostic use in clinicallaboratories.The instrument uses citratedhuman plasma to perform thefollowing parameters andcalculated parameters:Clotting Analysis Parameters:Prothrombin Time (PT); ActivatedPartial Thromboplastin Time(APTT); Fibrinogen (Clauss);Batroxobin Time; Extrinsic Factors(II, V, VII, X); Intrinsic Factors(VIII, IX, XI, XII); Protein C.Chromogenic AnalysisParameters: Antithrombin III;Factor VIII; Plasminogen;Heparin; Protein C; α2-Antiplasmin.Immunologic Analysis Parameters:D-dimer.Calculated Parameters: PT Ratio;PT INR; PT %; DerivedFibrinogen; Factor Assays %Activity. |
| Similarities between Sysmex CS-5100 and Sysmex CA-1500 | ||
| Analyzer Component | Proposed DeviceSysmex® CS-5100 | Predicate DeviceSysmex® CA-1500 |
| Sample Type | Human plasma3.2% sodium citrate | Same |
| Application type | Clotting Applications:Prothrombin Time (PT) withDade® Innovin®;Activated Partial ThromboplastinTime (APTT) withDade® Actin® FSL;Fibrinogen (Clauss) withDade® Thrombin Reagent;Coagulation Factor V withDade® Innovin®Coagulation Factor VII withDade® Innovin®Coagulation Factor VIII with Dade®Actin® FSLCoagulation Factor IX with Dade®Actin® FSLLupus Anticoagulant with LA 1Screening and LA 2 ConfirmationReagentsFactor V Leiden with Factor V LeidenAssayProtein C with Protein C Reagent | Same |
| Chromogenic Application:Antithrombin withINNOVANCE® Antithrombin;Protein C withBerichrom® Protein C | Same | |
| Immuno-Chemical Application:D-dimer withINNOVANCE® D-Dimer | Same | |
| Calculated Application:PT INR with Dade® Innovin® | Same | |
| Similarities between Sysmex CS-5100 and Sysmex CA-1500 | ||
| Analyzer Component | Proposed DeviceSysmex® CS-5100 | Predicate DeviceSysmex® 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 LeidenAssay: 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
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| Similarities between Sysmex CS-5100 and Sysmex CA-1500 | ||
|---|---|---|
| Analyzer Component | Proposed DeviceSysmex® CS-5100 | Predicate DeviceSysmex® 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 DeviceSysmex® CS-5100 | Predicate DeviceSysmex® CA-1500 |
| Sample Volumes in MicroMode(Plasma) | PT with Dade® Innovin® (50 μL)APTT with Dade® Actin® FSL (50 μL)Fibrinogen with Dade® ThrombinReagent (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 LA1Screening Reagent (100 μL)Lupus Anticoagulant with LA2Confirmation Reagent (100 μL)Factor V Leiden with Factor VLeiden Assay (50 μL) | Same |
| Rinse & Buffer Solutions | ||
| On-board | CA-CLEAN I CA-CLEAN IIDade® 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 DeviceSysmex® CS-5100 | Predicate DeviceSysmex® CA-1500 |
| Wavelengths used inAnalysis | 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 LA1Screening Reagent(Default = 660 nm; Sub-wavelength=none)Lupus Anticoagulant with LA2Confirmation Reagent(Default = 660 nm; Sub-wavelength=none)Factor V Leiden with Factor V LeidenAssay (Default = 660 nm; Sub-wavelength=none) | Same |
| Temperature Control | Sample incubation well:37 °C ± 1.0 °C | Same |
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| Differences between Sysmex CS-5100 and Sysmex CA-1500 | ||
|---|---|---|
| Analyzer Component | Proposed DeviceSysmex® CS-5100 | Predicate DeviceSysmex® CA-1500 |
| Operating Principle | Clotting:Transmitted Light Detection(Absorbance) at 340, 405, 575, 660 or800 nm. Wavelengths 340, 405 and575 are technically available but notvalidated in combination with theintended applications. | Scattered Light Detection at 660nm |
| Chromogenic:Transmitted Light Detection(Absorbance) at 340, 405, 575, 660,800 nm. Wavelengths 340, 575, 660,and 800 are technically available but notvalidated in combination with theintended applications. | Transmitted Light Detection(Absorbance) at 405, 575, 800 nm | |
| Immunochemical:Transmitted Light Detection(Absorbance) at 340, 405, 575, 660 or800 nm. Wavelengths 340, 405, 575,and 800 are technically available but notvalidated in combination with theintended applications. | Transmitted Light Detection(Absorbance) at 405, 575, or 800nm | |
| Light SourceClotting | Halogen Lamp | |
| Cap Piercing | Cap Piercer only | Both Cap Piercer model and Non-Cap Piercer models are available |
| Temperature Control | Detector: 37 ± 0.5 °CReagent probe: 37.5 ± 0.5 °C | Detector: 37 ± 1.0 °C Reagentprobe: 37 ± 1.0 °C |
| Reagent Cooling | 10 ± 2 °C, when ambienttemperature is 20 – 28 °C.During operation 4 – 15 °C, whenambient temperature is 15 - 30 °C | 15 ± 2 °C, when ambienttemperature 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 DeviceSysmex® CS-5100 | Predicate DeviceSysmex® CA-1500 |
| Clinical Reportable Range | LA2 with LA 2 ConfirmationReagent: 32.2 – 80.0 sec.;LA Ratio with LA 1 / LA 2 reagent :0.71 – 2.60 ratio | LA2 with LA 2 ConfirmationReagent: 32.2 – 111.2 sec.;LA Ratio with LA 1 / LA 2reagent : 0.71 – 2.98 ratio |
| Sample Volumes (Plasma) | Antithrombin withINNOVANCE® Antithrombin(14 μL)D-dimer with INNOVANCE®D-Dimer (15 μL) | Antithrombin withINNOVANCE®Antithrombin (10 μL)D-dimer withINNOVANCE® 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.
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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
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 | SitesCombined |
| Factor VLeiden withFactor VLeiden Assay(Ratio) | N = 87y = 0.965 x +0.137r = 0.991(r2 = 0.983) | N = 173y = 0.958 x +0.052r = 0.996(r2 = 0.991) | N = 84y = 1.039 x +0.040r = 0.979(r2 = 0.959) | N = 151y = 1.010 x +0.005r = 0.946(r2 = 0.895) | N = 495y = 0.976 x +0.058r = 0.983(r2 = 0.967) |
| CoagulationFactor VIIIwith Dade®Actin® FSL(% of norm) | N = 83y = 1.128 x -7.297r = 0.954(r2 = 0.910) | N = 155y = 1.010 x -1.157r = 0.992(r2 = 0.985) | N = 72y = 1.010 x +3.199r = 0.951(r2 = 0.904) | N = 122y = 1.046 x -1.651r = 0.920(r2 = 0.847) | N = 432y = 1.054 x -2.558r = 0.966(r2 = 0.933) |
| CoagulationFactor IX withDade® Actin®FSL(% of norm) | N = 87y = 1.021 x -1.607r = 0.982(r2 = 0.964) | N = 146y = 1.011 x -0.763r = 0.991(r2 = 0.982) | N = 73y = 0.999 x +1.627r = 0.972(r2 = 0.944) | N = 169y = 1.003 x -1.474r = 0.985(r2 = 0.971) | N = 475y = 1.014 x -1.227r = 0.985(r2 = 0.970) |
| LupusAnticoagulantwith LA 1ScreeningReagent(seconds) | N = 4y = n/ar = n/a(r2 = n/a) | N = 112y = 0.941 x +3.738r = 0.997(r2 = 0.993) | N = 88y = 0.965 x +0.470r = 0.993(r2 = 0.986) | N = 165y = 0.902 x +3.043r = 0.994(r2 = 0.987) | N = 369y = 0.952 x +1.523r = 0.993(r2 = 0.986) |
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| Sysmex® CS-5100: Method Comparison Summary Table, Passing-Bablok regression | |||||
|---|---|---|---|---|---|
| Application | 1st Site | 2nd Site | 3rd Site | 4th Site | SitesCombined |
| LupusAnticoagulantwith LA 2ConfirmationReagent(seconds) | N = 17y = n/ar = n/a(r2 = n/a) | N = 118y = 0.972 x +2.254r = 0.996(r2 = 0.992) | N = 79y = 0.938 x +2.369r = 0.997(r2 = 0.994) | N = 139y = 0.928 x +1.999r = 0.989(r2 = 0.979) | N = 353y = 0.964 x +1.219r = 0.989(r2 = 0.978) |
| LupusAnticoagulantwith LA1/ LA2Ratio(Ratio) | N = 4y = n/ar = n/a(r2 = n/a) | N = 106y = 0.933 x +0.071r = 0.990(r2 = 0.979) | N = 71y = 0.992 x -0.012r = 0.988(r2 = 0.976) | N = 125y = 0.917 x +0.078r = 0.992(r2 = 0.984) | N = 306y = 0.942 x +0.054r = 0.990(r2 = 0.980) |
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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 SiteWithin Run(%CV) | 2nd SiteWithin Run(%CV) | 3rd SiteWithin Run(%CV) | Sites Combined(%CV) |
| Factor V Leiden with Factor VLeiden Assay | 0.82 - 4.82 | 0.70 - 1.39 | 0.58 – 1.98 | 0.82 - 3.08 |
| Coagulation Factor VIII withDade® Actin® FSL | 2.29 - 3.95 | 1.94 - 4.20 | 2.04 - 5.25 | 2.15 - 4.46 |
| Coagulation Factor IX withDade® Actin® FSL | 1.79 – 4.70 | 2.01 - 4.11 | 2.26 - 4.63 | 2.12 - 4.49 |
| Lupus Anticoagulant with LA 1Screening Reagent (seconds) | 0.58 - 3.29 | 0.51 - 2.52 | 0.51 - 2.33 | 0.60 - 2.75 |
| Lupus Anticoagulant with LA 2Confirmation 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 |
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| Sysmex® CS-5100: Reproducibility Summary Table, Total CV(Within Site and Sites Combined) | ||||
|---|---|---|---|---|
| Application | 1st SiteTotal CVWithin Site(%CV) | 2nd SiteTotal CVWithin Site(%CV) | 3rd SiteTotal CVWithin Site(%CV) | Total CVSites Combined(%CV) |
| Factor V Leiden with Factor VLeiden Assay | 1.10 - 5.25 | 1.00 - 3.96 | 0.90 - 2.62 | 2.15 - 5.91 |
| Coagulation Factor VIII withDade® Actin® FSL | 4.45 - 6.30 | 2.88 - 4.80 | 3.78 - 6.09 | 4.02 - 7.12 |
| Coagulation Factor IX withDade® Actin® FSL | 4.58 - 9.13 | 2.25 - 5.12 | 3.96 - 6.71 | 4.34 - 7.26 |
| Lupus Anticoagulant with LA 1Screening Reagent (seconds) | 0.80 - 3.90 | 1.09 - 2.83 | 1.39 - 3.29 | 1.38 - 3.34 |
| Lupus Anticoagulant with LA 2Confirmation 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 |
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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 ofClinicallyReportableRange(% of norm) | Measured Limitof Quantitationbased onpredicate device(% of norm) | Maximum TotalError(% of norm) | |
| Coagulation Factor VIII withDade® Actin® FSL | 3.0 | 2.52 | 0.50 | |
| Coagulation Factor IX withDade® 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 withDade® Actin® FSL | 2.12 – 246.41 | 3.0 – 182.0 |
| Coagulation Factor IX withDade® Actin® FSL | 2.38 – 193.79 | 3.0 – 145.5 |
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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 LeidenAssay | 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 1Screening Reagent (fresh samples) | 185 | 32.2 seconds (2.5th Percentile) |
| Lupus Anticoagulant with LA 1Screening Reagent (frozen samples) | 191 | 32.8 seconds (2.5th Percentile) |
| Lupus Anticoagulant with LA 2Confirmation Reagent (fresh samples) | 185 | 34.7 seconds (2.5th Percentile) |
| Lupus Anticoagulant with LA 2Confirmation Reagent (frozen samples) | 191 | 35.7 seconds (2.5th Percentile) |
| Lupus Anticoagulant with LA1/ LA2Ratio (fresh samples) | 184 | 0.89Ratio (2.5th Percentile) |
| Lupus Anticoagulant with LA1/ LA2Ratio (frozen samples) | 191 | 0.91 Ratio (2.5th Percentile) |
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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 assayon Sysmex® CS-5100System | 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.
§ 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.