(114 days)
No reference devices were used in this submission.
No
The document describes a standard automated blood coagulation analyzer and its performance characteristics based on a fixed cut-off value, with no mention of AI or ML algorithms for analysis or interpretation.
No.
This device is an in vitro diagnostic (IVD) blood coagulation analyzer, meaning it analyzes samples taken from the body to provide diagnostic information, rather than directly treating or preventing a disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "is a fully automated blood coagulation analyzer intended for in vitro diagnostic use." It also lists various analyses it performs for diagnostic purposes, such as Prothrombin Time (PT) and D-dimer, which are used to aid in the diagnosis or exclusion of conditions like Deep Vein Thrombosis (DVT).
No
The device description explicitly states it is an "automated blood coagulation instrument" and mentions hardware components like the "Information Processing Unit (IPU) screen" and the ability to print on "external printers". It also lists associated hardware components like reagents, controls, calibrators, and consumable materials, which are sold separately but are integral to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Sysmex® CS-5100 is a fully automated blood coagulation analyzer intended for in vitro diagnostic use..."
This statement clearly identifies the device as being used outside of the body to examine specimens for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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
- Antithrombin (AT) with INNOVANCE® Antithrombin
- D-dimer with INNOVANCE® D-Dimer.
The performance of this device has not been established in neonate and pediatic patient populations.
Product codes
JPA
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
- Consumable materials
The subject of this 510(k) notification is to expand the use of the INNOVANCE® D-Dimer for the exclusion of Deep Vein Thrombosis on Sysmex CS-5100. All other established indications, performance and technology characteristics as cleared under K150678 remain unchanged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The performance of this device has not been established in neonate and pediatric patient populations.
Intended User / Care Setting
in the clinical laboratory.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The INNOVANCE® D-Dimer assay was evaluated on the Sysmex® CS-5100 System in a multicenter study to validate the exclusion of a first event of Deep Vein Thrombosis (DVT) using frozen specimens collected prospectively from 1907 consecutive outpatients presenting to the emergency or ambulatory department with suspected DVT. Of these 1907 patients, 368 were excluded from analysis (including 213 patients reported to have a previously documented or chronic DVT) resulting in a total of 1539 patients. All potentially eligible patients were evaluated using the Wells' rules to estimate their pre-test probability (PTP) with regard to DVT, and then categorized into likely or unlikely, or alternatively as high, intermediate or low PTP. Patients with a high PTP score were excluded from enrollment. Patients with no or a positive D-dimer result with the D-dimer assay used at the respective study center were evaluated by imaging methods, e.g. ultrasound. Patients with a negative D-dimer result with the D-dimer assay used at the respective study center underwent imaging at the physician's discretion. All patients with a negative clinical diagnosis of DVT at presentation were followed up after three months to evaluate potential development of DVT. Patients with unobtainable follow-up data were excluded from analysis resulting in n= 1317 patients available for final analysis. The overall prevalence of DVT in the 1317 patients was 6.1 % (80 of 1317) with 7.0 % in the US population and 4.7 % in the European population.
The specimens were tested with the INNOVANCE® D-Dimer assay and results were compared to a cut-off value of 0.50 mg/L FEU. A D-dimer result
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2016
Siemens Healthcare Diagnostics Products GmbH Nils Neumann Regulatory Affairs Manager Emil-von-Behring-Str. 76 35041 Marburg Germany
Re: K161317
Trade/Device Name: Sysmex CS-5100 Regulation Number: 21 CFR 864.5400 Regulation Name: Coagulation instrument Regulatory Class: Class II Product Code: JPA Dated: August 2, 2016 Received: August 3, 2016
Dear Mr. Neumann:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
1
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Kelly Oliner -S
For
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name Sysmex CS-5100
Indications for Use (Describe)
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 -
· Antithrombin (AT) with INNOVANCE® Antithrombin
· D-dimer with INNOVANCE® D-Dimer.
The performance of this device has not been established in neonate and pediatic patient populations.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) leth kind
510(k) Premarket Notification for Sysmex® Automated Coagulation Analyzer CS-5100
3
Image /page/3/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the text is a graphic of orange dots arranged in a circular pattern.
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92 and follows the FDA guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", issued July 28, 2014.
1. Submitter
| Siemens Healthcare Diagnostics Products GmbH | |
|---|---|
| Emil-von-Behring-Str. 76 | |
| 35041 Marburg, Germany | |
| Contact Person: | Nils Neumann |
| Email: | neumann.nils@siemens.com |
| Phone: | + 49 6421 39 7133 |
| Facsimile: | + 49 6421 39 4977 |
| Date Prepared: | September 01, 2016 |
| 2. Device | |
| Name of Device: | Sysmex 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 |
| 3. Predicate Device | |
| Name of Device: | Sysmex CA-1500 (K011235) |
| Common or Usual Name: | Automated Coagulation Instrument |
| Classification Name: | Multipurpose system for in vitro coagulation studies (21 CFR |
| 864.5425) | |
| Regulatory Class: | 2 |
| Product Code: | JPA |
| 510(k) Review Panel: | Hematology |
The predicate has not been subject to a design-related recall for any of the applications associated with this Premarket Notification. No reference devices were used in this submission.
4
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
- 트 Calibrators
- I Consumable materials
The subject of this 510(k) notification is to expand the use of the INNOVANCE® D-Dimer for the exclusion of Deep Vein Thrombosis on Sysmex CS-5100. All other established indications, performance and technology characteristics as cleared under K150678 remain unchanged.
5. Intended Use / Indications for 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 (Fbq) with Dade® Thrombin Reagent
- . Antithrombin (AT) with INNOVANCE® Antithrombin
- . D-dimer with INNOVANCE® D-Dimer.
The performance of this device has not been established in neonate and pediatric patient populations.
6. Comparison of Technological Characteristics with the Predicate Device
Both the subject and predicate instruments employ the same technological characteristics in that they automatically analyze various clotting tests using reagents, calibrators and controls previously cleared for automated coagulation analyzers. The reagents perform at least equally well on both the subject and predicate instruments. At a high level, the devices have the following same technological elements:
5
Device Comparison Table
Similarities to the Predicate Device
| Similarities between Sysmex CS-5100 and Sysmex CA-1500 | ||
|---|---|---|
| Analyzer Component | Proposed Device | |
| Sysmex CS-5100 | Predicate Device | |
| Sysmex CA-1500 | ||
| Intended Use | ||
| Statement | 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 Antithrombin (AT) with
INNOVANCE® Antithrombin D-dimer with INNOVANCE® D-
Dimer The performance of this device has
not been established in neonate and
pediatric patient populations. | The intended use of the Sysmex
CA-1500 is as a fully
automated, computerized blood
plasma coagulation analyzer for
in vitro diagnostic use in clinical
laboratories.
The instrument uses citrated
human plasma to perform the
following parameters and
calculated parameters:
Clotting Analysis Prameters:
Prothrombin Time (PT);
Activated Partial
Thromboplastin Time (APTT);
Fibrinogen (Clauss); Batroxobin
Time; Extrinsic Factors (II, V,
VII, X); Intrinsic Factors (VIII, IX,
XI, XII); Protein C.
Chromogenic Analysis
Parameters: Antithrombin III;
Factor VIII; Plasminogen;
Heparin; Protein C; α2-
Antiplasmin.
Immunologic Analysis
Parameters: D-dimer.
Calculated Parameters: PT
Ratio; PT INR; PT %; Derived
Fibrinogen; Factor Assays %
Activity |
| Regulatory
Classification | JPA Class 2
System, Multipurpose for in vitro
coagulation studies | Same |
| 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 | Immuno-chemical Application:
D-dimer
with INNOVANCE® D-Dimer | Same |
| Clinical Reportable
Range | D-dimer with
INNOVANCE® D-Dimer
0.19 to 35.2 mg/L FEU | Same |
| Specimen Processing | Automatic Pipetting and Dilution | Same |
| Random Access | Yes | Same |
| Liquid Level Sensing | Yes - reagent and sample | Same |
| Bar code Reader | Sample + reagent | Same |
| STAT Testing | Yes | Same |
| Sampling Capabilities | Normal and Micro Mode | Same |
| Sample Volumes in
Normal Mode | D-dimer with INNOVANCE® D-
Dimer 13 µL | Same |
T
6
7
Differences to the Predicate Device
| Differences between Sysmex CS-5100 and Sysmex CA-1500 | ||
|---|---|---|
| Analyzer | ||
| Component | Proposed Device | Predicate Device |
| Labeling/ | ||
| Instrument | ||
| Reference Guide | ||
| Application Sheet | ||
| for | ||
| D-Dimer with | ||
| INNOVANCE® D- | ||
| Dimer | ||
| Section: | ||
| Performance | ||
| Characteristics | Note: | |
| For the exclusion of deep vein | ||
| thrombosis (DVT) the diagnostic | ||
| performance was assessed in a | ||
| population of patients with the | ||
| suspicion of a first event of DVT. For | ||
| other patient populations (e. g. with | ||
| recurrent or chronic DVT) the | ||
| effectiveness of the device to exclude | ||
| DVT has not been verified. |
Results obtained for each study
population are detailed below: | The following instrument-specific
sensitivity,specificity and negative
predictive value (NPV) with upper and
lower 95 % confidence limits (CL)
were obtained with the
INNOVANCE® D-Dimer clinical cutoff
of 0.50 mg/L (FEU) for patients with
unlikely pre-test probability: |
| | DVT
Patients
US/OUS
n | DVT
Patients
US/OUS
n |
| | Sen-
sitivity
(LCL*) % | Sen-
sitivity
(CL) % |
| | Spe-
cificity
(LCL*) % | Spe-
cificity
(CL) % |
| | NPV+
(LCL*)% | NPV+
(CL)% |
| | 1317 | 262 |
| | 97.5
(91.3) | 100.0
(83.9) |
| | 45.1
(42.3) | 38.6
(32.4) |
| | 99.0
(96.5) | 100
(96.1) |
| | DVT
Patients
US
n | |
| | Sen-
sitivity
(LCL*) % | |
| | Spe-
cificity
(LCL*) % | |
| | NPV+
(LCL*)% | |
| | 803 | |
| | 98.2
(90.4) | |
| | 38.8
(35.3) | |
| | 99.2
(95.6) | |
| | DVT
Patients
OUS
n | |
| | Sen-
sitivity
(LCL*) % | |
| | Spe-
cificity
(LCL*) % | |
| | NPV+
(LCL*)% | |
| | 514 | |
| | 95.8
(78.9) | |
| | 54.7
(50.2) | |
| | 98.7
(92.9) | |
| | * standardized to a prevalence of 15 %
- Lower bound (LCL) of the two-sided 95 %
confidence interval | |
The above described differences do not raise new questions as to safety and effectiveness of the new device.
8
7. Performance Data
Performance Data: Extended indication for the exclusion of deep vein thrombosis (DVT). See original submission (K150678) for previously conducted analytical and clinical studies:
- -Method comparison
- -Reproducibility
- -Detection Capability
- Linearity & Measuring Range
- -Reference Interval
- -D-dimer PE exclusion validation
7.1 D-Dimer DVT Exclusion Validation Study
The INNOVANCE® D-Dimer assay was evaluated on the Sysmex® CS-5100 System in a multicenter study to validate the exclusion of a first event of Deep Vein Thrombosis (DVT) using frozen specimens collected prospectively from 1907 consecutive outpatients presenting to the emergency or ambulatory department with suspected DVT. Of these 1907 patients, 368 were excluded from analysis (including 213 patients reported to have a previously documented or chronic DVT) resulting in a total of 1539 patients. All potentially eligible patients were evaluated using the Wells' rules to estimate their pre-test probability (PTP) with regard to DVT, and then categorized into likely or unlikely, or alternatively as high, intermediate or low PTP. Patients with a high PTP score were excluded from enrollment. Patients with no or a positive D-dimer result with the D-dimer assay used at the respective study center were evaluated by imaging methods, e.g. ultrasound. Patients with a negative D-dimer result with the D-dimer assay used at the respective study center underwent imaging at the physician's discretion. All patients with a negative clinical diagnosis of DVT at presentation were followed up after three months to evaluate potential development of DVT. Patients with unobtainable follow-up data were excluded from analysis resulting in n= 1317 patients available for final analysis. The overall prevalence of DVT in the 1317 patients was 6.1 % (80 of 1317) with 7.0 % in the US population and 4.7 % in the European population.
The specimens were tested with the INNOVANCE® D-Dimer assay and results were compared to a cut-off value of 0.50 mg/L FEU. A D-dimer result