(114 days)
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.
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.
Acceptance Criteria and Device Performance for Sysmex CS-5100 (D-Dimer DVT Exclusion)
This document describes the acceptance criteria and study proving the Sysmex CS-5100, specifically for the INNOVANCE® D-Dimer assay's extended indication for exclusion of Deep Vein Thrombosis (DVT), meets these criteria.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the INNOVANCE® D-Dimer assay on the Sysmex CS-5100 for DVT exclusion are specifically defined by statistical measures of diagnostic accuracy, primarily Sensitivity, Specificity, and Negative Predictive Value (NPV), with a focus on their lower bound of the 95% confidence interval (LCL). The table below summarizes the reported device performance across different study populations. The predicate device (Sysmex CA-1500) data is included for comparison where available.
Comparison of DVT Exclusion Performance: Sysmex CS-5100 vs. Sysmex CA-1500 (Predicate)
| Metric | Acceptance Criteria (Predicate - Sysmex CA-1500) | Reported Device Performance (Sysmex CS-5100) |
|---|---|---|
| (All Study Sites: US/OUS) | N=262 patients | N=1317 patients |
| Sensitivity % (LCL) | 100.0 (83.9) | 97.5 (91.3) |
| Specificity % (LCL) | 38.6 (32.4) | 45.1 (42.3) |
| NPV* % (LCL) (standardized to 15% prev) | 100 (96.1) | 99.0 (96.5) |
| (US Sites Only) | Not explicitly provided as separate acceptance criteria for predicate | N=803 patients |
| Sensitivity % (LCL) | - | 98.2 (90.4) |
| Specificity % (LCL) | - | 38.8 (35.3) |
| NPV* % (LCL) (standardized to 15% prev) | - | 99.2 (95.6) |
| (OUS Sites Only) | Not explicitly provided as separate acceptance criteria for predicate | N=514 patients |
| Sensitivity % (LCL) | - | 95.8 (78.9) |
| Specificity % (LCL) | - | 54.7 (50.2) |
| NPV* % (LCL) (standardized to 15% prev) | - | 98.7 (92.9) |
*The predicate device's performance is listed as "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." The specific wording for acceptance criteria for the new device is: "The values must be equal to or better than the predicate's performance while maintaining an equivalent confidence interval". The reported performance for the Sysmex CS-5100 matches or exceeds the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The DVT exclusion validation study for the Sysmex CS-5100 involved a initial prospective collection of 1907 consecutive outpatients with suspected DVT. After exclusions (including 213 patients with previously documented or chronic DVT), a total of 1317 patients were available for final analysis.
The data provenance is multicenter, prospective. The study included patients from both US and OUS (Outside US) sites:
- US sites: 803 patients
- OUS sites: 514 patients
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their specific qualifications used to establish the ground truth for the test set.
However, the ground truth was established by:
- Imaging methods (e.g., ultrasound) for patients with no or a positive D-dimer result by the study center's D-dimer assay, or at the physician's discretion for patients with a negative D-dimer.
- Three-month follow-up to evaluate potential development of DVT for all patients with a negative initial clinical diagnosis of DVT.
This implies that the ground truth was determined by clinical diagnosis using imaging results and clinical follow-up by treating physicians or specialists, rather than by independent expert reviewers of the D-Dimer results themselves.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the test set in the traditional sense (e.g., 2+1, 3+1 expert review of independent interpretations).
The ground truth was established through a combination of:
- Imaging: Decisions based on imaging were likely made by radiologists or sonographers.
- Clinical follow-up: Clinical outcomes were assessed by physicians.
There is no mention of a formal adjudication process between multiple independent reviewers of the D-dimer results or the imaging findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted as part of this submission for the Sysmex CS-5100's DVT exclusion indication.
This is an in vitro diagnostic device (automated coagulation analyzer), and its performance is evaluated based on the accuracy of its quantitative D-dimer measurements and the derived diagnostic metrics (Sensitivity, Specificity, NPV) against clinical ground truth, rather than human interpretation with and without AI assistance.
6. Standalone (Algorithm Only) Performance
The study primarily evaluates the standalone performance of the INNOVANCE® D-Dimer assay on the Sysmex CS-5100. The device generates a D-dimer result, which is then interpreted by comparing it to a cut-off value (0.50 mg/L FEU) to determine a positive or negative diagnosis for DVT exclusion. This is an "algorithm only" type of performance, as it quantifies a biomarker without direct human visual interpretation of an image or signal.
7. Type of Ground Truth Used
The ground truth used was a combination of clinical outcomes data and diagnostic imaging:
- Diagnostic Imaging: "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."
- Outcomes Data (Clinical Follow-up): "All patients with a negative clinical diagnosis of DVT at presentation were followed up after three months to evaluate potential development of DVT."
This establishes a robust clinical diagnosis of DVT as the ground truth.
8. Sample Size for the Training Set
The document does not provide information on a specific training set size or methodology for the INNOVANCE® D-Dimer assay on the Sysmex CS-5100 related to its DVT exclusion indication.
This submission is for an extended indication of an existing device (Sysmex CS-5100) and an existing assay (INNOVANCE® D-Dimer), which likely had its primary development and calibration (analogous to training) performed prior to this specific DVT exclusion validation study. The current study focuses on clinical validation of the assay's performance for this specific indication.
9. How the Ground Truth for the Training Set Was Established
As noted above, the document does not describe a specific training set or how its ground truth was established for the DVT exclusion indication. The information provided pertains to the validation (test) set.
It can be inferred that earlier development work for the INNOVANCE® D-Dimer assay, possibly on previous Sysmex analyzers, involved methods similar to the current validation study to establish its accuracy for general D-dimer measurements. However, details of such "training set" establishment are not part of this 510(k) summary for the extended DVT exclusion indication.
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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
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CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Kelly Oliner -S
For
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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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
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510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92 and follows the FDA guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", issued July 28, 2014.
1. Submitter
| Siemens Healthcare Diagnostics Products GmbH | |
|---|---|
| Emil-von-Behring-Str. 76 | |
| 35041 Marburg, Germany | |
| Contact Person: | Nils Neumann |
| Email: | neumann.nils@siemens.com |
| Phone: | + 49 6421 39 7133 |
| Facsimile: | + 49 6421 39 4977 |
| Date Prepared: | 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 CFR864.5425) |
| 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 CFR864.5425) |
| 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.
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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
- 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:
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Device Comparison Table
Similarities to the Predicate Device
| Similarities between Sysmex CS-5100 and Sysmex CA-1500 | ||
|---|---|---|
| Analyzer Component | Proposed DeviceSysmex CS-5100 | Predicate DeviceSysmex CA-1500 |
| Intended UseStatement | The Sysmex CS-5100 is a fullyautomated blood coagulationanalyzer intended for in vitrodiagnostic use using plasmacollected from venous bloodsamples in 3.2% sodium citratetubes to analyze clotting,chromogenic and immunoassaymethods in the clinical laboratory.For determination of:Prothrombin Time (PT) secondsand PT INR with Dade® Innovin® Activated PartialThromboplastin Time (APTT) withDade® Actin® FSL Fibrinogen (Fbg) with Dade®Thrombin Reagent Antithrombin (AT) withINNOVANCE® Antithrombin D-dimer with INNOVANCE® D-Dimer The performance of this device hasnot been established in neonate andpediatric patient populations. | The intended use of the SysmexCA-1500 is as a fullyautomated, computerized bloodplasma coagulation analyzer forin vitro diagnostic use in clinicallaboratories.The instrument uses citratedhuman plasma to perform thefollowing parameters andcalculated parameters:Clotting Analysis Prameters:Prothrombin Time (PT);Activated PartialThromboplastin Time (APTT);Fibrinogen (Clauss); BatroxobinTime; 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 AnalysisParameters: D-dimer.Calculated Parameters: PTRatio; PT INR; PT %; DerivedFibrinogen; Factor Assays %Activity |
| RegulatoryClassification | JPA Class 2System, Multipurpose for in vitrocoagulation studies | Same |
| Similarities between Sysmex CS-5100 and Sysmex CA-1500 | ||
| Analyzer Component | Proposed DeviceSysmex CS-5100 | Predicate DeviceSysmex CA-1500 |
| Sample Type | Human plasma,3.2% sodium citrate | Same |
| Application | Immuno-chemical Application:D-dimerwith INNOVANCE® D-Dimer | Same |
| Clinical ReportableRange | D-dimer withINNOVANCE® D-Dimer0.19 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 inNormal Mode | D-dimer with INNOVANCE® D-Dimer 13 µL | Same |
T
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Differences to the Predicate Device
| Differences between Sysmex CS-5100 and Sysmex CA-1500 | ||
|---|---|---|
| AnalyzerComponent | Proposed Device | Predicate Device |
| Labeling/InstrumentReference GuideApplication SheetforD-Dimer withINNOVANCE® D-DimerSection:PerformanceCharacteristics | Note:For the exclusion of deep veinthrombosis (DVT) the diagnosticperformance was assessed in apopulation of patients with thesuspicion of a first event of DVT. Forother patient populations (e. g. withrecurrent or chronic DVT) theeffectiveness of the device to excludeDVT has not been verified.Results obtained for each studypopulation are detailed below: | The following instrument-specificsensitivity,specificity and negativepredictive value (NPV) with upper andlower 95 % confidence limits (CL)were obtained with theINNOVANCE® D-Dimer clinical cutoffof 0.50 mg/L (FEU) for patients withunlikely pre-test probability: |
| DVTPatientsUS/OUSn | DVTPatientsUS/OUSn | |
| 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) | |
| DVTPatientsUSn | ||
| Sen-sitivity(LCL*) % | ||
| Spe-cificity(LCL*) % | ||
| NPV+(LCL*)% | ||
| 803 | ||
| 98.2(90.4) | ||
| 38.8(35.3) | ||
| 99.2(95.6) | ||
| DVTPatientsOUSn | ||
| 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.
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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 <0.50 mg/L FEU was considered negative and a D-dimer result ≥0.50 mg/L FEU was considered positive. The instrument-specific sensitivity, specificity, negative predictive value (NPV) and positive value (PPV) with lower bound (LCL) of a two-sided 95 % confidence interval were calculated. Results obtained for each study population are detailed below.
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| US sites DVT | Reference (Imaging and 3-month follow-up) | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| INNOVANCE®D-Dimer on CS-5100 | Positive | 55 | 457 | 512 |
| D-Dimer on CS-5100 | Negative | 1 | 290 | 291 |
| 5100 | Total | 56 | 747 | 803 |
| Sensitivity %= | 98.2 | 95% LCL= | 90.4 | |
| Specificity %= | 38.8 | 95% LCL= | 35.3 | |
| NPV %= | 99.7 | 95% LCL= | 98.1 | |
| NPV* %= | 99.2 | 95% LCL= | 95.6 | |
| PPV %= | 10.7 | 95% LCL= | 8.3 | |
| PPV* %= | 22.1 | 95% LCL= | 17.7 |
*standardized to a prevalence of 15%
| OUS sites DVT | Reference (Imaging and 3-month follow-up) | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| INNOVANCE®D-Dimer on CS-5100 | Positive | 23 | 222 | 245 |
| Negative | 1 | 268 | 269 | |
| Total | 24 | 490 | 514 | |
| Sensitivity %= | 95.8 | 95% LCL= | 78.9 | |
| Specificity %= | 54.7 | 95% LCL= | 50.2 | |
| NPV %= | 99.6 | 95% LCL= | 97.9 | |
| NPV* %= | 98.7 | 95% LCL= | 92.9 | |
| PPV % | 9.4 | 95% LCL= | 6.3 | |
| PPV* %= | 27.2 | 95% LCL= | 19.6 |
*standardized to a prevalence of 15%
| US and OUS sites DVT | Reference (Imaging and 3-month follow-up) | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| INNOVANCE®D-Dimer on CS-5100 | Positive | 78 | 679 | 757 |
| Negative | 2 | 558 | 560 | |
| Total | 80 | 1237 | 1317 | |
| Sensitivity %= | 97.5 | 95% LCL= | 91.3 | |
| Specificity %= | 45.1 | 95% LCL= | 42.3 | |
| NPV %= | 99.6 | 95% LCL= | 98.7 | |
| NPV* %= | 99.0 | 95% LCL= | 96.5 | |
| PPV %= | 10.3 | 95% LCL= | 8.3 | |
| PPV* %= | 23.9 | 95% LCL= | 19.9 |
*standardized to a prevalence of 15%
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8. Conclusion
The modified Sysmex® CS-5100 Coagulation Analyzer, with the expanded indication of the INNOVANCE® D-Dimer for the exclusion of Deep Vein Thrombosis, is substantially equivalent to the legally marketed predicate device FDA cleared under K011235.
§ 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.