(114 days)
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No
The summary describes a standard automated blood plasma coagulation analyzer and its performance studies focus on method comparison and statistical metrics like Coefficient of Variation and Regression Equation, which are typical for analytical instruments and do not indicate the use of AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is an analyzer used for diagnostic purposes, not for treating a condition. Its function is to measure coagulation, which provides information for diagnosis rather than direct therapy.
Yes
The device is an automated blood plasma coagulation analyzer, which is used to measure clotting times and other parameters of blood plasma. These measurements are used in diagnosing bleeding disorders, thrombotic conditions, and monitoring anticoagulant therapy. Therefore, it is a diagnostic device.
No
The device is described as an "Automated blood plasma coagulation analyzer," which is inherently a hardware device that performs physical analysis of blood samples. The summary focuses on performance studies comparing it to another hardware analyzer.
Yes, based on the provided information, the Sysmex® CA-6000 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's an "automated blood plasma coagulation analyzer." This means it's designed to analyze biological samples (blood plasma) outside of the body to provide information about a patient's health status (coagulation). This is the core definition of an in vitro diagnostic device.
- Device Description: The description "Automated blood plasma coagulation analyzer" further reinforces its function as a device used for in vitro testing.
The other sections, while providing details about the device and its performance, do not contradict its classification as an IVD. The fact that it analyzes blood plasma for coagulation is the key indicator.
N/A
Intended Use / Indications for Use
The Sysmex® CA-6000 is substantially equivalent in intended use and technological characteristics to the Electra 1000C™ Automatic Coagulation Timer, manufactured by Medical Laboratory Automation, Inc., Pleasntville, NY, previously cleared under Document Control No., K894052. Sysmex® CA-6000 is intended for use as an automated blood plasma coagulation analyzer.
Product codes
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Device Description
Automated Coagulation Instruments
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
As demonstrated by in-house correlation studies, the performance claims of the proposed device are similar to the predicate device. During those studies, specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay. The following summary shows the results of the comparison studies between the proposed and the predicate devices.
Summary of Method Comparison Studies between CA-6000 and MLA 1000C
Prothrombin Time (Dade Innovin, seconds): Sample Size = 119, Coefficient of Variation = 0.997, Regression Equation = Y= 1.02X + 0.4
Prothrombin Time (Dade Innovin, INR): Sample Size = 119, Coefficient of Variation = 0.997, Regression Equation = Y= 1.07X - 0.1
Derived Fibrinogen (Dade Innovin): Sample Size = 139, Coefficient of Variation = 0.988, Regression Equation = Y= 1.03X - 6.2
Prothrombin Time (Dade Thromboplastin C Plus, seconds): Sample Size = 133, Coefficient of Variation = 0.983, Regression Equation = Y= 1.02X - 0.1
Prothrombin Time (Dade Thromboplastin C Plus, INR): Sample Size = 133, Coefficient of Variation = 0.984, Regression Equation = Y= 1.02X - 0.1
Derived Fibrinogen (Dade Thromboplastin C Plus): Sample Size = 126, Coefficient of Variation = 0.992, Regression Equation = Y=0.76X +63.9
Activated Partial Thromboplastin Time: Sample Size = 128, Coefficient of Variation = 0.971, Regression Equation = Y= 1.00X + 1.7
Fibrinogen (Clauss): Sample Size = 230, Coefficient of Variation = 0.984, Regression Equation = Y=0.98X -15.0
Thrombin Time: Sample Size = 148, Coefficient of Variation = 0.888, Regression Equation = Y= 1.98X - 5.0
Factor VII (Dade Innovin): Sample Size = 130, Coefficient of Variation = 0.987, Regression Equation = Y=0.97X - 2.2
Factor VII (Dade Thromboplastin C Plus): Sample Size = 131, Coefficient of Variation = 0.979, Regression Equation = Y=0.94X - 4.4
Factor VIII: Sample Size = 118, Coefficient of Variation = 0.973, Regression Equation = Y= 1.04X - 2.2
Antithrombin III: Sample Size = 132, Coefficient of Variation = 0.980, Regression Equation = Y=0.98X + 0.6
Plasminogen: Sample Size = 158, Coefficient of Variation = 0.999, Regression Equation = Y=1.03X-0.7
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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FEB - 6 1997
510(k) Summary of Safety and Effectiveness Information SYSMEX ® Automated Coagulation Analyzer CA-6000 October 11, 1996
Dade International Inc. 9750 N.W. 25 Street Miami, FL 33172 Contact Person: Radames Riesgo at 305-392-5615 or by facsimile at 305-392-5622.
| Trade or Proprietary Name: | Sysmex® Automated Coagulation Analyzer CA-6000 | |
|---|---|---|
| Common or Usual Name: | Automated Coagulation Instruments | |
| Classification Name: | Coagulation instrument (21 CFR §864.5400) | |
| Registration Number: | Manufacturing Site | |
| TOA Medical Electronics Co. | ||
| Kobe, Japan | 7010360 | |
| Importer | ||
| Sysmex™ Corporation of America | ||
| Gilmer Road 6699 RFD | ||
| Long Grove, IL 60047-9596 | 1422681 | |
| Distributor | ||
| Dade International Inc. | ||
| 9750 N.W. 25 Street | ||
| Miami, FL 33172 | 1025506 |
The Sysmex® CA-6000 is substantially equivalent in intended use and technological characteristics to the Electra 1000C™ Automatic Coagulation Timer, manufactured by Medical Laboratory Automation, Inc., Pleasntville, NY, previously cleared under Document Control No., K894052. Sysmex® CA-6000 is intended for use as an automated blood plasma coagulation analyzer.
1
510(k) Summary of Safety and Effectiveness Information Sysmex® Automated Coagulation Analyzer CA-6000 Attachment C, Page 2
As demonstrated by in-house correlation studies, the performance claims of the proposed device are similar to the predicate device. During those studies, specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay. The following summary shows the results of the comparison studies between the proposed and the predicate devices.
| | | Coefficient of
Variation | Regression
Equation |
|------------------------------------------------------------|-----|-----------------------------|------------------------|
| Prothrombin Time
(Dade® Innovin®, seconds) | 119 | 0.997 | Y= 1.02X + 0.4 |
| Prothrombin Time
(Dade® Innovin®, INR) | 119 | 0.997 | Y= 1.07X - 0.1 |
| Derived Fibrinogen
(Dade® Innovin®) | 139 | 0.988 | Y= 1.03X - 6.2 |
| Prothrombin Time
(Dade® Thromboplastin C Plus, seconds) | 133 | 0.983 | Y= 1.02X - 0.1 |
| Prothrombin Time
(Dade® Thromboplastin C Plus, INR) | 133 | 0.984 | Y= 1.02X - 0.1 |
| Derived Fibrinogen
(Dade® Thromboplastin C Plus) | 126 | 0.992 | Y=0.76X +63.9 |
| Activated Partial Thromboplastin Time | 128 | 0.971 | Y= 1.00X + 1.7 |
| Fibrinogen (Clauss) | 230 | 0.984 | Y=0.98X -15.0 |
| Thrombin Time | 148 | 0.888 | Y= 1.98X - 5.0 |
| Factor VII
(Dade® Innovin®) | 130 | 0.987 | Y=0.97X - 2.2 |
| Factor VII
(Dade® Thromboplastin C Plus) | 131 | 0.979 | Y=0.94X - 4.4 |
| Factor VIII | 118 | 0.973 | Y= 1.04X - 2.2 |
| Antithrombin III | 132 | 0.980 | Y=0.98X + 0.6 |
| Plasminogen | 158 | 0.999 | Y=1.03X-0.7 |