(98 days)
No
The document describes automated blood plasma coagulation analyzers and their performance characteristics, but there is no mention of AI, ML, or related technologies. The performance studies focus on correlation and regression analysis, which are standard statistical methods, not indicative of AI/ML.
No.
The device is an automated blood plasma coagulation analyzer intended for diagnostic purposes, not for treating or preventing disease.
Yes
The device is described as an "automated blood plasma coagulation analyzer" and is intended for use in evaluating plasma samples from healthy individuals and patients with pathological conditions, which are clear indications of a diagnostic device. The performance studies also show it measures various coagulation parameters.
No
The device is described as "Automated blood plasma coagulation analyzers" and references previous 510(k)s for detailed descriptions of the "systems" and "instruments," indicating it includes hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "automated blood plasma coagulation analyzers." This indicates the device is used to analyze biological samples (blood plasma) outside of the body.
- Device Description: The description reinforces that these are "Automated blood plasma coagulation analyzers," further confirming their function in analyzing biological samples.
- Performance Studies: The performance studies describe evaluating "plasma samples" and conducting "comparative performance evaluations... to evaluate specimens." This directly involves testing biological samples.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. This description perfectly aligns with the information provided about the Sysmex® CA-1000 & CA-5000.
N/A
Intended Use / Indications for Use
Sysmex® CA-1000 & CA-5000 are intended for use as automated blood plasma coagulation analyzers.
Product codes
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Device Description
The Sysmex® CA-1000, software version 24 and CA-5000, software version 13 are substantially equivalent to the Sysmex® CA-1000 and CA-5000, K931149/A, K933886, K942096/S1 and K942097/S1, which were originally cleared to market on November 3, 1993 and January 27, 1994, respectively.
The systems were described in details in premarket notifications, document control numbers: K931149/A, K933886, K942096/S1 and K942097/S1. The devices belong to the same family of instruments and they are equivalent in their technological features and performance.
Mentions image processing
Not Found
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
In a clinical study, plasma samples with each representative analyte of the core coagulation assays were evaluated by the proposed and the predicate device. This group, which represented approximately even numbers of males and females, consisted of approximately 40 samples.
In this clinical study, the following comparative performance evaluations were conducted using the current and the proposed software versions to evaluate specimens from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay:
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study. Sample Number (n):
Prothrombin Time (PT), seconds: 39
Activated Partial Thromboplastin Time (APTT), seconds: 37
Fibrinogen (Clauss), mg/dL: 41
Derived Fibrinogen: 19
Factor VII Assay: 49
Factor VIII Assay: 38
Thrombin Time: 42
Coefficient of Correlation (r):
Prothrombin Time (PT), seconds: 0.999
Activated Partial Thromboplastin Time (APTT), seconds: 0.978
Fibrinogen (Clauss), mg/dL: 0.995
Derived Fibrinogen: 0.951
Factor VII Assay: 0.996
Factor VIII Assay: 0.995
Thrombin Time: 0.951
Regression Equation:
Prothrombin Time (PT), seconds: Y = 0.97X + 0.1
Activated Partial Thromboplastin Time (APTT), seconds: Y = 0.99X + 0.7
Fibrinogen (Clauss), mg/dL: Y = 0.96X + 10.4
Derived Fibrinogen: Y = 1.02X - 9.8
Factor VII Assay: Y = 0.95X + 1.0
Factor VIII Assay: Y = 0.92X + 0.6
Thrombin Time: Y = 1.00X - 0.3
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.
K931149/A, K933886, K942096/S1, K942097/S1
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
MAR | 8 |997
ATTACHMENT D
510(k) Summary of Safety and Effectiveness Information
1
510(k) Summary of Safety and Effectiveness Information 510(k) Additional Information - Premarket Notification Sysmex® Automated Coagulation Analyzer CA-1000 Sysmex® Automated Coagulation Analyzer CA-5000 December 9, 1996
| Sysmex Corporation of America |
|---|
| Gilmer Road 6699 RFD |
| Long Grove, IL 60047 |
| Contact Person: Margaret Barranco at (847) 726-3677, or by facsimile at (847) 726-3669 |
| Trade or Proprietary Name: | Sysmex® Automated Coagulation Analyzer CA-1000
Sysmex® Automated Coagulation Analyzer CA-5000 | |
|----------------------------|-------------------------------------------------------------------------------------------------------|---------|
| 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 |
The Sysmex® CA-1000, software version 24 and CA-5000, software version 13 are substantially equivalent to the Sysmex® CA-1000 and CA-5000, K931149/A, K933886, K942096/S1 and K942097/S1, which were originally cleared to market on November 3, 1993 and January 27, 1994, respectively.
Sysmex® CA-1000 & CA-5000 are intended for use as automated blood plasma coagulation analyzers . The systems were described in details in premarket notifications, document control numbers: K931149/A, K933886, K942096/S1 and K942097/S1. The devices belong to the same family of instruments and they are equivalent in their technological features and performance.
2
510(k) Additional Information - Premarket Notification Sysmex® Automated Coagulation Analyzcr CA-1000 Sysmex® Automated Coagulation Analyzer CA-5000 Attachment D, Page 2
The technological characteristics of the predicate device are similar to those previously described for the proposed devices.
In a clinical study, plasma samples with each representative analyte of the core coagulation assays were evaluated by the proposed and the predicate device. This group, which represented approximately even numbers of males and females, consisted of approximately 40 samples.
In this clinical study, the following comparative performance evaluations were conducted using the current and the proposed software versions to evaluate specimens from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay:
| Test | Sample
Number (n) | Coefficient of
Correlation (r) | Regression
Equation |
|----------------------------------------------------------|----------------------|-----------------------------------|------------------------|
| Prothrombin Time (PT), seconds | 39 | 0.999 | Y = 0.97X + 0.1 |
| Activated Partial Thromboplastin
Time (APTT), seconds | 37 | 0.978 | Y = 0.99X + 0.7 |
| Fibrinogen (Clauss), mg/dL | 41 | 0.995 | Y = 0.96X + 10.4 |
| Derived Fibrinogen | 19 | 0.951 | Y = 1.02X - 9.8 |
| Factor VII Assay | 49 | 0.996 | Y = 0.95X + 1.0 |
| Factor VIII Assay | 38 | 0.995 | Y = 0.92X + 0.6 |
| Thrombin Time | 42 | 0.951 | Y = 1.00X - 0.3 |