(130 days)
No
The summary describes a standard automated coagulation analyzer with updated hardware and software for immunological testing. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance metrics are standard for laboratory analyzers and do not suggest the use of AI/ML algorithms.
No
The device is described as an in vitro diagnostic (IVD) blood plasma coagulation analyzer used in clinical laboratories to perform coagulation tests. Its purpose is to provide accurate test results, which are used for diagnosis or monitoring, not to directly treat or prevent a disease.
Yes
The device is explicitly stated as being "for in vitro diagnostic use in clinical laboratories."
No
The device description clearly states it is a "fully automated, computerized blood plasma coagulation analyzer" that uses "clot, chromogenic and immunological detection technologies," indicating it is a hardware device with integrated software, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The intended use of the Sysmex® CA-500 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories."
The "Device Description" also reiterates this: "The Sysmex® CA-500 series is a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories."
These statements clearly indicate that the device is intended to be used outside of the body (in vitro) to diagnose conditions based on the analysis of blood plasma.
N/A
Intended Use / Indications for Use
The intended use of the Sysmex® CA-500 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 coagulation tests.
Product codes
GKP
Device Description
The Sysmex® CA-500 series is a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories. The manufacturer has modified the series to include two new models with immunological testing capability. The proposed Sysmex CA-500 series can now provide accurate and precise test results for up to five parameters simultaneously and in random access. The CA-500 uses clot, chromogenic and immunological detection technologies for determination of the various parameters.
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
Not Found
Intended User / Care Setting
clinical laboratories
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Method Comparison Studies between CA-500 and CA-7000 or CA-6000.
The results of PT and APTT parameters using the new software version for the Sysmex® Automated Coagulation Analyzer CA-500 Series are substantially equivalent to the results for PT and APTT parameters obtained with the Sysmex® Automated Coagulation Analyzer CA-6000, which was cleared under Document Control No. K964139.
Test: D-Dimer Assay (Advanced D-Dimer), Predicate Device: CA-7000, Sample Number (n): 390, Coefficient of Correlation (r): 0.992, Regression Equation: Y = 1.01X + 0.14
Test: PT, seconds (Thromborel® S), Predicate Device: CA-6000, Sample Number (n): 248, Coefficient of Correlation (r): 0.999, Regression Equation: Y = 1.00X - 0.50
Test: PT, INR (Thromborel® S), Predicate Device: CA-6000, Sample Number (n): 248, Coefficient of Correlation (r): 0.999, Regression Equation: Y = 0.89X + 0.11
Test: Derived Fibrinogen (Thromborel® S), Predicate Device: CA-6000, Sample Number (n): 248, Coefficient of Correlation (r): 0.998, Regression Equation: Y = 1.08X + 0.04
Test: PT, seconds (Innovin®), Predicate Device: CA-6000, Sample Number (n): 243, Coefficient of Correlation (r): 0.999, Regression Equation: Y = 1.03X - 0.26
Test: PT, INR (Innovin®), Predicate Device: CA-6000, Sample Number (n): 243, Coefficient of Correlation (r): 0.999, Regression Equation: Y = 1.08X - 0.09
Test: Derived Fibrinogen (Innovin®), Predicate Device: CA-6000, Sample Number (n): 247, Coefficient of Correlation (r): 0.995, Regression Equation: Y = 1.09X - 0.17
Test: PT, seconds (Thromboplastin C Plus), Predicate Device: CA-6000, Sample Number (n): 245, Coefficient of Correlation (r): 0.997, Regression Equation: Y = 1.00X - 0.20
Test: PT, INR (Thromboplastin C Plus), Predicate Device: CA-6000, Sample Number (n): 245, Coefficient of Correlation (r): 0.998, Regression Equation: Y = 1.00X - 0.00
Test: Derived Fibrinogen (Thromboplastin C Plus), Predicate Device: CA-6000, Sample Number (n): 245, Coefficient of Correlation (r): 0.998, Regression Equation: Y = 1.12X + 0.03
Test: APTT (Actin®), Predicate Device: CA-6000, Sample Number (n): 864, Coefficient of Correlation (r): 0.982, Regression Equation: Y = 1.00X - 0.20
Test: APTT (Actin® FS), Predicate Device: CA-6000, Sample Number (n): 857, Coefficient of Correlation (r): 0.983, Regression Equation: Y = 1.00X + 0.10
Test: APTT (Actin® FSL), Predicate Device: CA-6000, Sample Number (n): 864, Coefficient of Correlation (r): 0.990, Regression Equation: Y = 1.00X + 0.10
Summary of Precision Studies Sysmex® Automated Coagulation Analyzer CA-500. All tests show %CV values within the maximum error criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Dade Behring Inc. 510(k) Premarket Notification Sysmex® Automated Coagulation Analyzer CA-500
510(k) Summary of Safety and Effectiveness Information Sysmex® Automated Coagulation Analyzer CA-500 April 30, 2003
MANUFACTURER AND CONTACT INFORMATION I.
| Contact Information: | Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101
Attn: Radames Riesgo
Phone: 305.480.7558
FAX: 305.552.5288 | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------|---------|
| Registration Number: | Manufacturing Site | |
| | Sysmex Corporation | |
| | Kobe, Japan | 9613959 |
| | Importer | |
| | Sysmex Corporation of America | |
| | One Wildlife Way | |
| | Long Grove, IL 60047-9596 | 1422681 |
| | Distributor | |
| | Dade Behring Inc. | |
| | Glasgow Site | |
| | P.O. Box 6101 | |
| | Newark, DE 19714-6101 | 2517506 |
DEVICE NAME AND CLASSIFICATION NAME II.
Trade or Proprietary Name: Sysmex Automated Coagulation Analyzer CA-500
Common or Usual Name: Automated Coagulation System
Coagulation Instrument (21 CFR §864.5400) Classification Name:
III. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE
Sysmex® Automated Coagulation Analyzer CA-7000 (K020979) Sysmex® Automated Coagulation Analyzer CA-6000 (K964139)
SEP - 8 2003
1
DEVICE DESCRIPTION IV.
The Sysmex® CA-500 series is a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories. The manufacturer has modified the series to include two new models with immunological testing capability. The proposed Sysmex CA-500 series can now provide accurate and precise test results for up to five parameters simultaneously and in random access. The CA-500 uses clot, chromogenic and immunological detection technologies for determination of the various parameters.
DEVICE INTENDED USE V.
The intended use of the Sysmex® CA-500 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 coagulation tests.
VI. SUBSTANTIAL EQIVALENCE
The Sysmex® Automated Coagulation Analyzer CA-550 or CA-560 is substantially equivalent in intended use for D-Dimer testing to the Sysmex® Automated Coagulation Analyzer CA-7000, which was cleared under Document Control No. K020979.
The results of PT and APTT parameters using the new software version for the Sysmex® Automated Coagulation Analyzer CA-500 Series are substantially equivalent to the results for PT and APTT parameters obtained with the Sysmex® Automated Coagulation Analyzer CA-6000, which was cleared under Document Control No. K964139.
2
VII. DEVICE PERFORMANCE CHARACTERISTICS
| Test | Predicate
Device | Sample
Number
(n) | Coefficient of
Correlation
(r) | Regression
Equation |
|-----------------------------------------------|---------------------|-------------------------|--------------------------------------|------------------------|
| D-Dimer Assay
(Advanced D-Dimer) | CA-7000 | 390 | 0.992 | Y = 1.01X + 0.14 |
| PT, seconds
(Thromborel® S) | CA-6000 | 248 | 0.999 | Y = 1.00X - 0.50 |
| PT, INR
(Thromborel® S) | CA-6000 | 248 | 0.999 | Y = 0.89X + 0.11 |
| Derived Fibrinogen
(Thromborel® S) | CA-6000 | 248 | 0.998 | Y = 1.08X + 0.04 |
| PT, seconds
(Innovin®) | CA-6000 | 243 | 0.999 | Y = 1.03X - 0.26 |
| PT, INR
(Innovin®) | CA-6000 | 243 | 0.999 | Y = 1.08X - 0.09 |
| Derived Fibrinogen
(Innovin®) | CA-6000 | 247 | 0.995 | Y = 1.09X - 0.17 |
| PT, seconds
(Thromboplastin C Plus | CA-6000 | 245 | 0.997 | Y = 1.00X - 0.20 |
| PT, INR
(Thromboplastin C Plus) | CA-6000 | 245 | 0.998 | Y = 1.00X - 0.00 |
| Derived Fibrinogen
(Thromboplastin C Plus) | CA-6000 | 245 | 0.998 | Y = 1.12X + 0.03 |
| APTT
(Actin®) | CA-6000 | 864 | 0.982 | Y = 1.00X - 0.20 |
| APTT
(Actin® FS) | CA-6000 | 857 | 0.983 | Y = 1.00X + 0.10 |
| APTT
(Actin® FSL) | CA-6000 | 864 | 0.990 | Y = 1.00X + 0.10 |
Summary of Method Comparison Studies between CA-500 and CA-7000 or CA-6000
3
| Assay | Control Level | n | Mean | Within
Run
%CV | Between
Run
%CV | Total
%CV | Max.
Error
Criteria
% CV |
|----------------------------------------------------|------------------------------------------|----|--------------|----------------------|-----------------------|--------------|-----------------------------------|
| PT, Seconds
(Thromborel® S) | Control Plasma N
Ci-Trol® Level 3 | 40 | 11.9
59.2 | 0.7
1.1 | 0.7
1.0 | 0.9
1.5 | 5 |
| PT, INR
(Thromborel® S) | Control Plasma N
Ci-Trol® Level 3 | 40 | 1.1
4.6 | 0.6
1.0 | 0.6
0.9 | 0.8
1.3 | 5 |
| Derived Fibrinogen, g/L
(Thromborel® S) | Control Plasma N
Path. Plasmapool | 40 | 2.3
4.8 | 1.6
1.9 | 0.6
1.7 | 1.6
2.5 | 10 |
| PT, Seconds
(Dade® Innovin®) | Control Plasma N
Ci-Trol® Level 3 | 40 | 11.5
38.0 | 0.4
0.9 | 0.2
1.5 | 0.4
1.8 | 5 |
| PT, INR
(Dade® Innovin®) | Control Plasma N
Ci-Trol® Level 3 | 40 | 1.1
3.7 | 0.4
0.9 | 0.2
1.6 | 0.4
1.8 | 5 |
| Derived Fibrinogen, g/L
(Dade® Innovin®) | Control Plasma N
Path. Plasmapool | 40 | 1.9
5.2 | 2.6
3.2 | 1.4
1.6 | 2.8
3.4 | 10 |
| PT, Seconds
(Thromboplastin C Plus) | Control Plasma N
Ci-Trol® Level 3 | 40 | 11.5
25.9 | 0.4
1.0 | 0.2
1.5 | 0.4
1.8 | 5 |
| PT, INR
(Thromboplastin C Plus) | Control Plasma N
Ci-Trol® Level 3 | 40 | 1.0
5.0 | 0.7
1.9 | 0.4
3.0 | 0.7
3.5 | 5 |
| Derived Fibrinogen, g/L
(Thromboplastin C Plus) | Control Plasma N
Path. Plasmapool | 40 | 2.5
5.0 | 1.5
1.6 | 1.3
0.6 | 1.9
1.6 | 10 |
| APTT
(Dade® Actin) | Control Plasma N
Ci-Trol® Level 3 | 40 | 26.8
57.9 | 1.0
0.6 | 3.4
1.3 | 3.5
1.4 | 5 |
| APTT
(Dade® Actin FS) | Control Plasma N
Ci-Trol® Level 3 | 40 | 27.1
63.8 | 0.5
0.3 | 0.2
1.5 | 0.5
1.5 | 5 |
| APTT
(Dade® Actin® FSL) | Control Plasma N
Ci-Trol® Level 3 | 40 | 29.3
61.4 | 0.4
0.4 | 0.2
1.4 | 0.4
1.5 | 5 |
| D-Dimer
(Advanced D-Dimer) | Adv. D-D Control 1
Adv. D-D Control 2 | 40 | 5.0
20.5 | 2.4
1.6 | 1.8
1.4 | 2.9
2.0 | 15 |
Summary of Precision Studies Sysmex® Automated Coagulation Analyzer CA-500
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing strokes, symbolizing the department's mission to protect and promote the health and well-being of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.
SEP - 8 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Radames Riesgo Manager, Regulatory Affairs & Compliance Dade Behring Inc. P.O. Box 6101 Newark, DE 19714
Re: K031377 Trade/Device Name: Sysmex® Automated Coagulation Analyzer CA-500 Regulation Number: 21 CFR 864.5400 Regulation Name: Coagulation instrument Regulatory Class: Class II Product Code: GKP Dated: August 7, 2003 Received: August 8, 2003
Dear Mr. Riesgo:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Sysmex® Automated Coagulation Analyzer CA-500
Indications for Use:
The intended use of the Sysmex® CA-500 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 coagulation tests.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jourdine Bautista
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K0231377
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)