(156 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a standard automated blood plasma coagulation analyzer with no mention of AI/ML capabilities in the intended use, device description, or performance studies.
No.
The device is an in vitro diagnostic (IVD) device used for analyzing blood plasma coagulation, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for in vitro diagnostic use in clinical laboratories."
No
The device description explicitly states it is a "compact, fully automated, computerized blood plasma coagulation analyzer" and refers to it as an "instrument," indicating it is a physical hardware device with integrated software, not software alone.
Yes, the Sysmex® CA-500 Series is an IVD (In Vitro Diagnostic) device.
This is explicitly stated in the Intended Use / Indications for Use section:
"The intended use of the Sysmex® CA-500 Series is as a compact, fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories."
N/A
Intended Use / Indications for Use
The intended use of the Sysmex® CA-500 Series is as a compact, 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 Parameters
- Prothrombin Time (PT) .
- Activated Partial Thromboplastin Time (APTT) .
- Fibrinogen (Clauss) .
- Thrombin Time .
Chromogenic Analysis Parameters - Antithrombin III ●
Calculated Parameters - PT Ratio .
- PT INR .
- Derived Fibrinogen .
Product codes (comma separated list FDA assigned to the subject device)
JPA
Device Description
The Sysmex® CA-500 is intended for use as an automated blood plasma coagulation analyzer.
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
in vitro diagnostic use in 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)
Data to support substantial equivalence to the predicate device were generated during correlation studies performed in house. In these studies, comparative performance evaluations were conducted using the proposed device and the predicate device 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. The following summary shows the results of the comparison between the proposed and the predicate devices.
Test, Sample Number (n), Coefficient of Correlation (r), Regression Equation
Prothrombin Time (Dade® Innovin®, seconds), 111, 0.991, Y = 0.98X + 0.3
Prothrombin Time (Dade® Innovin®, INR), 111, 0.991, Y = 0.99X + 0.03
Derived Fibrinogen (Dade® Innovin®), 104, 0.983, Y = 0.78X + 31.2
Prothrombin Time (Dade® Thromboplastin C Plus, seconds), 131, 0.997, Y = 1.00X + 0.02
Prothrombin Time (Dade® Thromboplastin C Plus, INR), 131, 0.997, Y = 1.00X + 0.01
Derived Fibrinogen (Dade® Thromboplastin C Plus), 131, 0.979, Y = 0.92X + 20.2
Prothrombin Time (Thromborel® S, seconds), 119, 0.990, Y = 0.99X + 0.2
Prothrombin Time (Thromborel® S, INR), 119, 0.989, Y = 1.00X + 0.01
Derived Fibrinogen (Thromborel® S), 115, 0.985, Y = 0.86X + 29.2
Activated Partial Thromboplastin Time (Dade® Actin®), 114, 0.997, Y = 1.00X - 0.3
Activated Partial Thromboplastin Time (Dade® Actin® FSL), 116, 0.997, Y = 1.01 X - 0.01
Activated Partial Thromboplastin Time (Pathromtin® SL), 114, 0.996, Y = 0.98X + 1.0
Fibrinogen (Clauss), 119, 0.989, Y = 0.95X + 20.3
Thrombin Time, 128, 0.806, Y = 0.54X + 9.8
Antithrombin III, 109, 0.927, Y = 0.91X + 10.8
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
SEP 3 0 1998
Premarket Notification 510(k) Summary of Safety and Effectiveness Information Sysmex ® Automated Coagulation Analyzer CA-500
510K
Summo
Dade Behring Inc. 1851 Delaware Parkway Miami, FL 33125
i.
Contact Person: Radames Riesgo at 305.636.7727 or by facsimile at 305.637.6887.
Trade or Proprietary Name: Sysmex® Automated Coagulation Analyzer CA-500
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
1981711
Importer Sysmex™ Corporation of America Gilmer Road 6699 RFD Long Grove, IL 60047-9596
1422681
Distributor Dade Behring Inc. 1851 Delaware Parkway Miami, FL 33125
1017272
The CA-500 is substantially equivalent in intended use and technological characteristics to its predecessor, the CA-6000 analyzer. Both instruments are manufactured by TOA Medical Electronics, CO, Ltd., Kobe, Japan. The CA-6000 analyzer was described in details under Document Control No. K964139. The Sysmex® CA-500 is intended for use as an automated blood plasma coagulation analyzer.
Data to support substantial equivalence to the predicate device were generated during correlation studies performed in house. In these studies, comparative performance evaluations were conducted using the proposed device and the predicate device to evaluate specimens from apparently healthy individuals and from patients with different pathological conditions which are
1
510(k) Summary of Safety and Effectiveness Information Sysmex® Automated Coagulation Analyzer CA-500 Page 2
100 100
expected to affect the results for a particular assay. The following summary shows the results of the comparison between the proposed and the predicate devices.
్ నిర్మా ఇతర ప్ర
| Test | Sample
Number
(n) | Coefficient of
Correlation
(r) | Regression
Equation |
|-------------------------------------------------------------|-------------------------|--------------------------------------|------------------------|
| Prothrombin Time
(Dade® Innovin®, seconds) | 111 | 0.991 | Y = 0.98X + 0.3 |
| Prothrombin Time
(Dade® Innovin®, INR) | 111 | 0.991 | Y = 0.99X + 0.03 |
| Derived Fibrinogen
(Dade® Innovin®) | 104 | 0.983 | Y = 0.78X + 31.2 |
| Prothrombin Time
(Dade® Thromboplastin C Plus, seconds) | 131 | 0.997 | Y = 1.00X + 0.02 |
| Prothrombin Time
(Dade® Thromboplastin C Plus, INR) | 131 | 0.997 | Y = 1.00X + 0.01 |
| Derived Fibrinogen
(Dade® Thromboplastin C Plus) | 131 | 0.979 | Y = 0.92X + 20.2 |
| Prothrombin Time
(Thromborel® S, seconds) | 119 | 0.990 | Y = 0.99X + 0.2 |
| Prothrombin Time
(Thromborel® S, INR) | 119 | 0.989 | Y = 1.00X + 0.01 |
| Derived Fibrinogen
(Thromborel® S) | 115 | 0.985 | Y = 0.86X + 29.2 |
| Activated Partial Thromboplastin Time
(Dade® Actin®) | 114 | 0.997 | Y = 1.00X - 0.3 |
| Activated Partial Thromboplastin Time
(Dade® Actin® FSL) | 116 | 0.997 | Y = 1.01 X - 0.01 |
| Activated Partial Thromboplastin Time
(Pathromtin® SL) | 114 | 0.996 | Y = 0.98X + 1.0 |
| Fibrinogen (Clauss) | 119 | 0.989 | Y = 0.95X + 20.3 |
| Thrombin Time | 128 | 0.806 | Y = 0.54X + 9.8 |
| Antithrombin III | 109 | 0.927 | Y = 0.91X + 10.8 |
Summary of Method Comparison Studies between CA-500 and CA-6000
2
Image /page/2/Picture/0 description: The image shows a black ink blot on a white background. The ink blot is irregular in shape, with a rounded body and some smaller extensions. The ink blot is solid black, with no internal details visible. The white background is plain and uniform.
PREMARKET NOTIFICATION THFUL AND ACCURATE STATEMEN [As Required by 21 CFR 807.87(j)]
I certify that, in my capacity as manager of Hemostasis Systems Integration of Dade Behring Inc., I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.
William M. Hoover
Manager, Systems Integration
15 May 1998
Date
K981711 Premarket Notification Number
*Must be signed by a responsible person of the firm required to submit the premarket notification (e.g., not a consultant for the 510(k) submitter).
3
2098 Gaither Road Rockville MD 20850
Food and Drug Administration
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
SEP 3 0 1998
Mr. Radames Riesgo Manager Regulatory Affairs DADE Behring, Inc. P.O. Box 520672 Miami, Florida 33152-0672
Re : K981711/S1
Trade Name: Sysmex® Automated Coaqulation Analyzer CA-500 Requlatory Class: II Product Code: JPA Dated: September 4, 1998 Received: September 8, 1998
Dear Mr. Riesgo:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K981711 510(k) Number (if known):
Revis.
Find to
Use
Device Name: Sysmex® Automated Coagulation Analyzer CA-500
Indications For Use:
The intended use of the Sysmex® CA-500 Series is as a compact, fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories. I a
The instrument uses citrated human plasma to perform the following parameters and calculated parameters:
Clotting Analysis Parameters
- Prothrombin Time (PT) .
- Activated Partial Thromboplastin Time (APTT) .
- Fibrinogen (Clauss) .
- Thrombin Time .
Chromogenic Analysis Parameters
-
Antithrombin III ●
Calculated Parameters -
PT Ratio .
-
PT INR .
-
Derived Fibrinogen .
(PLEASE DO NOT WITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rur E. Mahon
nru Dannou
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
00108