(62 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a standard automated coagulation analyzer performing predefined tests and calculations.
No
The device is an in vitro diagnostic (IVD) blood analyzer used to measure coagulation parameters. It is used for diagnosis and monitoring, not for therapy.
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 "fully automated, computerized blood plasma coagulation analyzer," indicating it is a physical instrument with hardware components, not solely software.
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."
N/A
Intended Use / Indications for Use
The Sysmex® CA-500 is intended for use as an automated citrated human plasma coagulation analyzer.
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 the following parameters and calculated parameters:
Clotting Analysis Parameters
- Prothrombin Time (PT)
- Activated Partial Thromboplastin Time (APTT)
- Fibrinogen (Clauss)
Chromogenic Analysis Parameters - Antithrombin III
- Protein C
Calculated Parameters - PT Ratio
- PT INR
- Batroxobin
- Protein C
- Heparin
- Derived Fibrinogen
Product codes (comma separated list FDA assigned to the subject device)
GKP, JPA
Device Description
Not Found
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)
Method Comparison Studies between CA-500 and BCT:
Test: Batroxobin, Sample Number (n): 183, Coefficient of Correlation (r): 0.984, Regression Equation: Y = 0.77X + 5.66
Test: Protein C, Chromogenic, Sample Number (n): 114, Coefficient of Correlation (r): 0.963, Regression Equation: Y = 1.05X - 1.02
Test: Heparin, Chromogenic, Sample Number (n): 53, Coefficient of Correlation (r): 0.977, Regression Equation: Y = 0.92X - 0.01
Summary of Method Comparison Studies between CA-500 and BFA:
Test: Protein C. Coagulometric, Correlation: 0.974, Coefficient of Regression: = = 1.02X -
Summary of Precision Studies Sysmex® Automated Coagulation Analyzer CA-500:
Assay: Batroxobin Time; Control Level: CPN; n: 40; Mean: 19.0; Within Run %CV: 1.0; Between Run %CV: 1.2; Total %CV: 1.5
Assay: Batroxobin Time; Control Level: Pool Plasma 2; n: 40; Mean: 44.5; Within Run %CV: 1.9; Between Run %CV: 0.7; Total %CV: 1.9
Assay: Protein C Coagulometric; Control Level: CPN; n: 40; Mean: 94.4; Within Run %CV: 4.8; Between Run %CV: 3.6; Total %CV: 5.8
Assay: Protein C Coagulometric; Control Level: CPP; n: 40; Mean: 33.5; Within Run %CV: 9.0; Between Run %CV: 6.2; Total %CV: 10.4
Assay: Protein C Chromogenic; Control Level: CPN; n: 40; Mean: 93.2; Within Run %CV: 1.6; Between Run %CV: 1.0; Total %CV: 1.8
Assay: Protein C Chromogenic; Control Level: CPP; n: 40; Mean: 30.9; Within Run %CV: 3.6; Between Run %CV: 1.4; Total %CV: 3.6
Assay: Heparin; Control Level: Ci-Trol Hep Hi; n: 32; Mean: 0.4; Within Run %CV: 4.0; Between Run %CV: 5.2; Total %CV: 6.4
Assay: Heparin; Control Level: Ci-Trol Hep Lo; n: 32; Mean: 0.2; Within Run %CV: 5.6; Between Run %CV: 4.7; Total %CV: 7.1
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
§ 864.5400 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
SEP 2 1 1999
510(k) Summary of Safety and Effectiveness Information Sysmex ® Automated Coagulation Analyzer CA-500 July 20, 1999
Dade Behring Inc. 1851 Delaware Parkway Miami, FL 33125 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 | |
| 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 |
The Sysmex® CA-500 is substantially equivalent in intended use to the Behring Coagulation Timer (BCT), which was previously cleared under Document Control No. K955278; or to the Behring Fibrintimer A (BFA), which was previously cleared under Document Control Nos. K924124 and K926551. The Sysmex® CA-500 is intended for use as an automated citrated human plasma coagulation analyzer.
1
510(k) Summary of Safety and Effectiveness Information Sysmex® Automated Coagulation Analyzer CA-500 Attachment 4, 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.
Summary of Method Comparison Studies between CA-500 and BCT
| Test | Sample
Number
(n) | Coefficient of
Correlation
(r) | Regression
Equation |
|------------------------|-------------------------|--------------------------------------|------------------------|
| Batroxobin | 183 | 0.984 | Y = 0.77X + 5.66 |
| Protein C, Chromogenic | 114 | 0.963 | Y = 1.05X - 1.02 |
| Heparin, Chromogenic | 53 | 0.977 | Y = 0.92X - 0.01 |
Summary of Method Comparison Studies between CA-500 and BFA
| I est | 11/1 37 1 12 12 12 12 12 12 12 12 12
. | Sample
Number | Correlation | Coefficient of Regression &
And and the mail of the mail of the mail of the mail of the mail of the mail of the mail of the mail of the mail of the states of the states of the states of the states of th
Courtion |
|--------------------------|-------------------------------------------|------------------|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Protein C. Coagulometric | | | 0.974 | = = 1.02X - |
Summary of Precision Studies Sysmex® Automated Coagulation Analyzer CA-500
| Assay | Control Level | n | Mean | Within
Run %CV | Between
Run %CV | Total
%CV |
|---------------------------------------|----------------|----|------|-------------------|--------------------|--------------|
| Batroxobin Time | CPN | 40 | 19.0 | 1.0 | 1.2 | 1.5 |
| (Batroxobin Reagent, sec) | Pool Plasma 2 | 40 | 44.5 | 1.9 | 0.7 | 1.9 |
| Protein C Coagulometric | CPN | 40 | 94.4 | 4.8 | 3.6 | 5.8 |
| (Protein C Reagent, Coagulometric, %) | CPP | 40 | 33.5 | 9.0 | 6.2 | 10.4 |
| Protein C Chromogenic | CPN | 40 | 93.2 | 1.6 | 1.0 | 1.8 |
| (Berichrom Protein C, %) | CPP | 40 | 30.9 | 3.6 | 1.4 | 3.6 |
| Heparin | Ci-Trol Hep Hi | 32 | 0.4 | 4.0 | 5.2 | 6.4 |
| (Berichrom Heparin, IU/ml) | Ci-Trol Hep Lo | 32 | 0.2 | 5.6 | 4.7 | 7.1 |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle.
SEP 2 1 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Radames Riesgo Manager, Regulatory Affairs Biology Dade Behring, Inc. 1851 Delaware Parkway Miami, Florida 33125
Re: K992423
Trade Name: Sysmex® Automated Coagulation Analyzer CA-500 Regulatory Class: II Product Code: GKP, JPA Dated: August 25, 1999 Received: August 26, 1999
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, Drug, 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 Regulations, 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.
3
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 Sutman
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
4
K992423 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 the following parameters and calculated parameters:
Clotting Analysis Parameters
- Prothrombin Time (PT) ●
- Activated Partial Thromboplastin Time (APTT) .
- Fibrinogen (Clauss) .
Chromogenic Analysis Parameters
- Antithrombin III ●
- Protein C t
Calculated Parameters
- PT Ratio .
- PT INR ●
- Batroxobin .
- Protein C ●
- Heparin .
- Derived Fibrinogen .
(PLEASE DO NOT WITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jha Khan
7/20/99
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number -
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)