(48 days)
Not Found
No
The document does not mention AI, DNN, or ML, and the description focuses on standard automated coagulation analysis techniques.
No
The device is an in vitro diagnostic (IVD) device used in clinical laboratories to analyze blood plasma coagulation, not to treat or directly manage a patient's condition.
Yes
The intended use states it is an "in vitro diagnostic device" used to analyze blood plasma coagulation.
No
The device description explicitly states it is an "automated citrated human plasma coagulation analyzer," indicating it is a physical instrument that performs laboratory tests, 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-6000 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories."
This statement clearly indicates that the device is intended to be used outside of the body (in vitro) for diagnostic purposes in a clinical laboratory setting.
N/A
Intended Use / Indications for Use
The Sysmex® CA-6000 is intended for use as an automated citrated human plasma coagulation analyzer.
The intended use of the Sysmex® CA-6000 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) .
- Thrombin Time .
- Extrinsic Factors (II, V, VII, X) ●
- Intrinsic Factors (VIII, IX, XI, XII) ●
- Batroxobin .
- . Protein C
Chromogenic Analysis Parameters
- Antithrombin III .
- . Plasminogen
- Factor VIII .
Calculated Parameters
- PT Ratio .
- PT INR .
- Protein C .
- Heparin ●
- a2-Antiplasmin .
- Derived Fibrinogen .
- Factor Assays % Activity .
Product codes (comma separated list FDA assigned to the subject device)
GKP
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
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)
Summary of Method Comparison Studies between CA-6000 and BCT
- Test: Factor VIII Chromogenic Assay, Sample Number (n): 92, Coefficient of Correlation (r): 0.931, Regression Equation: Y = 1.02X + 0.96
- Test: α2-Antiplasmin Chromogenic Assay, Sample Number (n): 128, Coefficient of Correlation (r): 0.990, Regression Equation: Y = 1.05X + 5.35
Summary of Precision Studies Sysmex® Automated Coagulation Analyzer CA-6000
- Assay: Factor VIII, Control Level: CPN, n: 40, Mean: 96.1, Within Run %CV: 1.8, Between Run %CV: 4.1, Total %CV: 4.4
- Assay: Factor VIII, Control Level: CPP, n: 40, Mean: 28.7, Within Run %CV: 2.7, Between Run %CV: 3.6, Total %CV: 4.4
- Assay: α2-Antiplasmin, Control Level: CPN, n: 40, Mean: 100.1, Within Run %CV: 2.0, Between Run %CV: 1.2, Total %CV: 2.3
- Assay: α2-Antiplasmin, Control Level: CPP, n: 40, Mean: 41.5, Within Run %CV: 7.1, Between Run %CV: 4.3, Total %CV: 7.9
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.
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.
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K993i74-
NOV - 9 1999
510(k) Summary of Safety and Effectiveness Information Sysmex ® Automated Coagulation Analyzer CA-6000 September 21, 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-6000
| 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-6000 is substantially equivalent in intended use to the Behring Coagulation Timer (BCT), which was previously cleared under Document Control No. K955278. The Sysmex® CA-6000 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-6000 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-6000 and BCT
| Test | Sample
Number
(n) | Coefficient of
Correlation
(r) | Regression
Equation |
|----------------------------------|-------------------------|--------------------------------------|------------------------|
| Factor VIII Chromogenic Assay | 92 | 0.931 | Y = 1.02X + 0.96 |
| α2-Antiplasmin Chromogenic Assay | 128 | 0.990 | Y = 1.05X + 5.35 |
Summary of Precision Studies Sysmex® Automated Coagulation Analyzer CA-6000
| Assay | Control Level | n | Mean | Within
Run %CV | Between
Run %CV | Total %CV |
|----------------|---------------|----|-------|-------------------|--------------------|-----------|
| Factor VIII | CPN | 40 | 96.1 | 1.8 | 4.1 | 4.4 |
| | CPP | 40 | 28.7 | 2.7 | 3.6 | 4.4 |
| α2-Antiplasmin | CPN | 40 | 100.1 | 2.0 | 1.2 | 2.3 |
| | CPP | 40 | 41.5 | 7.1 | 4.3 | 7.9 |
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features the department's name encircling a stylized symbol. The symbol consists of four abstract human profiles facing right, with flowing lines suggesting movement or progress.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 9 1999
Mr. Radames Riesgo Manager, Regulatory Affairs Biology Dade Behring, Inc. 1851 Delaware Parkway Miami, Florida 33125
Re: K993174
Trade Name: Sysmex® Automated Coagulation Analyzer CA-6000 Regulatory Class: II Product Code: GKP Dated: September 21, 1999 Received: September 22, 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.
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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
K9931 24 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Sysmex® Automated Coagulation Analyzer CA-6000
Indications for Use:
The intended use of the Sysmex® CA-6000 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) .
- Thrombin Time .
- Extrinsic Factors (II, V, VII, X) ●
- Intrinsic Factors (VIII, IX, XI, XII) ●
- Batroxobin .
- . Protein C
Chromogenic Analysis Parameters
- Antithrombin III .
- . Plasminogen
-
Factor VIII .
Calculated Parameters
- PT Ratio .
- PT INR .
- Protein C .
- Heparin ●
- a2-Antiplasmin .
- Derived Fibrinogen .
- Factor Assays % Activity .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
isa E. Malini
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 1/693174
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)