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) .
Batroxobin .
Protein C .
Heparin

· Thrombin Time
Extrinsic Factors (II, V, VII, X) .
Intrinsic Factors (VIII, IX, XI, XII) .

Chromogenic Analysis Parameters

Antithrombin III .
. Protein C

Calculated Parameters

PT Ratio ●
. PT INR
. Derived Fibrinogen
Factor Assays % Activity .

Device Description

The Sysmex® CA-500 is intended for use as an automated blood plasma coagulation analyzer.

AI/ML Overview

The Sysmex® Automated Coagulation Analyzer CA-500 is intended for use as an automated blood plasma coagulation analyzer. The device's performance was compared to a predicate device, the Behring Coagulation Timer (BCT).

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes "in-house correlation studies" to demonstrate that the performance claims of the proposed device are similar to the predicate device. The acceptance criteria can be inferred from the reported performance, which shows high correlation coefficients (r ≥ 0.960) between the CA-500 and the BCT for the measured coagulation factors.

Test	Acceptance Criteria (Implied)	Reported Device Performance (Coefficient of Correlation (r))	Regression Equation
Coagulation Factor VII	Sufficiently high correlation with predicate device (r > X)	0.976	Y = 0.97X – 1.55
Coagulation Factor VIII	Sufficiently high correlation with predicate device (r > X)	0.960	Y = 1.00X + 3.71

Note: The specific numerical acceptance criteria (e.g., r > 0.95) are not explicitly stated in the provided text but are inferred from the reported strong correlations.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size (Test Set):
- Coagulation Factor VII: 80 specimens
- Coagulation Factor VIII: 94 specimens
Data Provenance: The 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 country of origin is not specified but the manufacturing site is Kobe, Japan, and the distributor is Dade Behring Inc. in Newark, DE, USA. The studies are described as "in-house correlation studies," suggesting they were conducted by the manufacturer or a contracted entity. The data is prospective, as samples were "evaluated" during these studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not mention the use of experts to establish ground truth in the context of the correlation studies. The ground truth for the device's performance is established by comparison to a predicate device, the Behring Coagulation Timer (BCT), rather than an independent expert consensus on patient conditions.

4. Adjudication Method for the Test Set:

Not applicable. The study is a method comparison study between the proposed device and a predicate device, not an assessment requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The study focuses on the analytical performance of the device compared to a predicate device, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, the study describes the standalone performance of the Sysmex® Automated Coagulation Analyzer CA-500 in comparison to the predicate device. It evaluates the device's ability to measure coagulation factors.

7. The Type of Ground Truth Used:

The "ground truth" for this study is the measurements obtained from the predicate device, the Behring Coagulation Timer (BCT). The study assesses the correlation and agreement of the Sysmex CA-500 with a previously cleared device, not against absolute pathological or outcomes data independent of a measurement instrument.

8. The Sample Size for the Training Set:

The document does not mention a "training set" as this is not an AI/machine learning device that would typically undergo a training phase. It is an automated coagulation analyzer being evaluated for substantial equivalence to a predicate device based on its analytical performance.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no mention of a training set for this device in the provided text.

Summary

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SEP 2 1 1999

510(k) Summary of Safety and Effectiveness Information Sysmex ® Automated Coagulation Analyzer CA-500 August 16, 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 SiteSysmex CorporationKobe, Japan	9613959
	ImporterSysmex Corporation of AmericaOne Wildlife WayLong Grove, IL 60047-9596	1422681
	DistributorDade Behring Inc.Glasgow SiteP.O. Box 6101Newark, 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. The Sysmex® CA-500 is intended for use as an automated blood plasma coagulation analyzer.

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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	SampleNumber(n)	Coefficient ofCorrelation(r)	RegressionEquation
Coagulation Factor VII	80	0.976	Y = 0.97X – 1.55
Coagulation Factor VIII	94	0.960	Y = 1.00X + 3.71

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

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: K992763

Trade Name: Sysmex® Automated Coagulation Analyzer CA-500 Regulatory Class: II Product Code: GKP, JPA Dated: August 16, 1999 Received: August 17, 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

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K 992763 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) .
Batroxobin .
Protein C .
Heparin

· Thrombin Time
Extrinsic Factors (II, V, VII, X) .
Intrinsic Factors (VIII, IX, XI, XII) .

Chromogenic Analysis Parameters

Antithrombin III .
. Protein C

Calculated Parameters

PT Ratio ●
. PT INR
. 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)

Peter E. Mafini

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993763

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

Regulation Number and Section

§ 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.