SYSMEX AUTOMATED COAGULATION ANALYZER CA-500

K981711 · Dade Behring, Inc. · JPA · Sep 30, 1998 · Hematology

Device Facts

• Record ID: K981711
• Device Name: SYSMEX AUTOMATED COAGULATION ANALYZER CA-500
• Applicant: Dade Behring, Inc.
• Product Code: JPA · Hematology
• Decision Date: Sep 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended 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 .

Device Story

Sysmex CA-500 is a compact, fully automated, computerized blood plasma coagulation analyzer for clinical laboratory use. Device processes citrated human plasma samples to perform clotting and chromogenic assays. Principle of operation involves automated analysis of coagulation parameters; system calculates PT Ratio, PT INR, and Derived Fibrinogen. Healthcare providers use output to assess patient coagulation status and manage pathological conditions. Device benefits include automated, high-throughput testing compared to manual methods, providing rapid, standardized results for clinical decision-making.

Clinical Evidence

Bench testing only. Comparative performance evaluation conducted against the predicate CA-6000 analyzer using 104-131 samples per assay. Results demonstrated high correlation (r values ranging from 0.806 to 0.997) across Prothrombin Time, APTT, Fibrinogen, Thrombin Time, and Antithrombin III assays.

Technological Characteristics

Compact, fully automated, computerized coagulation analyzer. Uses citrated human plasma. Performs clotting and chromogenic analysis. Connectivity and specific material standards not detailed. Software-controlled automated processing.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories to perform coagulation and chromogenic analysis on citrated human plasma samples. Parameters include PT, APTT, Fibrinogen (Clauss), Thrombin Time, and Antithrombin III, plus calculated PT Ratio, PT INR, and Derived Fibrinogen.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Sysmex CA-6000 analyzer (K964139)

Submission Summary (Full Text)

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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

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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<br>Number<br>(n) | Coefficient of<br>Correlation<br>(r) | Regression<br>Equation |
|-------------------------------------------------------------|-------------------------|--------------------------------------|------------------------|
| Prothrombin Time<br>(Dade® Innovin®, seconds) | 111 | 0.991 | Y = 0.98X + 0.3 |
| Prothrombin Time<br>(Dade® Innovin®, INR) | 111 | 0.991 | Y = 0.99X + 0.03 |
| Derived Fibrinogen<br>(Dade® Innovin®) | 104 | 0.983 | Y = 0.78X + 31.2 |
| Prothrombin Time<br>(Dade® Thromboplastin C Plus, seconds) | 131 | 0.997 | Y = 1.00X + 0.02 |
| Prothrombin Time<br>(Dade® Thromboplastin C Plus, INR) | 131 | 0.997 | Y = 1.00X + 0.01 |
| Derived Fibrinogen<br>(Dade® Thromboplastin C Plus) | 131 | 0.979 | Y = 0.92X + 20.2 |
| Prothrombin Time<br>(Thromborel® S, seconds) | 119 | 0.990 | Y = 0.99X + 0.2 |
| Prothrombin Time<br>(Thromborel® S, INR) | 119 | 0.989 | Y = 1.00X + 0.01 |
| Derived Fibrinogen<br>(Thromborel® S) | 115 | 0.985 | Y = 0.86X + 29.2 |
| Activated Partial Thromboplastin Time<br>(Dade® Actin®) | 114 | 0.997 | Y = 1.00X - 0.3 |
| Activated Partial Thromboplastin Time<br>(Dade® Actin® FSL) | 116 | 0.997 | Y = 1.01 X - 0.01 |
| Activated Partial Thromboplastin Time<br>(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

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## 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).

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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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)

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