SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500

K992763 · Dade Behring, Inc. · GKP · Sep 21, 1999 · Hematology

Device Facts

• Record ID: K992763
• Device Name: SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
• Applicant: Dade Behring, Inc.
• Product Code: GKP · Hematology
• Decision Date: Sep 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5400
• Device Class: Class 2

Intended 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 .

Device Story

Sysmex CA-500 is a fully automated, computerized blood plasma coagulation analyzer for clinical laboratory use. Device accepts citrated human plasma samples; performs clotting and chromogenic assays to measure coagulation parameters (e.g., PT, APTT, Fibrinogen, Factor assays). Instrument automates sample processing and analysis; provides quantitative results for clinical decision-making regarding patient coagulation status. Healthcare providers use output to monitor hemostasis and manage anticoagulant therapy.

Clinical Evidence

Bench testing only. Method comparison studies performed using clinical specimens from healthy individuals and patients with pathological conditions. Comparison of CA-500 against BCT predicate showed correlation (r) of 0.976 for Factor VII (n=80) and 0.960 for Factor VIII (n=94).

Technological Characteristics

Automated coagulation analyzer; utilizes citrated human plasma. Performs clotting and chromogenic analysis. Computerized system for automated measurement and calculation of coagulation parameters. Standalone clinical laboratory instrument.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories to perform coagulation and chromogenic analysis on citrated human plasma samples from patients requiring assessment of clotting parameters, including PT, APTT, Fibrinogen, and various coagulation factors.

Regulatory Classification

Identification

A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

Special Controls

*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.

Predicate Devices

• Behring Coagulation Timer (BCT) (K955278)

Submission Summary (Full Text)

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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 Site<br>Sysmex Corporation<br>Kobe, Japan | 9613959 |
| | Importer<br>Sysmex Corporation of America<br>One Wildlife Way<br>Long Grove, IL 60047-9596 | 1422681 |
| | Distributor<br>Dade Behring Inc.<br>Glasgow Site<br>P.O. Box 6101<br>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. 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 | Sample<br>Number<br>(n) | Coefficient of<br>Correlation<br>(r) | Regression<br>Equation |
|-------------------------|-------------------------|--------------------------------------|------------------------|
| 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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## 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 [phone].

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 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)

OR

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