SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560

K031377 · Dade Behring, Inc. · GKP · Sep 8, 2003 · Hematology

Device Facts

• Record ID: K031377
• Device Name: SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
• Applicant: Dade Behring, Inc.
• Product Code: GKP · Hematology
• Decision Date: Sep 8, 2003
• 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 coagulation tests.

Device Story

Sysmex CA-500 series is an automated coagulation analyzer for clinical laboratory use. Device performs chromogenic, clotting, and immunological assays on patient plasma samples. System features random access for up to 5 parameters, open tube sampling, and STAT capability. Incubation pipette detects sample surface, aspirates from open tubes, and dispenses into reaction racks. Instrument uses standard commercial plasma for calibration curves and offers two quality control programs (Mean control and L-J control). Sample identification via manual entry, numeric keys, or optional barcode scanner with host computer integration for analysis orders. Output provides quantitative coagulation results to assist clinicians in diagnostic decision-making.

Clinical Evidence

Bench testing only. Performance evaluated via method comparison studies against predicate devices (CA-6000, CA-7000) across multiple assays (PT, APTT, Fibrinogen, D-Dimer). Sample sizes ranged from 243 to 864 per assay. Results showed high correlation (r=0.982–0.999). Precision studies (within-run, between-run, total) demonstrated acceptable performance with %CV < 5%. Additional testing included carryover, interference, and reportable range validation.

Technological Characteristics

Fully automated coagulation analyzer; utilizes clot, chromogenic, and immunological detection principles. Processes citrated human plasma. Supports simultaneous random-access testing for up to five parameters. Software-controlled operation.

Indications for Use

Indicated for use in clinical laboratories for performing coagulation tests on citrated human plasma samples.

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

• Sysmex® Automated Coagulation Analyzer CA-7000 (K020979)
• Sysmex® Automated Coagulation Analyzer CA-6000 (K964139)

Submission Summary (Full Text)

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K031377

Dade Behring Inc. 510(k) Premarket Notification Sysmex® Automated Coagulation Analyzer CA-500

## 510(k) Summary of Safety and Effectiveness Information Sysmex® Automated Coagulation Analyzer CA-500 April 30, 2003

#### MANUFACTURER AND CONTACT INFORMATION I.

| Contact Information: | Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101<br>Attn: Radames Riesgo<br>Phone: [phone]<br>FAX: [phone] | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------|---------|
| 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 |

#### DEVICE NAME AND CLASSIFICATION NAME II.

Trade or Proprietary Name: Sysmex Automated Coagulation Analyzer CA-500

Common or Usual Name: Automated Coagulation System

Coagulation Instrument (21 CFR §864.5400) Classification Name:

## III. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE

Sysmex® Automated Coagulation Analyzer CA-7000 (K020979) Sysmex® Automated Coagulation Analyzer CA-6000 (K964139)

SEP - 8 2003

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#### DEVICE DESCRIPTION IV.

The Sysmex® CA-500 series is a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories. The manufacturer has modified the series to include two new models with immunological testing capability. The proposed Sysmex CA-500 series can now provide accurate and precise test results for up to five parameters simultaneously and in random access. The CA-500 uses clot, chromogenic and immunological detection technologies for determination of the various parameters.

#### DEVICE INTENDED USE V.

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 coagulation tests.

### VI. SUBSTANTIAL EQIVALENCE

The Sysmex® Automated Coagulation Analyzer CA-550 or CA-560 is substantially equivalent in intended use for D-Dimer testing to the Sysmex® Automated Coagulation Analyzer CA-7000, which was cleared under Document Control No. K020979.

The results of PT and APTT parameters using the new software version for the Sysmex® Automated Coagulation Analyzer CA-500 Series are substantially equivalent to the results for PT and APTT parameters obtained with the Sysmex® Automated Coagulation Analyzer CA-6000, which was cleared under Document Control No. K964139.

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# VII. DEVICE PERFORMANCE CHARACTERISTICS

| Test | Predicate<br>Device | Sample<br>Number<br>(n) | Coefficient of<br>Correlation<br>(r) | Regression<br>Equation |
|-----------------------------------------------|---------------------|-------------------------|--------------------------------------|------------------------|
| D-Dimer Assay<br>(Advanced D-Dimer) | CA-7000 | 390 | 0.992 | Y = 1.01X + 0.14 |
| PT, seconds<br>(Thromborel® S) | CA-6000 | 248 | 0.999 | Y = 1.00X - 0.50 |
| PT, INR<br>(Thromborel® S) | CA-6000 | 248 | 0.999 | Y = 0.89X + 0.11 |
| Derived Fibrinogen<br>(Thromborel® S) | CA-6000 | 248 | 0.998 | Y = 1.08X + 0.04 |
| PT, seconds<br>(Innovin®) | CA-6000 | 243 | 0.999 | Y = 1.03X - 0.26 |
| PT, INR<br>(Innovin®) | CA-6000 | 243 | 0.999 | Y = 1.08X - 0.09 |
| Derived Fibrinogen<br>(Innovin®) | CA-6000 | 247 | 0.995 | Y = 1.09X - 0.17 |
| PT, seconds<br>(Thromboplastin C Plus | CA-6000 | 245 | 0.997 | Y = 1.00X - 0.20 |
| PT, INR<br>(Thromboplastin C Plus) | CA-6000 | 245 | 0.998 | Y = 1.00X - 0.00 |
| Derived Fibrinogen<br>(Thromboplastin C Plus) | CA-6000 | 245 | 0.998 | Y = 1.12X + 0.03 |
| APTT<br>(Actin®) | CA-6000 | 864 | 0.982 | Y = 1.00X - 0.20 |
| APTT<br>(Actin® FS) | CA-6000 | 857 | 0.983 | Y = 1.00X + 0.10 |
| APTT<br>(Actin® FSL) | CA-6000 | 864 | 0.990 | Y = 1.00X + 0.10 |

### Summary of Method Comparison Studies between CA-500 and CA-7000 or CA-6000

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| Assay | Control Level | n | Mean | Within<br>Run<br>%CV | Between<br>Run<br>%CV | Total<br>%CV | Max.<br>Error<br>Criteria<br>% CV |
|----------------------------------------------------|------------------------------------------|----|--------------|----------------------|-----------------------|--------------|-----------------------------------|
| PT, Seconds<br>(Thromborel® S) | Control Plasma N<br>Ci-Trol® Level 3 | 40 | 11.9<br>59.2 | 0.7<br>1.1 | 0.7<br>1.0 | 0.9<br>1.5 | 5 |
| PT, INR<br>(Thromborel® S) | Control Plasma N<br>Ci-Trol® Level 3 | 40 | 1.1<br>4.6 | 0.6<br>1.0 | 0.6<br>0.9 | 0.8<br>1.3 | 5 |
| Derived Fibrinogen, g/L<br>(Thromborel® S) | Control Plasma N<br>Path. Plasmapool | 40 | 2.3<br>4.8 | 1.6<br>1.9 | 0.6<br>1.7 | 1.6<br>2.5 | 10 |
| PT, Seconds<br>(Dade® Innovin®) | Control Plasma N<br>Ci-Trol® Level 3 | 40 | 11.5<br>38.0 | 0.4<br>0.9 | 0.2<br>1.5 | 0.4<br>1.8 | 5 |
| PT, INR<br>(Dade® Innovin®) | Control Plasma N<br>Ci-Trol® Level 3 | 40 | 1.1<br>3.7 | 0.4<br>0.9 | 0.2<br>1.6 | 0.4<br>1.8 | 5 |
| Derived Fibrinogen, g/L<br>(Dade® Innovin®) | Control Plasma N<br>Path. Plasmapool | 40 | 1.9<br>5.2 | 2.6<br>3.2 | 1.4<br>1.6 | 2.8<br>3.4 | 10 |
| PT, Seconds<br>(Thromboplastin C Plus) | Control Plasma N<br>Ci-Trol® Level 3 | 40 | 11.5<br>25.9 | 0.4<br>1.0 | 0.2<br>1.5 | 0.4<br>1.8 | 5 |
| PT, INR<br>(Thromboplastin C Plus) | Control Plasma N<br>Ci-Trol® Level 3 | 40 | 1.0<br>5.0 | 0.7<br>1.9 | 0.4<br>3.0 | 0.7<br>3.5 | 5 |
| Derived Fibrinogen, g/L<br>(Thromboplastin C Plus) | Control Plasma N<br>Path. Plasmapool | 40 | 2.5<br>5.0 | 1.5<br>1.6 | 1.3<br>0.6 | 1.9<br>1.6 | 10 |
| APTT<br>(Dade® Actin) | Control Plasma N<br>Ci-Trol® Level 3 | 40 | 26.8<br>57.9 | 1.0<br>0.6 | 3.4<br>1.3 | 3.5<br>1.4 | 5 |
| APTT<br>(Dade® Actin FS) | Control Plasma N<br>Ci-Trol® Level 3 | 40 | 27.1<br>63.8 | 0.5<br>0.3 | 0.2<br>1.5 | 0.5<br>1.5 | 5 |
| APTT<br>(Dade® Actin® FSL) | Control Plasma N<br>Ci-Trol® Level 3 | 40 | 29.3<br>61.4 | 0.4<br>0.4 | 0.2<br>1.4 | 0.4<br>1.5 | 5 |
| D-Dimer<br>(Advanced D-Dimer) | Adv. D-D Control 1<br>Adv. D-D Control 2 | 40 | 5.0<br>20.5 | 2.4<br>1.6 | 1.8<br>1.4 | 2.9<br>2.0 | 15 |

### Summary of Precision Studies Sysmex® Automated Coagulation Analyzer CA-500

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing strokes, symbolizing the department's mission to protect and promote the health and well-being of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.

SEP - 8 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Radames Riesgo Manager, Regulatory Affairs & Compliance Dade Behring Inc. P.O. Box 6101 Newark, DE 19714

Re: k031377 Trade/Device Name: Sysmex® Automated Coagulation Analyzer CA-500 Regulation Number: 21 CFR 864.5400 Regulation Name: Coagulation instrument Regulatory Class: Class II Product Code: GKP Dated: August 7, 2003 Received: August 8, 2003

Dear Mr. Riesgo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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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 coagulation tests.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jourdine Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K0231377

Prescription Use (Per 21 CFR 801.109)

OR

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