SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000

K020979 · Dade Behring, Inc. · GKP · Jun 27, 2002 · Hematology

Device Facts

• Record ID: K020979
• Device Name: SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
• Applicant: Dade Behring, Inc.
• Product Code: GKP · Hematology
• Decision Date: Jun 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5400
• Device Class: Class 2

Intended Use

The intended use of the Sysmex® CA-7000 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

The Sysmex CA-7000 is a fully automated, computerized coagulation analyzer designed for clinical laboratory use. It processes citrated human plasma samples to perform various coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen, and specific factor/chromogenic assays. The device automates sample handling and measurement, providing quantitative results that assist clinicians in evaluating patient coagulation status and managing pathological conditions. Healthcare providers use the output to inform clinical decision-making regarding patient hemostasis and therapeutic monitoring. The system functions as a high-throughput diagnostic tool, replacing manual or semi-automated methods to improve laboratory efficiency and result consistency.

Clinical Evidence

Clinical correlation studies compared the CA-7000 against predicate devices (CA-6000 and BCS) using patient samples (n=104 to 381 per assay). Results showed strong correlation (r=0.953 to 0.999). Precision studies (n=40 per control level) demonstrated robust performance with total CVs generally <5% for most assays, with some reaching up to 9.2% for specific heparin controls. No clinical outcomes data provided; evidence is based on analytical method comparison and precision testing.

Technological Characteristics

Automated coagulation analyzer; utilizes citrated human plasma; performs coagulometric and chromogenic assays; computerized processing; high-throughput clinical laboratory form factor; in vitro diagnostic use.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories to perform coagulation tests on citrated human plasma samples from patients requiring coagulation assessment.

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-6000 (K964139, K992321, K993174, K001145)
• Behring Coagulation System (BCS™ System) (K970431, K000973)

Submission Summary (Full Text)

{0}------------------------------------------------

16 2099

## 510(k) Summary of Safety and Effectiveness Information Sysmex® Automated Coagulation Analyzer CA-7000 March 26, 2002

Dade Behring Inc. 13251 NW 9th Terrace Miami, FL 33182 Contact Person: Radames Riesgo at 305.480.7558 or by facsimile at 305.552.5288

JUN 2 7 2002

| Trade or Proprietary Name: Sysmex® Automated Coagulation Analyzer CA-7000 | | | | | |
|----------------------------------------------------------------------------|--|--|--|--|--|
|----------------------------------------------------------------------------|--|--|--|--|--|

| Common or Usual Name: | Automated Coagulation System | |
|-----------------------|--------------------------------------------------------------------------------------------|---------|
| 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 |
| | Distributer<br>Dade Behring Inc.<br>Glasgow Site<br>P.O. Box 6101<br>Newark, DE 19714-6101 | 2517506 |

The CA-7000 is substantially equivalent in intend use and technological characteristics to the Sysmex® Automated Coagulation Analyzer CA-6000, Sysmex Corporation, Kobe, Japan, which was cleared by FDA under Document Control Nos. K964139, K992321, K993174 and K001145; or the Behring Coagulation System (BCS™ System), Dade Behring, Marburg, Germany, which was cleared by FDA under Document Control Nos. K970431 and K000973.

As demonstrated by clinical correlation studies, the performance claims of the proposed device are similar to the predicate devices. 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 summaries show the results of the comparison studies between the proposed and the predicate devices as well as the results of of the precision studies performed with the CA-7000 analyzer.

{1}------------------------------------------------

| Test | Predicate<br>Device | Sample<br>Number<br>(n) | Coefficient of<br>Correlation<br>(r) | Regression<br>Equitation |
|-------------------------------------------------|---------------------|-------------------------|--------------------------------------|--------------------------|
| Prothrombin Time<br>(Innovin®, seconds) | CA-6000 | 155 | 0.999 | Y = 0.97X + 0.38 |
| Prothrombin Time<br>(Innovin®, INR) | CA-6000 | 155 | 0.999 | Y = 0.95X + 0.04 |
| Prothrombin Time<br>(Thromborel® S, seconds) | BCS | 174 | 0.997 | Y = 1.09X - 1.54 |
| Prothrombin Time<br>(Thromborel® S, % PT) | BCS | 168 | 0.984 | Y = 0.98X - 3.40 |
| Derived Fibrinogen | CA-6000 | 104 | 0.991 | Y = 1.02X + 0.12 |
| Activated Partial<br>Thromboplastin Time | CA-6000 | 151 | 0.997 | Y = 1.03X - 0.01 |
| Fibrinogen (Clauss) | CA-6000 | 134 | 0.994 | Y = 0.91X + 0.05 |
| Factor VII | BCS | 124 | 0.993 | Y = 1.14X - 2.66 |
| Factor VIII | BCS | 143 | 0.977 | Y = 1.10X - 4.46 |
| Protein C, coagulometric | BCS | 139 | 0.994 | Y = 1.14X - 4.77 |
| Thrombin Time | CA-6000 | 381 | 0.981 | Y = 0.78X + 2.72 |
| Batroxobin Time | BCS | 169 | 0.987 | Y = 1.02X + 0.75 |
| Lupus Anticoagulant<br>LA1 Screening Reagent | CA-6000 | 136 | 0.996 | Y = 0.92X - 1.25 |
| Lupus Anticoagulant<br>LA2 Confirmation Reagent | CA-6000 | 136 | 0.953 | Y = 0.66X + 10.59 |
| Lupus Anticoagulant<br>LA1/LA2 Ratio | CA-6000 | 136 | 0.987 | Y = 1.00X - 0.08 |
| Antithrombin III | BCS | 166 | 0.997 | Y = 0.96X - 1.07 |
| Heparin, chromogenic | BCS | 115 | 0.982 | Y = 1.02X + 0.01 |
| Plasminogen, chromogenic | BCS | 142 | 0.994 | Y = 0.96X + 0.55 |
| a2- Antiplasmin,<br>chromogenic | BCS | 144 | 0.982 | Y = 0.95X + 3.18 |
| Protein C, chromogenic | BCS | 156 | 0.996 | Y = 0.98X - 0.63 |
| Factor VIII, chromogenic | BCS | 136 | 0.990 | Y = 1.10X - 1.52 |

#### Summary of Method Comparison Studies Between CA-6000 or BCS

- --

{2}------------------------------------------------

| Assay | Control Level | n | mean | Within<br>Run<br>%CV | Between<br>Run<br>%CV | Total<br>%CV |
|---------------------------------------------------------------------------|-------------------------------------------------------------------|----------|---------------|----------------------|-----------------------|--------------|
| Prothrombin Time | Control Plasma N | 40 | 11.9 | 0.4 | 0.2 | 0.4 |
| (Dade® Innovin® Reagent, seconds) | Ci-Trol®Control Level3 | 40 | 37.2 | 0.5 | 2.0 | 2.1 |
| Prothrombin Time | Control Plasma N | 40 | 1.1 | 0.4 | 0.2 | 0.4 |
| (Dade® Innovin® Reagent, INR) | Ci-Trol®Control Level3 | 40 | 3.4 | 0.5 | 2.1 | 2.1 |
| Prothrombin Time | Control Plasma N | 40 | 12.0 | 0.4 | 0.5 | 0.6 |
| (Thromborel®S Reagent, seconds) | Control Plasma P | 40 | 25.1 | 0.9 | 1.1 | 1.4 |
| Prothrombin Time | Control Plasma N | 40 | 91.9 | 0.6 | 0.6 | 0.8 |
| (Thromborel®S Reagent, % of norm) | Control Plasma P | 40 | 36.1 | 1.0 | 1.2 | 1.5 |
| Derived Fibrinogen | Control Plasma N | 40 | 1.9 | 5.4 | 2.2 | 5.5 |
| (Dade® Innovin® Reagent, g/L) | Path. plasmapool | 40 | 5.7 | 3.2 | 1.3 | 3.3 |
| Activated Partial Thromboplastin Time | Control Plasma N | 40 | 29.6 | 0.7 | 0.3 | 0.7 |
| (Dade® Actin® FSL Reagent, seconds) | Ci-Trol®Control Level3 | 40 | 70.4 | 0.6 | 0.4 | 0.7 |
| Fibrinogen (Clauss) | Control Plasma N | 40 | 2.5 | 1.4 | 0.7 | 1.5 |
| (Dade® Thrombin Reagent, g/L) | Control Plasma P | 40 | 0.9 | 2.5 | 1.2 | 2.6 |
| Factor VII | Control Plasma N | 40 | 99.7 | 2.4 | 3.4 | 4.1 |
| (Dade® Innovin® Reagent) | Control Plasma P | 40 | 31.5 | 1.7 | 2.4 | 2.8 |
| Factor VIII | Control Plasma N | 40 | 104.6 | 6.5 | 5.2 | 8.1 |
| (Dade® Actin® FSL Reagent) | Control Plasma P | 40 | 33.8 | 5.9 | 3.9 | 6.8 |
| Protein C Coagulometric | Control Plasma N | 40 | 112.5 | 3.2 | 1.2 | 3.2 |
| (Portein C Reagent, % of norm) | Control Plasma P | 40 | 40.9 | 4.3 | 2.4 | 4.6 |
| Thrombin Time | Control Plasma N | 40 | 16.5 | 0.6 | 1.1 | 1.3 |
| (Test Thrombin Reagent, seconds) | Path. plasmapool | 40 | 19.7 | 3.5 | 4.4 | 5.5 |
| Assay | Control Level | n | Mean | Within<br>Run<br>%CV | Between<br>Run<br>%CV | Total<br>%CV |
| Batroxobin Time<br>(Batroxobin Reagent, seconds) | Control Plasma N<br>Path. plasmapool | 40<br>40 | 20.1<br>58.3 | 1.1<br>1.2 | 0.6<br>0.7 | 1.2<br>1.4 |
| Lupus Anticoagulant<br>(LA1 Screening Reagent)<br>(seconds) | Control Plasma N<br>LA Control High | 40<br>40 | 36.1<br>90.6 | 1.6<br>1.5 | 2.7<br>1.5 | 3.1<br>2.1 |
| Lupus Anticoagulant<br>(LA2 Confirmation Reagent)<br>(seconds) | Control Plasma N<br>LA Control High | 40<br>40 | 34.6<br>40.4 | 1.0<br>1.0 | 0.4<br>0.9 | 1.0<br>1.3 |
| Lupus Anticoagulant<br>(LA1 / LA2)<br>(ratio) | Control Plasma N<br>LA Control High | 40<br>40 | 1.04<br>2.24 | 1.0<br>1.2 | 2.5<br>0.9 | 2.7<br>1.5 |
| Antithrombin III<br>(Berichrom™ Antithrombin III (A)<br>Reagent) | Control Plasma N<br>Control Plasma P | 40<br>40 | 92.6<br>31.7 | 1.6<br>1.8 | 0.7<br>0.7 | 1.7<br>1.9 |
| Heparin<br>(Berichrom™ Heparin Reagent) | Ci-Trol®Heparin<br>Control Low<br>Ci-Trol®Heparin<br>Control High | 40<br>40 | 0.06<br>0.22 | 7.3<br>1.9 | 6.1<br>2.1 | 9.2<br>2.8 |
| Plasminogen<br>(Berichrom™ Plasminogen Reagent)<br>(% of norm) | Control Plasma N<br>Control Plasma P | 40<br>40 | 101.4<br>34.6 | 1.2<br>1.3 | 1.4<br>2.5 | 1.8<br>2.8 |
| α2-Antiplasmin<br>(Berichrom™ α2-Antiplasmin<br>Reagent)<br>(% of norm) | Control Plasma N<br>Control Plasma P | 40<br>40 | 98.8<br>35.4 | 1.5<br>3.2 | 0.9<br>1.8 | 1.7<br>3.5 |
| Protein C,<br>(Berichrom™ Protein C Reagent)<br>(% of norm) | Control Plasma N<br>Control Plasma P | 40<br>40 | 101.9<br>33.3 | 1.7<br>2.7 | 0.8<br>2.4 | 1.8<br>3.5 |
| Factor VIII Chromogenic<br>(Factor VIII Chromogenic Assay)<br>(% of norm) | Control Plasma N<br>Control Plasma P | 40<br>40 | 107.5<br>29.6 | 1.7<br>1.4 | 3.8<br>2.4 | 4.2<br>2.8 |

### Summary of Precision Studies Sysmex® Automated Coagulation Analyzer CA-7000

{3}------------------------------------------------

(

## Summary of Precision Studies (Continued) Sysmex® Automated Coagulation Analyzer CA-7000

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 7 2002

Mr. Radames Riesgo Manager, Regulatory Affairs and Compliance Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, DE 19714-6101

Re: k020979

> Trade/Device Name: Sysmex® Automated Coagulation Analyzer CA-7000 Regulation Number: 21 CFR 864.5400 Regulation Name: Coagulation Instrument Regulatory Class: Class II Product Code: GKP Dated: June 21, 2002 Received: June 24, 2002

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, 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 (PMA), 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 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{5}------------------------------------------------

. . 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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsmaldsmamain.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

{6}------------------------------------------------

# 510(k) Number (if known): _ K O&O 979

Device Name: Sysmex® Automated Coagulation Analyzer CA-7000

#### Indications for Use:

The intended use of the Sysmex® CA-7000 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)

Josephine Bautista

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

Prescription Use (Per 21 CFR 801.109)

OR

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