SYSMEX CA-6000

K964139 · Dade Intl., Inc. · GKP · Feb 6, 1997 · Hematology

Device Facts

• Record ID: K964139
• Device Name: SYSMEX CA-6000
• Applicant: Dade Intl., Inc.
• Product Code: GKP · Hematology
• Decision Date: Feb 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5400
• Device Class: Class 2

Intended Use

Sysmex® CA-6000 is intended for use as an automated blood plasma coagulation analyzer.

Device Story

Sysmex CA-6000 is an automated coagulation analyzer for clinical laboratory use. It processes blood plasma samples to perform coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen, Thrombin Time, and various clotting factors (VII, VIII, Antithrombin III, Plasminogen). The device automates sample handling and measurement, providing quantitative results to clinicians to assist in diagnosing and monitoring coagulation disorders. It functions as a benchtop laboratory instrument operated by trained laboratory personnel.

Clinical Evidence

Bench-only correlation studies comparing CA-6000 to predicate MLA 1000C. Sample sizes ranged from 118 to 230 per assay. Results showed strong correlation (r=0.888–0.999) for PT, APTT, Fibrinogen, Thrombin Time, and Factors VII, VIII, Antithrombin III, and Plasminogen. No clinical prospective or retrospective patient outcome data provided.

Technological Characteristics

Automated coagulation analyzer; utilizes optical/mechanical sensing principles for clot detection. Benchtop form factor. Designed for clinical laboratory environment. Software-controlled automated processing of plasma samples.

Indications for Use

Indicated for use as an automated blood plasma coagulation analyzer for clinical laboratory testing of patient blood samples to assess coagulation status.

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

• Electra 1000C™ Automatic Coagulation Timer (K894052)

Submission Summary (Full Text)

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K964139
FEB - 6 1997

# 510(k) Summary of Safety and Effectiveness Information
## SYSMEX® Automated Coagulation Analyzer CA-6000
### October 11, 1996

Dade International Inc.
9750 N.W. 25 Street
Miami, FL 33172
Contact Person: Radames Riesgo at 305-392-5615 or by facsimile at 305-392-5622.

**Trade or Proprietary Name:** Sysmex® Automated Coagulation Analyzer CA-6000
**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 |
| *Importer* | |
| Sysmex™ Corporation of America | |
| Gilmer Road 6699 RFD | |
| Long Grove, IL 60047-9596 | 1422681 |
| *Distributor* | |
| Dade International Inc. | |
| 9750 N.W. 25 Street | |
| Miami, FL 33172 | 1025506 |

The Sysmex® CA-6000 is substantially equivalent in intended use and technological characteristics to the Electra 1000C™ Automatic Coagulation Timer, manufactured by Medical Laboratory Automation, Inc., Pleasntville, NY, previously cleared under Document Control No., K894052. Sysmex® CA-6000 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-6000
Attachment C, 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-6000 and MLA 1000C

| Test | Test | Coefficient of variation (r) | Regressed equation |
| --- | --- | --- | --- |
| Prothrombin Time (Dade® Innovin®, seconds) | 119 | 0.997 | Y= 1.02X + 0.4 |
| Prothrombin Time (Dade® Innovin®, INR) | 119 | 0.997 | Y= 1.07X - 0.1 |
| Derived Fibrinogen (Dade® Innovin®) | 139 | 0.988 | Y= 1.03X - 6.2 |
| Prothrombin Time (Dade® Thromboplastin C Plus, seconds) | 133 | 0.983 | Y= 1.02X - 0.1 |
| Prothrombin Time (Dade® Thromboplastin C Plus, INR) | 133 | 0.984 | Y= 1.02X - 0.1 |
| Derived Fibrinogen (Dade® Thromboplastin C Plus) | 126 | 0.992 | Y=0.76X +63.9 |
| Activated Partial Thromboplastin Time | 128 | 0.971 | Y= 1.00X + 1.7 |
| Fibrinogen (Clauss) | 230 | 0.984 | Y= 0.98X -15.0 |
| Thrombin Time | 148 | 0.888 | Y= 1.98X - 5.0 |
| Factor VII (Dade® Innovin®) | 130 | 0.987 | Y= 0.97X - 2.2 |
| Factor VII (Dade® Thromboplastin C Plus) | 131 | 0.979 | Y= 0.94X - 4.4 |
| Factor VIII | 118 | 0.973 | Y= 1.04X - 2.2 |
| Antithrombin III | 132 | 0.980 | Y= 0.98X + 0.6 |
| Plasminogen | 158 | 0.999 | Y= 1.03X - 0.7 |