SYSMEX CA-1000/SYSMEX CA-5000

K964946 · Sysmex Corp. · JPA · Mar 18, 1997 · Hematology

Device Facts

• Record ID: K964946
• Device Name: SYSMEX CA-1000/SYSMEX CA-5000
• Applicant: Sysmex Corp.
• Product Code: JPA · Hematology
• Decision Date: Mar 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

Sysmex® CA-1000 & CA-5000 are intended for use as automated blood plasma coagulation analyzers.

Device Story

Sysmex CA-1000 and CA-5000 are automated coagulation analyzers used in clinical laboratories. Devices process blood plasma samples to perform coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (Clauss and Derived), and Factor VII/VIII assays. Systems utilize automated detection methods to measure coagulation parameters. Results are provided to clinicians to assist in diagnosing and monitoring patients with coagulation disorders or pathological conditions. Devices are operated by trained laboratory personnel. Clinical utility involves comparing results against established predicate versions to ensure analytical performance consistency.

Clinical Evidence

Clinical study evaluated ~40 plasma samples per analyte from healthy individuals and patients with pathological conditions. Method comparison between previous and proposed software versions showed high correlation: PT (r=0.999), APTT (r=0.978), Fibrinogen (r=0.995), Derived Fibrinogen (r=0.951), Factor VII (r=0.996), Factor VIII (r=0.995), and Thrombin Time (r=0.951).

Technological Characteristics

Automated coagulation analyzer; optical/mechanical sensing principle for clot detection. System performs plasma-based coagulation assays. Software-controlled operation. No specific materials or connectivity standards provided.

Indications for Use

Indicated for use as automated blood plasma coagulation analyzers for clinical laboratory testing of plasma samples from healthy individuals and patients with pathological conditions affecting coagulation assays.

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-1000 (K931149/A)
• Sysmex CA-5000 (K933886)
• Sysmex CA-1000 (K942096/S1)
• Sysmex CA-5000 (K942097/S1)

Submission Summary (Full Text)

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K964946
MAR 18 1997

# ATTACHMENT D

## 510(k) Summary of Safety and Effectiveness Information

016

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# 510(k) Summary of Safety and Effectiveness Information
510(k) Additional Information - Premarket Notification

Sysmex® Automated Coagulation Analyzer CA-1000
Sysmex® Automated Coagulation Analyzer CA-5000
December 9, 1996

Sysmex Corporation of America
Gilmer Road 6699 RFD
Long Grove, IL 60047
Contact Person: Margaret Barranco at [phone], or by facsimile at [phone].

**Trade or Proprietary Name:** Sysmex® Automated Coagulation Analyzer CA-1000
Sysmex® Automated Coagulation Analyzer CA-5000

**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

The Sysmex® CA-1000, software version 24 and CA-5000, software version 13 are substantially equivalent to the Sysmex® CA-1000 and CA-5000, K931149/A, K933886, K942096/S1 and K942097/S1, which were originally cleared to market on November 3, 1993 and January 27, 1994, respectively.

Sysmex® CA-1000 & CA-5000 are intended for use as automated blood plasma coagulation analyzers. The systems were described in details in premarket notifications, document control numbers: K931149/A, K933886, K942096/S1 and K942097/S1. The devices belong to the same family of instruments and they are equivalent in their technological features and performance.

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510(k) Additional Information - Premarket Notification
Sysmex® Automated Coagulation Analyzer CA-1000
Sysmex® Automated Coagulation Analyzer CA-5000
Attachment D, Page 2

The technological characteristics of the predicate device are similar to those previously described for the proposed devices.

In a clinical study, plasma samples with each representative analyte of the core coagulation assays were evaluated by the proposed and the predicate device. This group, which represented approximately even numbers of males and females, consisted of approximately 40 samples.

In this clinical study, the following comparative performance evaluations were conducted using the current and the proposed software versions to evaluate specimens from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay:

Summary of Method Comparison Evaluations
Software Version 21 versus Software Version 24

| Test | Sample Number (n) | Coefficient of Correlation (r) | Regression Equation |
| --- | --- | --- | --- |
| Prothrombin Time (PT), seconds | 39 | 0.999 | Y = 0.97X + 0.1 |
| Activated Partial Thromboplastin Time (APTT), seconds | 37 | 0.978 | Y = 0.99X + 0.7 |
| Fibrinogen (Clauss), mg/dL | 41 | 0.995 | Y = 0.96X + 10.4 |
| Derived Fibrinogen | 19 | 0.951 | Y = 1.02X - 9.8 |
| Factor VII Assay | 49 | 0.996 | Y = 0.95X + 1.0 |
| Factor VIII Assay | 38 | 0.995 | Y = 0.92X + 0.6 |
| Thrombin Time | 42 | 0.951 | Y = 1.00X - 0.3 |