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

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.

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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
K031377

B. Instrument Name:
Sysmex® Automated Coagulation Analyzer CA-500 (series)

C. System Descriptions:

1. Modes of Operation:
Random access of up to 5 parameters, open tube, STAT

2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ x ☐ or No ☐

3. Sample Identification:
Manually with the numeric key and analysis parameter keys, gaining ID Nos. and analysis parameters collectively from the host computer. Manually entering ID Nos. so that analysis orders will be automatically received from the host computer using ID nos. that have been read with the optional bar code scanner so that analysis order information will be automatically received from the host computer

4. Specimen Sampling and Handling:
The incubation pipette on the instrument detects sample surface, aspirates a sample from an open tube and dispenses it out into a reaction tube in the reaction tube rack.

5. Assay Types:
The instrument is capable of running the following coagulation assays: prothrombin time activated partial thromboplastin time, fibrinogen, d-dimer, antithrombin III, and thrombin time.

6. Reaction Types:
Chromogenic (Antithrombin III), clotting (PT, APTT, Fibrinogen, Thrombin Time) and immunological (d-dimer)

7. Calibration:
The instrument uses standard commercial plasma material to plot standard curves

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8. Quality Control:
2 QC programs are available. A Mean control that uses the average data of 2 consecutive analysis made on a QC sample (Commercial control plasma or pooled plasma), and a L-J control that uses data of a single analysis on a QC sample.

D. Other Supportive Performance Characteristics Data Not Covered In The "L. Performance Characteristics" Section Of The SE Decision Summary.

| Test | Predicate Device | CA-500 Model | N | Coefficient of Correlation | Regression Equation |
| --- | --- | --- | --- | --- | --- |
| D-Dimer (Advanced D-Dimer) | CA-7000 | CA-560 | 390 | 0.992 | Y=1.01X +0.14 |
| PT, secs (Thromborel® S) | CA-6000 | CA-560 | 248 | 0.999 | Y=1.00X -0.50 |
| PT, INR (Thromborel® S) | CA-6000 | CA-560 | 248 | 0.999 | Y=0.89X +0.11 |
| Derived Fibrinogen (Thromborel® S) | CA-6000 | CA-560 | 248 | 0.998 | Y=1.08X +0.04 |
| PT, secs (Innovin®) | CA-6000 | CA-560 | 243 | 0.999 | Y=1.03X -0.26 |
| PT, INR (Innovin®) | CA-6000 | CA-560 | 243 | 0.999 | Y=1.08X-0.09 |
| Derived Fibrinogen (Innovin®) | CA-6000 | CA-560 | 247 | 0.995 | Y=1.09X -0.17 |
| PT, secs (Thromboplastin C Plus) | CA-6000 | CA-560 | 245 | 0.997 | Y=1.00X -0.20 |
| PT, INR (Thromboplastin C Plus) | CA-6000 | CA-560 | 245 | 0.998 | Y=1.00X -0.00 |
| Derived Fibrinogen (Thromboplastin C Plus) | CA-6000 | CA-560 | 245 | 0.998 | Y=1.12X+0.03 |
| APTT (Actin®) | CA-6000 | CA-540 | 864 | 0.982 | Y=1.00X-0.20 |
| APTT (Actin® FS) | CA-6000 | CA-540 | 857 | 0.983 | Y=1.00X +0.10 |
| APTT (Actin® FSL) | CA-6000 | CA-540 | 864 | 0.990 | Y=1.00X +0.10 |

E. Other Supportive Information:
Within run, between run and total %CV demonstrated acceptable performance (&lt;5%)
Software verification and validation data
Carryover studies
Interference Studies
Reportable Ranges

F. Conclusion:
All studies demonstrated acceptable performance. I recommend that the device is found substantially equivalent to a legally marketed device.