AMAX CS-190 COAGULATION ANALYZER SYSTEM

K955720 · Sigma Diagnostics, Inc. · JPA · Mar 13, 1996 · Hematology

Device Facts

• Record ID: K955720
• Device Name: AMAX CS-190 COAGULATION ANALYZER SYSTEM
• Applicant: Sigma Diagnostics, Inc.
• Product Code: JPA · Hematology
• Decision Date: Mar 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The Amelung AMAX CS-190 Coagulation Analyzer is an automated random access multipurpose analyzer. The AMAX CS-190 Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time(PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the AMAX CS-190 Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III).

Device Story

Automated random access multipurpose coagulation analyzer; utilizes mechanical (ball method) or photo-optical principles to detect fibrin formation. Performs clot-based assays (PT, APTT, fibrinogen, factor assays) and chromogenic assays (AT III). Used in clinical laboratory settings by trained personnel. Provides quantitative results for coagulation parameters; assists clinicians in diagnosing and monitoring coagulation disorders. Benefits patients through rapid, automated, and precise coagulation testing.

Clinical Evidence

Bench testing only. Comparison studies performed against TOA CA-5000 (mechanical), BBL Fibrometer, and manual spectrophotometric methods. PT (optical) r=0.989; APTT (optical) r=0.907; Factor IX (optical) r=0.954; Factor X (optical) r=0.980; Fibrinogen (optical) r=0.979; AT III r=0.848. Precision studies showed CV <4% for PT/APTT, <9% for factor assays, <10% for fibrinogen, and <6% for AT III.

Technological Characteristics

Automated random access analyzer; dual-mode detection: mechanical (ball method) and photo-optical. Performs clot-based and chromogenic assays. No specific materials, connectivity, or software architecture details provided.

Indications for Use

Indicated for clinical laboratory use to perform coagulation testing, including PT, APTT, fibrinogen, factor assays, and chromogenic assays like AT III, for patients requiring coagulation status assessment.

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.

Reference Devices

• TOA Medical Electronics CA-5000
• BBL Fibrometer

Submission Summary (Full Text)

{0}

510(k) NOTIFICATION
Sigma Diagnostics
545 South Ewing Avenue
St. Louis, MO 63103
AMAX CS-190
Coagulation Analyzer
December 15, 1995

K955720

MAR 13 1996

# ATTACHMENT 1

## Summary of Safety and Effectiveness

{1}

510(k) NOTIFICATION
Sigma Diagnostics
545 South Ewing Avenue
St. Louis, MO 63103
AMAX CS-190
Coagulation Analyzer
December 15, 1995

# ATTACHMENT 1

## 510(k) Summary of Safety and Effectiveness

The Amelung AMAX CS-190 Coagulation Analyzer is an automated random access multipurpose analyzer. The AMAX CS-190 Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time(PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the AMAX CS-190 Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III).

In comparison studies of clot based assays between the AMAX CS-190 Coagulation Analyzer (photo-optical or mechanical) and the TOA Medical Electronics CA-5000 (mechanical), the following regression statistics were obtained:

| PT (optical) | r = 0.989 | y = 1.113x - 0.9 |
| --- | --- | --- |
| APTT (optical) | r = 0.907 | y = 0.848x + 7.3 |
| Factor IX (optical) | r = 0.954 | y = 0.950x + 0.7 |
| Factor IX (mechanical) | r = 0.882 | y = 0.882x + 2.3 |
| Factor X (optical) | r = 0.980 | y = 1.019x + 0.0 |
| Factor X (mechanical) | r = 0.976 | y = 1.001x - 0.3 |
| Fibrinogen (optical) | r = 0.979 | y = 1.211x + 0.9 |

In comparison studies of mechanical clot based assays between the AMAX CS-190 Coagulation Analyzer and the BBL Fibrometer, the following regression statistics were obtained:

| PT | r = 0.985 | y = 1.067x - 0.3 |
| --- | --- | --- |
| APTT | r = 0.885 | y = 1.427x + 0.4 |

In comparison studies of chromogenic assays between the AMAX CS-190 Coagulation Analyzer and the manual spectrophotometric method, the following regression statistics were obtained:

| AT III | r = 0.848 | y = 0.848x + 5.0 |
| --- | --- | --- |

The coefficient of variation for precision studies was less than 4% for the PT and APTT assays, less than 9% for the factor assays, less than 10% for the fibrinogen assays, and less than 6% for AT III.

The safety and effectiveness of the AMAX CS-190 Coagulation Analyzer is demonstrated by its substantial equivalency to the predicate devices.