(125 days)
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No
The description focuses on automated coagulation analysis using mechanical and photo-optical principles, with no mention of AI or ML terms or functionalities.
No
The CS-400™ Coagulation Analyzer is used for in vitro diagnostic (IVD) coagulation studies and factor assays, providing information to detect fibrin formation and perform clotting tests. It is a diagnostic device, not a therapeutic one.
Yes
The device is described as a system for "in vitro coagulation studies" used to "perform a series of coagulation studies and coagulation factor assays," which are typically done to detect or characterize medical conditions.
No
The device description clearly states it is an "automated instrument" and an "automated random access multipurpose analyzer," indicating it is a physical hardware device.
Yes, the Amelung CS-400™ Coagulation Analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is for "in vitro coagulation studies." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVD devices.
- Function: The device performs "coagulation studies and coagulation factor assays" using patient samples (blood, presumably). These tests are performed on biological specimens outside of the living organism to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details how the analyzer detects fibrin formation and performs various coagulation tests (PT, APTT, fibrinogen, factor assays, chromogenic assays). These are all common in vitro diagnostic tests.
- Associated Reagents and Controls: The intended use mentions "associated reagents and controls," which are essential components of an IVD system used to ensure the accuracy and reliability of the tests.
Therefore, based on the provided information, the Amelung CS-400™ Coagulation Analyzer clearly fits the definition of an In Vitro Diagnostic device.
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Intended Use / Indications for Use
The CS-400™ Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
Product codes (comma separated list FDA assigned to the subject device)
JPA
Device Description
The Amelung CS-400™ Coagulation Analyzer is an automated random access multipurpose analyzer. The CS-400™ 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 CS-400™ Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison studies of assays between the CS-400™ Coagulation Analyzer and the Amelung AMAX CS-190™ Coagulation Analyzer:
PT (optical): r = 0.921, y = 1.061x + 0.6
PT (mechanical): r = 0.924, y = 1.038x - 0.5
APTT (optical): r = 0.964, y = 1.072x - 0.5
APTT (mechanical): r = 0.972, y = 0.938x + 1.0
Factor IX (optical): r = 0.945, y = 0.943x + 4.6
Factor IX (mechanical): r = 0.924, y = 0.977x + 3.7
Factor X (optical): r = 0.966, y = 0.920x + 9.5
Factor X (mechanical): r = 0.974, y = 0.898x + 8.7
Fibrinogen (optical): r = 0.967, y = 1.064x - 11.3
Fibrinogen (mechanical): r = 0.977, y = 1.074x - 2.2
AT III (chromogenic): r = 0.972, y = 0.920x + 11.7
Precision studies (coefficients of variation):
PT (optical): Within Run
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
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.(b)
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.
0
000 20 1997
510(k) NOTIFICATION
Sigma Diagnostics Inc. June 12, 1997
2019
CS-400™ Coagulation Analyzer Catalog No. A1208
510(k) Summary of Safety and Effectiveness
The Amelung CS-400™ Coagulation Analyzer is an automated random access multipurpose analyzer. The CS-400™ 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 CS-400™ Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III).
In comparison studies of assays between the CS-400™ Coagulation Analyzer and the Amelung AMAX CS-190™ Coagulation Analyzer, the following regression statistics were obtained:
| PT (optical) | r = 0.921 | y = 1.061x + 0.6 |
|---|---|---|
| PT (mechanical) | r = 0.924 | y = 1.038x - 0.5 |
| APTT (optical) | r = 0.964 | y = 1.072x - 0.5 |
| APTT (mechanical) | r = 0.972 | y = 0.938x + 1.0 |
| Factor IX (optical) | r = 0.945 | y = 0.943x + 4.6 |
| Factor IX (mechanical) | r = 0.924 | y = 0.977x + 3.7 |
| Factor X (optical) | r = 0.966 | y = 0.920x + 9.5 |
| Factor X (mechanical) | r = 0.974 | y = 0.898x + 8.7 |
| Fibrinogen (optical) | r = 0.967 | y = 1.064x - 11.3 |
| Fibrinogen (mechanical) | r = 0.977 | y = 1.074x - 2.2 |
| AT III (chromogenic) | r = 0.972 | y = 0.920x + 11.7 |
The following coefficients of variation were obtained from precision studies:
| Within Run | Total | |
|---|---|---|
| PT (optical) |