(190 days)
Not Found
No
The description focuses on mechanical principles and standard statistical analysis, with no mention of AI or ML terms.
No
The device is an analyzer used for detection and analysis of fibrin formation and other clotting tests, which means it is a diagnostic device, not a therapeutic device.
Yes
The device is described as an "Automated random access multipurpose analyzer" used for "detection of fibrin formation utilizing mechanical principles (ball method) to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests." This indicates its use in analyzing biological samples to provide information for diagnosis.
No
The device description explicitly states it is an "automated random access multipurpose analyzer" that utilizes "mechanical principles (ball method)" for detection, indicating it is a hardware device with integrated software, not a software-only device.
Yes, the Amelung KC 40 Micro Coagulation Analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that it is used for "the detection of fibrin formation utilizing mechanical principles (ball method) to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests." These are all tests performed on biological samples (like blood plasma) outside of the body to provide information about a person's health.
- Device Description: The description reinforces its function as an analyzer for performing these types of tests.
- Performance Studies: The performance studies compare the device's results to other established devices used for the same types of in vitro tests.
IVD devices are defined as those intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Amelung KC 40 fits this definition perfectly.
N/A
Intended Use / Indications for Use
The Amelung KC 40 Micro Coagulation Analyzer is an automated random access multipurpose analyzer. The KC 40 can be used for the detection of fibrin formation utilizing mechanical principles (ball method) to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests.
Product codes
Not Found
Device Description
The Amelung KC 40 Micro Coagulation Analyzer is an automated random access multipurpose analyzer. The KC 40 can be used for the detection of fibrin formation utilizing mechanical principles (ball method) to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Comparison studies between the KC 40 and the TOA Medical Electronics CA-5000:
- PT: r = 0.980, y = 1.123x + 0.616
- APTT: r = 0.936, y = 1.101x + 4.570
- Fibrinogen: r = 0.931, y = 1.163x - 29.927
- Factor IX: r = 0.944, y = 0.964x + 7.937
- Factor X: r = 0.970, y = 1.040x - 1.884
Comparison studies between the KC 40 and the BBL Fibrometer:
- PT: r = 0.980, y = 1.009x + 0.701
- APTT: r = 0.915, y = 1.244x - 0.778
Precision studies:
- Coefficient of variation for PT and APTT assays was less than 5%.
- Coefficient of variation for fibrinogen assay was less than 6%.
- Coefficient of variation for factor assays was less than 10%.
Key Metrics
Not Found
Predicate Device(s)
TOA Medical Electronics CA-5000, BBL Fibrometer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510(k) NOTIFICATION
SFP 1 0 1996
Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103
KC 40 Micro Coagulation Analyzer February 27, 1996
ATTACHMENT 1
510(k) Summary of Safety and Effectiveness
The Amelung KC 40 Micro Coagulation Analyzer is an automated random access multipurpose analyzer. The KC 40 can be used for the detection of fibrin formation utilizing mechanical principles (ball method) to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests.
In comparison studies between the KC 40 and the TOA Medical Electronics CA-5000, the following regression statistics were obtained:
| PT | r = 0.980 | y = 1.123x + 0.616 |
|---|---|---|
| APTT | r = 0.936 | y = 1.101x + 4.570 |
| Fibrinogen | r = 0.931 | y = 1.163x - 29.927 |
| Factor IX | r = 0.944 | y = 0.964x + 7.937 |
| Factor X | r = 0.970 | y = 1.040x - 1.884 |
In comparison studies between the KC 40 and the BBL Fibrometer, the following regression statistics were obtained:
| PT | r = 0.980 | $y = 1.009x + 0.701$ |
|---|---|---|
| APTT | r = 0.915 | $y = 1.244x - 0.778$ |
The coefficient of variation for precision studies was less than 5% for the PT and APTT assays. less than 6% for the fibrinogen assay, and less than 10% for the factor assays.
The safety and effectiveness of the KC 40 Micro Coagulation Analyzer is demonstrated by its substantial equivalency to the predicate devices.