(85 days)
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No
The summary describes a semi-automated mechanical clot detection system and does not mention any AI or ML components. The performance studies focus on correlation and precision with predicate devices, not on the training or testing of an AI/ML model.
No
The device is described as a "Micro Coagulation Analyzer" for determining prothrombin times, activated partial thromboplastin times, fibrinogen concentrations, and other clotting tests. This indicates it is an in vitro diagnostic device used for measurement and analysis, not for treating a condition.
Yes
The device is designed for the determination of prothrombin times (PT), activated partial thromboplastin times (APTT), fibrinogen concentrations, and other clotting tests, all of which are used to measure specific parameters to aid in medical diagnosis.
No
The device is described as a "semi-automated mechanical clot detection system," which explicitly indicates the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is designed for the "determination of prothrombin times (PT), activated partial thromboplastin times (APTT), fibrinogen concentrations and other clotting tests." These are all tests performed on biological samples (likely blood or plasma) in vitro (outside the body) to provide diagnostic information about a patient's coagulation status.
- Device Description: The description reinforces the intended use by stating it's a "semi-automated mechanical clot detection system designed for the determination of prothrombin times (PT), activated partial thromboplastin times (APTT), fibrinogen concentrations and other clotting tests."
- Performance Studies: The performance studies describe testing the device using "samples" and "specimens," which are biological materials. The results are presented as correlations and comparisons to other devices used for the same diagnostic purposes.
The core function of the device is to analyze biological samples in vitro to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
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Intended Use / Indications for Use
The Amelung KC 1 A Micro Coagulation Analyzer is a semi-automated mechanical clot detection system designed for the determination of prothrombin times (PT), activated partial thromboplastin times (APTT), fibrinogen concentrations and other clotting tests. Any clotting time test that has fibrin formation as its endpoint may be performed on the KC 1 A.
Product codes
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Device Description
The Amelung KC 1 A Micro Coagulation Analyzer is a semi-automated mechanical clot detection system designed for the determination of prothrombin times (PT), activated partial thromboplastin times (APTT), fibrinogen concentrations and other clotting tests.
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
physician office laboratories (POL)
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
In beta sites performance studies, three physician office laboratories (POL) analyzed more than 45 samples using the KC 1 A. Split samples from the same specimens were also analyzed using the KC 1 A at Sigma Diagnostics, the study's reference laboratory. PT and APTT assays were performed at all sites.
In in-house performance studies. PT and APTT were performed on more than one hundred samples using both the KC 1 A and the Fibrometer. The CA-5000 was used as the predicate device for the fibrinogen.
Key Metrics
Site #1: PT: r = 0.981 y = 1.018x + 0.129; APTT: r = 0.935 y = 1.050x + 2.057
Site #2: PT: r = 0.992 y = 0.950x + 0.617; APTT: r = 0.922 y = 1.026x + 1.924
Site #3: PT: r = 0.981 y = 1.012x + 0.181; APTT: r = 0.929 y = 0.961x + 3.964
In-house: PT: r = 0.987 y = 1.046x - 0.280; APTT: r = 0.867 y = 1.263x - 1.647; Fibrinogen: r = 0.932 y = 1.065x + 29.375
Precision studies: Results were within acceptable limits. The coefficient of variation (CV) for all studies was less than 6%.
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103
KC 1 A Micro Coagulation Analyzer December 15, 1995
MAR 12 4955334
ATTACHMENT 1
Summary of Safety and Effectiveness
1
510(k) NOTIFICATION
Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103
KC 1 A Micro Coagulation Analyzer December 15, 1995
ATTACHMENT 1
510(k) Summary of Safety and Effectiveness
The Amelung KC 1 A Micro Coagulation Analyzer is a semi-automated mechanical clot detection system designed for the determination of prothrombin times (PT), activated partial thromboplastin times (APTT), fibrinogen concentrations and other clotting tests. Any clotting time test that has fibrin formation as its endpoint may be performed on the KC 1 A.
In beta sites performance studies, three physician office laboratories (POL) analyzed more than 45 samples using the KC 1 A. Split samples from the same specimens were also analyzed using the KC 1 A at Sigma Diagnostics, the study's reference laboratory. PT and APTT assays were performed at all sites. The correlation coefficient and the regression equation for these comparisons were as follows:
| Site #1: | PT: | r = 0.981 | y = 1.018x + 0.129 |
|---|---|---|---|
| APTT: | r = 0.935 | y = 1.050x + 2.057 | |
| Site #2: | PT: | r = 0.992 | y = 0.950x + 0.617 |
| APTT: | r = 0.922 | y = 1.026x + 1.924 | |
| Site #3: | PT: | r = 0.981 | y = 1.012x + 0.181 |
| APTT: | r = 0.929 | y = 0.961x + 3.964 |
Precision studies were also performed at all sites. Results were within acceptable limits.
In in-house performance studies. PT and APTT were performed on more than one hundred samples using both the KC 1 A and the Fibrometer. The CA-5000 was used as the predicate device for the fibrinogen. The correlation coefficient and the regression equation were as follows:
| PT: | r = 0.987 | $y = 1.046x - 0.280$ |
|---|---|---|
| APTT: | r = 0.867 | $y = 1.263x - 1.647$ |
| Fibrinogen: | r = 0.932 | $y = 1.065x + 29.375$ |
Precision studies were performed in-house. The coefficient of variation (CV) for all studies was less than 6%.
These data clearly demonstrate that the performance of the KC 1 A Micro Coagulation Analyzer is substantially equivalent to the performance of the predicate device.