(84 days)
CA-5000
Not Found
No
The description focuses on a semi-automated mechanical clot detection system and standard statistical metrics, with no mention of AI or ML terms.
No
The device is described as an analyzer designed for "determination of prothrombin times (PT), activated partial thromboplastin times (APTT), fibrinogen concentrations and other clotting tests." This indicates it is a diagnostic device used to measure physiological parameters, not to treat or cure a disease.
Yes
The device is designed for the determination of various clotting times (PT, APTT, fibrinogen concentrations, and other clotting tests), which are used to assess a patient's coagulation status, indicating its diagnostic purpose.
No
The device is described as a "semi-automated mechanical clot detection system," which clearly indicates it includes hardware components for mechanical clot detection, not 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 comparisons are made against reference laboratories and predicate devices used for similar in vitro diagnostic tests.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The Amelung KC 4 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 4 A.
Product codes
KG5535
Device Description
The Amelung KC 4 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 4 A.
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
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
Not Found
Summary of Performance Studies
In beta sites performance studies, three physician office laboratories (POL) analyzed more than 45 samples using the KC 4 A. Split samples from the same specimens were also analyzed using the KC 4 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 4 A and the Fibrometer. The CA-5000 was used as the predicate device for Fibrinogen, Factor IX, and Factor X assays.
Key Metrics
Site #1: PT: r = 0.991 y = 0.981x + 0.492, APTT: r = 0.960 y = 1.066x + 0.379
Site #2: PT: r = 0.989 y = 1.019x - 0.248, APTT: r = 0.965 y = 1.029x + 1.021
Site #3: PT: r = 0.974 y = 1.012x + 0.326, APTT: r = 0.927 y = 0.786x + 9.470
Precision studies were also performed at all sites. Results were within acceptable limits.
PT: r = 0.988 $y = 1.051x - 0.241$
APTT: r = 0.896 $y = 1.235x + 0.873$
Fibrinogen: r = 0.930 $y = 1.067x + 30.749$
Factor IX: r = 0.897 $y = 0.958x - 3.403$
Factor X: r = 0.974 $y = 1.010x - 0.166$
Precision studies were performed in-house. The coefficient of variation (CV) for all studies was less than 9%.
Predicate Device(s)
CA-5000
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
Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103
KC 4 A Micro Coagulation Analyzer December 15, 1995
KG5535
12/11/2000
ATTACHMENT 1
Summary of Safety and Effectiveness
1
510(k) NOTIFICATION
KC 4 A Micro Coagulation Analyzer December 15, 1995
ATTACHMENT 1
510(k) Summary of Safety and Effectiveness
The Amelung KC 4 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 4 A.
In beta sites performance studies, three physician office laboratories (POL) analyzed more than 45 samples using the KC 4 A. Split samples from the same specimens were also analyzed using the KC 4 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 = 0.991 | y = 0.981x + 0.492 |
|---|---|---|---|
| APTT: | r = 0.960 | y = 1.066x + 0.379 | |
| Site #2: | PT: | r = 0.989 | y = 1.019x - 0.248 |
| APTT: | r = 0.965 | y = 1.029x + 1.021 | |
| Site #3: | PT: | r = 0.974 | y = 1.012x + 0.326 |
| APTT: | r = 0.927 | y = 0.786x + 9.470 |
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 4 A and the Fibrometer. The CA-5000 was used as the predicate device for Fibrinogen, Factor IX, and Factor X assays. The correlation coefficient and the regression equation were as follows:
| PT: | r = 0.988 | $y = 1.051x - 0.241$ |
|---|---|---|
| APTT: | r = 0.896 | $y = 1.235x + 0.873$ |
| Fibrinogen: | r = 0.930 | $y = 1.067x + 30.749$ |
| Factor IX: | r = 0.897 | $y = 0.958x - 3.403$ |
| Factor X: | r = 0.974 | $y = 1.010x - 0.166$ |
Precision studies were performed in-house. The coefficient of variation (CV) for all studies was less than 9%.
These data clearly demonstrate that the performance of the KC 4 A Micro Coagulation Analyzer is substantially equivalent to the performance of the predicate device.