(195 days)
No
The description focuses on standard photometric analysis and correlation studies, with no mention of AI/ML terms or methodologies.
No
The device is described as a coagulation analyzer intended for clinical use to perform coagulation tests, not to treat a condition.
Yes
The "Intended Use / Indications for Use" states it performs "all coagulometric, chromogenic and immunologic coaqulation tests" and the "Device Description" states it measures "coagulation, fibrinolysis factors and inhibitors as well as to measure the function of the homeostatic system as a whole," which are all diagnostic functions.
No
The device description explicitly states it is a "fully automatic photo-optical coagulation instrument," indicating it is a hardware device that uses photo-optical technology.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "intended for clinical use to perform all coagulometric, chromogenic and immunologic coagulation tests." These tests are performed on samples taken from the human body (like blood) to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description further clarifies that it is used "in conjunction with the Behringwerke AG test kits for measurement of coagulation, fibrinolysis factors and inhibitors as well as to measure the function of the homeostatic system as a whole." This confirms it's used to analyze biological samples.
- Performance Studies: The performance studies describe evaluating the device using "samples" and "control" materials, which are typical for IVD devices.
The definition of an IVD device is a medical device that is used to examine specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. The Behring Coagulation Timer clearly fits this definition.
N/A
Intended Use / Indications for Use
Behring Coagulation Timer is a photometric coagulation analyzer intended for clinical use to perform all coagulometric, chromogenic and immunologic coaqulation tests.
Product codes
Not Found
Device Description
Behring Coagulation Timer (BCT) is a fully automatic photo-optical coagulation instrument. The BCT is used in conjunction with the Behringwerke AG test kits for measurement of coagulation, fibrinolysis factors and inhibitors as well as to measure the function of the homeostatic system as a whole.
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
clinical use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Correlation:
Performance characteristics of the Behring Coagulation System and the Behring Fibrintimer A were compared by evaluating several representative assays. The two clotting assays evaluated were Thromborel S and Pathromtin. For Thromborel S. 83 samples were evaluated on the BCT vs. the BFA. A correlation coefficient of 0.997 with a y-intercept of 0.72 and a slope of 0.97.
For Pathromtin, 83 samples were evaluated on the BCT vs the BFA. A correlation coefficient of 0.99 was obtained, with a y-intercept of -0.87 and a slope of 1.0.
The two colorometric assays which were evaluated were Berichrom Plasminogen and Berichrom Protein C. For the Berichrom Plasminogen. 58 samples were evaluated on the BCT vs the Behring Chromotime System (K901829). A correlation coefficient of 0.96 was obtained, with a y-intercept of 9.9 and a slope of 0.97.
For Berichrom Protein C, 74 samples were evaluated on the BCT vs the Behring Chromotime System. A correlation coefficient of 0.99 was obtained, with a v-intercept of -0.69 and a slope of 1.0.
These studies support the substantial equivalence of the BCT and the BFA.
Precision:
Precision of the BCT was evaluated using the above mentioned representative assays. Each level of control was run in replicates of 8 for five days. to total n=40. Intra-assay precision was calculated from either an n=4 or n=8 precision values over the 5 days. Precision data is summarized in the table below.
Thromborel S: 3 levels ranging from 11 to 59 secs
Intra-Assay %CV: 0.50 to 0.81
Inter-Assay %CV: 2.04 to 6.36
Pathromtin: 3 levels ranging from 37 to 91 sec
Intra-Assay %CV: 1.55 to 2.95
Inter-Assay %CV: 1.75 to 2.51
Berichrom Plasminogen: 3 levels ranging from 38.52 to 111.74 % norm
Intra-Assay %CV: 2.85 to 3.61
Inter-Assay %CV: 2.19 to 3.95
Berichrom Protein C: 3 levels ranging from 77 to 104 % norm
Intra-Assay %CV: 3.33 to 3.96
Inter-Assay %CV: 1.90 to 2.54
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient, Y-intercept, Slope, Intra-Assay %CV, Inter-Assay %CV
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Attachment 1
510(k) Summary of Safety and Effectiveness for Behring Coagulation Timer
Manufactures Name, Address, Telephone, and contact person, date of 1 . preparation:
| Manufacturer | Behringwerke AG |
|---|---|
| Postfach 1140 | |
| 35001 Marburg | |
| Germany |
Distributor
Behring Diagnostics Inc. 151 University Avenue Westwood, MA 02090 617-320-3000 Attn: Kathleen Dray-Lyons
Preparation date: November 16, 1995
2 . Device Name/ Classification:
Behring Coagulation Timer: multipurpose system for in vitro coagulation studies Classification Number: class II (864.5425)
3 . Identification of the legally marketed device:
Behring Fibrintimer A
4 . Proposed Device Description:
Behring Coagulation Timer (BCT) is a fully automatic photo-optical coagulation instrument. The BCT is used in conjunction with the Behringwerke AG test kits for measurement of coagulation, fibrinolysis factors and inhibitors as well as to measure the function of the homeostatic system as a whole.
5. Proposed Device Intended Use:
Behring Coagulation Timer is a photometric coagulation analyzer intended for clinical use to perform all coagulometric, chromogenic and immunologic coaqulation tests.
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1
Medical device to which equivalence is claimed and comparison 6. information:
The Behring Coagulation Timer (BCT) is substantially equivalent in intended use and results obtained to the Behring Fibrintimer A (BFA) which was the subject of 510(k) K926551 . The BCT like the BFA performs fully automatic, rapid quantitative measurement of coagulation time by optical detection. Both analyzers use photometric technology and offer continuous access operation. Both the BCT and the BFA process samples in the Random Access mode.
The BCT differs from the BFA in that the BCT can provide an Autostart with barcoded samples along with an integrated barcode scanner.
The BCT also differs from the BFA in that the BCT performs three basic types of assays clotting (fibrin clot), chromogenic (color development), and Immunologic (antibodies + latex) whereas the BFA can perform only clotting assays.
7. Proposed Device Performance Characteristics:
Correlation:
Performance characteristics of the Behring Coagulation System and the Behring Fibrintimer A were compared by evaluating several representative assays. The two clotting assays evaluated were Thromborel S and Pathromtin. For Thromborel S. 83 samples were evaluated on the BCT vs. the BFA. A correlation coefficient of 0.997 with a y-intercept of 0.72 and a slope of 0.97.
For Pathromtin, 83 samples were evaluated on the BCT vs the BFA. A correlation coefficient of 0.99 was obtained, with a y-intercept of -0.87 and a slope of 1.0.
The two colorometric assays which were evaluated were Berichrom Plasminogen and Berichrom Protein C. For the Berichrom Plasminogen. 58 samples were evaluated on the BCT vs the Behring Chromotime System (K901829). A correlation coefficient of 0.96 was obtained, with a y-intercept of 9.9 and a slope of 0.97.
For Berichrom Protein C, 74 samples were evaluated on the BCT vs the Behring Chromotime System. A correlation coefficient of 0.99 was obtained, with a v-intercept of -0.69 and a slope of 1.0.
These studies support the substantial equivalence of the BCT and the BFA.
Precision:
Precision of the BCT was evaluated using the above mentioned representative assays. Each level of control was run in replicates of 8 for five days. to total n=40. Intra-assay precision was calculated from either an n=4 or n=8 precision values over the 5 days. Precision data is summarized in the table below.
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| Thromborel S:
| 3 levels ranging from 11 to 59 secs | BCT | |
|---|---|---|
| Intra-Assay %CV | 0.50 to 0.81 | |
| Inter-Assay %CV | 2.04 to 6.36 | |
| Pathromtin: | ||
| 3 levels ranging from 37 to 91 sec | BCT | |
| Intra-Assay %CV | 1.55 to 2.95 | |
| Inter-Assay %CV | 1.75 to 2.51 | |
| Berichrom Plasminogen: | ||
| 3 levels ranging from 38.52 to 111.74 % norm | BCT | |
| Intra-Assay %CV | 2.85 to 3.61 | |
| Inter-Assay %CV | 2.19 to 3.95 | |
| Berichrom Protein C: | ||
| 3 levels ranging from 77 to 104 % norm | BCT | |
| Intra-Assay %CV | 3.33 to 3.96 | |
| Inter-Assay %CV | 1.90 to 2.54 |
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