(90 days)
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No
The summary describes a fully automated coagulation instrument performing standard laboratory tests, with no mention of AI, ML, or related concepts.
No
The device is described as an instrument for performing quantitative assays of specific parameters in plasma, meaning it is used for diagnostic testing rather than treatment.
Yes
The device is intended to perform quantitative assays of specific parameters in plasma, which are used in conjunction with test kits to perform coagulation tests. These tests provide information for diagnosis or monitoring related to coagulation.
No
The device description explicitly states it is a "fully automated coagulation instrument," indicating it is a hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to perform quantitative assays of specific parameters in plasma." Plasma is a biological sample taken from the body, and performing assays on it to measure specific parameters is a core function of in vitro diagnostics.
- Device Description: The description further clarifies that it's a "fully automated coagulation instrument" used "in conjunction with Behring Diagnostics test kits to perform various coagulometric and chromogenic coagulation tests." Coagulation tests are performed on blood samples (specifically plasma in this case) outside of the body to assess blood clotting function, which is a classic example of an in vitro diagnostic test.
- Performance Studies: The performance studies describe analyzing "samples" and performing "various coagulation assays," which are conducted on biological specimens in a laboratory setting.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The Behring Coagulation System is an instrument intended to perform quantitative assays of specific parameters in plasma.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Behring Coagulation System (BCS) is a fully automated coagulation instrument. The BCS is used in conjunction with Behring Diagnostics test kits to perform various coagulometric and chromogenic coagulation 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
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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)
Comparative Analysis: Sample correlation data were collected on the BCS and either the BCT of BFA instruments using various coagulometric and chromogenic assays. Regression analysis on each assay used showed a range of correlation coefficients from 0.97 to 0.996.
Precision: Precision studies were performed following the NCCLS EP5 guideline using samples which were in the normal and abnormal ranges of various coagulation assays. The within-run precision ranged from 0.5 to 6.3%. The total precision ranged from 0.90 to 8.1%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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MAY - 5 1997
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Behring Coagulation System
1. Manufacturer and Contact Information:
Behring Diagnostics GmbH Manufacturer: P.O. Box 1149 35001 Marburg, Germany
Contact Information: Paul Rogers Behring Diagnostics Inc. 3403 Yerba Buena Road P.O. Box 49013 San Jose, CA 95161-9013 Tel: 408-239-2000
2. Device Classification Name:
The Behring Coagulation System is a Class II device and is classified as a multipurpose system for in vitro coagulation studies (21 CFR §864.5425).
3. Intended Use:
The Behring Coagulation System is an instrument intended to perform quantitative assays of specific parameters in plasma.
4. Substantial Equivalence:
Behring Diagnostics Inc. considers the BCS to be substantially equivalent to the Behring Coagulation Timer (K955278) and the Behring Fibrintimer A (K926551) in terms of intended use, instrument features, and overall performance characteristics.
Device Description and Performance Characteristics: ડે.
The Behring Coagulation System (BCS) is a fully automated coagulation instrument. The BCS is used in conjunction with Behring Diagnostics test kits to perform various coagulometric and chromogenic coagulation tests.
Comparative Analysis: Sample correlation data were collected on the BCS and either the BCT of BFA instruments using various coagulometric and chromogenic assays. Regression analysis on each assay used showed a range of correlation coefficients from 0.97 to 0.996.
Precision: Precision studies were performed following the NCCLS EP5 guideline using samples which were in the normal and abnormal ranges of various coagulation assays. The within-run precision ranged from 0.5 to 6.3%. The total precision ranged from 0.90 to 8.1%.