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The Behring Coagulation System (BCS) is an automated coagulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument performs the following parameters: Prothrombin Time (PT), Activated Pattial Thromboplast Time (APTT), Antithrombin Illa, Batroxibin, D-dimer, Deficient Plasmas, Fibrinogen, Heparin, Plasminogen, Protein C-clotting, Protein C-chromogenic, Thrombin Time, Von Willebrand factor.

The current BCS was determined to be substantially equivalent as a fully automated photometric coagulation analyzer in 510(k) notification K970431. The current BCS was cleared to perform coagulometric and chromogenic tests, such as the routine tests prothrombin time, partial thromboplastin time, and fibrinogen, as well as the special tests, single factor determination antithrombin IIIa, protein C and plasminogen. The modified BCS has the ability to perform coagulometric, chromogenic and immunochemical assays (e.g., latex enhanced turbidimetric test Advanced D-Dimer). The addition of the immunochemical measuring method is the subject of this modification.

The provided text describes the Behring Coagulation System 510(k) Modification (K992959). The modification allows the system to perform immunochemical assays, specifically referencing the Advanced D-Dimer test.

Here’s a breakdown of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state the pre-defined acceptance criteria (e.g., "correlation coefficient must be greater than X"). It only reports the results of the performance studies. The implication is that these results were deemed acceptable for substantial equivalence.

2. Sample Size and Data Provenance

• Correlation Study:

  • Test Set Sample Size: 316 samples
  • Data Provenance: Not explicitly stated, but the submission is from Dade Behring Marburg GmbH (Germany) and Dade Behring Inc. (USA), suggesting data could be from either or both regions. The text does not specify if it was retrospective or prospective.

• Precision Study:

  • Test Set Sample Size: Not explicitly stated as a single number but involved "two levels of control material and two levels of human plasma pools."
  • Data Provenance: Not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention using experts to establish ground truth. The studies described are comparative in nature (comparing the modified device's performance to a predicate device or established methods).

4. Adjudication Method

• The document does not mention any adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was performed or reported. This device is an automated coagulation system and not an imaging or diagnostic device that would typically involve human reader interpretation for a MRMC study.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The Correlation and Precision studies are standalone performance evaluations demonstrating the device's accuracy and reproducibility. The comparison to the Asserachrom® D-Di for correlation and the NCCLS Guideline EP5-A for precision indicates an evaluation of the device's performance properties.

7. Type of Ground Truth Used

• For the Correlation study: The "ground truth" was established by another commercially available and presumably validated assay, the Asserachrom® D-Di, which served as the reference method for comparison.
• For the Precision study: The "ground truth" or reference was based on established control material and human plasma pools, evaluated according to NCCLS Guideline EP5-A.

8. Sample Size for the Training Set

• The document does not mention any training set sample size. This device is an in vitro diagnostic instrument; typical AI/Machine Learning models that require distinct training and test sets are not explicitly described for its core functionality here. The "modification" refers to the ability to perform a new type of assay (immunochemical), which relies on established photometric principles rather than a learning algorithm that needs a training phase in the typical sense of AI.

9. How the Ground Truth for the Training Set was Established

• As no training set is described (see point 8), the method for establishing ground truth for a training set is not applicable/not mentioned.

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The Behring Coagulation System is an instrument intended to perform quantitative assays of specific parameters in plasma.

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.

This 510(k) summary for the Behring Coagulation System (BCS) focuses on establishing substantial equivalence to previously cleared devices rather than defining and proving specific acceptance criteria in the manner of a new device demonstrating clinical performance. Therefore, many of the requested elements for a study demonstrating acceptance criteria are not directly applicable or explicitly stated in this document.

However, I will extract the information that is present and explain why other requested information is not available in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission, specific "acceptance criteria" for novel clinical performance metrics are not explicitly defined in the document. Instead, the performance is compared against previously cleared devices (Behring Coagulation Timer (BCT) and Behring Fibrintimer A (BFA)). The criteria used for substantial equivalence in this context are:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Comparative Analysis (Regression): Not explicitly stated. The document mentions "Sample correlation data were collected... using various coagulometric and chromogenic assays," but does not provide the number of samples or patients used for these correlations.
• Sample Size for Precision Studies: Not explicitly stated. The document mentions "Precision studies were performed... using samples which were in the normal and abnormal ranges," but does not provide the number of samples or replicates.
• Data Provenance: Not explicitly stated. Typically, for such instrument validations, the studies would be conducted internally by the manufacturer or by a contracted lab. The country of origin is not mentioned, nor is whether the data was retrospective or prospective. Given the nature of laboratory instrument validation, it would likely involve prospectively run samples on the new and predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. For an in vitro diagnostic (IVD) instrument like the Behring Coagulation System, the "ground truth" for the test set is established by the reference methods or predicate devices themselves for comparative studies, or by the inherent properties of the quality control materials used for precision studies. Expert opinion is not typically used to establish ground truth for quantitative laboratory measurements in this context.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in imaging or diagnostic accuracy studies where expert readers might disagree on an interpretation. For a quantitative IVD instrument, the results are numerical, and the comparison is statistical (e.g., regression, precision statistics) rather than interpretive, so no adjudication method is required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is an in vitro diagnostic instrument, not an AI-powered diagnostic system that assists human readers in interpretation. Therefore, an MRMC study or analysis of human reader improvement with AI assistance is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, implicitly. The performance data presented (correlation and precision) reflects the "standalone" performance of the Behring Coagulation System instrument itself, without human interpretation influencing the measurement results. The instrument processes samples and generates numerical results directly.

7. The Type of Ground Truth Used

The "ground truth" in this context is established in two ways:

• For Comparative Analysis: The results obtained from the predicate devices (Behring Coagulation Timer and Behring Fibrintimer A) for the same samples serve as the comparative reference.
• For Precision Studies: The accepted values or expected ranges of the quality control materials used are considered the reference point for assessing precision.

8. The Sample Size for the Training Set

Not applicable. The Behring Coagulation System is an analytical instrument, not a machine learning or AI algorithm that requires a "training set." Its operation is based on established electrochemical or optical principles for coagulation assays, not on learned patterns from a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

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