(131 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation | Correlation Coefficient: 0.91 (between Advanced D-Dimer and Asserachrom® D-Di) |
| Y-intercept: 0.54 | |
| Slope: 0.98 | |
| Precision | Inter-assay precision: 0.8% to 3.8% |
| Intra-assay precision: 1.3% to 3.0% |
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
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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.
§ 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.