(71 days)
The BCT™ System is an automated coaqulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument performs the following parameters:
- Activated Partial Thromboplastin Time (APTT)
- Antithrombin IIIa
- Batroxobin
- D-dimer
- Deficient Plasmas
- Derived Fibrinogen
- Fibrinogen
- Heparin
- Lupus Anticoagulants
- Prothrombin Time (PT)
- Plasminogen
- Protein C-clotting
- Protein C-chromogenic
- Thrombin Time
- von Willebrand factor
The current BCT™ System was originally determined to be substantially equivalent as a coagulation analyzer in 510(k) Premarket Notification K955278. Subsequent to its clearance, the indications for use of the instrument were expanded through two additional Premarket Notifications, K001064 and K001067 for the addition of various analytes. The current BCT™ System was cleared to perform coagulometric, and chromogenic tests, such as the routine tests: prothrombin time, partial thromboplastin time, heparin, and fibrinogen, as well as the special tests: single factor determination, antithrombin IIIa, batroxobin, plasminogen, protein C, and D-dimer. The inclusion of the new testing parameter, lupus anticoagulants (LA), is the subject of this modification. The addition of the new proposed analyte to the instrument was accomplished without modification to the instrument principle, operation, hardware or instruction manual.
This document describes the modification of the Dade Behring BCT™ System to include the new testing parameter, lupus anticoagulants (LA). The study demonstrates that the modified BCT™ system is substantially equivalent to the Sysmex® CA-6000 System for measuring Lupus Anticoagulants.
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria for this 510(k) modification are based on demonstrating substantial equivalence to a predicate device (Sysmex® CA-6000 System) through correlation and precision studies. While explicit numerical acceptance criteria (e.g., minimum correlation coefficient) are not stated, the reported performance data is presented to show strong correlation, suggesting the device meets internal benchmarks for equivalence.
Correlation Study (Method Comparison):
| Assay | Acceptance Criteria (Implied: Strong Correlation to Predicate) | Reported Performance (Coefficient of Correlation (r)) | Regression Equation |
|---|---|---|---|
| LA 1 Screening Reagent (seconds) | R-value close to 1.0 | 0.968 | y=0.87x + 4.34 |
| LA 2 Confirmation Reagent (seconds) | R-value close to 1.0 | 0.882 | y=0.76x + 5.46 |
| LA 1/LA 2 Ratio | R-value close to 1.0 | 0.965 | y=1.08x + 0.05 |
| LA 1 Screening Reagent (normalized) | R-value close to 1.0 | 0.969 | y=0.89x + 0.11 |
| LA 2 Confirmation Reagent (normalized) | R-value close to 1.0 | 0.882 | y=0.84x + 0.15 |
| LA 1/LA 2 Ratio (normalized) | R-value close to 1.0 | 0.964 | y=0.97x + 0.04 |
Precision Study (Implied Acceptance Criteria for %CV based on typical industry standards for coagulation assays):
| Assay | Sample | Acceptance Criteria (Implied: Low %CV) | Reported Performance (Total %CV) |
|---|---|---|---|
| LA 1 Screening Reagent (seconds) | LA Control High | Typically |
§ 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.