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510(k) Data Aggregation
(273 days)
The BC-3600 auto hematology analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in clinical laboratories. The BC-3600 auto hematology analyzer provide complete blood count (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV) and leukocyte 3-Part differential (Lymph#, Mid#, Gran#, Lymph%, Mid%, Gran%) for whole blood specimens, collected in a salt of EDTA [dipotassium (K2) or tripotassium (K3)] obtained by venipuncture or fingerstick. The purpose of the BC-3600 Auto Hematology Analyzer is to identify the normal human patient, with normal system-generated parameters, from patients whose results require additional studies.
The BC-3600Auto Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for In Vitro Diagnostic Use in clinical laboratories. It is only to be used by trained medical professionals to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies. The analyzer provides analysis results of 16 parameters of human blood and three histograms.
The BC-3600 Auto Hematology Analyzer system consists of:
- The analyzer (BC-3600)
- Reagents (M-30D DILUENT, M-30CFL LYSE, M-30R RINSE, PROBE CLEANSER)
- Controls (BC-3D Control (High, Normal, Low levels))
- Calibrator (SC-CAL PLUS Calibrator)
The analyzer provides analysis results of 16 parameters (WBC, Lymph#, Mid#, Gran#, Lymph%, Mid%, Gran%, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV) of human blood and three histograms (WBC Histogram, RBC Histogram, PLT Histogram).
The provided text describes the Mindray BC-3600 Auto Hematology Analyzer and its substantial equivalence to the predicate device, BC-3200 Hematology Analyzer.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" against which the device performance is directly compared column-by-column. Instead, it describes performance characteristics and states that the device "met the pre-defined specification of the difference limits" or "passed specifications." We can infer the acceptance criteria from the context of these statements and the reported performance.
For method comparison against the predicate device (BC-3200), the acceptance criteria are implicitly defined by the parameters r (correlation coefficient), slope (95% CI), and intercept (95% CI) and the statement that biases met pre-defined limits. For flagging ability, the percentages for sensitivity, specificity, and efficiency serve as the reported performance, with implicit acceptance criteria for these values. For carryover, an explicit acceptance criterion is given.
| Performance Characteristic | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Method Comparison (vs. Predicate BC-3200) | (See Table 1 and accompanying text) | |
| Correlation Coefficient (r) | High correlation (e.g., typically >0.90 to 0.95 for quantitative assays) and slope/intercept within acceptable ranges indicating comparable measurements. | WBC: 0.999 |
| Lymph#: 0.985 | ||
| Mid#: 0.873 | ||
| Gran#: 0.998 | ||
| Lymph%: 0.982 | ||
| Mid%: 0.677 | ||
| Gran%: 0.985 | ||
| RBC: 0.997 | ||
| HGB: 0.998 | ||
| HCT: 0.997 | ||
| MCV: 0.994 | ||
| MCH: 0.991 | ||
| MCHC: 0.915 | ||
| RDW: 0.901 | ||
| PLT: 0.992 | ||
| MPV: 0.865 | ||
| Slopes and intercepts with 95% CI reported. Biases "met the pre-defined specification of the difference limits." | ||
| WBC Flagging Ability (vs. Manual Differential) | Implicitly, clinically acceptable levels of sensitivity, specificity, and efficiency. | Sensitivity: 73.6% |
| Specificity: 76.5% | ||
| Efficiency: 75.9% | ||
| Precision/Reproducibility | Coefficients of variation (CV%) and standard deviations (SD) for within-run, between-run, between-day, and within-device (and between-device for combined data) met specifications. | "The reproducibility results in each site met the specifications." |
| "All data in each site passed specifications." | ||
| Linearity Range (R2) | Coefficient of determination (R2) > 0.95 and parameters recovering within bias limits. | "data fitting a linear regression line with a coefficient of determination (R2) of >0.95 and the parameters measured recovering within the bias limits for each parameters based on CLSI EP06-A." |
| Carryover (WBC, RBC, HGB) | ≤ 0.5% | "results were within specifications (≤ 0.5%)" |
| Carryover (PLT) |
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