Search Results

The BC-5390 Auto Hematology Analyzer is a quantitative, automated hematology Analyzer for in vitro diagnostic use in clinical laboratories. The BC-5390 Auto Hematology Analyzer provides complete blood count (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV) and leukocyte 5-Part differential (Neut, Lym#, Mon#, Eos#, Bas#, Neu%, Lym%, Mon%, Eos%, Bas%) for whole blood specimens collected in a salt of EDTA [dipotassium (K2) or tripotassium (K3)) obtained from venous or capillary blood collection. The purpose of the BC-5390 Auto Hematology Analyzer is to identify the normal human patient, with normal system-generated parameters, from patients whose results require additional studies.

The BC-5390 Auto 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 laboratory professionals to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies.

The BC-5390 Auto Hematology Analyzer system consists of:

• Instrument: Sample Processing Unit (SPU) and Data Managing Unit (DMU)
• . Reagents M-53D DILUENT M-5LEO(I) LYSE M-5LEO(II) LYSE M-53LH LYSE PROBE CLEANSER
• Controls

BC-5D Hematology Control (High, Normal, Low, Pending) Note: Controls for BC-5390 Auto Hematology Analyzer will be submitted in parallel with this 510(k) by R&D Systems as separate 510(k).

• . Calibrator
  SC-CAL PLUS Hematology Calibrator (cleared as K955925)

The Analyzer provides analysis results of 21 parameters, 3 histograms and 1 scattergram of human blood. It supports two test panels: CBC and CBC+DIFF.

Here's an analysis of the acceptance criteria and study details for the Mindray BC-5390 Auto Hematology Analyzer, based on the provided text:

Key Takeaways on Device Performance:

The device's performance was primarily evaluated through a method comparison study against a predicate device (Sysmex XE-2100) and various studies adhering to CLSI (Clinical and Laboratory Standards Institute) guidelines. The results generally indicate good correlation and adherence to predefined specifications, supporting the device's substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a single, dedicated table with numerical targets, but instead describes performance studies and states that results "met the pre-defined specification" or "were within the specifications." The table below synthesizes the implicit acceptance criteria based on the reported study results, primarily from the method comparison against the predicate device (Sysmex XE-2100).

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

• Test Set Sample Size:

  • Method Comparison: 1531 whole blood samples (collected in K2EDTA).
  • WBC Morphology Flagging: 1514 samples.
  • Precision/Repeatability: Not explicitly stated, but "whole blood samples" for repeatability, and "three levels of samples" from commercial control material BC-5D (tested in duplicate, twice daily for 20 days across 3 sites) for reproducibility (total 240 replicates per level across all sites).
  • Linearity: Dilutions prepared from commercial analogs (WBC, PLT) or fresh whole blood (RBC/HGB), with 7 subsequent dilutions, each run in triplicate.
  • Carryover: High and low samples tested in triplicates.
  • Interference: Whole blood samples with added interfering substances.
  • Comparison of Whole Blood Mode and Predilute Mode: 124 leftover whole blood samples.
  • Comparison of CBC and CBC+DIFF Mode: 103 leftover whole blood samples (Whole blood CBC vs CD) and 75 samples (Predilute CBC vs CD).
  • Comparison of Capillary and Venous Blood: 57 paired specimens.
  • Comparison of K2EDTA and K3EDTA Anticoagulants: 70 paired fresh whole blood samples.
  • Sample Stability: Fresh samples covering normal and medical decision range.
  • Adult Reference Interval: 251 donors (121 male, 130 female).
  • Pediatric Reference Interval: 161 pediatric samples (45 neonate, 26 infant, 57 child, 33 adolescent).
  • LoB, LoD, LoQ: Five blank samples and five low-level samples, each tested 12 times.

• Data Provenance:

  • Country of Origin: Not explicitly stated for all studies. The method comparison was done at "three actual user sites." The comparison of capillary and venous blood, and K2EDTA vs K3EDTA anticoagulants were done at "the U.S. site" or "clinical laboratory in U.S." This implies at least some data originated from the US, but a global origin is not ruled out for all studies.
  • Retrospective or Prospective: Not explicitly stated. The description "whole blood samples... were analyzed," "patient's samples covered the normal and most abnormal conditions," "leftover whole blood samples," and collection of "fresh samples" suggests a mix, and for studies like method comparison and flagging, samples from a patient population would likely be collected prospectively or retrospectively from a clinical lab biobank. The reference interval studies explicitly describe collecting samples, indicating these were prospective.

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

• Number of Experts: For the WBC manual differential (used as ground truth for WBC morphology flagging rate), "three manual wedge smears were prepared and stained with Wright-Giemsa stain. A 400 cell WBC differential was performed on two smears per CLSI H20-A2." This implies at least two experts (or a single expert doing two reads, which is less likely for independent confirmation) were involved in the manual differential portion. The document doesn't specify if these were consensus reads or independent.
• Qualifications of Experts: Not explicitly stated for the manual differential readers. It mentions "trained laboratory professionals" in the device description, implying that these professionals would be performing the manual differentials. CLSI H20-A2 typically refers to the standard for manual differential counting, which implies trained medical technologists or clinical laboratory scientists.

4. Adjudication Method for the Test Set

• Method Comparison and Flagging: For the WBC manual differential, it states "A 400 cell WBC differential was performed on two smears per CLSI H20-A2." It does not explicitly mention an adjudication method (like 2+1 or 3+1). It's possible that if two readers performed the differential, a consensus or third reader was used for discordant results, but the document doesn't detail this. It simply states the manual differential was performed "per CLSI H20-A2," which provides guidelines for the procedure.

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

• No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done.
  • This study evaluates the improvement in human reader performance (e.g., accuracy, efficiency) with the assistance of an AI algorithm compared to performing the task without AI assistance. The document describes a standalone device, an automated hematology analyzer, which performs the cell counting and differential analysis itself. The comparison is between the device and a predicate device, and between the device and manual methods, not human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone study was done.
  • The "Method Comparison" study (pages 9-10) directly compares the BC-5390 Auto Hematology Analyzer's quantitative results for 21 parameters against a legally marketed predicate device, the Sysmex XE-2100 Automated Hematology Analyzer. This is a standalone performance evaluation of the new device against an established one.
  • The "WBC Morphology Flagging Ability" (page 10), which compares the BC-5390's flagging rate to manual WBC differential, is also a standalone performance assessment of the device's ability to identify abnormal samples.
  • All the other performance characteristic studies (Precision, Linearity, Carryover, Interference, Sample Stability, LoD/LoQ/LoB) evaluate the BC-5390's performance in isolation or against defined standards, without human intervention in the primary measurement process once the sample is loaded.

7. Type of Ground Truth Used

• Predicate Device Measurements: Primarily used for most quantitative parameter comparisons (e.g., WBC, RBC, HGB, etc.), where the Sysmex XE-2100 (K992875) was the reference. This represents an established and FDA-cleared measurement method.
• Expert Manual Differential: Used for the WBC morphology flagging ability study (400-cell WBC differential performed on manual wedge smears per CLSI H20-A2). This is a form of expert consensus/manual reference.
• Dilution Series / Established Standards: For linearity, carryover, and LoD/LoQ/LoB studies, the ground truth was based on prepared dilution series and reference materials.
• Literature Reference Intervals: For pediatric reference interval verification, the ground truth was published pediatric intervals from "Mayo and IOWA literature."

8. Sample Size for the Training Set

• The document does not provide information on the sample size used for the training set. This is typical for a 510(k) summary, which focuses on device validation/verification testing rather than details of the algorithm's development (training).

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

• As the document does not provide information on the training set, it also does not explain how the ground truth for any potential training set was established.

Ask a specific question about this device