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

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.

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

• Method Comparison and WBC Flagging Ability:
  • Sample Size: 1222 K2EDTA whole blood samples.
  • Data Provenance: Three actual user sites, two in China and one in the U.S. Patients aged 1 day to 100 years, with 547 females, 672 males, and 3 unknown. Retrospective/prospective not explicitly stated, but "Patient's samples covered the normal and most abnormal conditions" suggests selection, possibly from archives or collected for the study.
• Precision/Reproducibility: Not explicitly stated as a fixed test set size for patient samples, but control materials were run in duplicate twice a day for 20 days at three clinical sites. For within-run precision, ten replicates of whole blood samples were used around medical decision levels and analytical measuring range limits at three clinical sites.
• Linearity Range: Not explicitly stated as a fixed test set size, but "7 subsequent dilutions" were prepared and "three (3) from each of the 7 dilutions" were measured.
• Comparison of Whole Blood Mode and Predilute Mode Sample:
  • Sample Size: 61 pairs of samples.
  • Data Provenance: K2EDTA collection tube, not specified if US or China.
• Comparison of Venipuncture and Fingerstick Sample:
  • Sample Size: 52 paired specimens.
  • Data Provenance: Collected from donors (not specified where, but tested at the U.S. site).
• Comparison of K2EDTA and K3EDTA Anticoagulants Samples:
  • Sample Size: 60 paired fresh whole blood samples.
  • Data Provenance: Not specified where, but tested at an actual user site in the U.S.
• Sample Stability:
  • Whole Blood: 35 normal and abnormal samples collected at Finlay Laboratory (U.S. site).
  • Predilute: 25 normal and abnormal samples collected at NSH site (location not specified, likely one of the clinical sites mentioned earlier).
• Reference Interval:
  • Sample Size: 255 donors (124 adult male, 131 adult female).
  • Data Provenance: Not specified, but adult donors aged 19-85.
• Determination of LoB, LoD, LoQ:
  • Sample Size: 5 blank samples and 5 low-level samples, tested 12 times (blank) or 5 times (low-level).
  • Data Provenance: One clinical laboratory in China.

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

• Method Comparison and WBC Flagging Ability:
  • Number of Experts: Not explicitly stated. The text mentions "A 400 cell WBC differential was performed on two smears per CLSI H20-A2." This typically implies trained laboratory professionals, but the exact number and qualifications (e.g., years of experience, specific certifications) are not provided. CLSI H20-A2 (Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods) guides this process, which requires expert review.

4. Adjudication Method for the Test Set

• Method Comparison and WBC Flagging Ability: The text states "A 400 cell WBC differential was performed on two smears per CLSI H20-A2." This standard often outlines procedures for resolving discrepancies, but the specific adjudication method (e.g., 2+1, 3+1) is not detailed in the provided summary. It implies expert review for ground truth, but not a specific reader adjudication process for the study.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on the improvement of human readers with vs. without AI assistance was not performed. This device is an automated hematology analyzer, not an AI-assisted diagnostic tool for human interpretation of images. The comparison was primarily between the new device and the predicate device, and between the device's flagging ability and a manual differential (human expert determination).

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

• Yes, the performance data presented (e.g., method comparison, WBC flagging ability, precision, linearity, carryover) represents the standalone performance of the BC-3600 Auto Hematology Analyzer. The device is designed to be an automated analyzer providing quantitative results.

7. The Type of Ground Truth Used

• Method Comparison (vs. Predicate): The ground truth for this comparison was the results obtained from the predicate device (BC-3200).
• WBC Flagging Ability: The ground truth for this was established by manual differential counts performed by experts on peripheral blood smears, following CLSI H20-A2 guidelines.
• Precision/Reproducibility: Used commercial control materials (BC-3D control Low, Normal and High).
• Linearity Range: Used dilutions prepared from fresh whole blood and commercial high-value analogs for WBC and PLT.
• Comparisons (Modes, Samples, Anticoagulants): Used the BC-3600 results in different configurations/conditions to show equivalence.
• Sample Stability: Used the BC-3600 results at different time points compared against initial readings.
• Reference Interval: Determined by testing samples from 255 healthy donors.
• LoB, LoD, LoQ: Established using blank samples (diluent) and low-level samples created by adding whole blood to diluent.

8. The Sample Size for the Training Set

• The document describes validation and verification studies for a medical device submitted for 510(k) clearance, not the development or training of an AI algorithm. Therefore, there is no mention of a training set sample size as it pertains to AI/machine learning. The studies described are for demonstrating the performance of the final device against established standards and predicates. This device uses the "Coulter principle of Impedance method" and "Colorimetric method," classical laboratory techniques, not explicitly an AI/ML algorithm that would require a "training set."

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

• As stated above, this document does not describe the development or training of an AI algorithm, but rather the validation of an automated hematology analyzer based on traditional principles. Therefore, the concept of "ground truth for the training set" does not apply in this context.

Ask a specific question about this device