(165 days)
The UniCel® DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel® DxH 800 Analyzer provides:
- a Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood
- a Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)
The UniCel® DxH 800 Coulter® Cellular Analysis System (DxH 800 System) is intended for In Vitro Diagnostic Use in clinical laboratories. The DxH 800 System provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis as well as an automated method for enumeration of RBCs and TNCs in body fluids.
The purpose of the DxH 800 System is intended to separate the normal patient. with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patient's condition.
The instrument system is comprised of the analyzer and a suite of analytical reagents that allow for simultaneous quantitative determination of hematological parameters through the use of impedance, RF, flow cytometric light scatter, spectrophotometry, and supravital staining methodologies. Additional reagents provide system cleaning and quality control and calibration.
The provided text for the UniCel® DxH 800 Coulter® Cellular Analysis System (K081930) is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results with acceptance criteria.
Therefore, the information required to fully answer your request regarding acceptance criteria and the study proving the device meets them is not explicitly available in the provided document.
However, I can extract what is stated and highlight the missing information:
1. A table of acceptance criteria and the reported device performance
The document broadly states: "Accuracy, repeatability (precision), measuring (linearity) range and carryover studies were conducted and demonstrated acceptable performance per the manufacturer specifications."
Missing Information:
- Specific numerical acceptance criteria for accuracy, repeatability, linearity, and carryover for each parameter (e.g., WBC, RBC, Hgb, etc.).
- The actual reported performance values for each of these criteria.
| Characteristic | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|---|
| Accuracy | To be determined by manufacturer | "demonstrated acceptable performance" |
| Repeatability | To be determined by manufacturer | "demonstrated acceptable performance" |
| Linearity | To be determined by manufacturer | "demonstrated acceptable performance" |
| Carryover | To be determined by manufacturer | "demonstrated acceptable performance" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information:
- Specific sample sizes used for accuracy, repeatability, linearity, and carryover studies.
- Data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is an automated hematology analyzer, not an imaging device requiring expert interpretation for ground truth in the typical sense (like radiology). Ground truth for hematology analyzers is usually established by reference methods or validated manual counts.
Missing Information:
- Details on how ground truth was established for the performance studies (e.g., specific reference methods, manual microscopy, or comparison to predicate). If manual microscopy was used for differential counts, the number and qualifications of technicians would be relevant, but this is not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information:
- Adjudication methods are not applicable nor mentioned for this type of device and performance testing.
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
Missing Information:
- MRMC studies are typically for medical imaging devices where human readers interpret cases. This is an automated laboratory analyzer, so an MRMC study is not relevant and was not conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a standalone automated analyzer. Its performance data (accuracy, precision, linearity) inherently represent its standalone performance, as it is designed to replace or assist manual methods in laboratories. The summary refers to "acceptable performance per the manufacturer specifications," implying standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing Information:
- The document does not specify the type of ground truth (e.g., specific reference methods, manual counts, or comparison to predicate devices) used for the performance studies. For hematology parameters, ground truth is often established using established reference methods, manual microscopy, or comparisons to well-characterized predicate devices.
8. The sample size for the training set
The device is an automated hematology analyzer, not an AI/ML device that requires a "training set" in the common machine learning sense. Its algorithms are based on established physical principles (impedance, RF, flow cytometry, spectrophotometry) and pre-determined thresholds and calculations.
Missing Information:
- Not applicable in the context of this traditional automated laboratory device.
9. How the ground truth for the training set was established
Missing Information:
- Not applicable as it's not an AI/ML device with a "training set."
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”