(249 days)
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No
The summary describes a standard automated hematology analyzer using established methods for cell counting and differentiation, with no mention of AI or ML.
No
The device is described as a quantitative automated hematology analyzer for in vitro diagnostic use, intended to provide complete blood counts and leukocyte differentials to identify patients whose results require additional studies. It is a diagnostic tool, not designed for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for in vitro diagnostic use in clinical laboratories."
No
The device description explicitly states "The DxH™ 300 and DxH™ 300C COULTER® Cellular Analysis Analyzers are intended for In Vitro Diagnostic clinical laboratories." and refers to "two counting modes, whole blood and prediute mode," indicating a physical analyzer that processes blood samples, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The DxH 300 COULTER Cellular Analysis System and the DxH 300C COULTER Cellular Analysis System are quantitative automated hematology analyzers for in vitro diagnostic use in clinical laboratories."
This statement directly identifies the device as being intended for use outside of a living organism (in vitro) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The DxH 300 COULTER Cellular Analysis System and the DxH 300C COULTER Cellular Analysis System are quantitative automated hematology analyzers for in virro diagnostic use in clinical laboratories. The DxH 300 COULTER Cellular Analysis System and the DxH 300C COULTER Cellular Analysis System provide complete blood count, (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV) and Leukocyte 3-Part Differential [LY (%/#), MO (%/#), GR (%/#)] for whole blood specimens, collected in a salt of EDTA [dipotassium (K2) or tripotassium (K3)] obtained by venipuncture, heel or fingerstick. The purpose of the DxH 300 and the DxH 300C is to identify normal human patients, with normal system-generated parameters, from patients whose results require additional studies.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
1 300 and DxH™ 300C COUL TER® Cellular Analysis Analyzes are intended for In Vitro Diagnostic clinical laboratories. The DxH 300C has the capability to process samples in an fferentials pos of the DxH 300 Systems are to separate the nomal patient, with all nomal system enreres, p who needs additional studies of any of these parameters. These studies measurem imatano somrical of the antyrer and a suice of anneliza marker ormulario m national beranters mored the securitment milled del dinam minutare de propriamente del minder desi Parameters: WBC, Lymph #, Mo #, Gran#, Lymph %, Mo%, Gran%, RBC, HGB, HCT%, MCV, MCH, MCHC, RDW, RDW- SD, PLT, MPV. two counting modes, whole blood and prediute mode. The two modes is the amount of sample of sample ar
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
| Study | Study Design | Study Results |
|---|---|---|
| Accuracy | Based on CLSI EP9-A2, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Second Edition. Testing was done in accordance with CLSI H20-A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard – Second Edition | The DxH 300 systems demonstrated comparable results to the predicate device with reagents stated above. |
| Precision | Based on CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. | The DxH 300 systems demonstrated acceptable results with reagents stated above. |
| Linearity | Based on CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline | The DxH 300 systems demonstrated acceptable linearity results. |
| Carryover | Reference to the ICSH document: Guidelines for the Evaluation of Blood Cell Analyzers including those used for differential leukocyte and reticulocyte counting and cell marker applications. International Council for Standardization in Haematology: prepared by the ICSH expert panel on cytometry. Clin Lab Haematol, 16(2):157- 174, 1994 | The DxH 300 systems demonstrated acceptable carryover results. |
| Specimens | Specimen collection was done in accordance with CLSI H3- A6- Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture: Approved Standard- Sixth Edition | Acceptable sample and prepared sample stability results achieved. |
| Reference Values | Based on CLSI C28-A3, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory, Approved Guideline – Third Edition | Reference intervals established. |
| Performance | Testing was done in accordance with CLSI H20-A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard – Second Edition | The DxH 300 systems analysis of normal and clinical samples met the internal validation acceptance criteria |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.”
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510(k) Summary
OxH™ 300 COULTER® Cellular Analysis Syst
xH™ 300C COULTER® Cellular Analysis Syst