UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

K120771

BECKMAN COULTER, INC. · cleared 2013-03-22 · product code GKZ · Hematology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.2)
“The UniCel® DxH 800 COULTER® Cellular Analysis System (DxH 800) is intended for In Vitro Diagnostic Use in clinical laboratories. The DxH 800 System provides automated complete blood count, leukocyte differential, nucleated red blood cell (NRBC) enumeration and reticulocyte analysis as well as an automated method for enumeration of the Total Nucleated Cells (TNC) and Red Blood Cells (RBC) in body fluids. Pulse counts and digitized pulse measurements are sent to the System Manager for processing by the algorithms where the reported parameter values, flags and histograms are generated.”
AlgorithmThe data collected during each of the analytical processes is transferred to the System Manager where the digital raw values are processed by the algorithm using mathematical approaches designed for finding optimal separation between clusters of data. The identified clusters are used to calculate the frequency of cells within each population, generate parameter values, flags, histograms and data plots.
source quote (p.8)
“The data collected during each of the analytical processes is transferred to the System Manager where the digital raw values are processed by the algorithm using mathematical approaches designed for finding optimal separation between clusters of data. The identified clusters are used to calculate the frequency of cells within each population, generate parameter values, flags, histograms and data plots.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (12)

Retrospective clinical

sample size not stated

endpoints: accuracy claims (Bias and/or Difference) limits over the measuring ranges; performance requirements and provides results within acceptance limits for parameters reported from whole blood, when compared to the predicate device and for differential parameters when compared to manual reference results; performance requirements and provides results within acceptance limits for parameters reported from body fluid, when compared to the manual chamber count

standards: CLSI H26-A2, CLSI EP9-A2, CLSI H20-A2, CLSI H56-A

Retrospective clinical

sample size not stated

endpoints: equivalency of results (within defined limits) between the whole blood analytical cycles (test panels); equivalency between specimens analyzed as whole blood and as Pre-dilute (PD) specimens

standards: CLSI H26-A2, CLSI EP15-A2

Retrospective clinical

sample size not stated

endpoints: comparability between the sampling modes available on the updated DxH 800; comparable results for all parameters reported, for specimens analyzed using the sampling methods available (automated closed vial, manual closed vial and manual single tube open vial)

standards: CLSI H26-A2, CLSI EP15-A2

Bench

sample size not stated

endpoints: long term imprecision of the device; meets the performance requirements (within acceptance limits) for reproducibility (long term imprecision) using control products

standards: CLSI H26-A2, CLSI EP05-A2

Bench

sample size not stated

endpoints: short term imprecision of the device; meets performance requirements for repeatability, (within acceptance limits) for all parameters reported

standards: CLSI H26-A2, CLSI EP05-A2, CLSI H56-A

Bench

sample size not stated

endpoints: Limit of Blank, Lower Limit of Detection and Lower Limit of Quantitation testing; meets the performance requirements for LoB, LLoD and LLOQ results (within acceptance limits), for the WBC and PLT parameters in whole blood and the BF-TNC and BF-RBC parameters in body fluids

standards: CLSI H26-A2, CLSI EP17-A

Retrospective clinical

sample size not stated

endpoints: Clinical Sensitivity and Specificity to assess the ability of a test to detect presence or absence of a condition/abnormality; WBC Differential Suspect message flagging capability of the system

standards: CLSI H26-A2, CLSI H20-A2

Bench

sample size not stated

endpoints: linearity of the device; linear results, within acceptance limits, for Whole blood and Body Fluid

standards: CLSI H26-A2, CLSI EP06-A

Bench

sample size not stated

endpoints: whole blood and body fluid carryover performance; substantiate the modified NRBC carryover claim; meets the whole blood and body fluid carryover performance requirements (within acceptance limits), for the parameters measured

standards: CLSI H26-A2

Bench

sample size not stated

endpoints: equivalency of results for whole blood specimens collected into K2 and K3EDTA; comparable results, for all parameters reported, from specimens collected into K2 and K3EDTA

standards: CLSI H26-A2, CLSI H3-A6, CLSI H04-A6, CLSI EP15-A2

Bench

sample size not stated

endpoints: whole blood specimen stability; whole blood long term, short term and pre-dilute sample stability

Retrospective clinical

sample size not stated

endpoints: comparability of whole blood reference ranges for an adult population to the ranges established for the predicate device

standards: CLSI C28-A3

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

14
recalls in product code, 24mo
61
MAUDE reports in code, 12mo
-55%
vs code's own 3-yr baseline
2
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code GKZ (Abbott Laboratories, initiated 2025-09-18): "Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97788

  • recall_reason_pattern

    Software/algorithm-related recall in product code GKZ (Abbott Laboratories, initiated 2025-03-18): "When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96567

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Beckman Coulter Inc.) — same firm and product code, not necessarily this device · initiated 2025-08-13

    Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

    recall event 97464 (openFDA)

  • Recalling firm matches this device's applicant (Beckman Coulter Inc.) — same firm and product code, not necessarily this device · initiated 2025-08-13

    Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

    recall event 97464 (openFDA)

  • Recalling firm matches this device's applicant (Beckman Coulter Inc.) — same firm and product code, not necessarily this device · initiated 2025-08-13

    Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

    recall event 97464 (openFDA)

  • Recalling firm matches this device's applicant (Beckman Coulter Inc.) — same firm and product code, not necessarily this device · initiated 2025-08-13

    Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

    recall event 97464 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Hematology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K120771