Sight OLO

K190898

Sight Diagnostics Ltd. · cleared 2019-11-01 · product code GKZ · Hematology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface.”
Algorithmcomputer-vision algorithms visually scan stained blood sample under device fluorescence microscope and analyze the captured images. Software identifies visual differences between different blood components while relying on characteristics such as size, shape, intensity, and morphology.
source quote (p.7)
“Computer-vision algorithms visually scan stained blood sample under device fluorescence microscope and analyze the captured images. Software identifies visual differences between different blood components while relying on characteristics such as size, shape, intensity, and morphology.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (14)

Retrospective clinical

n=679 patients · 3 site(s)

endpoints: correlation; bias; slope; intercept

standards: CLSI H20-A2, CLSI H26-A2, CLSI EP09-A3

Bench

sample size not stated · 3 site(s)

endpoints: mean; standard deviation (SD); coefficient of variation (CV)

standards: CLSI EP05-A3

Bench

n=240 other · 3 site(s)

endpoints: within run precision; between run precision; between day precision; between instrument precision; between site precision; total precision

standards: CLSI EP05-A3

Bench

n=60 other

endpoints: limit of blank; limit of detection; limit of quantification

standards: CLSI EP17-A2

Bench

n=10 patients

endpoints: linearity range

standards: CLSI H26-A2, CLSI EP06-A

Bench

sample size not stated

endpoints: susceptibility to interferants; critical concentration of interferant

standards: CLSI EP07-A2, CLSI EP09-2

Bench

n=10 patients

endpoints: sample stability

standards: CLSI EP25-A

Bench

n=3 other

endpoints: shelf-life stability

Bench

sample size not stated

endpoints: calibration and functional specifications during shipping

standards: ASTM D7386-16

Reader study (MRMC)

n=208 patients · 3 site(s)

endpoints: sensitivity; specificity

standards: CLSI H20-A2

Retrospective clinical

n=240 patients · 1 site(s)

endpoints: reference intervals

standards: CLSI EP28-A3c

Retrospective clinical

n=80 patients

endpoints: reference intervals

standards: CLSI EP28-A3c

Retrospective clinical

n=67 patients

endpoints: comparable performance characteristics for capillary and venous whole blood specimens

standards: CLSI EP09-A3

Retrospective clinical

n=40 patients · 1 site(s)

endpoints: comparable performance between the K2EDTA anticoagulated microtube capillary samples and the 2-drop fingertip samples

Reported performance (2 observations)

sensitivity93
source quote (p.16)
“Sensitivity (PPA) 93.0%”
specificity80.6
source quote (p.16)
“Specificity (NPA) 80.6%”

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 (SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel) — same firm and product code, not necessarily this device · initiated 2024-05-13

    One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside of the device specification.

    recall event 94678 (openFDA)

  • Recalling firm matches this device's applicant (SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel) — same firm and product code, not necessarily this device · initiated 2022-06-14

    The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may incorrectly appear to be within or outside the reference range.

    recall event 90533 (openFDA)

  • Recalling firm matches this device's applicant (SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel) — same firm and product code, not necessarily this device · initiated 2022-01-20

    In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on software versions 2.59.3 and all earlier versions, which can potentially lead to displaying and printing incorrectly-configured reference range values

    recall event 89645 (openFDA)

  • Recalling firm matches this device's applicant (SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel) — same firm and product code, not necessarily this device · initiated 2021-03-17

    Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software

    recall event 88401 (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/K190898