Dario Blood Glucose Monitoring System

K150817

LabStyle Innovations Ltd. · cleared 2015-12-21 · product code NBW · Clinical Chemistry

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.5)
“The Dario Blood Glucose Monitoring System consists of a device housing that includes a blood glucose meter and lancing device. The system also includes test strips, lancets, control solutions and a mobile application. The Dario meter is powered via the 3.5mm audio headphone jack of the smart mobile device. Users are instructed to insert the test strip into the meter, apply the blood or control solution to the test strip, after which the meter will process the test in approximately six (6) seconds and display the test result on the smart mobile device screen via the mobile application. The Dario Blood Glucose Monitoring System uses Apple's iOS smart mobile device technology to view the glucose test results via a mobile application. This application is available for download via the smart mobile device's application store. The meter calculates the blood glucose level based on an internal algorithm. The Dario application displays the test result via the smart mobile device display.”
Algorithminternal algorithm
source quote (p.5)
“The meter calculates the blood glucose level based on an internal algorithm.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedNo

Validation studies (3)

Retrospective clinical

n=100 cases

endpoints: 100% of individual glucose results fell within 15 mg/dL of the YSI reference at glucose concentrations < 75 mg/dL; 99.6% of individual glucose results fell within 20% of the results of YSI at glucose concentrations ≥ 75mg/dL

standards: ISO 15197:2003

Reader study (MRMC)

n=100 cases

endpoints: accuracy of blood glucose level results obtained by users with the Dario when compared to a reference method; ease of use of the subject device by lay users

standards: ISO 15197:2003

Bench

sample size not stated

endpoints: measurement repeatability; intermediate measurement precision

standards: ISO 15197:2003

Reported performance (6 observations)

accuracyas written: “Accuracy for glucose concentrations < 75 mg/dL (within ±15% of YSI reference)”100
source quote (p.7)
“The results showed that 100% of individual glucose results fell within 15 mg/dL of the YSI reference at glucose concentrations < 75 mg/dL”
accuracyas written: “Accuracy for glucose concentrations ≥ 75 mg/dL (within ±20% of YSI reference)”99.6
source quote (p.7)
“and 99.6% of individual glucose results fell within 20% of the results of YSI at glucose concentrations ≥ 75mg/dL.”
accuracyas written: “User Performance Accuracy for glucose concentrations < 75 mg/dL (within ±15%)”100
source quote (p.9)
“Results for glucose concentrations less than 75 mg/dL: Within ± 15% 11/11 (100%)”
accuracyas written: “User Performance Accuracy for glucose concentrations ≥ 75 mg/dL (within ±20%)”98.88
source quote (p.9)
“Results for glucose concentrations greater than or equal to 75 mg/dL: Within ± 20% 88/89 (98.88%)”
ppvas written: “Precision/Repeatability CV for blood glucose concentrations ≥ 100 mg/dL”4
source quote (p.7)
“The results for measurement repeatability and intermediate measurement precision evaluation showed a CV ≤ 4% at blood glucose concentrations ≥ 100 mg/dL”
ppvas written: “Precision/Repeatability Standard Deviation for blood glucose concentrations < 100 mg/dL”3
source quote (p.7)
“and a standard deviation of ≤ 3 mg/dL at blood glucose concentrations <100 mg/dL.”

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

6
recalls in product code, 24mo
4328
MAUDE reports in code, 12mo
-35%
vs code's own 3-yr baseline
2
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code NBW (Trividia Health, Inc., initiated 2026-02-06): "The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended act" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98317

  • recall_reason_pattern

    Software/algorithm-related recall in product code NBW (Telcare, LLC, initiated 2025-01-30): "Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System.. The i" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96230

Recalls attributed to this device

  • Recalling firm matches this device's applicant (LABSTYLE INNOVATIONS 7, Derekh Menakhem Begin Ramat Gan Israel) — same firm and product code, not necessarily this device · initiated 2019-08-29

    The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading.

    recall event 83761 (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 Clinical Chemistry 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/K150817