One Drop Blood Glucose Monitoring System

K161834

AgaMatrix, Inc. · cleared 2016-11-30 · product code NBW · Clinical Chemistry

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.5)
“The One Drop Blood Glucose Monitoring System (BGMS) consists of: 1 One Drop Blood Glucose Meter 1 One Drop Owner's Guide 1 Carry Case 1 Lancing Device 10 Lancets 100 One Drop Glucose Test Strips AgaMatrix Glucose Control Solution (available separately)”
AlgorithmThe fundamental scientific technology and the electronics that sends the electrical signals to the assay algorithm are all the same as the predicate device AgaMatrix Jazz Wireless 2 BGMS (K152365).
source quote (p.5)
“The fundamental scientific technology and the electronics that sends the electrical signals to the assay algorithm are all the same as the predicate device AgaMatrix Jazz Wireless 2 BGMS (K152365).”
Adaptive (vs locked)No
source quote (p.5)
“The unit of measure displayed on the meter screen is fixed in mg/dL and cannot be modified by the user.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: Sample Type; Sample Sites; Sample Volume; Average Test Time; Test range; Operating Temperature; Measurement Range; Calibration; Control Levels; Operating Humidity; Hematocrit Range; Altitude Study; Detection method; Enzyme; Calibration Coding

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

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

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/K161834