Clinical Chemistry · 510(k) · 2015
Dario Blood Glucose Monitoring System
LabStyle Innovations Ltd.. Cleared by FDA on 21 December 2015 under submission K150817, product code NBW (system, test, blood glucose, over the counter). What FDA's record says, in FDA's words.
Device record · K150817
- Device. Dario Blood Glucose Monitoring SystemDEVICE
- Company. LabStyle Innovations Ltd.COMPANY
- Decision. 21 December 2015, 510(k), substantially equivalent (traditional review); received 27 March 2015DECISION
- Panel. Clinical ChemistryPANEL
- Product code. NBW, System, Test, Blood Glucose, Over The CounterCODE
- Regulation. 21 CFR 862.1345, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
7KH'DULR%ORRG*OXFRVH0RQLWRULQJ6\VWHPFRQVLVWVRIWKH'DULR%ORRG*OXFRVH0HWHU'DULR*OXFRVH7HVW6WULSV 'DULR*OXFRVH&RQWURO6ROXWLRQVDQGWKH'DULR$SSDVWKHGLVSOD\FRPSRQHQWRIWKH'DULR%ORRG*OXFRVH0RQLWRULQJ 6\VWHP7KH'DULR%ORRG*OXFRVH0RQLWRULQJ6\VWHPLVLQWHQGHGIRUWKHTXDQWLWDWLYHPHDVXUHPHQWRIJOXFRVH VXJDU LQ IUHVK FDSLOODU\ ZKROH EORRG VDPSOHV GUDZQ IURP WKH ILQJHUWLSV 7KH 'DULR %ORRG *OXFRVH 0RQLWRULQJ 6\VWHP LV LQWHQGHGWREHXVHGE\DVLQJOHSHUVRQDQGVKRXOGQRWEHVKDUHG The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. The DarioBlood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The Dario Glucose Control Solutions are for use with the Dario Blood Glucose Meter and the Dario Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 432,413 reports filed against devices carrying product code NBW. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · Medline · Medline Industries, LP · report 1417592-2026-53966
30 September 2026 · Malfunction · Medline · Medline Industries, LP · report 1417592-2026-53967
30 September 2026 · Malfunction · MEDLINE · Medline Industries, LP · report 1417592-2026-53980
It was reported that 1 OUT OF THE 6 GLUCOSE METERS ORDERED (ITEM#: MPH4540) WERE DEFECTIVE AND INCORRECTLY READING GLUCOSE LEVELS. SHE ADVISED WHEN LEVEL 2 TEST STRIPS ARE ENTERED, THE READING SHOULD BE BETWEEN 74-99 AND THIS ITEM KEPT HAVING A READING OF 71.
30 September 2026 · Malfunction · Medline · Medline Industries, LP · report 1417592-2026-53982
It was reported that the device was not working.
30 September 2026 · Malfunction · Medline · Medline Industries, LP · report 1417592-2026-53984
It was reported that the device was not working.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code NBW, in Clinical Chemistry, or cleared in 2015. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.