VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System +1 more— 510(k) K260687
Substantially EquivalentVivachek Biotech (Hangzhou) Co., Ltd.
FDA 510(k) clearance K260687 for VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System +1 more, Substantially Equivalent on 2026-10-09. Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.. Device class: 2.
Summary
Two monitoring systems from Vivachek Biotech are covered here: the VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System and a version without "BLE" in the name. Product code NBW is over-the-counter blood glucose test systems. The device names also mention ß-ketone, but the record carries only the glucose code.
Class II, 21 CFR 862.1345. The Clinical Chemistry panel reviewed it as a Traditional 510(k).
Vivachek filed from Hangzhou, China. Review took 220 days (March 3 to October 9, 2026).
Clearance details
- Device name as filed
- VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System.
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd.
- Product code
- Product code NBW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Recent devices under product code NBW
view all- K260689 — CVS Advanced PLUS Blood Glucose Monitoring System
- K260545 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System +2 more
- K262116 — TRUE METRIX Self Monitoring Blood Glucose System
- K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System +1 more
- K243060 — TeleRPM Gen2 Blood Glucose Monitoring System
More clearances from Vivachek Biotech (Hangzhou) Co., Ltd.
view all- K261280 — BioSieve Multi-Drug Urine Test Panel; BioSieve Multi-Drug Urine Home Test Panel
- K252554 — Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup
- K241869 — BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader
- K222126 — VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System
- K240124 — BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader
Adverse events under product code NBW
product code NBW- Death
- 18
- Injury
- 4,740
- Malfunction
- 42,679
- Other
- 6
- Total
- 47,443
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.