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FDA 510(k)

Accu-Chek Guide Me Blood Glucose Monitoring System

K-Number: K181131 · 2018-12-13

ApplicantRoche Diabetes Care
Decision Date2018-12-13
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Accu-Chek Guide Me Blood Glucose Monitoring System is a medical device manufactured by Roche Diabetes Care. It received FDA 510(k) clearance on 2018-12-13 under approval number K181131. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Accu-Chek Guide Me Blood Glucose Monitoring System?

Accu-Chek Guide Me Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-12-13. It is manufactured by Roche Diabetes Care. The 510(k) number is K181131.

When was Accu-Chek Guide Me Blood Glucose Monitoring System approved by the FDA?

Accu-Chek Guide Me Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-12-13, under approval number K181131.

What company makes Accu-Chek Guide Me Blood Glucose Monitoring System?

Accu-Chek Guide Me Blood Glucose Monitoring System is manufactured by Roche Diabetes Care.

What is the FDA product code for Accu-Chek Guide Me Blood Glucose Monitoring System?

The FDA product code for Accu-Chek Guide Me Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED

Related PubMed Literature

PMID: 41693672 Continuous Glucose Monitoring in Diabetes Care in Saudi Arabia: Addressing Performance Standards and Regulatory Gaps-Literature Review and Consensus Report. Journal of diabetes science and technology (2026) PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025) PMID: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023) PMID: 37272495 An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection. Journal of diabetes science and technology (2025)

Related Devices (Code: NBW)

K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc. K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring SystemsTaidoc Technology Corporation K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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