Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system

K-Number: K213131 · 2023-08-10

ApplicantRoche Diabetes Care GmbH
Decision Date2023-08-10
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diabetes Care GmbH. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K213131. 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 Solo diabetes manager blood glucose monitoring system?

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is Roche Diabetes Care GmbH. The 510(k) number is K213131.

When did Accu-Chek Guide Solo diabetes manager blood glucose monitoring system receive FDA 510(k) clearance?

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system received FDA 510(k) clearance on 2023-08-10, under 510(k) number K213131.

Who is the listed applicant for Accu-Chek Guide Solo diabetes manager blood glucose monitoring system?

The FDA 510(k) record lists Roche Diabetes Care GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accu-Chek Guide Solo diabetes manager blood glucose monitoring system?

The FDA product code for Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is NBW. This falls under the OB/GYN category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06704672Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes MellitusRECRUITINGNCT06141629Benefits of a Bolus Calculator in Pediatric Patients on Multiple Daily Insulin InjectionsCOMPLETEDNCT07459582Accuracy of Home Lactate Meter and Accu-chek Glucometer in Patients With Glycogen Storage DiseaseRECRUITINGNCT05643144Enhancing Shared Decision-making to Guide Care for People With Dementia and DiabetesRECRUITINGNCT07510919CGM in Acute Ischemic StrokeNOT_YET_RECRUITINGNCT07655076Simultaneous Measurement and Responsive Treatment - Part 2RECRUITING

Related PubMed Literature

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMID: 37272495An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection.Journal of diabetes science and technology (2023)

Other records listing Roche Diabetes Care GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232509Accu-Chek Safe-T-Pro Uno Lancing DeviceK232488Accu-Chek Safe-T-Pro Plus Lancing DeviceK213134Accu-Chek Solo micropump system with interoperable technologyK220849Accu-Chek Safe-T-Pro Plus Lancing DeviceK203711IWL2020 Blood Glucose Monitoring SystemK220608Accu-Chek FastClix Blood Lancing System

View all 11 devices →

Related Devices (Code: NBW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime CorporationK240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc.

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.

↑