Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
FDA 510(k) K213131 · Roche Diabetes Care GmbH
510(k) numberK213131
Submission
- Device name
- Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
- Applicant
- Roche Diabetes Care GmbH
Mannheim, DE - Received
- September 27, 2021
- Decision date
- August 10, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
Other 510(k)s with product code NBW
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| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care | 08/27/2026SE |
| K262116 | TRUE METRIX Self Monitoring Blood Glucose SystemNBW · Special | Trividia Health, Inc. | 07/23/2026SE |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood…NBW · Traditional | ACON Laboratories, Inc. | 10/10/2025SE |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring SystemNBW · Traditional | Guangdong Transtek Medical Electronics Co., Ltd. | 01/30/2025SE |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | Bionime Corporation | 11/04/2024SE |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemNBW · Traditional | Sejoy Biomedical Co., Ltd. | 10/08/2024SE |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care U.S., Inc. | 08/27/2024SE |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose…NBW · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 08/16/2024SE |
| K241304 | WaveSense Jazz Blood Glucose Monitoring SystemNBW · Special | Agamatrix | 06/06/2024SE |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW · Traditional | Ascensia Diabetes Care | 02/23/2024SE |
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| K213134 | Accu-Chek Solo micropump system with interoperable technologyQFG · Traditional | 08/10/2023SE |
| K220849 | Accu-Chek Safe-T-Pro Plus Lancing DeviceFMK · Traditional | 05/19/2022SE |
| K203711 | IWL2020 Blood Glucose Monitoring SystemNBW · Traditional | 05/06/2022SE |
| K220608 | Accu-Chek FastClix Blood Lancing SystemQRL · Traditional | 04/29/2022SE |
| K220364 | Accu-Chek Safe-T-Pro Uno Lancing DeviceFMK · Traditional | 04/05/2022SE |
| K214022 | Accu-Chek Softclix Blood Lancing SystemQRL · Traditional | 02/17/2022SE |
| K181131 | Accu-Chek Guide Me Blood Glucose Monitoring SystemNBW · Special | 12/13/2018SE |
| K160944 | ACCU-CHEK Guide Blood Glucose Monitoring SystemNBW · Traditional | 08/31/2016SE |
Questions and answers
When was Accu-Chek Guide Solo diabetes manager blood glucose monitoring system cleared by the FDA?
Accu-Chek Guide Solo diabetes manager blood glucose monitoring system (K213131) received a 510(k) decision of Substantially Equivalent on August 10, 2023, 682 days after the submission was received.
What is the product code of K213131?
The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.