Accu-Chek Aviva Expert Blood Glucose Monitoring System
FDA 510(k) K131366 · Roche Diagnostics Operations, Inc.
510(k) numberK131366
Submission
- Device name
- Accu-Chek Aviva Expert Blood Glucose Monitoring System
- Applicant
- Roche Diagnostics Operations, Inc.
Indianapolis, IN, US - Received
- May 13, 2013
- Decision date
- October 11, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFR – Glucose Dehydrogenase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LFR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152328 | FreeStyle InsuLinx Blood Glucose Monotioring SystemLFR · Special | Abott Laboratories | 09/17/2015SE |
| K142089 | Accu-Chek Aviva Expert SystemLFR · Traditional | Roche Diagnostics Corporation | 12/17/2014SE |
| K133537 | EGV1.1 Self Monitoring Blood Glucose System and EGV1.1 Pro Monitoring Blood Glucose SystemLFR · Special | Eps Bio Technology Corp. | 04/28/2014SE |
| K131727 | Cera-Chek 1070 Blood Glucose Monitoring SystemLFR · Traditional | Ceragem Medisys, Inc. | 02/28/2014SE |
| K122688 | Nova Max Mini Blood Glucose and B-Ketone MonitorLFR · Traditional | Nova Biomedical Corporation | 04/04/2013SE |
| K121433 | Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood…LFR · Traditional | Hmd Biomedical, Inc. | 02/14/2013SE |
| K122435 | Nova One Blood Glucose MonitorLFR · Traditional | Nova Biomedical Corporation | 12/20/2012SE |
| K113314 | Precichek NS-101 Poct Professional Blood Glucose Monitoring SystemLFR · Traditional | Hmd Biomedical, Inc. | 11/09/2012SE |
| K121224 | Genesis Health Technologies Blood Glucose Monitoring SystemLFR · Special | Taidoc Technology Corporation | 09/19/2012SE |
| K113307 | GL Goodlife Series Blood Glucose Monitoring SysmtemLFR · Traditional | Hmd Biomedical, Inc. | 07/27/2012SE |
More from Hmd Biomedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241220 | Tina-quant Lipoprotein(a) Gen.2 MolarityDFC · Traditional | 01/24/2025SE |
| K233454 | ONLINE TDM MethotrexateLAO · Traditional | 02/20/2024SE |
| K163633 | cobas HbA1c Test, cobas b 101 systemLCP · Traditional | 07/28/2017SE |
| K131029 | Accu-Chek Aviva Plus Test StripNBW · Special | 08/09/2013SE |
| K121610 | Cobas C 501 Tina-Quant HBA1CDX GEN.3 AssayPDJ · Traditional | 08/08/2013SE |
| K113072 | Tina-Quant Albumin GEN.2DCF · Traditional | 05/14/2012SE |
Questions and answers
When was Accu-Chek Aviva Expert Blood Glucose Monitoring System cleared by the FDA?
Accu-Chek Aviva Expert Blood Glucose Monitoring System (K131366) received a 510(k) decision of Substantially Equivalent on October 11, 2013, 151 days after the submission was received.
What is the product code of K131366?
The FDA product code is LFR – Glucose Dehydrogenase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.