# K160949: Go Dose System

- Pathway: 510(k) (Traditional)
- Applicant: Eli Lilly and Company
- Decided: Dec 22, 2016 after 261 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011571 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082512: Intelligent Dosing System for Insulin-MY Insulin Doser, Dimensional Dosing Systems, Inc. (2008) Summary page 6.

## Indications for use
The Go Dose System, comprised of the Go Dose and Go Dose Pro applications, is for use in home and clinical settings to aid in the review, analysis, and evaluation of historical blood glucose test values to support type 2 diabetes mellitus management. The Go Dose System is a mobile application for use with iPad or iPhone mobile devices. The Go Dose System provides recommendations for titrating prandial Humalog dosing one meal at a time using blood glucose values entered by the patient. Go Dose and Go Dose Pro applications are not intended to replace the care provided by a licensed health care provider or to provide any diagnosis on patient blood glucose values. Go Dose and Go Dose Pro applications are for prescription use only. Go Dose is for prescription use only by persons who are: • Diagnosed with type 2 diabetes mellitus (DM) • Aged 18-85 years • Failing to achieve glycemic targets despite optimization of insulin glargine, with or without metformin • Requiring treatment intensification with Humalog 100 units per mL (U-100) • For whom the set blood glucose target range of 85-114 mg/dL (4.7-6.3 mmol/L) is appropriate Go Dose should be used multiple times per day, as directed by your healthcare provider, for entering blood glucose values and getting Humalog dosing recommendations. The Go Dose daily adjusted dosing algorithm was tested using Humalog 100 units per mL (U-100) in patients with type 2 diabetes who were also taking insulin glargine, with or without metformin. The algorithm for Go Dose is not designed for the titration of NPH, regular insulin, or basal and analog insulins at concentrations other than 100 unit/mL. Go Dose Pro is intended for use by health care providers who have experience prescribing mealtime insulin, including providing direction to patients within the scope of a preplanned treatment program for adjustments to prescribed insulin. Health care providers should use the Go Dose Pro to aid in the review, analysis and evaluation of historical blood glucose test values to support diabetes management in patients that meet the following criteria: • Diagnosed with type 2 diabetes mellitus (DM) • Aged 18-85 years • Failing to achieve glycemic targets despite optimization of insulin glargine, with or without metformin • Requiring treatment intensification with Humalog 100 units per mL (U-100) • For whom the set blood glucose target range of 85-114 mg/dL (4.7-6.3 mmol/L) is appropriate The Go Dose design is based on a dosing algorithm that was tested using Humalog 100 units per mL (U-100) in patients with type 2 diabetes who were also taking insulin glargine, with or without metformin. The algorithm for Go Dose is not designed for the titration of NPH, regular insulin, or basal and analog insulins at concentrations other than 100 unit/mL.

Source page: https://510kreport.com/device/K160949
Methodology: https://510kreport.com/methodology