Multi-Analyte Test Strips (Glucose + Ketone) | DSR
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Multi-Analyte Test Strips (Glucose + Ketone)

Multi-analyte test strip systems use one meter to read a glucose strip and a separate β-hydroxybutyrate (β-HB) ketone strip, which helps with early Diabetic Ketoacidosis (DKA) detection. Urine strips detect acetoacetate, which lags behind β-HB early in DKA; blood ketone strips use the enzyme β-Hydroxybutyrate Dehydrogenase (β-HBDH) and the cofactor NAD+ to measure β-HB directly.

As of October 2026, FDA's device database listed glucose and ketone systems or strips from Abbott (Precision Xtra), Nova Biomedical (Nova Max Plus), Keto-Mojo and ForaCare as in commercial distribution. Ketone sensing has also reached Continuous Glucose Monitors (CGM): FDA authorized Abbott's prescription Libre Duo 10 Day dual glucose-ketone sensor in August 2026, and Abbott still listed it as coming soon in October 2026.

Diabetic Supply Rescue Editorial Team
5 min read
Last updated: October 09, 2026
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10 glossary terms
15 citations

Introduction to Multi-Analyte [Test Strips](/sell-diabetic-supplies/)

A multi-analyte system lets one meter check two things from a fingerstick: blood glucose and β-hydroxybutyrate (β-HB), the ketone body present in the greatest concentration during Diabetic Ketoacidosis (DKA) [1]. DKA develops when a lack of insulin lets ketones build up in the blood faster than the body can use them [1]. Here's what surprised us when we read the labeling. Despite the name, none of the systems we checked uses one strip for both readings: the meter is shared, but glucose and ketones each get their own strip [3][4][7].

How it Works

Blood ketone strips are electrochemical. They rely on the enzyme β-Hydroxybutyrate Dehydrogenase (β-HBDH), which needs a helper molecule (a cofactor) called NAD+ to oxidize β-HB [2]. That reaction produces a small electrical current, and the meter turns the size of the current into a β-HB reading; FDA's review of the Nova Max Plus describes its ketone strip working this way [3].

Urine strips work differently. They use a nitroprusside reaction that detects acetoacetate, another ketone body, and can't measure β-HB at all [1]. Early in DKA the balance shifts toward β-HB, so the acetoacetate rise lags behind. That's why urine tests can underestimate total ketones at the start of DKA and overestimate them as it resolves [1].

Market Overview

The split into "medical" and "consumer" brands is real, but looser than it sounds: all four brands below sell systems that are FDA-cleared for, or marketed to, people with diabetes. Here is where each stood in October 2026:

  • Medical: Abbott's Precision Xtra Blood Glucose & Ketone Monitoring System and Precision Xtra Blood β-Ketone Test Strips were still listed as in commercial distribution in FDA's device identifier database (GUDID) [4]. The system dates to a 1999 clearance filed under the MediSense name [10]. Abbott also has a professional-use FreeStyle Precision Pro glucose and β-ketone system, cleared in 2013 [10]. Nova Biomedical's Nova Max Plus is cleared for people with diabetes at home and for healthcare professionals, with ketone testing from the fingertip only [3], and GUDID still listed it as in distribution [5]. Nova's hospital meters, the StatStrip line, are cleared for glucose and lactate rather than ketones [14].
  • Consumer: Keto-Mojo says its GK+ glucose and ketone system is FDA-cleared for people with diabetes and can also be used by people without diabetes who follow a ketogenic or low-carbohydrate diet [6]. GUDID lists Keto-Mojo's β-ketone strips and monitoring system as in distribution [15]. ForaCare sells the Test N'GO Advance Blood Glucose/β-Ketone Monitoring System, which sends readings over Bluetooth to its iFORA app [8], and GUDID lists FORA ketone strips for its Test N'GO Advance, GTel and 6 Connect meters [9].

New systems are still being cleared. Our search of FDA's device database turned up ACON Laboratories' On Call Sure GK Blood Glucose & Ketone Monitoring System, a fingerstick meter cleared in October 2025, and Abbott's Libre Duo 10 Day, a wearable sensor that measures both glucose and ketones, authorized in August 2026 [10]. As of October 2026, Abbott had not yet launched the Libre Duo in the US.

Technological Advancements

Two design features show up across the systems we read about:

  • One strip port for both strip types. The Keto-Mojo GK+ instructions have you run a glucose test, eject that strip, then insert a ketone strip into the same meter; glucose counts down from 5 seconds and ketones from 9 [7]. ForaCare lists a 10-second ketone test that needs 0.8 µL of blood on the Test N'GO Advance [8]. The labeling we read doesn't explain how each meter tells the strip types apart.
  • Hematocrit handling. Hematocrit is the share of blood volume made up of red blood cells, and it can push strip readings off. FDA's review of the Nova Max Plus tested blood with hematocrit from 20% to 64% and set a claimed range of 25% to 60% for both glucose and ketones [3]. ForaCare advertises hematocrit compensation on the Test N'GO Advance [8].

Future Developments

Ketone sensing has now moved from strips into a continuous sensor. On August 25, 2026, FDA granted De Novo authorization to Abbott's Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, the only device listed under FDA's new glucose-ketone product code [11]. Abbott says the sensor lasts up to 10 days, is intended for people with diabetes ages 2 and older, and was planned for US launch later in 2026 [12]. In October 2026, Abbott's US site still called it "coming soon" and labeled it prescription-only [13]. We cover how the sensor works in Multi-Analyte Sensing in CGM.

Abbott expects Libre Duo to work with Beta Bionics' iLet and Sequel Med Tech's twiist automated insulin delivery (AID) systems by the end of 2026. It also announced an exclusive integration of its dual sensors with MiniMed dosing systems, expected in 2027 [12]. Those dates are company plans, not FDA decisions. The groundwork goes back at least to 2021, when Abbott researchers tested a ketone-only sensor for 14 days in 12 healthy adults on low-carbohydrate diets, using Precision Xtra fingerstick strips as the reference [2]. Whether a continuous sensor, a fingerstick strip or both fits your situation is a decision to make with your care team.

References

  1. Continuous Ketone Monitoring Consensus Report 2021 (Nguyen KT, Xu NY, Klonoff DC, et al.; J Diabetes Sci Technol 2022;16(3):689-715)Source
  2. Feasibility of Continuous Ketone Monitoring in Subcutaneous Tissue Using a Ketone Sensor (Alva S, Castorino K, Cho H, Ou J; J Diabetes Sci Technol 2021;15(4):768-774)Source
  3. 510(k) decision summary K091547: Nova Max Plus Blood Glucose and β-Ketone Monitoring System (Nova Biomedical; FDA, cleared January 15, 2010)Source
  4. FDA Global Unique Device Identification Database (GUDID) via openFDA: Precision Xtra records (Abbott Diabetes Care), commercial distribution statusSource
  5. FDA Global Unique Device Identification Database (GUDID) via openFDA: Nova Max records (Nova Biomedical), commercial distribution statusSource
  6. Keto-Mojo home page, including the regulatory statement for the GK+ blood glucose and ketone monitoring system (Keto-Mojo)Source
  7. How to Test Glucose & Ketones Using the Keto-Mojo GK+ Meter (Keto-Mojo Help Center)Source
  8. Test N'GO Advance Blood Glucose/β-Ketone Monitoring System: product page and specifications (ForaCare)Source
  9. FDA Global Unique Device Identification Database (GUDID) via openFDA: FORA ketone test strip records (Fora Care Inc.), commercial distribution statusSource
  10. openFDA 510(k) database search: devices with "ketone" in the device name, sorted by decision date (FDA)Source
  11. openFDA premarket records for product code SJD (integrated continuous glucose ketone monitoring system): DEN250049, Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, granted August 25, 2026 (FDA)Source
  12. Abbott receives FDA authorization for world's first dual glucose-ketone sensing technology for people with diabetes (Abbott press release)Source
  13. Libre DUO 10 Day system: coming soon (Abbott FreeStyle Libre US product page)Source
  14. openFDA 510(k) database search: Nova Biomedical StatStrip hospital meter clearances (FDA)Source
  15. FDA Global Unique Device Identification Database (GUDID) via openFDA: Keto-Mojo β-ketone and glucose records (Keto-Check, Inc.), commercial distribution statusSource

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