US Market Leader Product Generations | DSR
History & Major Events

US Market Leader Product Generations

LifeScan's OneTouch, Roche's Accu-Chek, Ascensia's Contour and Abbott's FreeStyle test strips each went through US product generations that FDA records document: new glucose dehydrogenase enzymes, smaller blood samples and the end of manual coding. As of October 2026, all four manufacturers still sell strips in the US, while several of their older meters are out of distribution.

Diabetic Supply Rescue Editorial Team
7 min read
Last updated: October 13, 2026
Last reviewed: October 13, 2026
Advanced
9 glossary terms
19 citations

The four strip families we follow here, LifeScan's OneTouch, Roche's Accu-Chek, Ascensia's Contour and Abbott's FreeStyle, went through the same kind of generational change between 2010 and 2016. FDA decision summaries show their strips moving to glucose dehydrogenase (GDH) enzymes, needing smaller drops of blood, and dropping the code a user once had to set by hand [1][2][3][4]. What surprised us is how often a brand name stayed the same while the chemistry underneath it changed. As of October 2026, all four companies still list test strips for US users, and some sell two generations side by side.

How we chose these four

Each of these brands has a long, traceable run of FDA clearances, so we can follow it generation by generation. We didn't find a primary source that ranks US strip sales, so we don't rank them. The closest independent check we found is a 2018 Diabetes Technology Society study of 18 FDA-cleared meters bought from consumer outlets, which its authors said covered about 90% of the systems in use from 2013 to 2015. Only 6 of the 18 met the study's accuracy standard in all three rounds of testing [5]. Clearance, in other words, didn't guarantee how a store-bought unit performed.

FDA's current guidance for over-the-counter meters was finalized in September 2020 and replaced the version issued on October 11, 2016. It sets out the accuracy studies FDA expects a maker to submit before a home meter is cleared [6].

LifeScan OneTouch: Ultra, then Verio

OneTouch Ultra 2 and OneTouch Verio are the clearest before-and-after pair we found. When FDA cleared the OneTouch Verio system in February 2011, its decision summary compared it line by line with the Ultra 2 [1]. The Ultra 2 used glucose oxidase, needed a 1 µL drop and relied on the user to set a calibration code. Verio used FAD-dependent glucose dehydrogenase (GDH-FAD), needed 0.4 µL and required no coding [1]. It also widened the accepted hematocrit range from 30-55% to 20-60% [1]. Hematocrit is the share of blood made up of red cells, and it can skew strip readings.

The Ultra name didn't stay tied to the old chemistry. OneTouch Ultra Plus Flex, cleared in December 2015, runs on GDH-FAD strips with a 0.4 µL sample, and FDA compared it with the Verio system rather than the Ultra 2 [7]. As of October 2026, LifeScan lists the OneTouch Verio Flex, Verio Reflect, Ultra 2 and Ultra Plus Flex meters, along with OneTouch Verio, Ultra and Ultra Plus strips [8]. Older meters, including the OneTouch UltraMini, Verio IQ and Ping, are listed in FDA's device identifier database (GUDID) as no longer in commercial distribution as of December 4, 2025 [9].

Roche Accu-Chek: Aviva, Aviva Plus, Guide

Roche passed through a modified enzyme before reaching the one most of these strips use now. The original Accu-Chek Aviva system used GDH-PQQ, a glucose dehydrogenase paired with a helper molecule called pyrroloquinoline quinone, and a code key [2]. GDH-PQQ has a known weakness. It also reacts with maltose and related sugars, including breakdown products of icodextrin dialysis solution, which can push readings falsely high [10]. Like other GDH enzymes, though, it doesn't depend on the oxygen in the blood sample the way glucose oxidase does [10].

Accu-Chek Aviva Plus, cleared in September 2011, kept the Aviva name but switched to a modified (mutant) GDH-PQQ, with a 0.6 µL sample and a 5-second test [2]. Accu-Chek Guide, cleared in August 2016, moved to GDH-FAD on the same 0.6 µL drop, and its meter needs no calibration or coding by the user [11]. As of October 2026, Roche's US site lists four meters (Accu-Chek Guide, Guide Me, Guide Link and Aviva Plus) and three strips: Guide, Aviva Plus and SmartView [12]. GUDID shows the Accu-Chek Nano and Compact Plus as no longer in commercial distribution, with end dates between 2017 and 2022 [13].

Ascensia Contour: the Next line changes hands

Ascensia's paperwork carries its own history. The Contour Next USB meter, cleared in November 2015, lists Bayer Healthcare as the applicant [14]; the Contour Next One, cleared a year later, lists Ascensia Diabetes Care [3]. Both run on the same Contour Next strips, which use GDH-FAD and take a 0.6 µL drop [3].

The meter is where this generation changed. Contour Next One added Bluetooth Low Energy and a revised glucose calculation algorithm that FDA's summary says was meant to improve accuracy compared with the Contour Next system. It also doubled the time to add more blood to the same strip, from 30 seconds to 60 [3]. Ascensia markets that feature as Second-Chance sampling [15]. As of October 2026, its US site shows the Contour Next EZ, Next Gen and Next One meters alongside the Contour Plus Blue [16].

Abbott FreeStyle: one name, two enzymes

FreeStyle Lite is the plainest case of a new generation hidden inside an old name. The earlier FreeStyle Lite system (510(k) K070850) used GDH-PQQ strips. Abbott's 2010 clearance for FreeStyle Lite and FreeStyle Freedom Lite switched them to GDH-FAD and kept everything else: a 0.3 µL sample, a 5-second test, no calibration, and up to 60 seconds to apply a second sample [4]. These strips also measure differently. FDA describes them as coulometric, which means the meter counts the total electric charge from the reaction, while the OneTouch Verio and Accu-Chek Guide summaries describe amperometric strips, which measure current [4][1][11]. We wrote more about that difference separately.

FreeStyle Precision Neo strips, cleared in September 2017, use yet another GDH variant, GDH-NAD, with a 5-second test and no coding. FDA's review included testing on the blood glucose meter built into the FreeStyle Libre reader [17]. As of October 2026, GUDID lists FreeStyle Lite and FreeStyle Precision Neo products as in commercial distribution [18].

The generations side by side

Strip familyEarlier generationLater generation
OneTouchUltra 2: glucose oxidase, 1 µL, user coding [^1]Verio and Ultra Plus: GDH-FAD, 0.4 µL, no coding [^1][^7]
Accu-ChekAviva: GDH-PQQ, code key [^2]Aviva Plus: mutant GDH-PQQ, 0.6 µL [^2]; Guide: GDH-FAD, 0.6 µL [^11]
ContourNext USB meter, 30-second re-application [^3]Next One meter, 60-second re-application, same strips [^3]
FreeStyleLite (K070850): GDH-PQQ [^4]Lite (2010): GDH-FAD, 0.3 µL [^4]; Precision Neo: GDH-NAD [^17]

Enzyme choice matters most for people with known interferences, such as those on icodextrin dialysis. Which strip fits a particular person is a decision for their care team, guided by the strip's labeling.

Store-brand strips and True Metrix

Not every strip on a pharmacy shelf comes from these four companies. Trividia Health's True Metrix meters are also sold under store and distributor brand names. On April 28, 2026, FDA issued a safety communication recommending that all True Metrix users move to another way of testing blood glucose when possible, and keep testing with their current meter until they can [19]. The problem is a software design issue: the meter shows the same E-5 error code for a very high reading and for a strip error [19]. FDA updated the page on May 19, 2026, after Trividia sent an updated correction notice, and said its recommendations had not changed [19]. Picking a replacement meter is a conversation to have with a pharmacist or health care provider.

References

  1. FDA 510(k) Decision Summary K093745: OneTouch Verio Blood Glucose Monitoring System (LifeScan)Source
  2. FDA 510(k) Decision Summary K101299: ACCU-CHEK Aviva Plus Blood Glucose Monitoring System (mutant GDH-PQQ)Source
  3. FDA 510(k) Decision Summary K160682: CONTOUR NEXT ONE Blood Glucose Monitoring SystemSource
  4. FDA 510(k) Decision Summary K092602: FreeStyle Lite and FreeStyle Freedom Lite Blood Glucose Monitoring Systems (Abbott Diabetes Care)Source
  5. Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors (Klonoff DC, et al. Diabetes Care. 2018;41(8):1681-1688)Source
  6. FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (final, September 2020)Source
  7. FDA 510(k) Decision Summary K151611: OneTouch Ultra Plus Flex Blood Glucose Monitoring SystemSource
  8. OneTouch Products (LifeScan)Source
  9. openFDA GUDID device identifier records: LifeScan OneTouch Verio IQ, Ping and UltraMini (commercial distribution status)Source
  10. Glucose biosensors: an overview of use in clinical practice (Yoo EH, Lee SY. Sensors (Basel). 2010;10(5):4558-76)Source
  11. FDA 510(k) Decision Summary K160944: ACCU-CHEK Guide Blood Glucose Monitoring SystemSource
  12. Accu-Chek (Roche Diabetes Care, US site)Source
  13. openFDA GUDID device identifier records: Roche Accu-Chek Nano and Compact Plus (commercial distribution status)Source
  14. FDA 510(k) Premarket Notification Database: K150942, Contour Next USB Blood Glucose Monitoring System (Bayer Healthcare)Source
  15. CONTOUR NEXT Test Strips (Ascensia Diabetes Care)Source
  16. Ascensia Diabetes Care (US site)Source
  17. FDA 510(k) Decision Summary K171941: FreeStyle Precision Neo Blood Glucose Test Strips (Abbott Diabetes Care)Source
  18. openFDA GUDID device identifier records: Abbott FreeStyle Lite and FreeStyle Precision Neo (commercial distribution status)Source
  19. Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health: FDA Safety Communication (issued April 28, 2026; updated May 19, 2026)Source
Question 1 of 3
Test Strip Manufacturers Quiz

Which company manufactures OneTouch test strips?

Was this article helpful?

Explore More Topics

Continue your research with related categories