The Rise of White-Label and Generic Test Strips

The Rise of White-Label and Generic [Test Strips](/sell-diabetic-supplies/)

A store-brand or "generic" strip can mean two different things. A white-label product is a meter and strip system that one manufacturer builds and a store or distributor sells under its own name [1]. A third-party strip is made by a different company to work in someone else's meter [2]. Both go through the FDA's 510(k) clearance process [2], but they carry different risks, and the name on the box rarely tells you who made what's inside.

Store brands are often a maker's meter with a new name

FDA records show how small the change behind a store brand can be. When the FDA cleared the ReliOn Premier Classic meter in December 2019, the applicant was i-SENS, and the listed changes to its CareSens N Voice meter were a black case instead of a white one, a beep in place of the voice function, and the new name [3]. The ReliOn Premier BLU, cleared in August 2023, was i-SENS's CareSens N Premier BT with a new name and an added target-range display with colored backlights [4].

Here's what surprised us about the scale. When Trividia Health recalled its True Metrix meters in 2026, the FDA's list of affected US products carried more than 30 store, pharmacy and distributor names. Walgreens and CVS are on it, and so are Kroger, Publix, Humana and ReliOn [5].

When the maker has a problem, every label has it

Sharing a manufacturer means sharing its recalls. On April 28, 2026, the FDA issued a safety communication, updated May 19, 2026, about a Class I recall, the most serious type [1]. It covers all True Metrix, True Metrix Air, True Metrix Go and True Metrix Pro systems, including cobranded products sold under store or distribution partner names [1]. The problem was software: the meters show the same E-5 error code for a very high glucose reading and for a test strip error [1].

As of October 2026, the FDA recommends that all True Metrix users move to another way of testing when possible, until corrected meters are available [1]. It also says users should keep testing with their True Metrix meter until they have that alternative, and should talk with their health care provider or pharmacist about the switch [1].

A fix has been cleared. On July 23, 2026, the FDA cleared a modified True Metrix that moves very high glucose results from E-5 to a new "EHi" code [6]. Trividia said it expected the upgraded meter at most retail pharmacies beginning in September 2026 [7]. We haven't confirmed which store brands carry it yet.

Third-party strips are built to fit someone else's meter

The FDA defines third-party test strips as strips "manufactured and distributed by a company other than the company that manufactures and distributes the glucose meter" [2]. Its guidance also names the catch. Meters and strips work as one system, so a change to the meter can break a strip made by an outsider [2]. The FDA asks third-party makers to explain in their 510(k) submission how they will handle that risk, and it suggests an agreement with the meter maker as one way to learn about design changes [2].

The two best-documented examples both targeted LifeScan's OneTouch Ultra family. GenStrip, from applicant Shasta Technologies, was cleared on November 30, 2012, for OneTouch Ultra, Ultra2 and UltraMini meters bought before July 2010 [8]. UniStrip1, from UniStrip Technologies, followed on November 6, 2013, for Ultra-family meters bought before October 2012 [9].

Each clearance also named calibration codes: 4, 10 or 13 for GenStrip, and 49 for UniStrip1 [8][9]. A calibration code is a number set on the meter so it matches the chemistry of a strip lot. The FDA summaries don't say what changed in the meters after those purchase dates. They do show the practical limit, though: a newer meter with the same name fell outside the clearance.

Decision Diagnostics, which described itself as GenStrip's exclusive worldwide sales agent, said in 2016 that a second strip, GenUltimate!, was also designed for the OneTouch Ultra family [10]. As of October 2026 we couldn't confirm from FDA records or manufacturer pages whether GenStrip, GenUltimate! or UniStrip1 is still sold.

The patent fight over GenStrip

The meter maker pushed back in court. According to Decision Diagnostics' own announcements, two Johnson & Johnson divisions, including LifeScan, began a series of patent and trademark lawsuits against the company and its PharmaTech subsidiary in September 2011 [10][11]. The company said that in January 2016 the Federal Circuit upheld the USPTO's rejection of U.S. Patent 7,250,105, the J&J patent at the center of the case [10]. In June 2016 it announced a final settlement ending J&J's claims against PharmaTech [11].

Those are one side's announcements, and we couldn't check the court records ourselves. Our article on third-party generic strip litigation covers the cases in more detail.

Medicare pushed on price too

The Centers for Medicare & Medicaid Services (CMS) launched its Competitive Bidding Program for diabetes supplies in nine test markets in 2011, with the stated intent of lowering costs [12]. The program went national in July 2013 [13]. A study that followed 529,627 insulin-treated Medicare beneficiaries found that six months into the national rollout, about 37% got only part of their prescribed testing supplies or none, up 48.1% and 60.0% in the two groups studied [13].

That study measured access, not brands. We couldn't find a primary source that measures how far bidding moved Medicare strip sales toward store-brand or third-party products, so it remains an open question. Strip prices matter so much partly because of the razor-and-blade business model, where cheap meters lead to steady strip sales.

Clearance is a floor, not a guarantee

For over-the-counter meters, the FDA's September 2020 guidance asks that 95% of results fall within ±15% of a reference method and 99% within ±20% across the meter's claimed range [2]. Clearance is a snapshot, though. A 2018 study bought 18 FDA-cleared systems from consumer outlets; together they made up about 90% of systems in use from 2013 to 2015 [14]. Only 6 met the researchers' pre-set accuracy standard in all three rounds of testing, and 4 met it in none [14]. The abstract doesn't break results out by store brand, so it can't tell us whether white-label systems did better or worse.

The most useful thing we took away is that the name on the box tells you who sells a strip, while the FDA 510(k) record tells you who made it and which meters it was cleared for. Which meter and strips fit your care is a decision to make with your care team or pharmacist.