Regulatory Pathways (510k) for Test Strips

Blood glucose meters and their test strips reach the US market through a 510(k), the FDA's premarket notification. The maker doesn't prove from scratch that its system is safe and effective. It shows the system is "substantially equivalent" to one already legally sold, and the FDA order agreeing with that is what "cleared" means [1]. Meters and strips are Class II devices, the middle risk tier, under the regulation 21 CFR 862.1345, "glucose test system," and FDA lists the 510(k) as their submission route [2].

Where strips sit in FDA's classification

Regulation 862.1345 carries 10 product codes, the three-letter labels FDA uses to group similar devices, and every one is Class II [2]. Home meters fall under NBW, "system, test, blood glucose, over the counter" [2]. The prescription guidance covers three codes named for strip chemistry: CGA (glucose oxidase), CFR (hexokinase) and LFR (glucose dehydrogenase) [3]. Another prescription code, PZI, is defined as a meter for multiple-patient testing near the patient in hospitals and other professional settings [2].

Here's what surprised us. FDA lets some 510(k)s go to accredited private reviewers instead of FDA staff, through its Third Party Review Program [1]. Its records mark the chemistry codes as eligible, but not NBW, the home-use code [2].

Predicates and substantial equivalence

A predicate is the legally marketed device a new one is compared against. It can be a device sold before May 28, 1976, one already cleared through a 510(k), or one authorized through FDA's De Novo process, among others [1]. The new device needs the same intended use as its predicate. Its technology can match, or it can differ in ways that don't raise new questions of safety and effectiveness, with data showing it is as safe and effective [1].

FDA's guidance on substantial equivalence uses a glucose meter as a worked example. Because meters of this type have "relatively high inherent total error," FDA says a new one should be judged the way its predicate was: by comparing its results with a well-validated laboratory method traceable to a higher-order standard [4]. A maker can cite more than one predicate. It can't take intended use from one device and technology from another with a different intended use; FDA calls that a "split predicate" and says it is inconsistent with the 510(k) standard [4].

Why home and professional meters have separate guidances

As of October 2026, FDA's recommendations sit in two guidances, both issued September 29, 2020, and each replaced an October 2016 version [3][5]. For years the agency asked for the same information no matter who would use the meter [5]. It split them because the users differ. Hospital patients can be acutely ill and are more likely to have conditions that interfere with a reading. Home users vary widely in age, dexterity and vision, and their strips face rougher storage and handling [5].

Infection control was the other reason. Meters can spread bloodborne pathogens when they're shared without effective cleaning and disinfection, and professional meters are more likely to be used on many patients [3]. The prescription guidance adds that most meters used in clinics had been cleared with home-use claims and studied in relatively healthy people [3].

One footnote changed how we read the split. The over-the-counter guidance also covers home-use meters that a clinician prescribes [5]. The line is drawn by setting, home versus point of care, not by whether a prescription was written.

The CLIA difference

CLIA, the Clinical Laboratory Improvement Amendments of 1988, requires labs that test human samples to hold a certificate, and a site running only simple "waived" tests can get a Certificate of Waiver [6]. Tests FDA clears for home use are waived automatically [6]. Prescription point-of-care meters aren't. FDA expects them to be categorized as moderate complexity at clearance unless the maker also earns a waiver, and it encourages a combined 510(k) and CLIA waiver submission [3].

What a 510(k) summary contains

Every 510(k) includes either a 510(k) summary or a 510(k) statement. The statement is a promise to send safety and effectiveness information to anyone who asks in writing, within 30 days [7]. The summary, required by 21 CFR 807.92, names the device and its predicate, explains how the device works and what it's for, compares the two technologies, and briefly describes the tests behind the claim [7]. It can't include raw data, trade secrets or "puffery," and FDA posts it online 30 days after the decision [7].

How to read a decision summary

The 510(k) summary comes from the company. The Accu-Chek Guide's database record also links a "Decision Summary," filed under "FDA Review" [8]. Its 13 pages follow lettered sections that make a good map [9]:

• Section G, regulatory information: regulation 862.1345, Class II, codes NBW and LFR [9].
• Section H, intended use: single-patient use with blood from the fingertip, palm or upper arm, and not for diagnosing diabetes or for newborns [9].
• Section J, substantial equivalence: the predicate, the Accu-Chek Aviva Connect (K141867), and a comparison table. The enzyme is one difference: an FAD-dependent glucose dehydrogenase in the Guide, listed as "Mut. Q-GDH" for the predicate [9].
• Sections M and P, performance: precision across 3 strip lots, a 20 to 600 mg/dL measuring range, interference testing, accuracy against a hexokinase lab method, a 120-person lay-user study, and checks for hematocrit, altitude and disinfection [9].
• Section R, conclusion: one sentence saying the data support a substantial equivalence decision [9].

That predicate has since left the market. As of October 2026, FDA's device identifier database lists all four Aviva Connect entries as not in commercial distribution, the most recent since September 2021 [10]. The Guide's own review ran from April 5 to August 31, 2016, as a Traditional 510(k) [8], while FDA describes the usual decision time as 90 days [1]. The record doesn't say why this one took longer.

Connected meters and cybersecurity

Meters that send readings over Bluetooth add software and security review. The K160944 memo notes that the Guide transmits data wirelessly and that FDA reviewed Roche's hazard analysis and software development processes [9]. FDA's premarket cybersecurity guidance, revised in February 2026, covers section 524B of the FD&C Act for "cyber devices" [11].

What a clearance tells you

Clearance means FDA agreed a system is as safe and effective as its predicate for the uses on its label [1]. It isn't a ranking, and the two guidances are recommendations; FDA says other information can be enough if it shows substantial equivalence [3][5]. The accuracy numbers each guidance asks for are covered in ISO 15197:2013 and Regulatory Standards, and what happens after strips ship is in Post-Market Surveillance and Lot-to-Lot Variability. To check a meter yourself, look up its name in FDA's 510(k) database, open the decision summary and start with section J.