← Product Code [NBW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBW) · K201258

# EASYMAX Tag Self-Monitoring Blood Glucose System (K201258)

_Eps Bio Technology Corp. · NBW · Sep 1, 2021 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBW/K201258

## Device Facts

- **Applicant:** Eps Bio Technology Corp.
- **Product Code:** [NBW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBW.md)
- **Decision Date:** Sep 1, 2021
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 862.1345
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry
- **Attributes:** Pediatric

## Indications for Use

The EASYMAX® Tag Self-Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

## Device Story

Self-monitoring blood glucose system; measures glucose in capillary whole blood via test strips; intended for home use by patients with diabetes. Device consists of handheld meter; utilizes electrochemical biosensor technology. Modifications include: name change, physical redesign (rectangular shape, white color, two-button interface, bottom-loading strip port), power source change (CR2032 battery), increased memory (880 results), and addition of NFC connectivity. New features include automatic control solution identification, user-settable hypo/hyperglycemia indicators, meal-time tagging, and multi-day averaging. Patient applies blood sample to strip; meter processes signal; displays glucose concentration. Data aids patient in diabetes management. System supports single-patient use; validated for cleaning/disinfection with PDI SANI-CLOTH wipes.

## Clinical Evidence

Bench testing only. Verification and validation activities were performed to assess the impact of hardware and firmware modifications. Design outputs met pre-determined design inputs, and risk mitigation was verified according to ISO 14971:2007 standards.

## Technological Characteristics

Electrochemical glucose biosensor. Power: 1x CR2032 lithium battery. Connectivity: NFC. Form factor: 74 x 47 x 12.4 mm, 26g. Memory: 880 results. Features: automatic control solution identification, meal tagging, hypo/hyperglycemia indicators, 7/14/30/90 day averaging. Single-patient use; validated for chemical disinfection.

## Regulatory Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

## Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

## Predicate Devices

- EasyMax MU Self-Monitoring Blood Glucose System ([K121207](/device/K121207.md))

## Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K201258

B Applicant

EPS Bio Technology Corp.

C Proprietary and Established Names

EASYMAX Tag Self-Monitoring Blood Glucose System

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  NBW | Class II | 21 CFR 862.1345 - Glucose Test System | CH - Clinical Chemistry  |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. EasyMax MU Self-Monitoring Blood Glucose System, K121207.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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- Change in the device name from EasyMax MU Self-Monitoring Blood Glucose System to EASYMAX Tag Self-Monitoring Blood Glucose System.
- Meter buttons were changed from three front buttons to two front buttons, meter shell color changed from black to white and meter shape changed from oval to rectangular.
- The test strip port was moved from the top to the bottom of the meter.
- Removal of the strip ejection button.
- Dimensions of the meter were changed from 94 x 50 x 19.5 (mm) to 74 x 47 x 12.4 (mm) and the meter weight without batteries changed from 39 g to 26 g.
- The power source was changed from 2 AAA batteries to one CR2032 lithium battery.
- The meter memory capacity was changed from 480 test results to 880 test results.
- Change from the need for the user to manually tag a control solution test to the addition of a meter feature that automatically identifies control solutions.
- Addition of user settable hypoglycemia and hyperglycemia indicators, before meal and after meal icons, and 7/14/30/90 days average calculations.
- Near field communication (NFC) connectivity was added to the meter.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

The device system is intended for single-patient use only. Disinfection efficacy studies were previously performed on the exterior meter materials (k121207) by an outside testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant PDI SANI-CLOTH® Germicidal disposable wipes (EPA Reg. No.: 9480-4). A robustness study was performed by the sponsor demonstrating that there was no change in performance or in external materials of the meter after 208 cleaning and disinfection cycles (with an additional 8552 cleaning wipes) to support 4 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBW/K201258](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBW/K201258)

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