← Product Code [NBW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBW) · K061118

# ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM (K061118)

_Lifescan, Inc. · NBW · May 19, 2006 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBW/K061118

## Device Facts

- **Applicant:** Lifescan, Inc.
- **Product Code:** [NBW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBW.md)
- **Decision Date:** May 19, 2006
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 862.1345
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

The OneTouch UltraMini Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch UltraMini System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch UltraMini Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

## Device Story

System measures glucose in fresh capillary whole blood; utilizes test strips and meter for in vitro diagnostic use. Operated by patients at home or healthcare professionals in clinical settings. Device is a modified version of the OneTouch Ultra Blood Glucose Monitoring System, featuring ergonomic, physical, electronic, and firmware updates. Input consists of blood sample applied to test strip; meter processes signal to provide quantitative glucose concentration. Output displayed to user to aid in diabetes management and monitoring effectiveness of control. No changes to fundamental scientific technology or operating principles compared to predicate.

## Clinical Evidence

No clinical data provided; substantial equivalence supported by design control activities, risk analysis, and verification/validation testing of physical, electronic, and software modifications.

## Technological Characteristics

Glucose test system; electrochemical sensing principle. Components: meter, test strips, control solution, lancing device. Modifications include ergonomic/physical design, electronic/hardware, and software/firmware. No change to fundamental scientific technology. Connectivity/software details not specified beyond firmware updates.

## 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

- OneTouch Ultra Blood Glucose Monitoring System

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k061118

This 510(k) submission contains information/data on modifications made to the SUBMITTERS own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTERS previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k043197 - OneTouch® Ultra® Blood Glucose Monitoring System (also k024194, k011479 and k002134).

2. Submitters statement that the INDICATION/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, users and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This device incorporates changes to the physical design, electronic hardware and software/firmware.

4. Comparison Information (similarities and differences) to applicants legally marketed predicate device including: labeling, intended use, physical characteristics, analyte, detection methods, and sampling locations.

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

c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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 submitters 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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBW/K061118](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBW/K061118)

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