← Product Code [NBW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBW) · K132272

# GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION (K132272)

_Glooko, Inc. · NBW · Oct 17, 2013 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBW/K132272

## Device Facts

- **Applicant:** Glooko, Inc.
- **Product Code:** [NBW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBW.md)
- **Decision Date:** Oct 17, 2013
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 862.1345
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry
- **Attributes:** Software as a Medical Device

## Indications for Use

The Glooko device system for Glooko Application is data management software intended for use in home and professional settings to aid individuals with diabetes and their healthcare professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for Glooko Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their mobile devices running on Android operating system. The Glooko device system for Glooko Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.

## Device Story

System aids diabetes management by downloading, reviewing, and analyzing blood glucose data. Inputs: blood glucose readings from compatible, FDA-cleared commercial meters. Hardware: MeterSync Cable (with integrated IR adapter) connects meter to Android mobile device (3.5mm jack or IR). Software: Glooko Application on Android OS; collects/stores historical data; allows user-generated notes/meal tags; generates graphs and statistics. Used in home or professional settings by patients or clinicians. Output: visual display of glucose trends, statistics, and logs on mobile device or web browser. Facilitates data sharing between patient and healthcare provider. Does not provide treatment decisions.

## Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements; no clinical data provided.

## Technological Characteristics

System consists of MeterSync Cable (with integrated IR adapter) and Android-based software. Connectivity: 3.5mm audio jack or IR interface to blood glucose meters; USB OTG for specific models. Software: Android OS 2.3.3+. Data transmission: local download to mobile device, sync to web browser via authentication. Sterilization: N/A.

## 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

- Glooko Device System for Glooko Logbook+ Application (k130886)

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k132272

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable for the Glooko Device System for Glooko Application:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. Glooko Device System for Glooko Logbook+ Application (k130886).

2. Submitter's 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.

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: software modification for operation on the Android operating system (OS) and modification to the cable design to allow operation with Android OS mobile devices.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including labeling, intended use, physical characteristics, and data transmission/viewing on Android OS vs. iOS.

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 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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBW/K132272](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NBW/K132272)

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