One Drop Blood Glucose Monitoring System

K161834 · Agamatrix, Inc. · NBW · Nov 30, 2016 · Clinical Chemistry

Device Facts

• Record ID: K161834
• Device Name: One Drop Blood Glucose Monitoring System
• Applicant: Agamatrix, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 30, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The One Drop Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop Blood Glucose Monitoring System is intended for self-testing outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The One Drop Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates. The One Drop Blood Glucose Test Strips are for use with the One Drop Blood Glucose Meter to quantitatively measure blood glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Device Story

System measures glucose concentration in capillary blood; user inserts test strip into meter; blood applied to strip tip; chemical reaction generates electrical current; meter measures current magnitude to determine glucose concentration. Used at home by patients with diabetes for self-monitoring. Meter displays results in mg/dL. Data transmitted via Bluetooth to smart devices (iOS/Android) for tracking. Benefits include convenient, portable monitoring of diabetes control effectiveness.

Clinical Evidence

No clinical data provided; substantial equivalence based on identical fundamental scientific technology and performance specifications to the predicate device.

Technological Characteristics

Glucose oxidase electrochemical biosensor; non-coding; powered by two CR2032 3V lithium batteries. Dimensions: 2.76" x 0.47"; weight 20g. Housing: ABS polymer with aluminum plating. Connectivity: Bluetooth for data transfer to smart devices. Measurement range: 20-600 mg/dL. Operating conditions: 50-104°F, 10-90% humidity, up to 10,000 ft altitude.

Indications for Use

Indicated for single-patient use for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. Intended for use by people with diabetes mellitus to monitor glucose levels.

Regulatory Classification

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

• AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System (K152365)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K161834

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 (delete/add items as necessary): One Drop Blood Glucose Monitoring System

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System (k152365)
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 (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:

1. Name of the device system was changed from Agamatrix Jazz Wireless 2 Blood Glucose Monitoring System to One Drop Blood Glucose Monitoring System.
2. The meter length was increased by 0.2 inches to 2.76 inches and meter width increased by 0.08 inches to 0.47 inches.
3. The meter weight was increased by 2 grams
4. The meter housing material was changed from an ABS polymer blend with color pigment added to ABS polymer blend covered with aluminum plating

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics (including efficacy of cleaning and disinfection agents on the materials of the meter and robustness of the system to repeated cleaning and disinfection).
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 One Drop Blood Glucose Monitoring System is intended for single-patient use only. Disinfection efficacy studies were performed on materials comprising the meter demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfecting agent, PDI Super Sani-Cloth® Germicidal Disposable Wipe (EPA Registration #9480-4). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 520 cleaning and disinfection cycles with PDI Super Sani-Cloth® Germicidal Disposable Wipe (EPA Registration #9480-4). The robustness studies were designed to simulate 5 years of single-

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patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

This device was cleared after the FDA issued final guidance documents for prescription use blood glucose monitoring systems (BGMS) and over-the-counter use blood glucose monitoring systems (SMBG). However, the recommendations in the guidance documents were not followed for this device since the submission was received prior to the finalization of the guidance documents.