SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM

K100398 · Standard Diagnostics, Inc. · NBW · Jun 9, 2010 · Clinical Chemistry

Device Facts

• Record ID: K100398
• Device Name: SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Standard Diagnostics, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 9, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The SD Check GOLD blood glucose monitoring system is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, palm, forearm, upper arm, calf and thigh. It is intended for use by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

SmartLink™ GOLD Blood Glucose Monitoring System is a portable, battery-operated in vitro diagnostic device for measuring glucose concentration in capillary whole blood. System components include a meter, test strips, lancets, lancing device, and control solutions. User applies blood sample to test strip; meter processes sample and displays glucose concentration in mg/dL. Device stores 500 results with 7, 14, and 30-day averages for normal, pre-meal, and post-meal states. Features include hypo-warning, alarms, and pre/post-meal marking. Used by patients at home or healthcare professionals in clinical settings to monitor diabetes management. Healthcare providers use stored trends to assess glycemic control. Benefits include convenient, rapid self-monitoring of blood glucose levels to aid in diabetes management.

Clinical Evidence

No clinical sensitivity/specificity testing performed. System accuracy evaluated via method comparison with predicate device per EN ISO 15197:2003. User performance study conducted with lay consumers using capillary blood from fingertip, palm, forearm, and upper arm to demonstrate accuracy.

Technological Characteristics

Portable, battery-operated (3V type 2032) glucose meter. Uses electrochemical test strips. Features include 500-result memory, LCD display, and no-coding technology. Complies with EN ISO 15197:2003, IEC 61010-1, and IEC 61010-2 safety standards. Connectivity includes internal memory storage for trend analysis.

Indications for Use

Indicated for people with diabetes for quantitative glucose measurement in fresh capillary whole blood (finger, palm, forearm, upper arm, calf, thigh) to monitor diabetes control. Not for neonates, diagnosis, or screening.

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

• Standard Diagnostics SD Check GOLD blood glucose monitoring system (k082683)

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 k100398

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):

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.)

Standard Diagnostics SD Check GOLD blood glucose monitoring system, k082683

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:

- Change in the color of the film applied to the test strip
- Changing user calibration from coding to no coding
- Increasing the memory from 400 measurements to 500 measurements
- Widening the testing temperature from 10-40°C to 10-45°C.
- Optional hypoglycemia warning function at 60, 70, or 80 mg/dL
- Post-meal reminder alarm, reminder alarms for any time of day
- Addition of averages for normal, pre-meal or post-meal states to current averages for 7, 14, and 30 day
- Extending shelf life of test strips from 18 months to 24 months

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance 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
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.