FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE

K133197 · Fujirebio Diagnostics,Inc. · JJX · Jan 17, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133197
• Device Name: FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The FDI Glucose Controls are intended for use with Embrace No Code blood glucose meter and test strips. The controls are used to check that the meter and test strips are working together properly. The FDI Glucose Controls for the Embrace No Code are intended for use by healthcare professionals and people with diabetes mellitus at home.

Device Story

FDI Glucose Controls consist of viscosity-adjusted, aqueous liquid solutions containing known glucose concentrations; packaged in red-colored, dropper-tipped plastic bottles for visual confirmation of application. Used by healthcare professionals and patients with diabetes at home to verify proper function of Embrace No Code blood glucose meters and test strips. User applies control solution to test strip; meter reads glucose level; user compares result against lot-specific target range printed on vial label. Validates system performance; ensures accuracy of patient blood glucose readings; aids in diabetes management.

Clinical Evidence

Bench testing only. Real-time stability study supports 24-month shelf life at 15–30°C. Open-vial stability study supports 90-day usage period at 15–30°C. Value assignment performed using Embrace No Code monitor across three lots of test strips; ranges calculated as ±20% of the mean. Traceability established to NIST SRM 917.

Technological Characteristics

Buffered aqueous solution containing D-Glucose, viscosity modifiers, and preservatives. Packaged in plastic dropper-tipped bottles. Non-hazardous; no human or animal-derived materials. Traceable to NIST SRM 917. Shelf life: 24 months. Open-vial stability: 90 days.

Indications for Use

Indicated for healthcare professionals and patients with diabetes mellitus to validate the performance of the Embrace No Code blood glucose monitoring system.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k133197

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.