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 Description

The FDI Glucose Controls for the Embrace No Code consist of a viscosity-adjusted, aqueous liquid control solution containing known quantities of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control and a red coloration to aid the user to visually confirm application. The product is non-hazardous and contains no human or animal derived materials.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "FDI Level I and Level II Glucose Controls for the Embrace No Code." This device is a quality control solution for a blood glucose meter, not a diagnostic device that performs analysis or diagnosis. Therefore, several of the requested sections (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable to this type of submission.

Here's an analysis of the acceptance criteria and study information provided, focusing on what is relevant for a quality control device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Characteristic	Details
Real Time Stability (Shelf Life)	Acceptance Criteria: Not explicitly stated as a numerical value, but implied to demonstrate a shelf life of 24 months.
	Reported Device Performance: Samples were periodically removed and tested in triplicate on a commercially available clinical chemistry analyzer. The study supports a shelf life of 24 months when stored at 15–30℃.
Open Vial Stability	Acceptance Criteria: Not explicitly stated as a numerical value, but implied to demonstrate an open vial stability of 90 days.
	Reported Device Performance: Test and control vials were evaluated for 13 weeks. Each day, test group vials were opened, stood for ten minutes, then closed and stored at room temperature. Weekly, one test vial and one control vial were assayed in triplicate using the ACE Glucose assay. The study supports the claimed open vial stability of 90 days when stored at 15 - 30°C.
Value Assignment (Target Range)	Acceptance Criteria: Acceptable ranges for each control level are generally determined by calculating ± 20% of each control lot's calculated mean for three lots of strips. This suggests that the measured glucose values from the control solution, when tested on the Embrace No Code meter, should fall within a specific range established by the manufacturer, which is based on a ±20% variation around the mean and a ±5% lot-to-lot variability.
	Reported Device Performance:Level I: Target Range (mg/dL) can vary lot-to-lot, but compared to predicate (88-136 mg/dL), the new product appears to maintain similar target ranges (e.g. 0.07% Glucose compared to 0.08% for predicate).Level II: Target range for the new product is 179 - 275 mg/dL, compared to 174 - 269 mg/dL for the predicate, indicating similar performance.
Traceability	Acceptance Criteria: Traceability to a recognized standard (NIST SRM 917).
	Reported Device Performance: Each control is traceable to a 70 mg/dL (Low) and a 150 mg/dL (High) in-house Standard, which are themselves traceable to the NIST Standard Reference Material 917.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable as the device is a control solution, not a diagnostic test being evaluated for clinical performance on patient samples. The "test set" in this context refers to the samples of the control solution itself, tested for stability and value assignment.

Real Time Stability: Samples were "periodically removed" and "tested in triplicate." The exact number of control solution samples tested over the 24-month period is not specified.
Open Vial Stability: A "number of test and control vials" was evaluated for 13 weeks. Weekly, "one test group vial and one control group vial was assayed in triplicate." The exact initial number of vials is not specified.
Value Assignment: The control solutions are analyzed using "a single Embrace No Code monitor," "three different lots of test strips," and "10 replicates per strip lot, over three days." This indicates 30 measurements per control level per lot of test strips across three days.
Data Provenance: Not specified, but generally, such studies are conducted in-house by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable. The "ground truth" for a control solution relates to its known glucose concentration, which is established through analytical chemistry methods and traceability to reference standards like NIST SRM 917, not through expert consensus or clinical diagnosis.

4. Adjudication Method

This is not applicable for a control solution. Adjudication methods are used in studies involving subjective interpretation of results, typically by human readers (e.g., radiologists, pathologists), to resolve discrepancies.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a quality control solution for a blood glucose meter, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical control solution, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the glucose control solutions is established by:

Traceability to NIST Standard Reference Material 917 (SRM917): This is a primary reference material for glucose. The in-house standards are produced using SRM917, and the control solutions are then referenced to these in-house standards.
Analytical Chemistry Methods: The manufacturing process involves precise formulation to achieve specific glucose concentrations. "Value Assignment" refers to the process of confirming these known concentrations when tested with the Embrace No Code meter.

8. The Sample Size for the Training Set

This is not applicable as the device is a quality control solution, not a machine learning algorithm that requires a training set. The term "training set" is generally used in the context of AI/ML model development.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as #8.

Summary

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Ki33197

510(k) Premarket Notification: FDI Glucose Controls for the Embrace No Code Fujirebio Diagnostics, Inc.

JAN 1 7 2014

510(k) Summary

Date of Preparation:	January 10, 2014
Introduction:	According to the requirements of 21 CFR 807.92, thefollowing information provides sufficient detailtounderstand the basis for a determinationofsubstantial equivalence.
Submitter:	Fuiirebio Diagnostics, Inc.940 Crossroads BlvdSequin. TX 78155Phone: (830) 372-1391 ex. 210Fax: (830) 372-4130Establishment Registration Number: 1643621
Contact Person:	Kent Pruett
Device Name:	FDI Level I and Level II Glucose Controls for theEmbrace No Code
Common Name:	Single Analyte Control Solution, All Types (Assavedand Unassayed)
Classification Name:	Quality Control Material (assayed and unassayed).
Classification:	Class I, Reserved per 21 CFR 862.1660
Product Code:	JJX
Panel:	75 (Chemistry)
Predicate Device:	Name:	Omnis Embrace Glucose ControlSolutions
	Manufacturer:510(k) No.:	BionosticsK091914
Device Description:	The FDI Glucose Controls for the Embrace No Codeconsist of a viscosity-adjusted, aqueous liquid controlsolution containing known quantities of glucose. Theproduct is packaged in plastic dropper tipped bottlesfor easy application of the control and a red colorationto aid the user to visually confirm application. Theproduct is non-hazardous and contains no human oranimal derived materials.

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510(k) Premarket Notification: FDI Glucose Controls for the Embrace No Code Fujirebio Diagnostics, Inc.

Intended Use:

The FDI Glucose Controls are intended for use with Omnis 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.

Characteristic/Aspect	Predicate Device	New Product
Name	Omnis Embrace Glucose ControlSolutions	FDI Level I and Level II GlucoseControls for the Embrace NoCode
510(k), Date	K09191411/06/2009
Number of Levels	2	Same
Analyte	Glucose	Same
Glucose (% w/v) I	0.08%(1)	0.07%
Glucose (% w/v) II	0.15%(1)	Same
Target Range(mg/dL) I	88 - 136(2)	Same(3)
Target Range(mg/dL) II	174 - 269(2)	179 - 275(3)
Container	Plastic bottle with dropper-tip	Same
Fill Volume	4.0 mL	3.6 mL
Color	Red	Same
Matrix	Viscosity-adjusted, aqueousglucose control solution of D-glucose and other non-reactiveingredients	Buffered aqueous solution of D-Glucose, a viscosity modifier,preservatives, and other non-reactive ingredients
Indications for Use	To validate the performance ofthe blood glucose monitoringsystem.	To check that the meter and teststrips are working togetherproperly.
Target Population	Professional and home use	Same

Comparison to Predicate Devices:

(1)Based data presented in K091914 Decision Summary

(2)Derived from the control ranges assigned by the manufacturer

(3)Based on a +/- 5% glucose concentration variability lot-to-lot and ± 20% range

Performance Studies: Tests were performed to verify specific performance characteristics:

Real Time Stability: Samples were periodically removed and tested in triplicate on a commercially available clinical chemistry analyzer. The study supports a shelf life of 24 months when stored at 15–30℃.

Open Vial Stability: A number of test and control vials was evaluated for 13 weeks. Each day all test group vials were opened, allowed to stand for ten minutes, then closed and stored at room temperature. Each week one test group vial and one control group vial was assayed in triplicate using the ACE Glucose assay. The Control vial was opened on the date of performing the assay and then discarded after testing was complete. The study supports the claimed open vial stability of 90 days when stored at 15 - 30°C.

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510(k) Premarket Notification: FDI Glucose Controls for the Embrace No Code Fujirebio Diagnostics, Inc.

Test Precision: Studies performed per CLSI Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline -Second Edition. CLSI document EP5-A2; 2004. No precision claims will be made for this product.

Value Assignment: The control solutions are analyzed using a single Embrace No Code monitor using three different lots of test strips, 10 replicates per strip lot, over three days. Range of acceptable values for each level is determined by calculating ± 20% of each control lot's calculated mean for three lots of strips. Acceptable ranges are based on predetermined acceptance criteria for glucose recovery for each lot. The glucose control value ranges are lot dependent; therefore the range for each lot is printed on the control solution vial label.

Traceability: Each control is traceable to a 70 mg/dL (Low) and a 150 mg/dL (High) in-house Standard traceable to the NIST Standard Reference Material 917. The in-house Standards are produced using SRM917.

Comparison of the performance characteristics, formulation and Conclusion: intended use support the claim of substantial equivalence.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes resembling a human figure with outstretched arms, possibly representing health, well-being, and service.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66 Silver Spring, MD 20993-0002

January 17, 2014

FUJIREBIO DIAGNOSTICS, INC. KENT PRUETT DIRECTOR OF QUALITY/REGULATORY AFFAIRS 940 CROSSROADS BLVD SEGUIN TX 78155

Re: K133197

Trade/Device Name: FDI Level I and Level II Glucose Controls For The Embrace No Code Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJX Dated: October 29, 2013 Received: November 5, 2013

Dear Mr. Pruett:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I vithe Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements medical device-rented ad relise of the) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Pruett

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration .

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K133197

Device Name FDI Level I and Level II Glucose Controls for the Embrace No Code

Indications for Use (Describe)

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. I

The FDI Glucose Controls for the Embrace No Code are intended for use by healthcare professionals and people with diabetes mellitus at home.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

. :: FOR FDA USE ONLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . : ...

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Stayce Beck

FORM FDA 3881 (9/13)

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.