OMNIS Health Embrace Glucose Control Solution is intended for in vitro diagnostic use to assess the performance of the OMNIS Health Embrace blood glucose test systems by healthcare professionals and in the home by people with diabetes mellitus.

Device Description

OMNIS Health Embrace Glucose Control Solution is a two-level, viscosity-adjusted, aqueous liquid glucose control solution. OMNIS Health Embrace Glucose Control Solution is intended for use to verify the performance of OMNIS Health Embrace blood glucose test systems at glucose levels within the normal fasting blood glucose range for non-diabetic persons, and at elevated ranges consistent with hyperglycemia. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip. OMNIS Health Embrace Glucose Control Solution is a non-hazardous aqueous solution containing no human or animal-derived materials.

AI/ML Overview

The provided 510(k) summary for the “OMNIS Health Embrace Glucose Control Solution” describes a quality control product for a blood glucose test system, not a diagnostic device that performs analysis or makes a diagnosis. Therefore, the typical acceptance criteria and study designs applicable to diagnostic devices with human subject data (e.g., sensitivity, specificity, MRMC studies, expert ground truth) are not relevant here.

Instead, the study presented focuses on the performance and stability of the control solution itself, ensuring it functions correctly to verify the performance of the glucose test system it's designed for.

Here is an analysis based on the information provided, tailored to the nature of this device:

Acceptance Criteria and Device Performance for OMNIS Health Embrace Glucose Control Solution

The OMNIS Health Embrace Glucose Control Solution is a two-level, viscosity-adjusted, aqueous liquid glucose control solution intended to verify the performance of OMNIS Health Embrace blood glucose test systems. The acceptance criteria for such a product relate to its stability and its ability to consistently provide a known glucose value for quality control.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly list quantitative acceptance criteria values for each test. However, it indicates types of performance requirements that were met, which imply underlying acceptance criteria (e.g., stability within a defined range, consistent mean response).

Acceptance Criteria Type	Reported Device Performance/Verification
a) Closed bottle stability (Shelf-life)	Tests were conducted to verify. (Implies performance met predefined shelf-life specifications.)
b) Stability after opening (Use-life)	Tests were conducted to verify. (Implies performance met predefined use-life specifications.)
c) Transport Stability	Tests were conducted to verify. (Implies performance maintained stability under transport conditions.)
d) Preservative Efficacy	Tests were conducted to verify. (Implies the preservative successfully maintained the solution's integrity.)
e) Test mean response and precision data	Tests were conducted to verify. (Implies consistent and precise glucose readings when used with the OMNIS Health Embrace blood glucose test systems, likely falling within established reference ranges).

Note on "Mid Assigned Value": The comparison table with predicate devices lists "Mid Assigned Value*" for L1 (low) and L2 (high) levels as 114 mg/dL and 229 mg/dL respectively. This is not a performance result of the control solution itself when tested, but rather the target value (mid-point of assigned ranges on OMNIS Health glucose test strips) that the control solution is calibrated to represent. The "test mean response and precision data" likely confirmed that when the control solution was tested with the OMNIS Health Embrace system, the results fell within the expected range around these assigned values with acceptable precision.

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

The 510(k) summary does not specify the sample sizes (number of samples, replicates, or batches) used for each of the non-clinical tests (shelf-life, use-life, transport stability, preservative efficacy, mean response, and precision).

The data provenance is implied to be retrospective from internal non-clinical testing conducted by Bionostics, Inc. The country of origin of the data is USA, where Bionostics, Inc. is located.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable for this type of device and study. The "ground truth" for a control solution is typically established through analytical chemistry methods to determine the precise concentration of the analyte (D-glucose) and then verified through rigorous testing on the target device. It does not involve human expert interpretation of a diagnostic output in the same way clinical diagnostic devices do.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation of results or images. For a control solution, the "ground truth" (the known glucose concentration) is analytically determined, and the device's performance is assessed against this known value using objective, quantitative metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically reserved for diagnostic imaging or interpretation devices where human readers play a critical role in the diagnostic process and the effectiveness of AI assistance needs to be evaluated. This device is a quality control solution and does not involve human interpretation in its primary function.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

While the term "standalone study" usually refers to diagnostic algorithms, the non-clinical tests described (stability, mean response, precision) function as an "algorithm only" equivalent in verifying the intrinsic properties and performance of the control solution itself. These studies assess the chemical and physical characteristics of the control solution independently of a human user's interpretation of its results. The OMNIS Health Embrace Glucose Control Solution's performance is measured by how consistently it produces expected results on the OMNIS Health Embrace blood glucose test systems, rather than by its own diagnostic output.

7. The Type of Ground Truth Used

The ground truth for this device is based on analytical chemistry standards and established reference values for glucose concentration. The "Mid Assigned Values" (e.g., 114 mg/dL and 229 mg/dL) represent the target, known concentrations that the control solution is designed to mimic when tested by the OMNIS Health Embrace blood glucose test system. The control solution itself is the ground truth for the system it's meant to evaluate.

8. The Sample Size for the Training Set

Not applicable. The OMNIS Health Embrace Glucose Control Solution is a manufactured chemical product, not an algorithm that requires a training set. The "development" and "optimization" mentioned in the description ("optimized to simulate the response of whole blood") refer to formulation adjustments and testing during product development, not machine learning model training.

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

Not applicable. As stated above, this is a chemical product, not an algorithm.

Summary

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K091914

510(k) Summary1

NOV - 6 2004

(a) (1)	Submitter's name, address	Contact Person
	Bionostics, Inc.	Minna Rannikko
	7 Jackson Road	Director, R&D
	Devens, MA 01434	(978) 772-7070 x 236

5 October 2009 Date of preparation of this summary:

OMNİS Health Embrace Glucose Control Solution (2) Device trade or proprietary name:
Device common or usual name or classification name:

75 JJX, single (specified) analyte controls (assayed and unassayed)

CLASSIFICATION
PRODUCT NOMENCLATURE	NUMBER	CLASS	PANEL
SINGLE ANALYTE CONTROL SOLUTION	862.1660	I	75 CLINICAL CHEMISTRY

Substantial Equivalence l.

OMNIS Health Embrace Glucose Control Solution is substantially equivalent in function, safety and efficacy to currently marketed devices for the same intended use:

Comparison of OMNIS Health Embrace Glucose Control Solution to predicate devices for substantial equivalency

	OMNIS HealthL1 Low Solution	EmbraceL1 Low Control	OMNIS HealthL2 High Solution	EmbraceL2 High Control
Product
510(k)		K090043		K090043
Net Fill	4 mL	2.5 mL	4 mL	2.5 mL
Color	red	red	red	red
Analyte	glucose	glucose	glucose	glucose
Glucose (% w/v)	0.08%	0.06%	0.15%	0.15%
Container	6 mL plastic vial	3 mL plastic vial	6 mL plastic vial	3 mL plastic vial
Matrix	aqueous	aqueous	aqueous	aqueous
Level	L1 (low)	L1 (low)	L2 (high)	L2 (high)
Mid AssignedValue* (mg/dL)	114	114	229	229

Mid Assigned Value is the mid-point of assigned ranges on OMNIS Health glucose test strips.

Devens, MA USA 01434 · (978) 772-7070 · Fax: (978) 772-7072 7 Jackson Road .

4 This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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11. Description of the new device

ﻨﺎ ﺷ

OMNIS Health Embrace Glucose Control Solution is a non-hazardous aqueous solution containing no human or animal-derived materials.

Intended use of the device (a) (1)

Technological characteristics of the device. (a) (2)

This material consists of viscosity-adjusted, aqueous glucose control solution prepared at two concentrations of D-glucose and has been optimized to simulate the response of whole blood on OMNIS Health Embrace blood glucose test systems. The solution contains no hazardous, human or animal derived components.

Summary of non-clinical tests submitted with the premarket notification for the (b) (1) device.

Tests were conducted to verify specific performance requirements:

a) Closed bottle stability (Shelf-life)
b) Stability after opening (Use-life)
c) Transport Stability
d) Preservative Efficacy
e) Test mean response and precision data
Summary of clinical tests submitted with the premarket notification for the device. (b) (2) N/A

Conclusions drawn from the clinical and non-clinical trials. (b) (3)

Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Bionostics, Inc. c/o Ms. Minna Rannikko Director, Research and Development 7 Jackson Road Devens, MA 01434

NOV - 6 2009

Re:

K091914 Trade/Device Name: OMNIS Health Embrace Glucose Control Solution Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I (reserved) Product Code: JJX Dated: September 23, 2009 Received: September 24, 2009

Dear Ms. Rannikko:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 comply with all the 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 devicerelated adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: OMNIS Health Embrace Glucose Control Solution

Indication For Use:

OMNIS Health Embrace Glucose Control Solution is intended to assess the performance of OMNIS Health Embrace Blood Glucose test systems. OMNIS Health Embrace Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.

For In Vitro Diagnostic Use

Prescription Use _ (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use __ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol Benser

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)__ K091914

510(K) PREMARKET NOTIFICATION - OMNIS Health Control Solution

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.