· Roche ACCU-CHEK Aviva® and ACCU-CHEK Aviva Combo® using Aviva Plus® test strips
· Roche ACCU-CHEK Active® using ACCU-CHEK Active test strips
Roche ACCU-CHEK Compact® and ACCU-CHEK Compact Plus® using ACCU-CHEK Compact test strips.
· Roche ACCU-CHEK Advantage using Comfort Curve® test strips

Glucose Meter-Check Solution for Roche ACCU-CHEK is intended for use by healthcare professionals and people with diabetes mellitus at home.

For In Vitro Diagnostic Use

Device Description

Glucose Meter-Check Solution is a single-level, viscosity-adjusted, aqueous liquid glucose control solution. Glucose Meter-Check Solution is intended for use to verify the performance of the Roche ACCU-CHEK brand BGM Systems listed in the package insert at recover glucose values within the interval recommended in ISO 15197:2003 In vitro diagnostic test systems - Requirements for blood glucose monitoring systems for selftesting in managing diabetes mellitus for most meter types (Aviva, SmartView, Advantage), and comparable to solutions currently marketed by Roche for others (Active, Compact). This mid-level glucose concentration will complement the current, low and high glucose concentrations available in quality control products distributed by Roche Diagnostics for these same BGM systems. 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.

Glucose Meter-Check Solution is a non-hazardous aqueous solution glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation.

This material consists of viscosity-adjusted, aqueous glucose control solution prepared with a single concentration of D-glucose and has been optimized to simulate the response of whole blood on the Roche ACCU-CHEK blood glucose monitoring systems. The solution contains no hazardous, human or animal derived components. The solution is recognized as a control automatically by the ACCU-CHEK Aviva and Nano SmartView meters to perform consistently as the Roche branded products.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Glucose Meter-Check® Solution for Roche ACCU-CHEK

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (%)
Value Assignment: At least 95% of individual measurements on each meter type (all strip lots) must be within the assigned range provided for each lot of test strips. The assigned range for control solution performance is considered ±15% of the grand mean.	100% of all values recovered were within value assignment ranges provided with each vial of test strips.
Stability (Closed Bottle): Unopened shelf-life of 2 years (24 months) at recommended storage temperatures (2°C to 30°C / 36°F to 86°F), as measured by YSI 2300 calibrated with N.I.S.T. 917 traceable materials.	Demonstrated for 2 years (24 months) on equivalent product.
Stability (After Opening): Less than 5% change in percent glucose recovery on YSI on vials evaluated for 3 months (93 days).	Meets stability requirements for 3 months (93 days).

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

Sample Size for Value Assignment: For each meter type and for 3 lots of test strips, 8 measurements of the Glucose Meter-Check Solution were taken on each of 5 meters. This results in 120 measurements per meter type (3 lots x 8 measurements/lot x 5 meters/lot).
Sample Size for Method Comparison/Equivalence: For each meter brand, 2 meters were used. For each meter, 1 measurement of Glucose Meter Check Solution was followed by 1 measurement of the Roche ACCU-CHEK branded control solution. This sequence was repeated until 25 sets of pairs were recorded per meter (25 measurements for the candidate device and 25 for the predicate device, per meter).
Data Provenance: Not explicitly stated (e.g., country of origin). The testing described appears to be retrospective laboratory testing performed by Bionostics, Inc. to characterize the new control solution and compare it to existing solutions. It is not patient-derived data.

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

N/A. This device is a quality control solution for glucose meters, not a diagnostic algorithm that interprets medical images or patient data. The "ground truth" here refers to the known glucose concentration of the control solution itself and the expected performance ranges of the glucose meters. The "ground truth" for the control solution's glucose level is established through analytical methods (YSI 2300 calibrated with N.I.S.T. 917 traceable materials), not expert interpretation.

4. Adjudication Method for the Test Set

N/A. No human interpretation (such as radiological reads) is involved, so no adjudication method is applicable. The evaluation criteria are quantitative and based on instrument readings.

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

No, an MRMC study was not done. This study pertains to the performance of a quality control solution with blood glucose meters, not an AI-assisted diagnostic tool that involves human readers.

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

Yes, in a sense. The core "performance" of the Glucose Meter-Check Solution is its ability to produce expected glucose values when tested on various blood glucose monitoring systems. The studies evaluated the control solution itself and its interaction with the meters, which are standalone devices. There is no human-in-the-loop aspect for the control solution's function or the meter's measurement.

7. The Type of Ground Truth Used

The ground truth used is analytical measurement of glucose concentration traceable to a recognized standard:

N.I.S.T. SRM 917 (National Institute of Standards and Technology Standard Reference Material 917)
Measurements were performed using a YSI 2300 (a glucose analyzer).
For the meter performance, the "ground truth" is defined by the expected assay ranges provided by Roche for their test strips and the assigned range for the Glucose Meter-Check solution (±15% of the grand mean).

8. The Sample Size for the Training Set

N/A. This is a quality control solution, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML. The device's formulation and performance specifications are developed through R&D and analytical testing, not supervised learning.

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

N/A. As there is no training set for a machine learning model, this question is not applicable.

Summary

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BIONOSTICS
Quality Solutions

510(k) Summary

K123851

FEB 1 4 2013

(a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road Devens, MA 01432
Contact Person Randy Byrd VP, Chief Technical Officer (978) 772-7070 x 272

. Date of preparation of this summary: 19 February 2013

(2) Device trade or proprietary name: Glucose Meter-Check® Solution for Roche ACCU-CHEK

Device common or usual name or classification name:

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

	CLASSIFICATION
REGULATION NAME	NUMBER	CLASS	PRODUCT CODE
Quality Control Material	862.1660	I, reserved	JJX

(3) Substantial Equivalence

Glucose Meter-Check Solution is substantially equivalent in function, safety and efficacy to the currently marketed device for the same intended use:

Comparison of Glucose Meter-Check"Solution to predicate device for substantial equivalency

	Item	Predicate Device	Candidate Device
	IntendedUse/Indications for Use	Glucose Meter-Check Solution for RocheGlucose Meter-Check Solution RocheACCU-CHEK is intended to assess theperformance of the following RocheACCU-CHEK blood glucose monitoringsystems:Roche ACCU-CHEK Aviva® and ACCU-CHEK Aviva Combo® using Aviva Plus®test stripsRoche ACCU-CHEK Active® using ACCU-CHEK Active test stripsRoche ACCU-CHEK Compact® and ACCU-CHEK Compact Plus® using ACCU-CHEKCompact test strips.Roche ACCU-CHEK Advantage usingComfort Curve® test strips	Same, with the addition of Roche NanoSmartView using SmartView test strips

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Similarities and Differences of the Blood Glucose Control, continued
Item	Predicate DeviceK081403	Candidate DeviceK123851
Stability	24 Months	same
Value assignment	determined by analysis of glucose oncommercial lots of glucose test stripsqualified for proper measurement usingmanufacturer recommended controlsolution	same
Traceability	N.I.S.T. SRM 917	same
Target range	90 to 112 mg/dL(range of midpoint value assignment forvarious meter types)	108 to 147 mg/dL(range of midpoint value assignmentfor various meter types)
Auto QC detection	no	yes, for Nano and Aviva BGMSno, for Active, Compact Plus andAdvantage BGMS
Matrix	Ingredient (w/v%) Current Solution	Ingredient (w/v%) Current Solution
	High Purity Water 91.6	High Purity Water 88.6
	Buffers 1.0	Buffers same
	Salts 0.5	Salts same
	Viscosity Modifier 6.6	Viscosity Modifier same
	Glucose 0.10	Glucose 0.12
	Preservatives 0.05	Preservatives same
	Dyes 0.08	Dyes same
Container	6 mL white LDPE	same
Analyte	glucose	same
Color	red	same
Net Fill	4 mL	same

midpoint of assigned values, depending on meter and test strip combination ® auto QC (control) detection for ACCU-CHEK Nano and Aviva BGMS

(4) Description of the new device

Glucose Meter-Check Solution is a single-level, viscosity-adjusted, aqueous liquid glucose control solution. Glucose Meter-Check Solution is intended for use to verify the performance of the Roche ACCU-CHEK brand BGM Systems listed in the package insert at recover glucose values within the interval 2 recommended in ISO 15197:2003 In vitro diagnostic test systems - Requirements for blood glucose monitoring systems for selftesting in managing diabetes mellitus for most meter types (Aviva, SmartView, Advantage), and comparable to solutions currently marketed by Roche for others (Active, Compact). This mid-level glucose concentration will complement the current, low and high glucose concentrations available in quality control products distributed by Roche Diagnostics for these same BGM systems. 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.

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Standard/Guidance Documents Referenced (if applicable):

ISO 15197:2003 In Vitro diagnostic test systems Requirements for blood glucose . monitoring systems for self-testing in managing diabetes mellitus.
9 ISO 14971:2009 Medical devices - Application of risk management to medical devices
. ISO 13485:2007 Medical Devices – Quality Management Systems – Requirements for regulatory purposes
. ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General Requirements
ISO 18113-4 In vitro diagnostic medical devices Information supplied by the .
manufacturer (labeling) Part 4: In vitro diagnostic reagents for self-testing ●
� EN 13640 Stability Testing of In Vitro Diagnostic Reagents
. Guidance for Industry and FDA Staff – Assayed and Unassayed Quality Control Material

(2) Intended use of the device

Glucose Meter-Check Solution Roche ACCU-CHEK is intended to assess the performance of the following Roche ACCU-CHEK blood glucose monitoring systems:

· Roche ACCU-CHEK Nano SmartView® using SmartView® test strips

· Roche ACCU-CHEK Aviva® and ACCU-CHEK Aviva Combo® using Aviva Plus® test strips
· Roche ACCU-CHEK Active® using ACCU-CHEK Active test strips
· Roche ACCU-CHEK Compact® and ACCU-CHEK Compact Plus® using ACCU-CHEK Compact test strips.
· Roche ACCU-CHEK Advantage using Comfort Curve® test strips

Glucose Meter-Check Solution for Roche ACCU-CHEK is intended for use by healthcare professionals and people with diabetes mellitus at home.

(6) Technological characteristics of the device.

Test Principle:

The BGMS with which this control solution is utilized utilize enzymatic measurement of glucose

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(b) (1) Summary of non-clinical tests submitted with the premarket notification for the device. Tests were conducted to verify specific performance requirements:

a) Value assignment process:
For 3 lots of test strips evaluated for each meter type, 8 measurements of the Glucose Meter-Check Solution on each of 5 meters providing 120 measurements of Glucose Meter-Check on each meter type.

Because the precision performance of the control solution on a blood glucose test system is primarily determined by the composition of the test strips, we assign the acceptable range of measurement as ± 15% to correspond to the value assignment ranges currently provided by Roche for the meters using the Roche appropriate ACCU-CHEK test strips. Each meter and strip combination is considered to be operating correctly if all measurements of Roche ACCU-CHEK branded control solutions are recovered within the assay ranges provided on each carton of test strips. Value assignment resulting from the grand mean of all measurements on each meter type (all strip lots) was considered valid if at least 95% of individual values obtained are within the assigned range provided for each lot of test strips.

b) Closed bottle stability: Stability characteristics were determined under un-opened conditions in real time stability studies of equivalent product to demonstrate an unopened shelf-life of 2 years (24 months) at the recommended storage temperatures, ranging from 2°C to 30°C (36°F to 86°F) as measured by YSI 2300 calibrated with N.I.S.T. 917 traceable materials.
c) Stability after opening: Glucose Meter-Check Solution for Bayer meets stability requirements as demonstrated by less than 5% change in percent glucose recovery on YSI on vials evaluated of 3 months (93 days).
d) Method comparison with predicate device

To evaluate equivalence', we performed a series of measurements at room temperature on two meters of each brand using the Glucose Meter Check Solution followed by one level of Roche ACCU-CHEK branded control solution appropriate for each test strip brand.

As an example, the Nano blood glucose meter was evaluated with one measurement of Glucose Meter Check Solution on each of two meters using one lot of test strips, followed by one measurement of SmartView control solution on each meter. This sequence was repeated until 25 sets of pairs were recorded. The entire process of value assignment and evaluation of equivalence elapsed over several testing days.

The individual values obtained on each measurement were compared to the relevant value assignment ranges for each test strip lot as well as to the value assignment ranges determined' for the Meter-Check control solution calculated as mean recovered from

1 BIOVR-1175 Evaluation of Equivalence – Glucose Meter-Check® Solution for Roche ACCU-CHEK Blood Glucose Meters, Rev. A

² BIOVR-1176 Value Assignment for Glucose Meter-Check® Solution for Roche ACCU-CHEK Blood Glucose Monitoring Systems, Rev. A.

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measurement on three (3) test strip lots ± 15% to correspond to the value assignment ranges currently utilized by Roche for the meters using SmartView test strips.

Detailed results are provided in Table 2: Summary Results of Control Performance Equivalence on the following page. Each quality control solution was measured in series as described above on each of the Infopia test systems.

The Acceptance Criteria (at least 95% of measurements obtained for the manufacturer recommended quality control solution were within the value assignment ranges provided on the test strips for that meter, test strip and control solution combination) were met with 100% of all values recovered within value assignment ranges provided with each vial of test strips. 100% of Meter Check measurements on the same meter and test strip combination were within the value assignment ranges established for Meter Check.

Test StripType	MeterBrand	Control Brand	PooledMean	PooledSD	PooledCV%	assayrange(mg/dL)	assayrange(%)	withinassayrange
SmartView	NanoSmartView	SmartView	121.0	1.8	1.5%	116-128	15%	100%
SmartView	NanoSmartView	Current Meter-Check	109.8	2.0	1.8%	105-115	15%	100%
SmartView	NanoSmartView	New Meter-Check	108.9	1.8	1.6%	92-124	15%	100%
Aviva Plus	Aviva	Aviva	46.6	0.6	1.2%	30-60	15mg/dL	100%
Aviva Plus	Aviva	Current Meter-Check	110.2	1.3	1.2%	85-115	15%	100%
Aviva Plus	Aviva	New Meter-Check	111.8	1.2	1.0%	92-124	15%	100%
Compact	Compact,CompactPlus	Compact Blue	204.4	2.8	1.4%	186-252	15%	100%
Compact	Compact,CompactPlus	Current Meter-Check	90.7	2.3	2.6%	82-111	15%	100%
Compact	Compact,CompactPlus	New Meter-Check	146.2	3.4	2.3%	125-169	15%	100%
Active	Active	Active	171.3	2.3	1.3%	154-207	15%	100%
Active	Active	Current Meter-Check	112.9	2.6	2.3%	95-129	15%	100%
Active	Active	New Meter-Check	176.4	3.6	2.0%	150-202	15%	100%
ComfortCurve	Advantage	Comfort Curve	57.9	2.5	4.4%	44-74	15mg/dL	100%
ComfortCurve	Advantage	Current Meter-Check	82.8	2.6	3.1%	76-103	15%	100%
ComfortCurve	Advantage	New Meter-Check	105.7	2.9	2.7%	94-127	15%	100%

Table 2: Summary Results of Control Performance Equivalence

This evaluation demonstrates the new Meter-Check solution is equivalent to both the currently marketed Meter-Check Solution cleared under K081403, and to the Roche ACCU-CHEK branded control solution recommended for use with each of these test systems.

(b) (2) Summary of clinical tests submitted with the premarket notification for the device. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 14, 2013

Bionostics, Inc c/o Randy Byrd 7 Jackson Road Devens, MA 01434

Re: K123851

Trade/Device Name: Glucose Meter-Check Solution for Roche ACCU-CHEK Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: I, reserved Product Code: JJX Dated: December 13, 2012 Received: December 17, 2012

Dear Mr. Byrd:

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for

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Page 2-Mr. Byrd

the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Carol C. Benson for

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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Indications for Use

· 510(k) Number (if known): K123851

Device Name: Glucose Meter-Check Solution for Roche ACCU-CHEK

Indications for Use:

Glucose Meter-Check Solution Roche ACCU-CHEK is intended to assess the performance of the following Roche ACCU-CHEK blood glucose monitoring systems:

· Roche ACCU-CHEK Nano SmartView® using SmartView® test strips

· Roche ACCU-CHEK Aviva® and ACCU-CHEK Aviva Combo® using Aviva Plus® test strips
· Roche ACCU-CHEK Active® using ACCU-CHEK Active test strips
Roche ACCU-CHEK Compact® and ACCU-CHEK Compact Plus® using ACCU-CHEK Compact test strips.
· Roche ACCU-CHEK Advantage using Comfort Curve® test strips

Glucose Meter-Check Solution for Roche ACCU-CHEK is intended for use by healthcare professionals and people with diabetes mellitus at home.

For In Vitro Diagnostic Use

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _ X (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 Diagnostics and Radiological Health (OIR)

Katherine /Serrano

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K123851

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.