(30 days)
Glucose Meter-Check Solution for Bayer is intended to assess the performance of the following Bayer blood glucose test systems:
- Bayer Contour Next blood glucose monitoring systems
- Bayer Breeze 2 blood glucose monitoring systems
- Bayer Contour and Contour TS blood glucose monitoring systems
Glucose Meter-Check Solution for Bayer is intended for use by healthcare professionals and people with diabetes mellitus at home.
For In Vitro Diagnostic Use
Glucose Meter-Check Control Solution is a viscosity-adjusted, aqueous liquid glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. Glucose Meter-Check Control Solution is intended for use to verify the performance of the Bayer BGM systems listed in the package insert and is intended for use by healthcare professionals and people with diabetes mellitus at home. 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.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Glucose Meter-Check® Solution for Bayer
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 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. | 100% of all values recovered within value assignment ranges provided with each vial of test strips for the manufacturer-recommended control solutions. |
| At least 95% of Meter-Check measurements on the same meter and test strip combination were within the value assignment ranges established for Meter-Check. | 100% of Meter-Check measurements on the same meter and test strip combination were within the value assignment ranges established for Meter-Check. |
| Unopened shelf-life: 2 years (24 months) at recommended storage temperatures (2°C to 30°C / 36°F to 86°F). | Demonstrated by real-time stability studies of equivalent product. |
| Stability after opening: less than 5% change in percent glucose recovery on YSI on vials evaluated of 3 months (93 days). | Met stability requirements as demonstrated. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific numerical sample size for the test set. However, it mentions:
- "a series of measurements" were performed.
- Glucose Meter-Check Solution and mid-level Bayer quality control solution were tested "for each strip/meter type."
- The table "Evaluation of Equivalence of Control Solutions" presents data for various test strip and meter brands (Breeze 2, Contour, Contour TS, Contour Next EZ). Each row represents a "Control Brand" (Bayer's own control, Current Meter-Check, New Meter-Check) with "Pooled Mean," "Pooled SD," "Pooled CV%" implying multiple measurements were pooled for each combination.
Data Provenance:
- The document states: "Current version blood glucose meters, test strips and quality control solutions were purchased through retail outlets for Bayer blood glucose monitoring systems." This suggests the data was collected from commercially available products, likely in the country where the testing was conducted (not specified, but presumably the US where the submission was made).
- The study appears to be prospective as it involved testing the performance of the new device against existing ones.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of study does not typically involve human experts establishing a "ground truth" in the diagnostic sense (e.g., radiologists interpreting images).
For this device (a quality control solution for blood glucose meters), the ground truth is based on:
- Value assignment ranges: These ranges are established by the test strip manufacturers (Bayer in this case) and Bionostics for their Meter-Check solutions.
- Measurement against reference methods: The document mentions "determined by analysis of glucose on commercial lots of glucose test strips qualified for proper measurement using manufacturer recommended control solution" and "Traceability: N.I.S.T. SRM 917." This indicates a reliance on standardized laboratory methods and reference materials, rather than expert interpretation.
4. Adjudication Method for the Test Set
No explicit adjudication method (like 2+1 or 3+1) is mentioned, as this is not a study relying on human interpretation of subjective data. The assessment is objective, based on whether numerical results fall within predefined ranges.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is designed to evaluate the performance of human readers (e.g., radiologists, pathologists) with and without AI assistance on a set of cases. This study is for a quality control solution used to verify the performance of blood glucose meters, not for an AI algorithm assisting human interpretation. Therefore, it does not involve human readers or assess an effect size of AI assistance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
While the device (quality control solution) doesn't have an "algorithm" in the typical AI sense, the performance testing described is analogous to a standalone performance evaluation. The device (control solution) is used directly with blood glucose meters, and its functionality is assessed based on whether the meter/strip system produces results within established ranges when the control solution is used. There is no human intervention required to interpret the control solution's performance; the meter provides a reading, and that reading is objectively compared to the expected range.
7. The Type of Ground Truth Used
The ground truth used is based on:
- Manufacturer-recommended value assignment ranges: These are the expected glucose values for a given meter/test strip/control solution combination.
- Traceability to N.I.S.T. SRM 917: This refers to the National Institute of Standards and Technology Standard Reference Material 917, which is a certified glucose standard, ensuring the accuracy of the glucose concentration.
- YSI analysis: The stability section mentions "percent glucose recovery on YSI," indicating that a YSI (Yellow Springs Instruments) analyzer, a highly accurate laboratory instrument, was used for reference measurements.
This type of ground truth is analogous to analytical reference methods or certified reference materials.
8. The Sample Size for the Training Set
Not applicable. This device is a quality control solution, not an AI algorithm that requires a "training set." The product's performance is driven by its chemical formulation and manufacturing processes, not by machine learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the words "BIONOSTICS Quality Solutions". The word "BIONOSTICS" is in all caps and is in a bold, sans-serif font. The words "Quality Solutions" are in a smaller, serif font and are located below the word "BIONOSTICS". The text is slightly slanted.
510(k) Summary1
JAN 2 5 2013
- (a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road Devens, MA 01434
Contact Person Randy Byrd VP, Chief Technical Officer (978) 862-1830
Date of preparation of this summary: 25 January 2013
- (2) Device trade or proprietary name:
Glucose Meter-Check® Solution for Bayer
Device common or usual name or classification name:
| CLASSIFICATION | ||||
|---|---|---|---|---|
| REGULATION NAME | NUMBER | CLASS | PRODUCT CODE | |
| Quality Control Material | 862.1660 | I, reserved | JJX |
(3) Substantial Equivalence
Glucose Meter-Check Solution for Bayer is substantially equivalent in function, safety and efficacy to currently marketed devices for the same intended use:
Comparison of Glucose Meter-Check Solution to predicate devices for substantial equivalency
| Similarities and Differences of the Blood Glucose Control | ||
|---|---|---|
| Item | Predicate Device:Glucose Meter-Check Solution for BayerK082395 | Candidate Device |
| IntendedUse/Indications for Use | Glucose Meter-Check® Solution isintended for in vitro diagnostic use toassess the performance of the Bayerblood glucose monitoring systems:Contour Next, Contour and Contour TS,and Breeze 2 by healthcare professionalsand in the home by people with diabetesmellitus | Same, with the addition of BayerContour Next BGMS |
| 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 | 76 to 106 mg/dL(range of midpoint value assignment forvarious meter types) | 94 to 135 mg/dL(range of midpoint value assignmentfor various meter types) |
¹ 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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| Item | Predicate Device Glucose Meter-Check Solution for Bayer K082395 | Candidate Device | ||
|---|---|---|---|---|
| Auto QC detection | no | no | ||
| Matrix | Ingredient (w/v%) | Current Solution | Ingredient (w/v%) | Current Solution |
| Glucose | 0.08 | Glucose | 0.11 | |
| pH | 7.15 | pH | same | |
| Buffer | 1.02 | Buffer | same | |
| Salt | 0.40 | Salt | same | |
| Viscosity Modifier | 15.0 | Viscosity Modifier | same | |
| Preservatives | 0.03 | Preservatives | same | |
| Dye | 0.05 | Dye | 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
(4) Description of the new device
Glucose Meter-Check Control Solution is a viscosity-adjusted, aqueous liquid glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. Glucose Meter-Check Control Solution is intended for use to verify the performance of the Bayer BGM systems listed in the package insert and is intended for use by healthcare professionals and people with diabetes mellitus at home. 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.
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.
- . 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
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(5) Intended use of the device
Glucose Meter-Check Solution for Bayer is intended to assess the performance of the following Bayer blood glucose test systems:
- Bayer Contour Next blood glucose monitoring systems .
- . Bayer Breeze 2 blood glucose monitoring systems
- . Bayer Contour and Contour TS blood glucose monitoring systems
Glucose Meter-Check Solution for Bayer is intended for use by healthcare professionals and people with diabetes mellitus at home.
(E) Technological characteristics of the device.
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 Bayer blood glucose test systems. The solution contains no hazardous, human or animal derived components.
Test Principle:
The BGMS with which this control solution is utilized utilize enzymatic measurement of glucose
(b) (1) Summary of non-clinical tests submitted with the premarket notification for the device. Tests were conducted to verify specific performance requirements:
a) 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)
b) 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).
c) Method comparison with predicate device:
Current version blood glucose meters, test strips and quality control solutions were purchased through retail outlets for Bayer blood glucose monitoring systems. To evaluate equivalence, we performed a series of measurements at room temperature on two Infopia meters using the Glucose Meter Check Solution followed by mid-level Bayer quality control solution for each strip/meter type. Specific Bayer-branded control solutions are recommended for use with all current Bayer-branded glucose meters based upon the test strip brand used with each meter.
The individual values obtained on each measurement were compared to the relevant value assignment ranges for meter/test strip/control combination as well as to the value assignment ranges detérmined as described above for the Meter-Check control solution calculated as mean recovered from 3 test strip lots ± 11% (Contour Next) or ± 16% (Contour, Contour TS and Breeze2) to correspond to the value assignment ranges currently utilized by Bayer for the meters using the relevant Bayer-branded test strips.
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Detailed results are provided in Table 2: Evaluation of Equivalence of Control Solutions on the following page. Each quality control solution was measured in series as described above on each of the Bayer 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 | Meter Brand | Control Brand | PooledMean | PooledSD | PooledCV% | assayrange(mg/dL) | assayrange (%) | withinassayrange |
|---|---|---|---|---|---|---|---|---|
| Breeze 2 | Breeze 2 | Breeze 2 | 111.9 | 4.4 | 4.0% | 93-127 | 15% | 100% |
| Current Meter-Check | 111.5 | 2.8 | 2.5% | 95-128 | 15% | 100% | ||
| New Meter-Check | 127.2 | 3.2 | 2.5% | 111-151 | 15% | 100% | ||
| Contour | Contour | Contour | 123.6 | 3.3 | 2.6% | 104-144 | 16% | 100% |
| Current Meter-Check | 72.3 | 4.8 | 6.7% | 60-84 | 16% | 100% | ||
| New Meter-Check | 117.0 | 6.3 | 5.4% | 102-140 | 16% | 100% | ||
| Contour TS | Contour TS | Contour TS | 119.7 | 1.4 | 1.2% | 102-140 | 16% | 100% |
| Current Meter-Check | 79.2 | 4.5 | 5.7% | 67-92 | 16% | 100% | ||
| New Meter-Check | 120.0 | 5.4 | 4.5% | 102-140 | 16% | 100% | ||
| Contour | Contour | Contour Next | 130.8 | 2.9 | 2.2% | 116-144 | 11% | 100% |
| Next EZ | Next | Current Meter-Checka | 103.5 | 2.5 | 2.4% | 92-115 | 11% | 100% |
| New Meter-Check | 121.0 | 1.7 | 1.4% | 110-138 | 11% | 100% |
Table 2: Evaluation of Equivalence of Control Solutions
Value assignment for Contour Next EZ determined on Current Meter-Check as mean ±11% to correspond to value assignment range determined by test strip manufacturer.
Greater than 95% (100%) for all measurements of Meter-Check Control Solution were found to be within these limits and therefore, the acceptance criteria are met.
(b) (2) Summary of clinical tests submitted with the premarket notification for the device. N/A
(b) (3) Conclusions drawn from the clinical and non-clinical trials.
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/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 image of an eagle with its wings outstretched.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
January 25, 2013
Bionostics Mr. Randy Byrd 7 Jackson Road Devens, MA 01434
Re: K123966
Trade/Device Name: Glucose Meter-Check Solution for Bayer BGM Systems Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: I, reserved Product Code: JJX Dated: December 20, 2012 Received: December 26, 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 (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.
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Page 2-Mr. Byrd
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/ucm 115809.htm for 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): K123966
Device Name: Glucose Meter-Check Solution for Bayer
Glucose Meter-Check Solution Bayer is intended to assess the Indications for Use: performance of the following Bayer blood glucose test systems:
· Bayer Contour Next blood glucose monitoring systems
· Bayer Breeze 2 blood glucose monitoring systems
· Bayer Contour and Contour TS blood glucose monitoring systems
Glucose Meter-Check Solution for Bayer 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 Diagnostics and Radiological Health (OIR)
Katherine Serrano 2013.01.24 09:36:03 -05'00'
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K123966
§ 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.