(30 days)
Not Found
No
The document describes a glucose control solution used to verify the performance of blood glucose monitoring systems. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
Explanation: This device is a control solution for blood glucose monitoring systems, used to verify their performance. It does not directly diagnose, treat, or prevent a disease, but rather ensures the accuracy of another device that may be used for such purposes. Therefore, it is an in-vitro diagnostic (IVD) device, not a therapeutic device.
No
The device is a control solution intended to assess the performance of blood glucose test systems, not to diagnose a condition itself. It verifies the accuracy of a diagnostic device.
No
The device description clearly states it is a "viscosity-adjusted, aqueous liquid glucose control solution" and is packaged in "plastic bottles with dropper tips". This indicates a physical, liquid product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use".
- Nature of the Device: The device is a control solution used to assess the performance of blood glucose monitoring systems. These systems are used to measure glucose levels in blood samples, which is a diagnostic test performed in vitro (outside the body). The control solution is an essential component for ensuring the accuracy and reliability of these in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
Glucose Meter-Check® Solution is intended for in vitro diagnostic use to assess the performance of the Bayer blood glucose monitoring systems: Contour Next, Contour and Contour TS, and Breeze 2 by healthcare professionals and in the home by people with diabetes mellitus.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
healthcare professionals and people with diabetes mellitus at home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical tests including closed bottle stability, stability after opening, and method comparison with predicate device.
Sample Size: Not explicitly stated as a single sample size for all studies.
Key Results:
- Closed bottle stability: Demonstrated an unopened shelf-life of 2 years (24 months) at recommended storage temperatures (2°C to 30°C).
- Stability after opening: Met stability requirements with less than 5% change in percent glucose recovery on YSI on vials evaluated for 3 months (93 days).
- 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.
- Measurements were performed at room temperature on two Infopia meters using Glucose Meter Check Solution and mid-level Bayer quality control solution for each strip/meter type.
- Acceptance Criteria (at least 95% of measurements for the manufacturer recommended quality control solution were within the value assignment ranges provided on the test strips) were met with 100% of all values recovered within value assignment ranges.
- 100% of Meter Check measurements on the same meter and test strip combination were within the value assignment ranges established for Meter Check.
- Table 2 shows detailed results for Breeze 2, Contour, Contour TS, and Contour Next EZ, indicating 100% of measurements were within the assay range for both control brands (Bayer control and Meter-Check).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Stability: Less than 5% change in percent glucose recovery.
- Method Comparison: 100% of values recovered within value assignment ranges, 100% of Meter Check measurements were within established value assignment ranges.
- Accuracy (Assay Range %):
- Breeze 2: 15%
- Contour: 16%
- Contour TS: 16%
- Contour Next EZ: 11%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Bayer | ||
| K082395 | Candidate Device | |
| Intended | ||
| Use/Indications for Use | Glucose Meter-Check® Solution is | |
| intended for in vitro diagnostic use to | ||
| assess the performance of the Bayer | ||
| blood glucose monitoring systems: | ||
| Contour Next, Contour and Contour TS, | ||
| and Breeze 2 by healthcare professionals | ||
| and in the home by people with diabetes | ||
| mellitus | Same, with the addition of Bayer | |
| Contour Next BGMS | ||
| Stability | 24 Months | same |
| Value assignment | determined by analysis of glucose on | |
| commercial lots of glucose test strips | ||
| qualified for proper measurement using | ||
| manufacturer recommended control | ||
| solution | same | |
| Traceability | N.I.S.T. SRM 917 | same |
| Target range | 76 to 106 mg/dL | |
| (range of midpoint value assignment for | ||
| various meter types) | 94 to 135 mg/dL | |
| (range of midpoint value assignment | ||
| for 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 Strip
Type | Meter Brand | Control Brand | Pooled
Mean | Pooled
SD | Pooled
CV% | assay
range
(mg/dL) | assay
range (%) | within
assay
range |
|--------------------|-------------|----------------------|----------------|--------------|---------------|---------------------------|--------------------|--------------------------|
| 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