(40 days)
Not Found
No
The device is a liquid control solution for a blood glucose monitoring system, used for quality control and performance verification. The description focuses on the chemical composition and physical properties of the solution, with no mention of AI or ML.
No.
The device is a control solution intended to verify the performance of a blood glucose monitoring system, not to directly treat or diagnose a medical condition.
No.
The device described is a control solution used to verify the performance of a blood glucose monitoring system, not to directly diagnose a medical condition in a patient.
No
The device description clearly states it is a liquid glucose control solution packaged in plastic bottles, indicating it is a physical 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".
- Purpose: The device is a "Glucose Control Solution" intended to "verify the performance of the Chdiagnostics Senova™ Blood Glucose Monitoring System". This is a classic function of an IVD control material, used to ensure the accuracy and reliability of a diagnostic test (in this case, blood glucose monitoring).
- Application: It is used with a blood glucose monitoring system, which is itself an IVD device. Control solutions are essential components of the quality control process for many IVD tests.
N/A
Intended Use / Indications for Use
Glucose Control Solution for Chdiagnostics Senova™ Blood Glucose Monitoring System is intended for use to verify the performance of the Chdiagnostics Senova™ BGM System at glucose levels within the reportable range. The Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.
For In Vitro Diagnostic Use
Product codes
JJX
Device Description
Glucose Control Solution for Chdiagnostics Senova™ is a three-level, viscosity-adjusted, aqueous liquid glucose control solution. Glucose Control Solution for Chdiagnostics Senova™ provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a blue color to help users see the solution while dispensing onto a test strip.
Glucose Control Solution for Chdiagnostics Senova™contains glucose values at three points within the reportable range and to verify performance of the Chdiagnostics Senova™ BGM.
Glucose Control Solution for Chdiagnostics Senova™ is a non-hazardous aqueous solution containing no biological materials.
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
Not Found
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)
Tests were conducted to verify specific performance requirements:
- a) Closed bottle stability
- b) Stability after opening
- c) Correlation to gravimetric D-glucose
- d) Test precision and range
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 2 0 2003 BIONOSTICS
510(k) Summary1
- (a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road Devens, MA 01432
Contact Person Kathleen Storro Director, QA & Regulatory Affairs (978) 772-7070 x 220
Date of preparation of this summary: 9 September 2003
- (2) Device trade or proprietary name:
Glucose Control Solution for Chdiagnostics Senova™ Blood Glucose System
Device common or usual name or classification name:
Single Analyte Control Solution, All Types (Assayed and Unassayed)
| CLASSIFICATION | |||
|---|---|---|---|
| PRODUCT NOMENCLATURE | NUMBER | CLASS | PANEL |
| SINGLE ANALYTE CONTROL SOLUTION | 862.1660 75 JJX | I | CHEMISTRY |
I. Substantial Equivalence
Glucose Control Solution for Chdiagnostics Senova™ is substantially equivalent in function, safety and efficacy to currently marketed devices produced by Bionostics. In example:
Comparison of Glucose Control Solution for Chdiagnostics Senova™ to predicate devices for substantial equivalency
| Characteristic | Predicate Device | Modified Device |
|---|---|---|
| Name: | Multi-Meter Glucose Calibration | |
| Verification Material | Glucose Control Solution for | |
| CHDiagnostics Senova | ||
| 510(k), Date: | K012430, 08/27/01 | |
| Number of levels: | 5 | 3 |
| Analytes: | Glucose | Glucose |
| Container: | plastic bottle | plastic bottle |
| Fill volume: | 4 mL | 4 mL |
| Color: | red | Blue |
| Matrix: | Buffered, aqueous solution of D- | |
| Glucose, viscosity modifier, | ||
| preservatives and other, non- | ||
| reactive ingredients. | Buffered, aqueous solution of D- | |
| Glucose, viscosity modifier, | ||
| preservatives and other, non-reactive | ||
| ingredients. |
1 This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1
II. Description of the new device
Glucose Control Solution for Chdiagnostics Senova™ is a three-level, viscosity-adjusted, aqueous liquid glucose control solution. Glucose Control Solution for Chdiagnostics Senova™ provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a blue color to help users see the solution while dispensing onto a test strip.
Glucose Control Solution for Chdiagnostics Senova™contains glucose values at three points within the reportable range and to verify performance of the Chdiagnostics Senova™ BGM.
Glucose Control Solution for Chdiagnostics Senova™ is a non-hazardous aqueous solution containing no biological materials.
(5) Intended use of the device
Glucose Control Solution for Chdiagnostics Senova™ is intended to be used to monitor and evaluate the analytical performance of the Chdiagnostics Senova™ BGM.
(6) Technological characteristics of the device.
This material consists of viscosity-adjusted, aqueous glucose control solutions prepared in three specific glucose concentrations. The solutions have been optimized to simulate the response of whole blood on the Chdiagnostics Senova™ BGM system.
(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
- b) Stability after opening
- c) Correlation to gravimetric D-glucose
- d) Test precision and range
Summary of clinical tests submitted with the premarket notification for the (b) (2) 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized symbol of three human profiles facing right, with flowing lines connecting them. The logo is black and white.
OCT 2 0 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kathleen Storro Director, OA and Regulatory Affairs Bionostics, Inc. 7 Jackson Road Devens, MA 01432
Re: K032819
Trade/Device Name: Glucose Control Solution for Chdiagnostics Senova™ Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: September 9, 2003 Received: September 11, 2003
Dear Ms. Storro:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number:
Glucose Control Solution for Chdiagnostics Senova™ Device Name:
Indications for Use:
Glucose Control Solution for Chdiagnostics Senova™ Blood Glucose Monitoring System is intended for use to verify the performance of the Chdiagnostics Senova™ BGM System at glucose levels within the reportable range. The Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.
For In Vitro Diagnostic Use
Division Sign-Off
for Jean Cooper
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K032819
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)