(34 days)
No
The device description and intended use clearly define it as a liquid control solution for verifying the performance of a blood glucose monitoring system. There is no mention of any computational or analytical capabilities that would involve AI or ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
The device is a control solution for verifying the performance of a blood glucose monitoring system, not for treating or diagnosing diabetes directly.
No
This device is a control solution, used to verify the performance of a blood glucose monitoring system, not to directly diagnose a medical condition.
No
The device description clearly states it is a liquid 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 document explicitly states "For In Vitro Diagnostic Use" under the "Intended Use / Indications for Use" section.
- Intended Use: The intended use is to "verify the performance of the FreeStyle BGM System at multiple glucose levels within the reportable range." This is a quality control function for a diagnostic device (the blood glucose monitor), which falls under the scope of in vitro diagnostics.
- Device Description: The description details a "glucose control solution" used for "performing periodic QC checks." This further reinforces its role in the diagnostic process.
Therefore, based on the provided information, this Glucose Control Solution is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Glucose Control Solution for TheraSense FreeStyle is intended to be used to monitor and evaluate the analytical performance of the TheraSense FreeStyle BGM.
Glucose Control Solution for TheraSense FreeStyle Blood Glucose Monitoring System is intended for use to verify the performance of the FreeStyle BGM System at multiple 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 TheraSense FreeStyle is a three-level, viscosityadjusted, aqueous liquid glucose control solution. Glucose Control Solution for TheraSense FreeStyle provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their circuits for laoving or am. 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 Control Solution for TheraSense FreeStyle contains glucose values at three points within the reportable range and verify performance of the TheraSense FreeStyle BGM.
Glucose Control Solution for TheraSense FreeStyle 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
BIONOSTICS
510(k) Summary*
- (a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road Devens, MA 01432
K013147
Contact Person Kathleen Storro Director, QA & Regulatory Affairs (978) 772-7070 x 220
Date of preparation of this summary: 18 September 2001
- (2) Device trade or proprietary name:
Glucose Control Solution for TheraSense FreeStyle® BGM
Device common or usual name or classification name:
Multi Analyte Control Solution, All Types (Assayed and Unassayed)
| PRODUCT NOMENCLATURE | NUMBER | CLASS | PANEL |
|---|---|---|---|
| SINGLE ANALYTE CONTROL SOLUTION | 862.1660 75 JJX | I | CHEMISTRY |
(3) Substantial Equivalence
Glucose Control Solution for TheraSense FreeStyle is substantially equivalent in function, safety and efficacy to currently marketed devices produced by Bionostics. In example:
Comparison Glucose Control Solution for TheraSense FreeStyle to predicate devices for substantial equivalency
| Characteristic | Predicate Devices | Modified Device | |
|---|---|---|---|
| Name: | Multi-Meter Glucose | ||
| Calibration Verification | |||
| Material | Glucose Control Solution | ||
| for LifeScan FastTake | Glucose Control Solution | ||
| for TheraSense FreeStyle | |||
| 510(k), Date: | K012430, 08/27/01 | K000318, 02/28/00 | |
| Number of levels: | 5 | 1 | 3 |
| Analytes: | Glucose | Glucose | Glucose |
| Container: | plastic bottle | plastic bottle | plastic bottle |
| Fill volume: | 4 mL | 4 mL | 4 mL |
| Color: | red | red | red |
| 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. | Buffered, aqueous | ||
| solution of D-Glucose, | |||
| viscosity modifier, | |||
| preservatives and other, | |||
| non-reactive ingredients. |
510(K) PREMARKET NOTIFICATION - Glucose Control for FreeStyle
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1
Description of the new device (4)
Glucose Control Solution for TheraSense FreeStyle is a three-level, viscosityadjusted, aqueous liquid glucose control solution. Glucose Control Solution for TheraSense FreeStyle provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their circuits for laoving or am. 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 Control Solution for TheraSense FreeStyle contains glucose values at three points within the reportable range and verify performance of the TheraSense FreeStyle BGM.
Glucose Control Solution for TheraSense FreeStyle is a non-hazardous aqueous solution containing no biological materials.
- Intended use of the device (5) Glucose Control Solution for TheraSense FreeStyle is intended to be used to monitor and evaluate the analytical performance of the TheraSense FreeStyle BGM.
Technological characteristics of the device. (6)
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 TheraSense FreeStyle BGM system.
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
- 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 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.
2
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines extending from its body, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 4 2001
Ms. Kathleen Storro Director, OA and Regulatory Affairs Bionostics, Inc. 2 Craig Road Acton, MA 01720
Re: K013147
Trade/Device Name: Glucose Control Solution for TheraSense FreeStyle Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: I, reserved Product Code: JJX Dated: September 18, 2001 Received: September 20, 2001
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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number: K013147
Glucose Control Solution for TheraSense FreeStyle Device Name:
Indications for Use:
Glucose Control Solution for TheraSense FreeStyle Blood Glucose Monitoring System is intended for use to verify the performance of the FreeStyle BGM System at multiple 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
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013147
(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)