(27 days)
Not Found
No
The device description and intended use focus on a liquid control material for verifying glucose meter calibration and linearity. There is no mention of AI, ML, or any computational analysis of data that would suggest the use of such technologies.
No.
This device is a control material used for verifying the performance and calibration of blood glucose meters, not for treating any medical condition or directly interacting with the patient in a therapeutic manner. It is an in vitro diagnostic tool.
No
Explanation: The device is a "Glucose Calibration Verification Material" used to verify the performance, linearity, and calibration of blood glucose meters. It is a control material, not a device that directly diagnoses a medical condition in a patient.
No
The device description clearly states it is a "five-level, viscosity-adjusted, aqueous liquid glucose control linearity set" and is packaged in "plastic bottles with dropper tips". This indicates a physical, liquid-based 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".
- Function: The device is a control material used to verify the performance, assess linearity and calibration, and verify the performance of blood glucose meters. These are all activities performed in vitro (outside the body) to assess the function of a diagnostic device.
- Intended User: The intended users are "laboratories selecting to measure liquid QC material as a part of their quality assurance program," which are typical settings for IVD use.
N/A
Intended Use / Indications for Use
Multi-Meter Glucose Calibration Verification Material is intended to be used to monitor and evaluate the analytical performance of a number of popular blood glucose meters (BGM) as listed in the package insert.
Multi-Meter Glucose Calibration Verification Material assayed controls are intended for use to verify the performance of multiple blood glucose meters as indicated on the package insert at their upper and lower ends of reportable range and at three points within the range. These controls can therefore be used to assess the linearity and calibration of the test system, or to verify the test systems' performance.
For In Vitro Diagnostic Use
Prescription Use (Per 21 CFR 801.109)
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
Multi-Meter Glucose Calibration Verification Material is a five-level, viscosity-adjusted, aqueous liquid glucose control linearity set. Multi-Meter Glucose Calibration Verification Material 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 red color to help users see the solution while dispensing onto a test strip.
Multi-Meter Glucose Calibration Verification Material contains glucose values at the lower and upper limits of reportable range as well as three points within the range and therefore, may be used to assess the linearity and calibration, or verify performance, for each of a number of blood glucose meters listed on the package insert.
Multi-Meter Glucose Calibration Verification Material 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
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests were conducted to verify specific performance requirements:
- a) Accelerated aging studies on most labile analytes, together with experience with other products with similar formulations support stability claim.
- b) Test precision
- c) Correlation to reference methodology
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
BIONOSTICS
AUG 2 7 2001
510(k) Summary*
- Submitter's name, address (a) (1) Bionostics, Inc. 2 Craig Road Acton, MA 10720
Contact Person Kathleen Storro Director, QA & Regulatory Affairs (978) 263-3856 x 220
Date of preparation of this summary: 27 July 2001
- Device trade or proprietary name: (2)
Multi-Meter Glucose Calibration Verification Material
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 | I | CHEMISTRY |
| 75 JJX |
Substantial Equivalence (3)
Multi Analyte Glucose Calibration Verification Material is substantially equivalent in function, safety and efficacy to currently marketed devices produced by Bionostics. In example:
Comparison of Multi-Meter Glucose Calibration Verification Material to predicate devices for substantial equivalency
| Characteristic | Predicate Devices | Predicate Devices | Modified Device |
|---|---|---|---|
| Name: | Sugar Chex Linearity for | ||
| One Touch | Quality Control Solution | ||
| for MediSense BGM | Multi-Meter Glucose | ||
| Calibration Verification | |||
| Material | |||
| 510(k), Date: | K925479, 01/29/93 | K002540, 09/18/2000 | |
| Number of levels: | 5 | 5 | 5 |
| Analytes: | Glucose | Glucose | Glucose |
| Container: | plastic bottle | plastic bottle | plastic bottle |
| Fill volume: | 2 mL | 4 mL | 4 mL |
| Color: | red | red | red |
| Matrix: | Stabilized human red | ||
| blood cells with glucose | |||
| in a medium with | |||
| perservatives. | 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. |
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)
Multi-Meter Glucose Calibration Verification Material is a five-level, viscosityadjusted, aqueous liquid glucose control linearity set. Multi-Meter Glucose Calibration Verification Material 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 red color to help users see the solution while dispensing onto a test strip.
Multi-Meter Glucose Calibration Verification Material contains glucose values at the lower and upper limits of reportable range as well as three points within the range and therefore, may be used to assess the linearity and calibration, or verify performance, for each of a number of blood glucose meters listed on the package insert.
Multi-Meter Glucose Calibration Verification Material is a non-hazardous aqueous solution containing no biological materials.
-
(5) Intended use of the device
Multi-Meter Glucose Calibration Verification Material is intended to be used to monitor and evaluate the analytical performance of a number of popular blood glucose meters (BGM) as listed in the package insert .. -
Technological characteristics of the device. (6)
This material consists of viscosity-adjusted, aqueous glucose control solutions prepared in five specific glucose concentrations. The solutions have been optimized to simulate the response of whole blood on a number of blood glucose meters listed in the package insert.
Summary of non-clinical tests submitted with the premarket notification for the (b) (1) device.
Tests were conducted to verify specific performance requirements:
- a) Accelerated aging studies on most labile analytes, together with experience with other products with similar formulations support stability claim.
- b) Test precision
- c) Correlation to reference methodology
- 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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 7 2001
Ms. Kathleen Storro Director, QA and Regulatory Affairs Bionostics, Inc. 2 Craig Road Acton, MA 01720
Re: K012430
Trade/Device Name: Multi-Meter Glucose Calibration Verification Material Regulation Number: 21 CFR 862.1660 Regulatory Class: I, reserved Product Code: JJX Dated: July 27, 2001 Received: July 31, 2001
Dear Ms. Storro:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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 1 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/cdrb/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: Ko12430
Multi-Meter Glucose Calibration Verification Material Device Name:
Indications for Use:
Multi-Meter Glucose Calibration Verification Material assayed controls are intended for use to verify the performance of multiple blood glucose meters as indicated on the package insert at their upper and lower ends of reportable range and at three points within the range. These controls can therefore be used to assess the linearity and calibration of the test system, or to verify the test systems' performance.
For In Vitro Diagnostic Use
(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) | ||
|---|---|---|
| -- | -- | -------------------------- |
| | Kesia Alexander for Sean Cuppex
(Division Sign-Off) |
| -- | ---------------------------------------------------------------------- |
|---|
Division of Clinical Laboratory Devices
| 510(k) Number | K017430 |
|---|---|
| --------------- | ---------------------------------------------------------- |