(39 days)
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No
The device description and performance studies focus on the chemical composition and analytical performance of a glucose control solution, with no mention of AI or ML technologies.
No
The device is a control solution for assessing the performance of blood glucose meters and test strips, not for treating any medical condition.
No
The device is a control solution intended to assess the performance of blood glucose meters and test strips, not to diagnose a medical condition itself.
No
The device description clearly states the product is comprised of buffered aqueous 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: "Glucose Meter-Check Solution for TaiDoc is intended for in vitro diagnostic use..." and "For In Vitro Diagnostic Use".
- Purpose: The device is used to assess the performance of blood glucose meters and test strips, which are themselves IVD devices used to measure glucose levels in a biological sample (blood) outside of the body.
- Nature of the Device: The device is a control solution, which is a common type of IVD used to verify the accuracy and performance of other IVD devices.
The description and performance studies further support its classification as an IVD, as they detail its composition, intended use with other IVD components (glucose meters and test strips), and analytical performance characteristics relevant to diagnostic testing.
N/A
Intended Use / Indications for Use
Glucose Meter-Check Solution for TaiDoc is intended for in vitro diagnostic use (i.e., for external use only) to assess the performance of blood glucose meters and test strips manufactured by TaiDoc Technology Corporation by healthcare professionals and in the home by people with diabetes mellitus. For In Vitro Diagnostic Use
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The control solutions are comprised of buffered aqueous liquid glucose control solution with viscosity modifiers to simulate certain properties of blood on the test strip and colored red to help users see the solution while dispensing onto a test strip. The control solutions are formulated to have performance comparable to those currently manufactured by TaiDoc Technology Corporation. The product is packaged in plastic bottles with dropper tips for dispensing the control solutions for use with test strips.
This is a non-hazardous aqueous glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation.
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 the relevant blood glucose test systems. The solution contains no hazardous, human or animal derived components. The analyte, d-glucose, is the same as detected by the blood glucose monitoring systems for which this control is intended.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare professionals and in the home by people with diabetes mellitus.
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)
Analytical performance
Traceability
Glucose concentration is confirmed utilizing YSI-supplied calibrators traceable to NIST SRM 917.
Stability
Closed bottle stability
Stability characteristics were determined under un-opened conditions in real time stability studies on three lots of equivalent product to demonstrate an unopened shelf-life of 2 years (24 months) at the recommended storage temperatures, ranging from 15°C to 30°C (59°F to 86°F) as measured by YSI 2300 calibrated with N.I.S.T. 917 traceable materials.
Stability after opening
Glucose Meter-Check Solution for TaiDoc meets stability requirements as demonstrated by less than 5% change in percent glucose recovery on YSI on vials from a single lot evaluated over 3 months (93 days in real time) stored at ambient temperature ranging from 21 to 23 °C (70 to 75 °F) in comparison to vials of the same product stored at 2-8 °C.
Value assignment
Value assignment for each lot of product is determined as the mean of measurement on each lot and level of control solution determined from measurement of 8 samples on each of 5 meters with three lots of commercially distributed test strips for a total of 120 measurements. Value assignment range is determined as the mean of all measurements ±15 mg/dl (glucose
§ 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.
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Quality Solutions
·
510(k) Summary1
K 131136
MAY 3 1 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: 30 May 2013
- (2) Device trade or proprietary name: Glucose Meter-Check® Solution for TaiDoc
Device common or usual name or classification name:
75 JJX, single (specified) analyte controls (assayed and unassayed)
| CLASSIFICATION | |||
|---|---|---|---|
| PRODUCT NOMENCLATURE | NUMBER | CLASS | PRODUCT CODCE |
| Quality Control Material | 862.1660 | I, reserved | JJX |
(3) Substantial Equivalence
This quality control material is substantially equivalent in function, safety and efficacy to currently marketed devices for the same intended use:
| | Fora, TaiDoc Control Solutions (GOD &
GDH) | Glucose Meter-Check for TaiDoc (GOD
& GDH) |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k), date | K093724 07.29.2010 | same |
| Net Fill | 4 mL | same |
| Intended Use | The FORA Glucose Control Solution and
Taidoc Glucose Control Solution are
intended for in vitro diagnostic use (i.e.
for external use only) to assess the
performance of the blood glucose test
meters and test strips manufactured by
Taidoc Technology Corporation by
healthcare professionals and in the
home by people with diabetes
mellitus. | Glucose Meter-Check Solution for
TaiDoc is intended for in vitro
diagnostic use (i.e., for external use
only) to assess the performance of
blood glucose meters and test strips
manufactured by TaiDoc Technology
Corporation by healthcare
professionals and in the home by
people with diabetes mellitus |
| Color | red | same |
| Analyte | d-glucose | same |
| Container | 6 mL LDPE vial with dispensing tip and
cap | same |
| Matrix | buffered, aqueous solution with salts,
viscosity modifier, preservatives and
other non-reactive ingredients | same |
1 This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1
| Fora, TaiDoc Control Solutions (GOD & GDH) | Glucose Meter-Check for TaiDoc (GOD & GDH) | |||
|---|---|---|---|---|
| Auto QC detection | No | same | ||
| Levels | 3 | 3 | ||
| Enzyme Type | GOD | GDH | GOD | GDH |
| Target Ranges | ||||
| Low: 60-80 | 35-65 | 1: 60-80 | 35-65 | |
| Normal: 100-150 | 112-168 | 2: 100-150 | 112-168 | |
| High: 250-350 | 224-336 | 3: 250-350 | 224-336 |
Table 5.1: Summary of Equivalent Characteristics
(4) Description of the new device
The control solutions are comprised of buffered aqueous liquid glucose control solution with viscosity modifiers to simulate certain properties of blood on the test strip and colored red to help users see the solution while dispensing onto a test strip. The control solutions are formulated to have performance comparable to those currently manufactured by TaiDoc Technology Corporation. The product is packaged in plastic bottles with dropper tips for dispensing the control solutions for use with test strips.
This is a non-hazardous aqueous 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
(5) Intended use of the device
Glucose Meter-Check Solution for TaiDoc is intended for in vitro diagnostic use (i.e., for external use only) to assess the performance and correct operation of blood glucose meters and test strips manufactured by TaiDoc Technology Corporation by healthcare professionals and in the home by people with diabetes mellitus.
2
(6) 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 the relevant blood glucose test systems. The solution contains no hazardous, human or animal derived components. The analyte, d-glucose, is the same as detected by the blood glucose monitoring systems for which this control is intended.
Test Principle
The BGMS with which this control solution is utilized all measure glucose concentration electrochemically in whole blood through enzymatic reactions utilizing glucose oxidase or glucose dehydrogenase enzymes.
(b) (1) Summary of non-clinical tests submitted with the premarket notification for the device.
Analytical performance
- a) Traceability, stability, expected values (controls, calibrators, or methods)
Traceability
Glucose concentration is confirmed utilizing YSI-supplied calibrators traceable to NIST SRM 917.
Stability
Closed bottle stability
Stability characteristics were determined under un-opened conditions in real time stability studies on three lots of equivalent product to demonstrate an unopened shelf-life of 2 years (24 months) at the recommended storage temperatures, ranging from 15°C to 30°C (59°F to 86°F) as measured by YSI 2300 calibrated with N.I.S.T. 917 traceable materials.
Stability after opening
Glucose Meter-Check Solution for TaiDoc meets stability requirements as demonstrated by less than 5% change in percent glucose recovery on YSI on vials from a single lot evaluated over 3 months (93 days in real time) stored at ambient temperature ranging from 21 to 23 °C (70 to 75 °F) in comparison to vials of the same product stored at 2-8 °C.
Value assignment
Value assignment for each lot of product is determined as the mean of measurement on each lot and level of control solution determined from measurement of 8 samples on each of 5 meters with three lots of commercially distributed test strips for a total of 120 measurements. Value assignment range is determined as the mean of all measurements ±15 mg/dl (glucose