(129 days)
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No
The document describes a control solution for a glucose meter, which is a chemical reagent used for quality control. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
The device is a control solution for verifying the performance of a glucose meter, not for treating a condition.
No
Explanation: This device is a control solution used to verify the performance and correct operation of a glucose meter, not to diagnose a medical condition.
No
The device description clearly states it is a "buffered aqueous solution with glucose," indicating it is a liquid chemical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "use to verify the performance and correct operation of the NIPRO TRUEresult Glucose Test Systems." This indicates it's used in vitro (outside the body) to assess the functionality of a diagnostic device.
- Device Description: It's described as a "buffered aqueous solution with glucose." This is a chemical reagent designed to interact with the glucose meter to produce a measurable result.
- Function: Control solutions are a standard component of IVD systems, used to ensure the accuracy and reliability of the diagnostic test.
Therefore, based on its intended use and description, the Glucose Meter-Check Control Solution for NIPRO TRUEresult fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Glucose Meter-Check Control Solution for NIPRO TRUEresult is intended for use to verify the performance and correct operation of the NIPRO TRUEresult Glucose Test Systems. Glucose Meter-Check Control Solution for NIPRO TRUEresult is intended for use by healthcare professionals and people with diabetes mellitus at home.
For In Vitro Diagnostic Use
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
Glucose Meter-Check Control Solution for NIPRO TRUEresult is a buffered aqueous solution with glucose containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. The Glucose Meter-Check Control Solution is formulated for optimal performance on NIPRO TRUEresult glucose meters. The product is provided in 2 levels, 1 representing hypoglycemia (low blood glucose) and 2, representing typical fasting blood glucose levels in non-diabetic persons.
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 people with diabetes mellitus at home.
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) Closed bottle stability (Shelf-life)
- b) Stability after opening (Use-life)
- c) Transport Stability
- d) Test response
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).
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§ 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
Quality Solutions
DEC 2 3 2011
510(k) Summary1
- (a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road Devens, MA 01434
Contact Person Randy Byrd VP, Chief Technical Officer (978) 772-7070 x 272
Date of preparation of this summary: 12 August 2011
- (2) Device trade or proprietary name: Glucose Meter-Check Control for NIPRO TRUEresult
Device common or usual name or classification name:
Single (Specified) Analyte Control, All Types, Assayed and Unassayed אר
| REGULATION MEDICAL
SPECIALTY | REGULATION
NUMBER | CLASS | REGULATION DESCRIPTION |
|---------------------------------|----------------------|-------|------------------------|
| Chemistry | 862.1660 | H | Glucose Control |
l. Substantial Equivalence
:
Glucose Meter-Check Control Solution for NIPRO TRUEresult substantially equivalent in function, safety and efficacy to currently marketed devices for the same intended use as shown in the following tables:
| Characteristic | Predicate Device | Modified Device |
|---|---|---|
| Name: | TRUEtest Control Solution | |
| (for use with TRUEresult BGM) | Glucose Meter-Check Control | |
| Solution for NIPRO TRUEresult | ||
| 510(k), Date: | K080641, Aug 19, 2008 | |
| Number of levels: | 2, representing hypoglycemic, | |
| and typical fasting glucose levels | 2, representing hypoglycemic, | |
| and typical fasting glucose levels | ||
| Analytes: | glucose | glucose |
| Container: | 6 mL LDPE vial with dispensing tip | |
| and cap | 6 mL LDPE vial with dispensing tip | |
| and cap | ||
| Fill volume: | 4 mL | 4 mL |
| Color: | 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. | ||
| Brands: | TRUEtest | Glucose Meter-Check |
.
:
1
II. Description of the new device
Glucose Meter-Check Control Solution for NIPRO TRUEresult is a buffered aqueous solution with glucose containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. The Glucose Meter-Check Control Solution is formulated for optimal performance on NIPRO TRUEresult glucose meters. The product is provided in 2 levels, 1 representing hypoglycemia (low blood glucose) and 2, representing typical fasting blood glucose levels in non-diabetic persons.
(a) (1) Intended use of the device
Glucose Meter-Check Control Solution for NIPRO TRUEresult is intended for use to verify the performance and correct operation of the NIPRO TRUEresult Glucose Test Systems. Glucose Meter-Check Control Solution for NIPRO TRUEresult is intended for use by healthcare professionals and people with diabetes mellitus at home.
Technological characteristics of the device. (a) (2)
This material consists of viscosity-adjusted, aqueous glucose control solution prepared with a concentration of D-glucose to provide recovery on the test systems in the ranges typically considered hypoglycemic, and normal, fasting glucose for a non-diabetic person. This solution has been optimized to simulate the response of whole blood on the blood glucose test systems manufactured by NIPRO. The solution contains no hazardous, human or animal derived components.
Summary of non-clinical tests submitted with the premarket notification for the device. (b) (1) Tests were conducted to verify specific performance requirements:
- a) Closed bottle stability (Shelf-life)
- b) Stability after opening (Use-life)
- c) Transport Stability
- d) Test response
(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.
.
2
10903 New Hampshire Avenue Silver Spring, MD 20993
Bionostics, Inc. Randy Byrd, Chief Technical Officer 7 Jackson Road Devens, MA 01434
DEC 2 3 2011
Re: K112352
RT12552
Trade/Device Name: Glucose Meter-Check Control Solutions level 1&2 for NIPRO TRUEresult Glucose Monitoring System Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed)
Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: November 7, 2011 Received: December 8, 2011
Dear Mr. Byrd:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 IQ(x) premantel is substantially equivalent (for the indications
referenced above and have determined the device anarketed in interstate referenced above and have delemined the devices devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices mendments, for use stated in the enclosure, to tegally manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food, Drug, commerce prior to May 28, 1976, the elacinent with the provisions of the Federal Food, Drug, devices that have been reclassined in accoldance with the provision of PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that a not require approval or a provisions of the Act. The Act. The Act. The Act. The Act. The You may, therefore, market the uevice, subject of the gentration and registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act merade requirements
devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (see above) mo class f (opena oevice can be found in Title 21,
additional controls. Existing major regulations affecting your device can be foun additional controls. Existing major l'Egulations areether Jour Co.
Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further
Code of Federal Code of Federal Regarations (Colley), and Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's sissuance of a subscannity with other requirements of the Act
that FDA has made a determination that your device with other requirements. You mu that FDA has made a determination inal your divises by other Federal agencies. You must
or any Federal statutes and regulations administered by registration and listin or any Federal statutes and regulations and limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to: reporting of comply with all the Act s requiremes, menusal device reporting (reporting (reporting of
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting practice CFR Part 807); labeling (21 CFR 1 alls 603); and good manufacturing practice
medical device-related adverse events) (21 CFR 803); and good manufacturing (21 CFR Part 800). T medical device-related adverse evelis) (21 CPN 005), and gion (21 CFR Part R20). This letter
requirements as set forth in the quality systems (QS) cegulation (21 CFR Part Re requirements as set forth in the quality systems (corrested in your Section 510(k) premarket
will allow you to begin marketing your device of your Section 510(k) marketed will allow you to begin marketing your device of your device to a legally marketed
notification. The FDA finding of substantial quivalence of your device to notification. The FDA finding of substanial equivalise or your device and thus, permits your device to
redicate device results in a classification for your device and thus, p proceed to the market.
3
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Virro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric' s (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 (701) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
jz
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: Device Name: K112352
Glucose Meter-Check® Control Solution for NIPRO TRUEresult®
Indications for Use:
Glucose Meter-Check Control Solution for NIPRO TRUEresult is intended for use to verify the performance and correct operation of the NIPRO TRUEresult Glucose Test Systems. Glucose Meter-Check Control Solution for NIPRO TRUEresult is intended for use by healthcare professionals and people with diabetes mellitus at home.
For In Vitro Diagnostic Use
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrent of CDRH, Office of Device Evaluation (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 1