(57 days)
No
The device is a liquid control material used to verify the performance of blood glucose meters. It does not process data or make decisions, which are typical functions of AI/ML in medical devices. The description focuses on the chemical composition and intended use for quality control.
No.
The device is a control for verifying the performance of blood glucose meters, not for diagnosing, treating, or preventing disease in patients.
No
This device is a control material used to verify the performance, linearity, and calibration of blood glucose meters. It does not diagnose medical conditions; rather, it ensures the accuracy of other diagnostic devices.
No
The device is a liquid control material packaged in vials with dropper tips, clearly indicating it is a physical product and 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".
- Intended Use: The device is intended to "verify the performance of multiple blood glucose meters" and "assess the linearity and calibration of the test system, or to verify the test systems' performance." This is a classic function of an in vitro diagnostic control material.
- Device Description: The description details a "glucose control linearity set" used for "performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program." This further reinforces its role in the quality control of in vitro diagnostic tests (blood glucose testing).
- Predicate Devices: The listed predicate devices (K012430, Multi-Meter Glucose Calibration Verification Material; K002540, RNA Medical Glucose Calibration Verification Control) are also IVD control materials, indicating the regulatory classification of this type of product.
N/A
Intended Use / Indications for Use
RNA GL4 Glucose Calibration Verification Control is intended for use to verify the analytical performance of certain blood glucose meters as listed on the package insert.
RNA GL4 Glucose Calibration Verification Control 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
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
RNA GL4 Glucose Calibration Verification Control is a seven-vial, viscosityadjusted, aqueous liquid glucose control linearity set which provides two, five-level CVC sets, optimized for use with MediSense Point of Care blood glucose systems PCx and i-STAT 1 using Precision PCx or Precision PCx Plus test strips. RNA GL4 Glucose Calibration Verification Control 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.
RNA GL4 Glucose Calibration Verification Control 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 of the blood glucose systems listed on the package insert.
RNA GL4 Glucose Calibration Verification Control 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
Not Found
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) Accelerated aging studies on most labile analytes, together with real time experience with products with similar formulations and failure mode to support stability claim.
b) Test precision
c) Correlation to reference methodology
Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
1621624
JUL 12 2002
BIONOS
510(k) Summary*
- (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: 15 May 2002
| (2) Device trade or proprietary name: | RNA GL4 Glucose
Calibration Verification Control |
| --------------------------------------- | ----------------------------------------------------- |
|---|
Device common or usual name or classification name:
Multi Analyte Control Solution, All Types (Assayed and Unassayed)
| PRODUCT NOMENCLATURE | CLASSIFICATION
NUMBER | CLASS | PANEL |
|---------------------------------|--------------------------|-------|-----------|
| SINGLE ANALYTE CONTROL SOLUTION | 862.1660 75 JJX | 1 | CHEMISTRY |
(3) Substantial Equivalence
RNA GL4 Glucose Calibration Verification Control 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 | Modified Device |
|---|---|---|
| Name: | Multi-Meter Glucose | |
| Calibration Verification | ||
| Material | RNA Medical Glucose | |
| Calibration Verification | ||
| Control | ||
| 510(k), Date: | K012430, 08/27/01 | K002540, 09/18/00 |
| Number of levels: | 5* | 5* |
| *7 vials per kit, only 5 levels | ||
| for use on specific devices | ||
| Analytes: | Glucose | Glucose |
| Container: | plastic bottle | plastic bottle |
| 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. |
- 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)
RNA GL4 Glucose Calibration Verification Control is a seven-vial, viscosityadjusted, aqueous liquid glucose control linearity set which provides two, five-level CVC sets, optimized for use with MediSense Point of Care blood glucose systems PCx and i-STAT 1 using Precision PCx or Precision PCx Plus test strips. RNA GL4 Glucose Calibration Verification Control 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.
RNA GL4 Glucose Calibration Verification Control 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 of the blood glucose systems listed on the package insert.
| Strip Type | Solution A | Solution B | Solution C | Solution D | Solution E | Solution F | Solution G |
|---|---|---|---|---|---|---|---|
| PCx Plus | |||||||
| strip lots beginning | |||||||
| with "6" | 40 | ||||||
| Level 1 | -- | 120 | |||||
| Level 2 | 220 | ||||||
| Level 3 | 290 | ||||||
| Level 4 | 370 | ||||||
| Level 5 | -- | ||||||
| PCx | |||||||
| strip lots beginning | |||||||
| with "1" | -- | 40 | |||||
| Level 1 | 103 | ||||||
| Level 2 | -- | 249 | |||||
| Level 3 | 324 | ||||||
| Level 4 | 440 | ||||||
| Level 5 |
Target midpoint values for Precision PCx and Precision PCx Plus test strips
RNA GL4 Glucose Calibration Verification Control is a non-hazardous aqueous solution containing no biological materials.
(5) Intended use of the device
RNA GL4 Glucose Calibration Verification Control is intended for use to verify the analytical performance of certain blood glucose meters as listed on the package insert.
(6) Technological characteristics of the device.
This material consists of viscosity-adjusted, aqueous glucose control solutions prepared in seven specific glucose concentrations. The solutions have been optimized to simulate the response of whole blood for the blood glucose meters in combination with test strips, listed in the package insert.
2
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 real time experience with products with similar formulations and failure mode to support stability claim.
- b) Test precision
- c) Correlation to reference methodology
- Summary of clinical tests submitted with the premarket notification for the (b) (2) device.
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.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half. Inside the circle is a stylized symbol that resembles three wavy lines or a caduceus without the staff.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 2 2002
Ms. Kathleen Storro Director, QA and Regulatory Affairs Bionostics 7 Jackson Road Devens, MA 01432
Re: K021624
Trade/Device Name: RNA GL4 Glucose Calibration Verification Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: May 15, 2002 Received: May 16, 2002
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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/cdrh/dsmaldsmamain.html".
Sincerely yours,
Steven Putman
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
5
KO21624 510(k) Number:
RNA GL4 Glucose Calibration Verification Control Device Name:
Indications for Use:
RNA GLA Glucose Calibration Verification Control 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
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number.
(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)
510(K) PREMARKET NOTIFICATION – GL4 Glucose CVC