(80 days)
For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the TRUEresult ™ and TRUE2go™ Meters and TRUEtest™ Test Strips.
The AbT Glucose Control Solutions consist of a viscosity-adjusted, aqueous liquid control solution containing known quantities of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is non-hazardous and contains no human or animal derived materials.
This document, K091460, is a 510(k) Premarket Notification for the AbT Glucose Control Solutions. It aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format for each performance characteristic. Instead, it implies acceptance by the successful completion of the studies and the comparison to the predicate device's characteristics. The performance study details are limited to the types of studies performed without specific quantitative results.
However, based on the Comparison to Predicate Devices section, we can infer some target ranges for glucose levels, which could be considered an implicit acceptance criteria tied to the predicate's performance.
| Characteristic | Acceptance Criteria (Inferred from Predicate Target Range) | Reported Device Performance (AbT Glucose Control Solutions) | Study Performed |
|---|---|---|---|
| Glucose Level 1 | 31 - 62 mg/dL (Predicate) | 28 - 62 mg/dL | Test precision |
| Glucose Level 2 | 90 - 125 mg/dL (Predicate) | 81 - 121 mg/dL | Test precision |
| Glucose Level 3 | 240 - 354 mg/dL (Predicate) | 215 - 315 mg/dL | Test precision |
| Accelerated Stability | Not explicitly stated, implied to meet predicate performance | Performance verified | Accelerated Stability |
| Open Vial Stability | Not explicitly stated, implied to meet predicate performance | Performance verified | Open Vial (Stability) |
Important Note: The document states for the predicate's Target Range "(1) Estimated from the manufacturer's published control ranges." This means the predicate's ranges are not direct measurements from this submission but publicly available information used for comparison. The new product also provides specific target ranges, which are the intended performance of the device.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide any specific sample sizes for the performance studies (Accelerated Stability, Open Vial, Test Precision).
Regarding data provenance, the document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions that "Tests were performed to verify specific performance characteristics."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The type of device (glucose control solutions, which are laboratory reagents) typically involves analytical testing rather than interpretation by human experts to establish ground truth for performance.
4. Adjudication Method for the Test Set:
This information is not provided and is generally not applicable for this type of device where objective analytical measurements are performed rather than subjective assessments.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or algorithms that require human interpretation, not for glucose control solutions which are used to verify the performance of a measuring instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable as the device is a chemical control solution, not an algorithm or a device with an AI component. The "performance" being evaluated is the stability and precision of the chemical solution itself, and its ability to elicit expected readings on the specified meters.
7. The Type of Ground Truth Used:
For the AbT Glucose Control Solutions, the ground truth is established by analytical measurement of the glucose concentration in manufactured lots of the control solutions. The "known quantities of glucose" in the solution form the basis of the ground truth. This is implied by the product description "containing known quantities of glucose." The stability and precision studies then assess how well the device maintains these known quantities over time and delivers consistent results when tested.
8. The Sample Size for the Training Set:
This information is not applicable as the AbT Glucose Control Solutions are not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this device.
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510(k) Premarket Notification: AbT Glucose Control Solutions American Biological Technologies, Inc.
AUG O 6 2009
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510(k) Summary 5
| Introduction: | According to the requirements of 21 CFR 807.92, thefollowing information provides sufficient detail tounderstand the basis for a determination ofsubstantial equivalence. | |
|---|---|---|
| Submitter: | American Biological Technologies, Inc.940 Crossroads BlvdSeguin, TX 78155(830) 372-1391 ex. 210Establishment Registration Number: 1643621 | |
| Contact Person: | John C. Gormley | |
| Device Name: | AbT Glucose Control Solutions Levels 1, 2. and 3 | |
| Common Name: | Single Analyte Control Solution, All Types (Assayedand Unassayed) | |
| Classification Name: | Quality Control Material (assayed and unassayed). | |
| Classification: | Class I per 21 CFR 862.1660 | |
| Product Code: | 75 JJX | |
| Panel: | Chemistry | |
| Predicate Devices: | Name:Manufacturer:510(k) No.: | TRUEtest Glucose Control Levels1, 2, and 3Home Diagnostics, Inc.K080641 |
| Device Description: | The AbT Glucose Control Solutions consist of aviscosity-adjusted, aqueous liquid control solutioncontaining known quantities of glucose. The productis packaged in plastic dropper tipped bottles for easyapplication of the control solutions to the test stripsand a red coloration to aid the user to visually confirmapplication of the control. The product is non-hazardous and contains no human or animal derivedmaterials. | |
| Intended Use: | The AbT Glucose Control Solutions are intended forin vitro diagnostic use (i.e. for external use only) by |
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510(k) Premarket Notification: AbT Glucose Control Solutions American Biological Technologies, Inc.
healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the TRUEresult™ and TRUE2go™ Meters and TRUEtest™ Test Strips.
Comparison to Predicate Devices:
| Characteristic/Aspect | Predicate Device No. 1 | New Product |
|---|---|---|
| Name | TRUEtest Glucose Control | AbT Glucose Control Solutions |
| 510(k), Date | K08064108/19/2008 | |
| Number of Levels | 3 | 3 |
| Analyte | Glucose | Glucose |
| Target Range(mg/dL) | 31 - 62(1) | 28 - 62 |
| 90 - 125(1) | 81 - 121 | |
| 240 - 354(1) | 215 - 315 | |
| Container | Plastic bottle with dropper-tip | Plastic bottle with dropper-tip |
| Fill Volume | 3.0 mL | 3.6 mL |
| Color | Red | Red |
| Matrix | Water, D-glucose, buffers,viscosity enhancing agents, salts,dyes and preservatives. | Buffered aqueous solution of D-Glucose, a viscosity modifier,preservatives, and other non-reactive ingredients |
| Indications for Use | To check the performance of theTRUEresult™ and TRUE2go™Meters and TRUEtest™ TestStrips. | To check the performance of theTRUEresult™ and TRUE2go™Meters and TRUEtest™ TestStrips. |
| Target Population | Professional and home use | Professional and home use |
(1) Estimated from the manufacturer's published control ranges.
Tests were performed to verify specific performance Performance Studies: characteristics:
-
- Accelerated Stability
-
- Open Vial
-
- Test precision
Conclusion:
Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple, using a black and white color scheme.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
American Biological Technologies, Inc. c/o Mr. John Gormley Director of Quality & Regulatory Affairs 940 Crossroads Blvd., Seguin, TX 78155
AUG 0 62009
K091460 Re:
Trade Name: AbT Glucose Control Solution Levels 1,2, 3 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Codes: JJX Dated: May 13, 2009 Received: May 18, 2009
Dear Mr. Gormley:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro 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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours,
G.C.H.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Premarket Notification: AbT Glucose Control Solutions American Biological Technologies, Inc.
4 Indications for Use Statement
510(k) Number (if known):
Device Name: AbT Glucose Control Solution
Indications for Use:
For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the TRUEresult ™ and TRUE2go™ Meters and TRUEtest™ Test Strips.
Prescription Use × (21 CFR Part 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091460
§ 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.