(63 days)
The Precision/Optium Point of Care Blood Glucose Test Strip with True Measure Technology is intended for in vitro diagnostic use. The test strip quantitatively measures glucose (D-glucose) in fresh neonatal, venous, arterial and fingertip capillary whole blood. The test strip is indicated for use by health care professionals in health care facilities. The test strip is to be used for monitoring diabetes mellitus. This strip may be used with the Precision Xtra and Optium meters.
The Precision/Optium Point of Care Blood Glucose Test Strips with True Measure Technology is to be used for blood glucose testing with the Precision Xtra/Optium and Precision PCx Blood Glucose Meters. These systems utilize amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measure of glucose in fresh whole blood and control solutions.
The provided text describes information about a 510(k) submission for a blood glucose test strip device, but it lacks specific details regarding acceptance criteria, direct performance metrics, or detailed study methodologies that would allow for a comprehensive answer to all the requested points.
However, based on the available information, I can provide the following:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state quantitative acceptance criteria or a detailed performance table. It broadly states that the studies "demonstrated that healthcare professionals could obtain blood glucose results that are substantially equivalent to a comparative method" and that the performance is "acceptable and comparable to the performance to a comparative method." To create a specific table, detailed performance data (e.g., bias, precision, correlation to a reference method) and their corresponding acceptance limits would be required. This information is typically found in the full 510(k) summary or appended study reports, which are not included in the provided snippets.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states "The performances of the Precision/Optium Point of Care Blood Glucose Test Strip with True Measure Technology was studied in the laboratory and in clinical settings by healthcare professionals." There is no specific sample size mentioned for the test set, nor is there information about the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
For a blood glucose test strip, the "ground truth" is typically established by measurements from a highly accurate laboratory reference method (e.g., YSI analyzer, hexokinase method), not by expert consensus in the same way it would be for an imaging diagnostic. Therefore, the concept of "experts used to establish ground truth" with specific qualifications (like radiologists) does not directly apply here. The "experts" involved would be the clinical laboratory personnel performing the reference method and the healthcare professionals using the device in the clinical study. No specific number or qualifications of these individuals are provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are primarily relevant for subjective assessments (e.g., image interpretation where multiple readers might disagree). For objective measurements like blood glucose, adjudication as described is generally not applicable. Instead, comparisons are made directly to a reference method. No adjudication method is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
MRMC studies and the concept of AI assistance improving human reader performance are relevant for diagnostic devices that involve human interpretation, particularly in imaging. This is not applicable to a blood glucose test strip, which provides a direct quantitative measurement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A blood glucose test strip is inherently a "standalone" device in that it produces a result directly from a biochemical reaction on the strip, interpreted by a meter. The performance described would be the "algorithm only" or device-only performance compared to a reference standard. The document confirms studies were done to demonstrate performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device would be established by a highly accurate laboratory reference method for glucose measurement (e.g., hexokinase method, YSI analyzer). The document mentions comparison to a "comparative method," which strongly implies such a laboratory reference standard.
8. The sample size for the training set
The document does not provide any information about a specific training set or its sample size. This type of information is typically more relevant for devices employing machine learning or AI algorithms with distinct training and test phases. For a biosensor test strip, the "training" (calibration and algorithm development) would be an integral part of its original design and development, rather than a separate, explicitly defined "training set" in the context of clinical validation data.
9. How the ground truth for the training set was established
As with point 8, the document does not distinguish a "training set" in this context. The "ground truth" for the development and calibration of the device's measurement algorithm would have been established using laboratory reference methods to correlate the electrochemical signal from the strip to actual glucose concentrations across a wide range.
{0}------------------------------------------------
Modified Precision Xtra/MediSense Optium Blood Glucose Test Strip Neonatal, venous and arterial claims Volume I of I 510(k) Notification 13-June-2002
Summary of Safety and Effectiveness
Submitted by: Janet Connolly, RAC Senior Regulatory Affairs Specialist Abbott Laboratories, MediSense Products 4A Crosby Drive Bedford, MA 01730-6230
Device Name: Precision/Optium Point of Care Blood Glucose Test Strips with True Measure Technology
Common Name: Reagent Blood Glucose Test Strip
Classification: Glucose Test System Class II per 21 CFR 862.1345
Predicate Device: Accu-Chek Comfort Curve Test Strip K980731
Description: The Precision/Optium Point of Care Blood Glucose Test Strips with True Measure Technology is to be used for blood glucose testing with the Precision Xtra/Optium and Precision PCx Blood Glucose Meters. These systems utilize amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measure of glucose in fresh whole blood and control solutions.
Intended Use: The Precision/Optium Point of Care Blood Glucose Test Strip with True Measure Technology is intended for in vitro diagnostic use. The test strip quantitatively measures glucose (D-glucose) in fresh venous. arterial, neonatal, and fingertip capillary whole blood. The test strip is indicated for use by health care professionals in health care settings,
This strip may be used with the Precision Xtra/Optium Blood Glucose Meters.
Comparison to The Precision/Optium Point of Care Blood Glucose Test Strip has Predicate Device: similar technological characteristics as the predicate device, Accu-Chek Comfort Curve Test Strip K980731.
{1}------------------------------------------------
| PerformanceStudies: | The performances of the Precision/Optium Point of Care BloodGlucose Test Strip with True Measure Technology was studied in thelaboratory and in clinical settings by healthcare professionals. Thestudies demonstrated that healthcare professionals could obtain bloodglucose results that are substantially equivalent to a comparativemethod. |
|---|---|
| Conclusion: | Results of laboratory and clinical testing demonstrate that theperformance of the Precision/Optium Point of Care Blood GlucoseTest Strips when used according to the intended use stated above isacceptable and comparable to the performance to a comparativemethod. |
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three wing-like shapes. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
AUG 1 6 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Janet Connolly, RAC Sr. Regulatory Affairs Specialist Abbott Laboratories, MediSense Products 4A Crosby Drive Bedford, MA 01730-1402
Re: K021960
Trade/Device Name: Abbott Laboratories, MediSense Products Precision Point of Care Blood Glucose Test Strips with True Measure Technology Abbott Laboratories, MediSense Products Optium Point of Care Blood Glucose Test Strips with True Measure Technology Regulation Number: 21 CFR 862.1345
Regulation Name: Glucose test system Regulatory Class: Class II Product Code: LFR Dated: June 13, 2002 Received: June 14, 2002
Dear Ms. Connolly:
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.
{3}------------------------------------------------
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/cdrl/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
{4}------------------------------------------------
INDICATIONS FOR USE FORM 510(k) Number (if known):
Abbott Laboratories, MediSense Products Precision Point of Care Device Name: Blood Glucose Test Strips with True Measure Technology.
Abbott Laboratories, MediSense Products Optium Point of Care Blood Glucose Test Strips with True Measure Technology
Indications For Use:
The Precision/Optium Point of Care Blood Glucose Test Strip with True Measure Technology is intended for in vitro diagnostic use. The test strip quantitatively measures glucose (D-glucose) in fresh neonatal, venous, arterial and fingertip capillary whole blood. The test strip is indicated for use by health care professionals in health care facilities. The test strip is to be used for monitoring diabetes mellitus.
This strip may be used with the Precision Xtra and Optium meters.
Nherts Znting for Jean Cooper
Division Sign Off
vision 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)
Or
Prescription Use (Per 21 CFR 801.108)
Over-The-Counter Use
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.