(65 days)
The BD Logic™ Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The BD Logic™ Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip.
The BD Logic™ Blood Glucose Monitor is intended for use in the quantitative measurement of glucose in capillary blood collected from fingertips.
The BD Logic™ Blood Glucose Monitor is designed to be simple and easy to use. It provides accurate blood glucose test results in 5 seconds using a small (0.3 µL) sample volume. The system also offers the convenience of containing all of the daily needs for diabetes care in one place as the System includes the blood glucose meter and conveniently holds the test strip vial, lancing device, spare lancets, insulin pen and additional insulin pen needles.
The BD Logic™ Blood Glucose Monitor is based on biosensor technology. When blood is applied to the Blood Glucose Test Strip, reagents on the test strip react with the blood and a current is generated. The BD Logic™ Blood Glucose Monitor employs amperometric technology to measure the glucose concentrations in the blood sample by measuring the amount of current that is generated and flows through the electrodes on the test strip.
Here's an analysis of the provided text regarding the BD Logic™ Blood Glucose Monitor, focusing on acceptance criteria and the study particulars:
The provided document is a 510(k) summary for the BD Logic™ Blood Glucose Monitor. As such, it establishes "substantial equivalence" to a predicate device rather than detailing specific, pre-defined acceptance criteria and their direct fulfillment through a dedicated study. The document states that "Laboratory and clinical studies demonstrate that the BD Logic™ Blood Glucose Monitor performed in an equivalent manner to the predicate and is suitable for its intended use" (See Section 7). However, it does not explicitly list numerical acceptance criteria or the full details of the studies conducted to prove these criteria.
Based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with specific numerical targets. It relies on the concept of "substantial equivalence" to a predicate device (Glucometer DEX Test Sensor). The implicit acceptance criterion is that the new device performs "in an equivalent manner" to the predicate.
| Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance |
|---|---|
| Quantitative measurement of glucose in capillary blood from fingertips | "Provides accurate blood glucose test results in 5 seconds using a small (0.3 µL) sample volume." |
| Performance equivalent to the Glucometer DEX Test Sensor | "Laboratory and clinical studies demonstrate that the BD Logic™ Blood Glucose Monitor performed in an equivalent manner to the predicate." |
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 mentions "Laboratory and clinical studies" but does not specify:
- The sample size used for the test set.
- The country of origin of the data.
- Whether the data were 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)
This information is not provided in the document. For blood glucose monitors, ground truth is typically established using a laboratory reference method, not by human experts interpreting results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods like '2+1' or '3+1' are typically used when human interpretation of data (e.g., medical images) is involved to establish ground truth, which is not the case for a blood glucose monitor's performance evaluation against a reference method.
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
An MRMC study is relevant for devices involving human interpretation of complex medical data (e.g., AI in radiology). This device is a blood glucose monitor, and thus an MRMC study is not applicable and was not conducted for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone system for measuring glucose. Its "performance" refers to the accuracy of its direct measurements. The 510(k) summary implies that the evaluation focused on the device's ability to accurately measure glucose, which can be considered its standalone performance. The document states it "performed in an equivalent manner to the predicate," which indicates a standalone performance comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For blood glucose monitors, the ground truth is typically established by laboratory reference methods (e.g., using a YSI glucose analyzer), which are considered highly accurate. While not explicitly stated, this is the standard practice for evaluating such devices. The document implies comparison to a "predicate" device, which would also have been validated against such reference methods.
8. The sample size for the training set
The document does not mention a "training set" in the context of device development or performance evaluation. Blood glucose monitors are typically characterized for their analytical performance directly through clinical and laboratory studies, not through machine learning training sets in the same way an AI algorithm would be.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of machine learning, this question is not applicable based on the provided document. The device operates based on biosensor technology and amperometric measurements, not a machine learning model that requires a labeled training set.
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1022581
510K Summary of Safety and Effectiveness
1. Submitted By:
OCT 0 9 2002
John Schalago Manager, Regulatory Affairs
Becton Dickinson Consumer Healthcare 1 Becton Drive Franklin Lakes, NJ 07417-1883
201-847-5663 Phone: Fax: 201-848-0457
2. Device Name:
| Trade Name: | BD LogicTM Blood Glucose Monitor |
|---|---|
| Common Names: | Glucose oxidase, glucose test system |
| Classification Name: | Glucose oxidase, glucose test system |
3. Predicate Device:
Glucometer DEX Test Sensor
Manufactured by: Bayer Diagnostics
4. Device Description:
The BD Logic™ Blood Glucose Monitor is intended for use in the quantitative measurement of glucose in capillary blood collected from fingertips.
The BD Logic™ Blood Glucose Monitor is designed to be simple and easy to use. It provides accurate blood glucose test results in 5 seconds using a small (0.3 µL) sample volume. The system also offers the convenience of containing all of the daily needs for diabetes care in one place as the System includes the blood glucose meter and conveniently holds the test strip vial, lancing device, spare lancets, insulin pen and additional insulin pen needles.
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Intended Use: 5.
The BD Logic™ Blood Glucose Monitor is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The BD Logic™ Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip.
6. Technological Characteristics:
The BD Logic™ Blood Glucose Monitor is based on biosensor technology. When blood is applied to the Blood Glucose Test Strip, reagents on the test strip react with the blood and a current is generated. The BD Logic™ Blood Glucose Monitor employs amperometric technology to measure the glucose concentrations in the blood sample by measuring the amount of current that is generated and flows through the electrodes on the test strip.
7. Performance Summary:
Laboratory and clinical studies demonstrate that the BD Logic™ Blood Glucose Monitor performed in an equivalent manner to the predicate and is suitable for its intended use.
The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E, under which a device can be marketed without pre-approval or classification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US patent Laws or their application by the courts.
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Image /page/2/Picture/0 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center consists of three stylized lines that resemble a person or abstract form.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
ood and Drug Administration 098 Gaither Road Rockville MD 20850
Mr. John A. Schalago MS, RAC Regulatory Affairs Manager Becton, Dickinson and Company l Becton Drive Franklin Lakes, NJ 07417
OCT 9 - 2002
Re: K022581
Trade/Device Name: BD Logic™ Blood Glucose Monitor Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW; JJX, CGA Dated: August 2, 2002 Received: August 5, 2002
Dear Ms. Schalago:
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 Butman
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
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Page 1 of 1
510(k) Number (if known
Device Name: BD Logic™ Blood Glucose Monitor
Indications For Use:
The BD Logic™ Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The BD Logic™ Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022581
Over-the-counter
000021
§ 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.