BD Logic™ and Paradigm Link™ Blood Glucose Monitors are intended to be used for the quantitative measurement of glucose in whole blood. The monitors are intended for use by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. BD monitors are not intended for use in the diagnosis of or screening for diabetes mellitus and are not intended for use on neonates.

BD Logic™ and Paradigm Link ™Blood Glucose Monitors are specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip, palm, and forearm.

Device Description

BD Logic and Paradigm Link Blood Glucose Monitors are intended for use in the quantitative measurement of glucose in capillary blood collected from the fingertip, palm and forearm.

BD Logic and Paradigm Link Blood Glucose Monitors are designed to be simple and easy to use. The monitors provide accurate blood glucose test results in 5 seconds using a small (0.3 uL) sample volume. The lancing device is available with a standard adjustable depth setting lancet cap and an off-finger lancet cap with a set lancing depth.

BD Logic and Paradigm Link Blood Glucose Monitoring Systems work by using 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. BD Logic and Paradigm Link Blood Glucose Monitoring Systems employ 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.

AI/ML Overview

The provided text describes the BD Logic™ and Paradigm Link™ Blood Glucose Monitors and their performance. However, it does not contain specific details about acceptance criteria or a study design that comprehensively demonstrates meeting those criteria. The "Performance Summary" section is a high-level statement rather than a detailed report.

Based on the available text, here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria for accuracy. However, it does highlight key performance aspects:

Acceptance Criteria (Implied / Stated)	Reported Device Performance
Accuracy (General)	"The monitors provide accurate blood glucose test results" (Device Description)
Accuracy (Alternate Site Testing - AST) - Steady State	"Clinical studies... demonstrate that BD Logic and Paradigm Link Blood Glucose Monitoring Systems are suitable for fingertip, palm or forearm testing when performed in accordance with the device labeling." (Performance Summary)
Accuracy (Alternate Site Testing - AST) - Dynamic Glycemic Change	"Clinical studies... demonstrate that during period of rapid glucose change, testing on the palm is equivalent to fingertip testing." (Performance Summary)
Test Time	"5 seconds" (Device Description)
Sample Volume	"small (0.3 uL)" (Device Description)

Study Details (Based on available information):

Based on the provided text, a detailed study design meeting all the requested criteria is not present. The "Performance Summary" section refers to "Clinical studies" generally.

1. Sample sized used for the test set and the data provenance:
* Sample Size: Not specified in the provided text.
* Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The mention of "Clinical studies were conducted" suggests prospective data collection, but this is not definitively stated.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Number of Experts: Not specified.
* Qualifications: Not specified. The studies involved comparison to a reference method, which is the implicit "ground truth," but the nature of the reference method and its operators (experts) are not detailed.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not specified. Adjudication methods are typically relevant for subjective assessments (e.g., interpreting images), not for quantitative measurements like blood glucose, where a reference laboratory method usually serves as the "ground truth."

4. 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 Study: No. This type of study (MRMC, AI assistance) is not applicable to a blood glucose monitor, which is a standalone diagnostic device, not an AI-assisted interpretation tool for human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Yes, this device is inherently a standalone algorithm/device. The performance discussed in the "Performance Summary" refers to the device's accuracy in measuring glucose levels.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The "Performance Summary" states "Clinical studies were conducted to evaluate the use...". For blood glucose monitors, the ground truth is typically established by comparison to a reference laboratory method (e.g., a YSI glucose analyzer) rather than expert consensus, pathology, or outcomes data, but this specific detail is not present in the provided text.

7. The sample size for the training set:
* This information is not provided. For a device like a blood glucose monitor, the term "training set" might not apply in the same way it does for machine learning models (i.e., there isn't typically an "algorithm" being trained on a specific data set to achieve its core function; rather, the device is designed and calibrated).

8. How the ground truth for the training set was established:
* Not applicable/not specified, as a distinct "training set" in the context of machine learning is not mentioned. The device's calibration and accuracy would be verified against established laboratory methods during its development.

Summary

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510(K) SUMMARY

Submitted By: l.

John Schalago Manager, Regulatory Affairs

BD Medical - Diabetes Care 1 Becton Drive Franklin Lakes, NJ 07417-1883

201-847-5663 Phone: 201-848-0457 Fax:

2. Device Name:

Trade Name:	BD LogicTM Blood Glucose MonitorParadigm LinkTM Blood Glucose Monitor
Common Names:	Glucose oxidase, glucose test system
Classification Name:	Glucose oxidase, glucose test system

3. Predicate Devices:

BD Logic™ Blood Glucose Monitor Paradigm LinkTM Blood Glucose Monitor Bayer Glucometer Dex® TheraSense FreeStyle®

4. Device Description:

BD Logic and Paradigm Link Blood Glucose Monitors are intended for use in the quantitative measurement of glucose in capillary blood collected from the fingertip, palm and forearm.

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510(K) SUMMARY (Continued)

Intended Use: 5.

BD Logic and Paradigm Link Blood Glucose Monitors are intended to be used for the quantitative measurement of glucose in whole blood. The monitors are intended for use by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. BD monitors are not intended for use in the diagnosis of or screening for diabetes mellitus and are not intended for use on neonates.

The BD Logic and Paradigm Link Blood Glucose Monitors are specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip, palm or forearm.

Technological Characteristics: 6.

7. Performance Summary:

Clinical studies were conducted to evaluate the use of BD Logic and Paradigm Link Blood Glucose Monitors for alternate anatomical site testing during steady state and periods of dynamic glycemic change. The results demonstrate that BD Logic and Paradigm Link Blood Glucose Monitoring Systems are suitable for fingertip, palm or forearm testing when performed in accordance with the device labeling. In addition, clinical study data demonstrate that during period of rapid glucose change, testing on the palm is equivalent to fingertip testing.

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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. John A. Schalago MSBME, RAC Regulatory Affairs Manager Becton Dickinson BD Medical-Diabetes Care 1 Becton Drive Franklin Lakes, NJ 07417

OCT 2 8 2004

K041478 Re:

Trade/Device Name: BD Logic™ and Paradigm Link™ Blood Glucose Monitoring Systems Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: October 12, 2004 Received: October 13, 2004

Dear Mr. 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 Cosmatic 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter whit anow you to oogin maining of substantial equivalence of your device to a legally premails. The Pice results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, It you desire spoorne mixensing of your device, please contact the Office of of questions on the promotion and Safety at (301) 594-3084. Also, please note the In 7 th o Diagues Dollywooding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may other 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/dsma/dsmamain.html.

Sincerely yours,

Seain M. Cooper, MS, DVM.
Seain M. Cooper MS DVM

Jean M. Cooper, MS, D.V.M. 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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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: BD Logic™ and Paradigm Link™ Blood Glucose Monitoring Systems

Indications For Use:

BD Logic™ and Paradigm Link™ Blood Glucose Monitors are intended to be used for BD Logic - and Faradigm Links glucose in whole blood. The monitors are intended for the qualitiative measuromont of graces an aid to monitor the effectiveness of diabetes use by people with diabetoo molitate as a the diagnosis of or screening for diabetes mellitus and are not intended for use on neonates.

BD Logic™ and Paradigm Link ™Blood Glucose Monitors are specifically indicated for BD Logic and Paradigm Elli. " glucose in whole blood samples obtained from the fingertip, palm, and forearm.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 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)

Alberts Salz
Division Sign-Off

Ivision Sian

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K011478

Page 1 of 1

Regulation Number and Section

§ 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.