BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR

K041478 · Becton Dickinson · CGA · Oct 28, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041478
• Device Name: BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR
• Applicant: Becton Dickinson
• Product Code: CGA · Clinical Chemistry
• Decision Date: Oct 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The BD Logic and BD Paradigm Link Blood Glucose Monitoring Systems are intended to be used for the quantitative measurement of glucose in capillary whole blood. The monitors are intended for use by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. The BD Logic and the BD Paradigm Link 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 the BD Paradigm Link are specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip, palm and forearm.

Device Story

System measures glucose in capillary whole blood; utilizes electrochemical biosensor technology with glucose oxidase reagent. User inserts test strip into meter; applies 0.3 μL blood sample via capillary action to strip end. Meter performs amperometric measurement; displays glucose concentration in 5 seconds. Used by patients at home for diabetes management. Includes meter, test strips, control solution, and lancing device. Off-finger testing (palm/forearm) requires specific lancing cap. Forearm testing restricted to steady-state conditions; finger/palm permitted during dynamic glucose changes. Provides plasma-equivalent results. Users must visually inspect sample; pink/clear samples (interstitial fluid) are rejected. Output aids patient in monitoring diabetes control.

Clinical Evidence

Clinical studies evaluated alternate site testing (fingertip, palm, forearm) during steady state and dynamic glycemic change. Results demonstrate suitability for all three sites. Data confirms palm testing is equivalent to fingertip testing during periods of rapid glucose change.

Technological Characteristics

Electrochemical biosensor; glucose oxidase enzyme; amperometric detection. Sample volume 0.3 μL. Test range 20-600 mg/dL. Hematocrit range 25-60%. Test time 5 seconds. System includes meter, test strips, lancing device, and off-finger lancing cap. Connectivity not specified. Sterilization method not specified.

Indications for Use

Indicated for people with diabetes mellitus to monitor glucose effectiveness via capillary whole blood from fingertip, palm, or forearm. Not for diagnosis, screening, or neonates.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

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

Submission Summary (Full Text)

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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: [phone] Fax:

#### 2. Device Name:

| Trade Name: | BD LogicTM Blood Glucose Monitor<br>Paradigm 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.

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.

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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.

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.

### 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 [phone]. 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 [phone] or [phone] 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

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