SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS

K012975 · Abbott Laboratories · NBW · Feb 28, 2002 · Clinical Chemistry

Device Facts

• Record ID: K012975
• Device Name: SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS
• Applicant: Abbott Laboratories
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Sof-Tact Diabetes Management System is intended for in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Sof-Tact System is for home (lay user) use. The Sof-Tact Diabetes Management System is specifically intended for the quantitative measurement of glucose in whole blood samples obtained from the finger, forearm, upper arm and the base of the thumb.

Device Story

System integrates blood collection and glucose assay into single user operation; utilizes amperometric biosensor technology. Input: fresh capillary whole blood sample from finger, forearm, upper arm, or base of thumb. Process: biosensor generates current proportional to glucose concentration in sample. Output: quantitative blood glucose measurement displayed to user. Used in home setting by lay users for diabetes management. Output informs patient glycemic status, enabling self-monitoring and clinical decision-making regarding diabetes management.

Clinical Evidence

Performance evaluated in laboratory and clinical settings by healthcare professionals and lay users. Studies confirmed lay user ability to obtain glucose results equivalent to predicate methods. Clinical evaluations across variable glycemic conditions showed no clinically significant difference between arm and finger glucose results, as confirmed by Clarke Error Grid analysis. Post-prandial testing up to 3 hours demonstrated performance comparability to predicates.

Technological Characteristics

Amperometric biosensor technology; quantitative measurement of glucose via current generation proportional to sample glucose concentration. Integrated blood collection and assay mechanism. Designed for home use.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood for home use by lay users. Samples may be obtained from the finger, forearm, upper arm, or base of the thumb.

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

• Precision Xtra Advanced Diabetes Management System (K983504)
• Amira AtLast Blood Glucose Monitoring System (K982076)
• TheraSense FreeStyle Blood Glucose Monitoring System (K992684)

Submission Summary (Full Text)

{0}------------------------------------------------

Sof-Tact Diabetes Management System 510(k) Notification

## Summary of Safety and Effectiveness

K012975

| <b>Submitted by:</b> | Janet S. Connolly, RAC |
|----------------------|-----------------------------------------|
| | Senior Regulatory Affairs Specialist |
| | Abbott Laboratories, MediSense Products |
| | 4A Crosby Drive |
| | Bedford, MA 01730 |

- Sof-Tact™ Diabetes Management System Device Name: SoftSense™ Diabetes Management System
Self-Monitoring Blood Glucose System Common Name:

Glucose Test System Classification: Class II per 21 CFR 862.1345

Precision Xtra™ Advanced Diabetes Management System-K983504 Predicate Devices: Amira AtLast Blood Glucose Monitoring System--K982076 TheraSense FreeStyle™ Blood Glucose Monitoring System-K992684

- The Abbott Laboratories MediSense Sof-Tact™ Diabetes Description: Management System for Blood Glucose Testing utilizes 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 whole blood and control solutions. The Sof-Tact Diabetes Management System integrates the process of blood collection from body sites including the forearm, upper arm and base of the thumb and glucose assay into a single operation by the user. A separate test port is available for blood collection glucose assay from the fingertip.
Intended Use: The Sof-Tact Diabetes Management System is intended for in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Sof-Tact is for home (lay user) use. The Sof-Tact Diabetes Management System is specifically intended for the quantitative measurement of glucose in whole blood samples obtained from the finger, forearm, upper arm and base of the thumb.

{1}------------------------------------------------

| Comparison to<br>Predicate Device: | The Sof-Tact Diabetes Management System has equivalent<br>technological characteristics and a similar intended used as the<br>Precision Xtra System (K983504), TheraSense FreeStyle Meter<br>(K992684) and the Amira AtLast Meter (K982076). |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Studies: | The performance of the Sof-Tact Diabetes Management System was<br>studied in the laboratory and in clinical settings by healthcare<br>professionals and lay users. The studies demonstrated that lay users<br>can obtain blood glucose that are substantially equivalent to the<br>current methods for blood glucose measurements, which include the<br>predicate devices listed above. Clinical evaluations indicate that<br>under variable glycemic conditions, glucose difference between arm<br>and finger was clinically insignificant as determined by Clarke Error<br>Grid. |
| Conclusion: | Results of laboratory and clinical testing demonstrate that the<br>performance of the Sof-Tact Diabetes Management System, when<br>used according to the intended use stated above, is acceptable and<br>comparable to the performance of the previously mentioned predicate<br>devices for blood glucose testing. In addition, results of clinical<br>performance testing demonstrate that trained operators and lay users<br>obtain equivalent whole blood glucose results. The Sof-Tact arm<br>glucose results at various post-prandial times up to 3 hours show no<br>clinically significant difference from finger glucose results. |

:

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health and Human Services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## FEB 2 8 2002

Ms. Janet S. Connolly, RAC Senior Regulatory Affairs Specialist Abbott Laboratories, MediSense Products 4A Crosby Drive Bedford, Massachusetts 01730

Re: k012975

Trade/Device Name: Sof-Tact™ Diabetes Management System Regulation Number: 21 CFR § 862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: NBW, LFR Dated: January 4, 2002 Received: January 7, 2002

Dear Ms. Connolly:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becall be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars comment date of the Medical Device American by and commence prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been results in assee approval of a premarket approval application (PMA). and Cosmetic Act (710) that to her request to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the revilabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classified (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to such additional controller Lineang components of the 21, In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, In ad be found in the Outs ocements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuation of a backers. In other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any Federal Statutes and regulations and admitted to: registration and listing (21 comply with an the Act 3 requirements, morealing, which and and in the disclined as set CFK Part 807), ademig (21 CFR Part 820); and if applicable, the electronic form in the quality systems (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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

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):

Sof-Tact™ Diabetes Management System Device Name:

## Indications For Use:

The Sof-Tact Diabetes Management System is intended for in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Sof-Tact System is for home (lay user) use.

The Sof-Tact Diabetes Management System is specifically intended for the quantitative measurement of glucose in whole blood samples obtained from the finger, forearm, upper arm and the base of the thumb.

Cean (open

(Division Sign-Off)
Division of Clinical Laboratory Devices
K012975

(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)

510/k) Num

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

Prescription Use (Per 21 CFR 801.108) Over-The-Counter Use