(176 days)
Not Found
No
The description focuses on amperometric biosensor technology and does not mention AI or ML.
No
The device is described as an in vitro diagnostic device for quantitative measurement of glucose, not for treating or preventing disease.
Yes.
The device is intended for "in vitro diagnostic use" for the "quantitative measurement of glucose in fresh capillary whole blood."
No
The device description explicitly mentions "amperometric biosensor technology" and the integration of "blood collection" and "glucose assay," indicating the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "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."
- Nature of the Test: The device measures glucose in a biological sample (blood) outside of the body. This is the definition of an in vitro diagnostic test.
- Purpose: The purpose is to provide a quantitative measurement of glucose, which is used for the diagnosis and management of diabetes.
The other sections of the document further support this by describing the technology used to analyze the blood sample and the intended use for monitoring blood glucose levels.
N/A
Intended Use / 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.
Product codes
NBW, LFR
Device Description
The Abbott Laboratories MediSense Sof-Tact™ Diabetes 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger, forearm, upper arm and the base of the thumb
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home (lay user)
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The performance of the Sof-Tact Diabetes Management System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that lay users can obtain blood glucose that are substantially equivalent to the current methods for blood glucose measurements, which include the predicate devices listed above. Clinical evaluations indicate that under variable glycemic conditions, glucose difference between arm and finger was clinically insignificant as determined by Clarke Error Grid. Results of laboratory and clinical testing demonstrate that the performance of the Sof-Tact Diabetes Management System, when used according to the intended use stated above, is acceptable and comparable to the performance of the previously mentioned predicate devices for blood glucose testing. In addition, results of clinical performance testing demonstrate that trained operators and lay users obtain equivalent whole blood glucose results. The Sof-Tact arm glucose results at various post-prandial times up to 3 hours show no clinically significant difference from finger glucose results.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Sof-Tact Diabetes Management System 510(k) Notification
Summary of Safety and Effectiveness
| Submitted by: | 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.
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| Comparison to
Predicate Device: | The Sof-Tact Diabetes Management System has equivalent
technological characteristics and a similar intended used as the
Precision Xtra System (K983504), TheraSense FreeStyle Meter
(K992684) and the Amira AtLast Meter (K982076). |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Studies: | The performance of the Sof-Tact Diabetes Management System was
studied in the laboratory and in clinical settings by healthcare
professionals and lay users. The studies demonstrated that lay users
can obtain blood glucose that are substantially equivalent to the
current methods for blood glucose measurements, which include the
predicate devices listed above. Clinical evaluations indicate that
under variable glycemic conditions, glucose difference between arm
and finger was clinically insignificant as determined by Clarke Error
Grid. |
| Conclusion: | Results of laboratory and clinical testing demonstrate that the
performance of the Sof-Tact Diabetes Management System, when
used according to the intended use stated above, is acceptable and
comparable to the performance of the previously mentioned predicate
devices for blood glucose testing. In addition, results of clinical
performance testing demonstrate that trained operators and lay users
obtain equivalent whole blood glucose results. The Sof-Tact arm
glucose results at various post-prandial times up to 3 hours show no
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.
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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 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/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