(56 days)
Not Found
No
The device description and intended use clearly define a liquid control solution for calibrating blood glucose monitors. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is used to assess the performance of blood glucose monitors, which are diagnostic devices, not therapeutic devices. The control solution itself doesn't treat any medical condition.
No
Explanation: The device is a control solution used to assess the performance of blood glucose monitors, not to diagnose a medical condition itself. Its intended use states "For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Roche Accu-chek Active, the Bayer Ascensia Contour, and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors."
No
The device description explicitly states it is a "viscosity-adjusted, aqueous liquid control solution" packaged in "plastic dropper tipped bottles," indicating it is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use".
- Function: The device is a control solution used to assess the performance of blood glucose monitors, which are themselves IVDs. Control solutions are a common type of IVD used to verify the accuracy and reliability of other diagnostic tests.
N/A
Intended Use / Indications for Use
The SMS Multi Glucose Control is intended for in vitro diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Bayer Ascensia Contour, the Roche Accu-chek Active and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The SMS Multi Glucose Control consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is nonhazardous and contains no human or animal derived materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals and in the home by people with diabetes mellitus
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests were performed to verify specific performance characteristics:
- Stability
- Open Vial
- Microbial Stress Stability
- Test precision
Conclusion: Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K011479, K023657, K011738, K060706
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
APR 1 8 2007
510(k) Summary 5.
- According to the requirements of 21 CFR 807.92, the Introduction: following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
- Specialty Medical Supplies (SMS) Submitter: 3882 NW 124th Avenue Coral Springs, FL 33065
- John C. Gormley Contact Person: American Biological Technologies, Inc. 940 Crossroads Blvd Sequin, TX 78155 (830) 372-1391 ex. 210 Establishment Registration Number: 1643621
- Device Name: SMS Multi Glucose Control
- Common Name: Single Analyte Control Solution, All Types (Assayed and Unassayed)
- Quality Control Material (assayed and unassayed). Classification Name:
- Class I per 21 CFR 862.1660 Classification:
- 75 JJX Product Code:
- Panel: Chemistry
- Predicate Devices:
- Name: Manufacturer: 510(k) No.:
- Name:
Manufacturer:
510(k) No.:
Ascensia Microfill Control Solution Bayer Healthcare K023657
LifeScan, Inc.
OneTouch Ultra Control Solution
1
| Name: | Accu-chek Active Control High
Level |
|---------------|----------------------------------------|
| Manufacturer: | Roche Diagnostics Corporation |
| 510(k) No.: | K011738 |
| Name: | Liberty Glucose Control |
| Manufacturer: | Liberty Healthcare Group, Inc. |
| 510(k) No.: | K060706 |
- The SMS Multi Glucose Control consists of a Device Description: viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is nonhazardous and contains no human or animal derived materials.
- The SMS Multi Glucose Control is intended for in vitro Intended Use: diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Bayer Ascensia Contour, the Roche Accu-chek Active and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.
Comparison to Predicate Device:
| Characteristic/
Aspect | Predicate
Device No. 1 | Predicate
Device No. 2 | Predicate
Device No. 3 | Predicate
Device No. 4 | New
Product |
|---------------------------|----------------------------------------|----------------------------------------------|----------------------------------------------|---------------------------------------|---------------------------------------|
| Name | OneTouch
Ultra Control
Solution | Ascensia
Microfill
Control
Solution | Accu-chek
Active
Control High
Level | Liberty
Glucose
Control | SMS Multi
Glucose
Control |
| 510(k), Date | K011479,
06/02/2000 | K023657
05/12/2003 | K011738
06/20/2001 | K060706
04/28/2006 | |
| Number of
Levels | 1 | 1 | 2 | 1 | 1 |
| Analytes | Glucose | Glucose | Glucose | Glucose | Glucose |
| Container | Plastic bottle
with dropper-
tip | Plastic bottle
with dropper-
tip | Plastic bottle
with dropper-
tip | Plastic bottle
with dropper
tip | Plastic bottle
with dropper
tip |
| Fill Volume | 3 mL | 2.5 mL | 4 mL | 3.6 mL | 3.6 mL |
| Color | Red | Red | N/A | Red | Red |
2
| Characteristic/
Aspect | Predicate
Device No. 1 | Predicate
Device No. 2 | Predicate
Device No. 3 | Predicate
Device No. 4 | New
Product |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Matrix | Buffered
aqueous
solution of D-
Glucose,
viscosity
modifier,
preservatives,
and other
non-reactive
ingredients | Buffered
aqueous
solution of D-
Glucose,
viscosity
modifier,
preservatives,
and other non-
reactive
ingredients | Buffered
solution
containing
Glucose,
preservative
and a
thickening
agent. | Buffered
aqueous
solution of D-
Glucose, a
viscosity
modifier,
preservatives
and other
non-reactive
ingredients | Identical to
Predicate
Device No.
4. |
| Indications for
Use | Used with
OneTouch
Ultra Brand
Systems, The
OneTouch
FastTake
System,
InDuo Brand
Systems and
OneTouch
UltraSmart
Systems to
check that
the meter and
test strips are
working
together as a
system and
that the user
is performing
the test
correctly | For use with
the Ascensia
Contour Blood
Glucose Meter
and the
Ascensia
MICROFILL
Test Strips as
a quality
control check. | Used to
perform
quality
control
checks to
ensure that
the Accu-
chek Active
System is
working
properly and
that the blood
glucose
results are
reliable. | Used to
check the
performance
of OneTouch
Ultra,
OneTouch
FastTake,
Accu-chek
Active, and
Ascensia
Contour
Blood
Glucose
Systems. | Used to
check the
performance
of
OneTouch
Ultra,
OneTouch
FastTake,
Accu-chek
Active, and
Ascensia
Contour
Blood
Glucose
Systems. |
| Target
Population | Professional
and home
use | Professional
and home use | Professional
and home
use | Professional
and home
use | Professional
and home
use |
Performance Studies:
Tests were performed to verify specific performance characteristics:
-
- Stability
-
- Open Vial
-
- Microbial Stress Stability
-
- Test precision
Conclusion:
Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Speciality Medical Supplies c/o Mr. John Gormley American Biological Technologies, Inc. 940 Crossroads Blyd. Seguin. TX 78155
APR 1 8 2007
Re: K070506
Trade/Device Name: SMS Multi Glucose Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material assayed and unassaved Regulatory Class: Class I, reserved Product Code: JJX Dated: February 21, 2007 Received: February 21, 2007
Dear Mr. Gormley:
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 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).
4
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., 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
5
4. Indications for Use Statement
510(k) Number (if known): K070500
Device Name: SMS Multi Glucose Control.
Indications For Use:
For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Roche Accu-chek Active, the Bayer Ascensia Contour, and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
Carol C. Benam
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K070506