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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the SMS Multi Glucose Control device. It details the device's characteristics, intended use, and comparison to predicate devices. However, the document does not contain specific acceptance criteria, reported device performance metrics, or detailed study results (sample sizes, ground truth establishment, expert qualifications, etc.) in the format requested.

The "Performance Studies" section only lists categories of tests performed (Stability, Open Vial, Microbial Stress Stability, Test precision) without providing any data or specific criteria for these tests. The "Conclusion" states that "Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence," but again, no specific performance data is presented.

Therefore, for aspects requiring quantitative data, specific study design details, or expert involvement, the information is not available in the provided text.

Here is the information that can be extracted or explicitly stated as not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Not specified in the document	Not specified in the document	The document lists categories of performance studies (Stability, Open Vial, Microbial Stress Stability, Test precision) but does not provide specific acceptance criteria or quantitative results for these tests.

2. Sample Size Used for the Test Set and Data Provenance

Sample size for test set: Not specified in the document.
Data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of experts: Not specified in the document.
Qualifications of experts: Not specified in the document.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Adjudication method: Not specified in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

Not applicable/Not mentioned. This device is a quality control solution for blood glucose monitors, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable/Not mentioned. This device is a control solution, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not specified in the document. For a quality control solution, ground truth would typically refer to the known concentration of the analyte (glucose) in the control solution, established through a traceable reference method. However, the document does not explicitly state how this "ground truth" was established for the performance studies.

8. The Sample Size for the Training Set

Not applicable/Not mentioned. This device is a quality control solution, not a machine learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not mentioned. This device is a quality control solution, not a machine learning algorithm requiring a training set and corresponding ground truth.

In summary, the provided 510(k) summary focuses on the device description, intended use, and substantial equivalence to predicate devices, rather than detailed performance study results with specific acceptance criteria and ground truth methodologies. For a device like a glucose control solution, the "performance studies" would likely involve laboratory testing to verify concentration, stability, and precision. However, the document does not elaborate on the specific methodologies or results of these tests.

Summary

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K070506

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.

K011479

OneTouch Ultra Control Solution

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Name:	Accu-chek Active Control HighLevel
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	PredicateDevice No. 1	PredicateDevice No. 2	PredicateDevice No. 3	PredicateDevice No. 4	NewProduct
Name	OneTouchUltra ControlSolution	AscensiaMicrofillControlSolution	Accu-chekActiveControl HighLevel	LibertyGlucoseControl	SMS MultiGlucoseControl
510(k), Date	K011479,06/02/2000	K02365705/12/2003	K01173806/20/2001	K06070604/28/2006
Number ofLevels	1	1	2	1	1
Analytes	Glucose	Glucose	Glucose	Glucose	Glucose
Container	Plastic bottlewith dropper-tip	Plastic bottlewith dropper-tip	Plastic bottlewith dropper-tip	Plastic bottlewith droppertip	Plastic bottlewith droppertip
Fill Volume	3 mL	2.5 mL	4 mL	3.6 mL	3.6 mL
Color	Red	Red	N/A	Red	Red

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Characteristic/Aspect	PredicateDevice No. 1	PredicateDevice No. 2	PredicateDevice No. 3	PredicateDevice No. 4	NewProduct
Matrix	Bufferedaqueoussolution of D-Glucose,viscositymodifier,preservatives,and othernon-reactiveingredients	Bufferedaqueoussolution of D-Glucose,viscositymodifier,preservatives,and other non-reactiveingredients	BufferedsolutioncontainingGlucose,preservativeand athickeningagent.	Bufferedaqueoussolution of D-Glucose, aviscositymodifier,preservativesand othernon-reactiveingredients	Identical toPredicateDevice No.4.
Indications forUse	Used withOneTouchUltra BrandSystems, TheOneTouchFastTakeSystem,InDuo BrandSystems andOneTouchUltraSmartSystems tocheck thatthe meter andtest strips areworkingtogether as asystem andthat the useris performingthe testcorrectly	For use withthe AscensiaContour BloodGlucose Meterand theAscensiaMICROFILLTest Strips asa qualitycontrol check.	Used toperformqualitycontrolchecks toensure thatthe Accu-chek ActiveSystem isworkingproperly andthat the bloodglucoseresults arereliable.	Used tocheck theperformanceof OneTouchUltra,OneTouchFastTake,Accu-chekActive, andAscensiaContourBloodGlucoseSystems.	Used tocheck theperformanceofOneTouchUltra,OneTouchFastTake,Accu-chekActive, andAscensiaContourBloodGlucoseSystems.
TargetPopulation	Professionaland homeuse	Professionaland home use	Professionaland homeuse	Professionaland homeuse	Professionaland homeuse

Performance Studies:

Tests were performed to verify specific performance characteristics:

1. Stability
1. Open Vial
1. Microbial Stress Stability
1. Test precision

Conclusion:

Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence.

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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).

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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

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4. Indications for Use Statement

510(k) Number (if known): K070500

Device Name: SMS Multi Glucose Control.

Indications For Use:

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

Regulation Number and Section

§ 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.