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 Microfill, and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.

Device Description

The Liberty Normal 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 non-hazardous and contains no human or animal derived materials.

AI/ML Overview

The provided document describes a Quality Control Material for blood glucose monitors, not an AI/ML-powered diagnostic device. Therefore, many of the requested categories for AI/ML device studies (such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set data, etc.) are not applicable.

The document focuses on demonstrating substantial equivalence to existing predicate devices based on comparable characteristics and performance studies relevant to control solutions.

Here's a breakdown of the available information relevant to acceptance criteria and performance, alongside an explanation of why certain AI/ML-specific questions cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic/Aspect	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Liberty Normal Glucose Control)
Device Type	Single Analyte Control Solution (Glucose)	Single Analyte Control Solution (Glucose)
Number of Levels	1 (matching most predicates)	1
Analytes	Glucose	Glucose
Container	Plastic bottle with dropper-tip	Plastic bottle with dropper-tip
Fill Volume	Comparable to predicates (e.g., 2.5 mL - 4 mL range)	3.6 mL
Color	Red (matching most predicates)	Red
Matrix	Buffered aqueous solution of D-Glucose, viscosity modifier, preservatives, and other non-reactive ingredients	Buffered aqueous solution of D-Glucose, viscosity modifiers, preservatives, and other non-reactive ingredients
Intended Use	To assess performance of specific blood glucose monitors	To assess performance of specific blood glucose monitors (Bayer Ascensia Microfill, Roche Accu-chek Active, LifeScan OneTouch Ultra, and FastTake)
Target Population	Professional and home use	Professional and home use
Performance Studies	Stability (Accelerated and Real-time), Open Vial, Microbial Stress Stability, Test precision data comparable to predicates	"Tests were performed to verify specific performance characteristics: Stability (Accelerated and Real-time), Open Vial, Microbial Stress Stability, Test precision." (Details not provided in this summary, but concluded to support substantial equivalence).

Explanation of Applicability/Non-Applicability to AI/ML Questions:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for a control solution. This device is a consumable quality control material, not a diagnostic algorithm. Performance is assessed through chemical stability and precision testing, not diagnostic accuracy on a patient dataset. The "test set" here would refer to vials of the control solution and measurements taken by various blood glucose meters.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth for a glucose control solution is established by precise chemical formulation and analytical testing, not by expert interpretation of medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for ambiguous diagnostic interpretations, not for the chemical properties and performance of a control solution.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This pertains to AI-assisted diagnostic reads, which is not what this device is.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a control solution, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground truth: For a glucose control solution, the ground truth is the known, precisely manufactured concentration of glucose within the solution, verified through analytical chemistry methods.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set. Its formulation is based on chemical engineering and existing predicate control solutions.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for this type of device.

Conclusion:

The Liberty Normal Glucose Control is a chemical control solution designed to verify the performance of blood glucose monitors. Its acceptance criteria and performance are established through demonstrating substantial equivalence to legally marketed predicate devices by comparing their physical characteristics, chemical matrix, intended use, and through standard performance studies for such products (stability, open vial, microbial stress, and test precision). The 510(k) summary indicates that these comparisons and studies support the claim of substantial equivalence. The document is not for an AI/ML diagnostic device, so questions related to AI/ML specific study designs are not relevant.

Summary

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Ka60706

5. 510(k) Summary

Introduction:	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter:	Liberty Healthcare Group, Inc. 8883 Liberty Lane Port St. Luce, FL 34952
Contact Person:	John C. Gormley American Biological Technologies, Inc. 940 Crossroads Blvd Seguin, TX 78155 (830) 372-1391 ex. 210 Establishment Registration Number: 1643621
Device Name:	Liberty Normal Glucose Control
Common Name:	Single Analyte Control Solution, All Types (Assayed and Unassayed)
Classification Name:	Quality Control Material (assayed and unassayed).
Classification:	Class I per 21 CFR 862.1660
Product Code:	75 JJX
Panel:	Chemistry
Predicate Devices:

Name:	OneTouch Ultra Control Solution
Manufacturer:	LifeScan, Inc.
510(k) No.:	K001427

Name:	Ascensia Microfill Control Solution
Manufacturer:	Bayer Healthcare
510(k) No.:	K023657

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Name:	Accu-chek Active Control High Level
Manufacturer:510(k) No.:	Roche Diagnostics CorporationK011738
Name:Manufacturer:510(k) No.:	Liberty Glucose ControlLiberty Healthcare Group, Inc.K052980
Device Description:	The Liberty Normal 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 non-hazardous and contains no human or animal derived

The Liberty Normal Glucose Control is intended for in Intended Use: vitro diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Bayer Ascensia Microfill, the Roche Accu-chek Active and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.
materials.

Comparison to Predicate Device:

Characteristic/Aspect	PredicateDevice No. 1	PredicateDevice No. 2	PredicateDevice No. 3	PredicateDevice No. 3	NewProduct
Name	OneTouchUltra ControlSolution	AscensiaMicrofillControlSolution	Accu-chekActiveControl HighLevel	LibertyGlucoseControl	LibertyNormalGlucoseControl
510(k), Date	K001427,06/02/2000	K0236705/12/2003	K01173806/20/2001	K05298011/30/2005
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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510(k) Premarket Notification: Liberty Normal Glucose Control American Biological Technologies, Inc.

Characteristic/Aspect	PredicateDevice No. 1	PredicateDevice No. 2	PredicateDevice No. 3	PredicateDevice No. 3	NewProduct
Matrix	Bufferedaqueoussolution of D-Glucose,viscositymodifier,preservatives,and othernon-reactiveingredients	Bufferedaqueoussolution of D-Glucose,viscositymodifier,preservatives,and other non-reactiveingredients	BufferedaqueoussolutioncontainingGlucose,preservativeand athickeningagent.	Bufferedaqueoussolution of D-Glucose,viscositymodifiers,preservatives, and othernon-reactiveingredients	Bufferedaqueoussolution ofD-Glucose,viscositymodifiers,preservatives, and othernon-reactiveingredients
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 MedisenseBloodGlucoseSystemsonly.	Used tocheck theperformanceofOneTouchUltra,OneTouchFastTake,Accu-chekActive, andAscensiaMicrofillBloodGlucoseSystems.
TargetPopulation	Professionaland homeuse	Professionaland home use	Professionaland homeuse	Professionaland homeuse	Professionaland homeuse

Performance Studies:

Tests were performed to verify specific performance characteristics:

1. Stability (Accelerated and Real-time)
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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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Liberty Healthcare Group, Inc. c/o Mr. John Gormley Vice President Quality Assurance/Regulatory Affairs American Biological Technologies, Inc. 940 Crossroads Blvd. Seguin, TX 78155

APR 2 8 2006

Re: K060706 Trade/Device Name: Liberty Normal Glucose Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: March 14, 2006 Received: March 23, 2006

Dear Mr. Gromley;

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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutz

Alberto Gutierrez, Ph.D. 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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র্বা Indications for Use Statement

510(k) Number (if known):

Device Name: Liberty Normal Glucose Control

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (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)

AND/OR

C.A.C

C:
Date

51006 K060706

safety

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.