The Glucoplus™ Blood Glucose Test System is comprised of Control Solutions and Test Strip biosensors for use only with the Glucoplus™ Blood Glucose Meter. It is for quantitative measurement of the concentration of glucose in capillary whole blood taken from the fingerstick by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.

It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Description

GlucoPlus™ Blood Glucose Monitoring System is comprised of an electrchemical biosensor glucose reagent test strip, a hand held meter, quality control solutions, a user manual, a check strip, a lancet, lancets and a logbook for recording test results. When the user inserts a test strip , the meter turns on. The user acquires a blood sample by touching the aperture of the test strip to the finger tip blood drop to fill the chamber on the strip. The meter sounds a beep to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its LCD.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that demonstrates the GlucoPlus device meets them, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a bulleted or numbered list. Instead, it presents system accuracy results, which are essentially the performance metrics against which the device's accuracy is judged. For blood glucose meters, these typically involve how close the meter's reading is to a reference method (like YSI). The FDA guidance for blood glucose meters at the time (though not explicitly cited as such here) often referenced ISO 15197 for system accuracy.

Here's an interpretation of the implied acceptance criteria from the "System accuracy results" section and the reported performance:

Acceptance Criterion (Implied from Performance Reporting)	Reported Device Performance (GlucoPlus™)
For Glucose < 75 mg/dL:
Readings within 5 mg/dL of YSI	14/28 (50%)
Readings within 10 mg/dL of YSI	25/28 (89.3%)
Readings within 15 mg/dL of YSI	28/28 (100%)
For Glucose ≥ 75 mg/dL:
Readings within ± 5% of YSI	58/172 (33.7%)
Readings within ± 10% of YSI	130/172 (75.6%)
Readings within ± 15% of YSI	160/172 (93%)
Readings within ± 20% of YSI	170/172 (98.8%)

Note: While the document presents these results, it doesn't explicitly state what percentage within each range would constitute "acceptance." However, the strong correlation (R > 0.98) and the overall system accuracy results, particularly 100% within 15 mg/dL for low glucose and 93% within ±15% for high glucose (with 98.8% within ±20%), are generally indicative of acceptable performance for blood glucose monitoring systems at the time of this submission. The FDA's clearance implies these results met their criteria.

2. Sample Sizes and Data Provenance:

Test Set Sample Size:
- Consumer Study (Lay Users): N = 120 specimens
- Consumer Study (Technician): N = 120 specimens
- Point of Care Study: N = 200 specimens (broken down as: Home Medical (58), Metabolism (62), Internal (80))
- System Accuracy: Based on the detailed breakdown: 28 measurements for glucose < 75 mg/dL and 172 measurements for glucose ≥ 75 mg/dL, totaling 200 measurements. This likely corresponds to the "Point of Care Study" total or a combined analysis of all samples against the YSI reference.
Data Provenance: The studies explicitly state "using capillary whole blood on clinical centers." This indicates prospective data collection within a clinical setting. The country of origin is not explicitly stated, but the sponsor's address is Quebec, Canada, and the FDA is in the USA, suggesting North American involvement.

3. Number of Experts and their Qualifications for Ground Truth:

The document does not specify the number of "experts" used to establish the ground truth. The ground truth was established by laboratory reference instruments, which are operated by trained laboratory personnel (technicians) rather than clinical experts in the sense of physicians or radiologists.

4. Adjudication Method:

This is not applicable as the ground truth was established by laboratory reference instruments (YSI). There was no human "adjudication" necessary between experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with imaging devices where human readers interpret images, sometimes with and without AI assistance. For a blood glucose meter, the primary evaluation is the device's accuracy against a gold standard reference, not how it improves human interpretation.

6. Standalone Performance Study (Algorithm Only):

Yes, a standalone performance study was done. The "Consumer Study" and "Point of Care Study" directly evaluate the GlucoPlus device's readings against a laboratory reference method (YSI), which represents its standalone performance without human input influencing the measurement itself. The user collects the sample and operates the device, but the measurement algorithm is the focus of these studies.

7. Type of Ground Truth Used:

The ground truth used was laboratory reference method (YSI). The YSI (Yellow Springs Instruments) analyzer is widely considered a gold standard for blood glucose measurement in laboratory settings due to its high accuracy.

8. Sample Size for the Training Set:

The document does not provide any information about a specific training set or its sample size. This type of information is often more relevant for AI/machine learning models where a large dataset is used to "train" the algorithm before testing. For a device like a blood glucose meter (especially from 2006), the "algorithm" is typically a predefined electrochemical calculation, not a learned model from a large training dataset in the modern AI sense. The development likely involved calibration and engineering optimization rather than distinct "training" and "test" sets of patient data.

9. How Ground Truth for Training Set was Established:

As no training set is mentioned (see point 8), the method for establishing its ground truth is also not provided.

Summary

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

510(k) Summary

This summary of the 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92

510(k) Number K061234

Sponsor:

GlucoPlus Inc. 2323 Halpern Ville St-Laurent, Quebec Canada H4S 1S3

Contact Information:

Jeffrey Fleishman Official Correspondent 215 815-0897 Fax 215 – 860-1071 Jbf1213@aol.com

Date Prepared: April 25, 2006

Proprietary Name: GlucoPlus™ Blood Glucose Monitoring System

Common Name: Blood Glucose Monitoring System

Classification Name:	Product Code	Device Class	RegulatoryNumbers
Test, Blood Glucose System Overthe Counter	NBW	2	21 CFR 862.1345
Glucose Oxidase	CGA	2
Single (Specified) analyte controls(assayed and unassayed)Quality Control Material	JJX	1	21 CFR 862.1345

Panel: (75) Chemistry

Predicate Device: GLUCOMETER ELITE Blood Glucose meter

Manufacturer: Bayer Corporation

510(k) Number K964630

Page 9

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

Device Description: GlucoPlus™ Blood Glucose Monitoring System is comprised of an electrchemical biosensor glucose reagent test strip, a hand held meter, quality control solutions, a user manual, a check strip, a lancet, lancets and a logbook for recording test results. When the user inserts a test strip , the meter turns on. The user acquires a blood sample by touching the aperture of the test strip to the finger tip blood drop to fill the chamber on the strip. The meter sounds a beep to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its LCD.

Similarities with Predicate Device:

Feature / Claim	Detail
Intended Use	The GlucoplusTM Blood Glucose Test System is comprisedof Control Solutions and Test Strip biosensors for use onlywith the GlucoplusTM Blood Glucose Meter. It is forquantitative measurement of the concentration of glucose incapillary whole blood taken from the fingerstick by peoplewith diabetes at home and/or by healthcare professionals ina clinical setting as an aid to monitor the effectiveness ofdiabetes control.It is not intended for the diagnosis of or screening fordiabetes mellitus, and is not intended for use on neonates.
Test Principle	GlucoPlusTM Blood Glucose Monitoring System utilizes atest strip that contains the enzyme glucose oxidase and aglucose meter. After the blood is drawn into the test strip,glucose in the sample reacts with potassium ferricyanide inthe test strip producing potassium ferrocyanide. Potassiumferrocyanide is produced in proportion to the glucoseconcentration in the blood sample. Oxidation of thepotassium ferrocyanide produces an electrical currentwhich is then converted by the meter to display the glucoseconcentration of the blood sample.
Warnings andPrecautions	For in vitro diagnostic use.
Sample Types	Fresh capillary whole blood samples from a fingerstick.
Hematocrit Range	30 – 55%
Power Source	3 V lithium battery (CR 2032)
Battery Use Life	More than 1000 tests

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

Differences with Predicate Device:

Feature	GlucoPlus TM	Glucometer Elite™
Blood SamplingInto Strip	Double Sided(Right or Left)	Sip- in SamplingFront end only
Sample Volume	1.5 µL	2.0 µL
Strip Packaging	25 Strips stored in a vial	Single strip in foil package.
Measuring time	Within 15 seconds	Within 30 seconds
Measuring Range	40 - 600 mg/dL	20 - 600 mg / dL
Measuring Unit	Test results are displayed ineither mg/dl or mmol/Ldepending on the meter setting.	mg/dl or mmol/L
Buttons	3 ButtonsCenter Button: PowerLeft Button: Setting FunctionsRight Button: Memory Functions	No Buttons
Setting Functions	Date, Time, Unit of Measure	None
Calibration	Built in Button	Calibration Strip
Data Download	Test Results can download byRS232 or USB interface	N/A
Average Display	Calculate mean results within1,7,14,21 and 28 days	Total mean results only.
Control Test Mode	N/A	The Control solution testresult will not store intomemory.
Flashing StripSymbol	Flashing Strip Symbol will displaywhen meter is powered on.	N/A
Ready to TestSymbol	User can apply blood to stripafter the display on LCD appears	The Function Number (F#)and the previous test resultbegin flashing alternately.

{3}------------------------------------------------

Data Demonstrating Substantial Equivalence:

The results of the consumer and point of care studies demonstrate good correlation (R>0.98) between ~40 - ~550 mg/dl in capillary whole blood specimens. The regression analysis of the data supports the Substantial Equivalency claim with the predicate device.

Consumer Study

Linear regression between GlucoPlus™ and YSI for lay users and technician

Accuracy of lay users compared toYSI using capillary whole blood on120 specimens at clinical centers	N=120$Y=0.96X-7.90$R=0.985Sy.x= 12.90Range=57-481 mg/dL
Accuracy of technician compared toYSI using capillary whole blood on120 specimens at clinical centers	N=120$Y=0.95X-6.60$R=0.989Sy.x=10.75Range=57-481 mg/dL

Point of Care Study Linear regression between GlucoPlus™ and GLUCOMETER ELITE® for test on department of Home Medical, Internal, and Metabolism

Home Medical	Metabolism	Internal	Total
N=58	N=62	N=80	N=200
Y=1.054X-6.34	Y= 1.031X-6.06	Y=1.046X-4.83	Y= 1.045X-5.81
R=0.990	R=0.986	R=0.997	R= 0.994
Sy.x=11.93	Sy.x=15.87	Sy.x=11.98	Sy.x=13.30
Range=59-341 mg/dL	Range=56-392 mg/dL	Range=38-548 mg/dL	Range=38-548 mg/dL

System accuracy results.

	Glucose concentration < 75 mg/dL
Within 5 mg/dL	Winthin 10 mg/dL	Within 15 mg/dL
14/28 (50%)	25/28 (89.3%)	28/28 (100%
	Glucose concentration □ 75 mg/dL

{4}------------------------------------------------

Within ± 5%	Within ± 10%	Within ± 15%	Within ± 20%
58/172 (33.7%)	130/172 (75.6%)	160/172 (93%)	170/172 (98.8%)

Page 12

Conclusion:

The description and data comparing the GlucoPlus™ and GLUCOMETER ELITE® system functions, intended use, hardware and software, laboratory and clinical evaluations supports the substantial equivalency claim to the predicate device.

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three horizontal lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

GlucoPlus Inc. c/o Mr. Jeffrey Fleishman Plasma Services Group, Inc. 315 Parkview Way Newtown, PA 18940

OCT 3 0 2006

Re: K061234 Trade/Device Name: Glucoplus™ Blood Glucose Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: October 2, 2006 Received: October 4, 2006

Dear Mr. Fleishman:

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).

{6}------------------------------------------------

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 Garcia

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

{7}------------------------------------------------

Indication of Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Glucoplus™ Blood Glucose Test System

Indications for Use:

It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Prescription Use X (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)

Division sign-Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

5100k

Regulation Number and Section

§ 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.