Excel™ GE Blood Glucose Test Strips quantitatively measure glucose in fresh capillary whole blood and give results that are comparable to laboratory methods. They are intended for in vitro diagnostic (external) use . by people with diabetes for self-monitoring of blood glucose. The Excel™ GE Blood Glucose Test Strips are designed to be used with Glucometer Elite® Blood Glucose Meters only.

Device Description

Excel™ GE Blood Glucose Test Strips quantitatively measure glucose in fresh capillary whole blood and give results that are comparable to laboratory methods. They are intended for in vitro diagnostic (external) use by people with diabetes for self-monitoring of blood glucose. The Excel™ GE Blood Glucose Test Strips are designed to be used with Glucometer Elite® Blood Glucose Meters only.

AI/ML Overview

The provided text describes the performance data for the Excel™ GE Blood Glucose Test Strips and Code Strip. Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" with numerical thresholds. However, it implicitly demonstrates performance through comparison with established laboratory methods (YSI) and aims for "equivalent performance" to a predicate device. Interpreting the presented data as the reported performance that met the implicit acceptance for substantial equivalence:

Performance Metric	Reported Device Performance (Excel™ GE Blood Glucose Test Strips)
Precision
Glucose Level 1 (e.g., ~45 mg/dL)	SD: 1.2 mg/dL, CV: 2.6-2.7%
Glucose Level 2 (e.g., ~80 mg/dL)	SD: 2.2-2.3 mg/dL, CV: 2.7-3.0%
Glucose Level 3 (e.g., ~150 mg/dL)	SD: 3.2-3.6 mg/dL, CV: 2.2%
Glucose Level 4 (e.g., ~345 mg/dL)	SD: 6.4-7.0 mg/dL, CV: 1.8-2.0%
Accuracy (Professional Users vs. YSI)
n	252-253
Regression Equation (y = mx + b)	y = 0.91x + 0.18 to y = 0.93x + 1.24
Correlation Coefficient (r)	0.9877 - 0.9949
Standard Error of Estimate (Sy.x)	7.55 - 11.45
Range	51 - 374 mg/dL
Accuracy (Lay Users vs. YSI)
n	128
Regression Equation (y = mx + b)	y = 0.92x + 6.99 to y = 0.95x + 3.92
Correlation Coefficient (r)	0.9883 - 0.9941
Standard Error of Estimate (Sy.x)	8.31 - 11.38
Range	51 - 374 mg/dL

2. Sample Size for the Test Set and Data Provenance

Precision Study:
- Sample Size: 20 for each glucose level, on each meter model (total of 20 x 4 x 2 = 160 tests, not distinct samples). The text states "20 samples" implying 20 distinct blood samples, each tested across 4 glucose levels and two meter models.
- Data Provenance: Not specified, but described as a "laboratory study."
Accuracy Studies (Professional and Lay Users):
- Sample Size:
  - Professional Users: 252 (Model 3901A) and 253 (Model 3901M) patient samples.
  - Lay Users: 128 patient samples.
- Data Provenance: "128 patients with diabetes at three clinical centers." This indicates a prospective clinical study involving actual patient samples. The country of origin is not specified.

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

Not applicable. This device is an in vitro diagnostic (IVD) for measuring blood glucose. The "ground truth" is established by a reference laboratory method, not human expert interpretation of images or clinical findings.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth is established by a laboratory reference method (YSI), not through human adjudication of differing interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. This is an IVD device for measuring blood glucose, not an imaging device or AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study. The performance is assessed against a laboratory reference method and compared to a predicate device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence, the device's performance (Excel™ GE Blood Glucose Test Strips used with Glucometer Elite® Glucose Meters) is evaluated in a standalone manner against the YSI laboratory reference method. The "algorithm" here is the combined chemistry and meter reading. The accuracy studies demonstrate the device's performance without human interpretation influencing the measurement result itself, though human professionals and lay users perform the blood application.

7. The Type of Ground Truth Used

Precision Study: The "ground truth" for precision is the mean glucose value obtained by the device itself, allowing for calculation of standard deviation and coefficient of variation.
Accuracy Studies: The "ground truth" was established using a YSI (Yellow Springs Instruments) laboratory method, which is a recognized reference standard for glucose measurement.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithm development. For this type of IVD, the development process typically involves optimizing the strip chemistry and meter calibration using various samples, but these are not usually referred to as a "training set" in the same way as for AI. The data presented are performance validation data.

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

As no specific "training set" for an AI or machine learning algorithm is mentioned, this question is not directly applicable. For the development of the test strip and meter, the ground truth for calibration and initial development would also typically rely on established laboratory reference methods like YSI.

Summary

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K991480

Section 5 510(k) SUMMARY (Summary of Safety and Effectiveness)

Submitted by:

Carol Adiletto Director of Clinical Affairs Selfcare, Inc. 200 Prospect Street Waltham, MA 02453-3457 USA Phone: (781) 647-3900 (781) 647-3939 Fax:

Contact Person:

Carol Adiletto Phone (781) 647-3900 x124

Summary Prepared:

March 27, 1999

Name of the device:

Excel™ GE Blood Glucose Test Strips and Code Strip

Classification name(s):

Excel™ GE Blood Glucose Test Strips are a Class II device (21 CFR § 862.1345) for home use

Classification of predicate device(s):

Excel™ GE Blood Glucose Test Strips and Code Strip are not materially different from the predicate device, Glucometer Elite® Blood Glucose Test Strips and Code Strip. The predicate device is distributed by Bayer and was cleared for use in the United States by K964630, K951537 and K924499.

Description of the device/intended use(s):

Excel ™ GE Blood Glucose Test Strips quantitatively measure glucose in fresh capillary whole blood and give results that are comparable to laboratory methods. They are intended for in vitro diagnostic (external) use by people with diabetes for self-monitoring of blood glucose. The Excel™ GE Blood Glucose Test Strips are designed to be used with Glucometer Elite® Blood Glucose Meters only.

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Statement of How the Technological Characteristics of the Device Compare to the Predicate device:

The technological characteristics of both devices are the same since they are electrochemical devices that quantitatively measure glucose amperometrically and have the same safety and effectiveness. They have the same intended use, i.e. use by people with diabetes for self-monitoring of blood glucose. The new device is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The Excel™ GE Blood Glucose Test Strips and Code Strip are intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control.

Summary of Performance Data:

Laboratory and clinical studies demonstrate that the Excel™ GE Blood Glucose Test Strips and Code Strip for use with Glucometer Elite® Blood Glucose Meters provides equivalent performance to the Glucometer Elite® Blood Glucose Test Strips and Code Strip for use with Glucometer Elite® Blood Glucose Meters.

Precision: A laboratory study of 20 samples (n=20), using Excel™ GE Blood Glucose Test Strips and Glucometer Elite® glucose meters to test whole blood samples at 4 different glucose levels (Glucose Level), showed the following performance:

Precision	Elite® Model 3901A				Elite® Model 3901M
GlucoseLevel	n	meanglucose(mg/dL)	SD(mg/dL)	CV(%)	n	meanglucose(mg/dL)	SD(mg/dL)	CV(%)
1	20	47	1.2	2.6	20	43	1.2	2.7
2	20	77	2.3	3.0	20	83	2.2	2.7
3	20	145	3.2	2.2	20	160	3.6	2.2
4	20	360	6.4	1.8	20	331	7.0	2.0

Accuracy	Elite® Model 3901A	Elite® Model 3901M
Accuracy of Professional userscompared to YSI using capillarywhole blood on 128 patients withdiabetes at three clinical centers	n = 252y = 0.91x + 0.18r = 0.9877Sy.x = 11.45Range = 51 - 374 mg/dL	n = 253y = 0.93x + 1.24r = 0.9949Sy.x = 7.55Range = 51 - 374 mg/dL
Accuracy of Lay users comparedto YSI using capillary wholeblood on 128 patients withdiabetes at three clinical centers	n = 128y = 0.92x + 6.99r = 0.9883Sy.x = 11.38Range = 51 - 374 mg/dL	n = 128y = 0.95x + 3.92r = 0.9941Sy.x = 8.31Range = 51 - 374 mg/dL

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and head. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 17 1999

Ms. Carol Adiletto Director of Clinical Affairs Selfcare, Inc. 200 Prospect Street Waltham, Massachusetts 02453-3457

Re: K991480

Trade Name: Excel™ GE Blood Glucose Test Strips and Code Strip Regulatory Class: II Product Code: CGA Dated: August 9, 1999 Received: August 11, 1999

Dear Ms. Adiletto:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman

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

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Section 4

Indications for Use Statement

5991480 510(k) Number (if known):

Device Name: Excel™ GE Blood Glucose Test Strips and Code Strip

Indications for Use:

Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K99480

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.019) OR

Over-The-Counter Use

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.