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.

Device Description

The Glucose assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF). Glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD) to nicotinamide adenine dinucleotide reduced (NADH). One micromole of NADH is produced for each micromole of glucose consumed. The NADH produced absorbs light at 340 nm and can be detected spectrophotometrically as an increased absorbance.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Glucose assay, as derived from the provided 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (Glucose Assay)
Correlation with Predicate Device (Hitachi 917 Glucose/HK assay)	Acceptable correlation with correlation coefficient as close to 1.0 as possible, slope as close to 1.0 as possible, and Y-intercept as close to 0 as possible.	AEROSET System vs. Hitachi 917: - Serum: r = 0.9995, slope = 1.09, Y-intercept = -5.50 mg/dL - Urine: r = 0.9998, slope = 1.09, Y-intercept = -1.35 mg/dL - CSF: r = 0.9998, slope = 1.09, Y-intercept = -4.29 mg/dL ARCHITECT c8000 System vs. Hitachi 917: - Serum: r = 0.9993, slope = 1.06, Y-intercept = -4.54 mg/dL - Urine: r = 0.9998, slope = 1.04, Y-intercept = -2.67 mg/dL - CSF: r = 0.9997, slope = 1.04, Y-intercept = -3.89 mg/dL
Correlation between AEROSET and ARCHITECT c8000 Systems	Acceptable correlation with correlation coefficient as close to 1.0 as possible, slope as close to 1.0 as possible, and Y-intercept as close to 0 as possible.	ARCHITECT c8000 System vs. AEROSET System: - Serum: r = 0.9996, slope = 0.97, Y-intercept = 0.85 mg/dL - Urine: r = 0.9999, slope = 0.96, Y-intercept = -1.36 mg/dL - CSF: r = 0.9998, slope = 0.95, Y-intercept = 0.22 mg/dL
Precision (Total %CV)	Acceptable precision, typically low %CV values which often indicate less than 5% or 10% depending on the analyte and clinical context. (Specific numerical criteria not explicitly stated but implied by acceptable performance.)	AEROSET System: - Serum: Level 1: 1.06%, Level 2: 1.41% - Urine: Level 1: 1.66%, Level 2: 1.35% - CSF: Level 1: 1.55%, Level 2: 1.69% ARCHITECT c8000 System: - Serum: Level 1: 2.15%, Level 2: 1.51% - Urine: Level 1: 1.01%, Level 2: 0.80% - CSF: Level 1: 1.07%, Level 2: 1.17%
Linearity (Quantitative Range)	Expected to be linear over a clinically relevant range.	- Serum/Plasma: Linear from 5 to 800 mg/dL - Urine/CSF: Linear from 1 to 800 mg/dL
Limit of Quantitation (Sensitivity)	Expected to be sensitive enough for clinical utility.	- Serum: 5.0 mg/dL - Urine/CSF: 1.0 mg/dL

Study Details

Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size used for the comparative performance studies (method comparison and precision studies).
- Data Provenance: Not specified, but generally for medical device submissions in the US, data often originates from clinical sites within the US or from sites that adhere to similar regulatory and ethical guidelines. No country of origin is mentioned. The studies appear to be prospective in nature, as they involve testing the new Glucose assay in comparison to a predicate device and conducting precision studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a clinical laboratory assay, not an imaging or diagnostic AI device that typically relies on human experts for ground truth. The "ground truth" for the test set is established by the predicate device (Hitachi 917 Glucose/HK assay) and the inherent chemical measurement of the analyte itself. There are no "experts" in the traditional sense involved in establishing ground truth for these types of assays; rather, it relies on accepted analytical methods.
Adjudication method for the test set:
- Not applicable. This is a quantitative chemical assay where the "adjudication" is the direct measurement and comparison of numerical results between the new device and the predicate device. There is no subjective human interpretation involved that would require an adjudication method like 2+1.
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:
- No, this is not an MRMC study. MRMC studies are typically performed for imaging or interpretive diagnostic AI systems where human readers evaluate cases with and without AI assistance. This device is a quantitative in vitro diagnostic assay.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance described is a standalone performance of the Glucose assay when run on the AEROSET and ARCHITECT c8000 systems. The device itself performs the measurement without human interpretation of the result, beyond reading the numerical value.
The type of ground truth used:
- The ground truth for the comparative studies is based on the measurements obtained from the predicate device, the Glucose/HK assay on the Hitachi 917 Analyzer. For linearity and sensitivity, the ground truth would be the known concentrations of calibrators or reference materials.
The sample size for the training set:
- The document does not mention a training set in the context of machine learning or AI. This device is a traditional chemical assay, not an AI/ML-based device.
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the AI/ML sense.

Summary

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510(k) Summary

MAY - 5 2006

Submitter's Name/Address Abbott Laboratories 1921 Hurd Drive Irving, TX 75038

Contact Person Linda Morris Senior Regulatory Specialist MS 2-11 Regulatory Affairs (972) 518-6711 Fax (972) 518-7479

Date of Preparation of this Summary:	February 13, 2006
Device Trade or Proprietary Name:	Glucose
Device Common/Usual Name orClassification Name:	Glucose
Classification Number/Class:	CFR/Class II

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K060383

Test Description:

Glucose - Conc. 510(k) April 19, 2006

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Substantial Equivalence:

The Glucose assay is substantially equivalent to the Glucose/HK assay (K953847) on the Hitachi 917 Analyzer. Both assays yield similar Performance Characteristics.

Similarities:

. Both assays are in vitro enzymatic chemical reaction assays.
. Both assays can be used for the quantitative analysis of glucose.
. Both assays yield similar results.
. Both assays are based on the hexokinase/G-6-PDH methodology.

Differences:

None

Intended Use:

The Glucose assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF).

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Performance Characteristics:

Comparative performance studies were conducted using the AEROSET® and ARCHITECT® c8000 Systems. The Glucose assay method comparison yielded acceptable correlation with the Glucose/HK assay on the Hitachi 917 Analyzer. The AEROSET System showed a correlation coefficient of 0.9995, slope of 1.09, and Y-intercept of - 5.50 mg/dL for the serum application, a correlation coefficient of 0.9998, slope of 1.09, and Y-intercept of - 1.35 mg/dL for the urine application, and a correlation coefficient of 0.9998, slope of 1.09, and Y-intercept of - 4.29 mg/dL for the CSF application when compared to the Hitachi 917 Analyzer. The ARCHITECT c8000 System showed a correlation coefficient of 0.9993, slope of 1.06, and Y-intercept of - 4.54 mg/dL for the serum application, a correlation coefficient of 0.9998, slope of 1.04, and Y-intercept of -- 2.67 mg/dL for the urine application, and a correlation coefficient of 0.9997, slope of 1.04, and Y-intercept of -3.89 mg/dL for the CSF application when compared to the Hitachi 917 Analyzer. The ARCHITECT c8000 System showed a correlation coefficient of 0.9996, slope of 0.97 and Y-intercept of 0.85 mg/dL for the serum application, a correlation coefficient of 0.9999, slope of 0.96, and Y-intercept of -1.36 mg/dL for the urine application, and a correlation coefficient of 0.9998. slope of 0.95, and Y-intercept of 0.22 mg/dL for the CSF application when compared to the AEROSET System. The Glucose assay method comparison yielded acceptable correlation between the AEROSET System and the ARCHITECT c8000 System.

Precision studies were conducted using the Glucose assay. On the AEROSET System, the total %CV for Level 1 is 1.06%, and Level 2 is 1.41% for the serum application, the total %CV for Level 1 is 1.66%, and Level 2 is 1.35% for the urine application, and the total %CV for Level 1 is 1.55%, and Level 2 is 1.69% for the CSF application. On the ARCHITECT c8000 System, the total %CV for Level 1 is 2.15%, and Level 2 is 1.51% for the serum application, the total %CV for Level 1 is 1.01%, and Level 2 is 0.80% for the urine application, and the total %CV for Level 1 is 1.07%, and Level 2 is 1.17% for the CSF application.

Glucose - Conc. 510(k) April 19, 2006

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The Glucose assay is linear from 5 to 800 mg/dL for the serum/plasma application. The Glucose assay is linear from 1 to 800 mg/dL for the urine/CSF application. The limit of quantitation (sensitivity) of the Glucose assay is 5.0 mg/dL for the serum application, and 1.0 mg/dL for the urine/CSF applications.

These data demonstrate that the performance of the Glucose assay is substantially equivalent to the performance of the Glucose/HK assay on the Hitachi 917 Analyzer.

Conclusion:

The Glucose assay is substantially equivalent to the Glucose/HK assay on the Hitachi 917 Analyzer as demonstrated by results obtained in the studies.

Glucose - Conc. 510(k) April 19, 2006

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Linda Morris Senior Regulatory Specialist Abbott Laboratories 1921 Hurd Drive Irving, TX 75038

MAY - 5 2006

Re: K060383 Trade/Device Name: Glucose test system Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: February 13, 2006 Received: February 22, 2006

Dear Ms. Morris:

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 introduce commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmounts, 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 (DMA), 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 misbandly no 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 additions 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 not he 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 protice 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 tolli the (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Alberto G. A.

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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Indications for Use

K060353 510(k) Number (if known):

Device Name: Glucose

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)
Division Sign-Off	Page 1 of ______
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)	K060383

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.