The Bayer ADVIA® 1650 Glucose Hexokinase II assay is an in vitro diagnosic device for use in the quantitative determination of glucose in human cerebrospinal fluid (CSF), serum, plasma (lithium heparin), and urine on the ADVIA® 1650 Chemistry system. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.

The Bayer ADVIA® 1650 Glucose Oxidase assay is an in vitro diagnostic device for use in the quantitative determination of glucose in human cerebrospinal fluid (CSF), serum, plasma and urine on the ADVIA® 1650 Chemistry system. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.

Device Description

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AI/ML Overview

Acceptance Criteria and Study for Bayer ADVIA® 1650 Glucose Assays

This document describes the acceptance criteria and the studies performed to demonstrate the performance of the Bayer ADVIA® 1650 Glucose Hexokinase II and Glucose Oxidase assays.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document focuses on demonstrating substantial equivalence to a predicate device rather than defining explicit acceptance criteria with specific numerical thresholds for accuracy, sensitivity, or specificity. Instead, the performance is evaluated through imprecision and method correlation studies against a legally marketed predicate device (Roche Glucose Hexokinase). The "acceptance criteria" can be inferred from the successful outcome of these studies, demonstrating comparable performance to the predicate.

Performance Metric	Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (ADVIA® 1650 Glucose Oxidase)	Reported Device Performance (ADVIA® 1650 Glucose Hexokinase II)
Imprecision (Within-run CV%)	Comparable to Roche Glucose Hexokinase (e.g., ≤ 1.8% at similar levels)
- Level 1	≤ 1.6% (Roche at 31 mg/dL)	1% (at 58.0 mg/dL)	1.2% (at 60.2 mg/dL)
- Level 2	≤ 1.8% (Roche at 59 mg/dL)	1.1% (at 34.2 mg/dL)	1.7% (at 36.9 mg/dL)
Method Correlation	Strong correlation with predicate device (high r-value, regression close to Y=X)
- Regression Equation	(Implicitly close to Y=X)	$Y = 0.97x + 4.47$	$Y = 1.03x - 1.25$
- Syx (Standard Error of Y on X)	(Implicitly low)	7.6	6.4
- Correlation Coefficient (r)	(Implicitly high, e.g., > 0.95)	0.994	0.987
Analytical Range	Sufficient for intended use	0-750 mg/dL	0-700 mg/dL

2. Sample Size and Data Provenance for Test Set

Glucose Oxidase:
- Sample Size: N = 56
- Data Provenance: Not explicitly stated, but the comparison is made against a "Roche (On Integra)" system, implying clinical samples were tested on both systems. The document does not specify the country of origin, nor whether the samples were retrospective or prospective.
Glucose Hexokinase:
- Sample Size: N = 55
- Data Provenance: Not explicitly stated, but the comparison is made against a "Roche (On Integra)" system, implying clinical samples were tested on both systems. The document does not specify the country of origin, nor whether the samples were retrospective or prospective.
Imprecision Study:
- The sample sizes for the imprecision study are not explicitly stated as 'N' for each level, but typical laboratory imprecision studies involve multiple replicates (e.g., 20 or more) over several days for each level. The reported "Within-run CV(%)" suggests a specific set of measurements, but the exact number of samples or runs is not detailed.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a diagnostic assay for quantitative determination of glucose. The "ground truth" is established by the reference measurement on the predicate device itself, which is a chemical analyzer. No human experts are involved in establishing the "ground truth" for the test results.

4. Adjudication Method for the Test Set

Not applicable. Since the device performs a quantitative chemical analysis, the direct output of the instrument (glucose concentration) is used for comparison. There is no qualitative assessment or interpretation by observers requiring adjudication.

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

Not applicable. This is not an imaging device or a subjective interpretation device where human readers are involved. It is a quantitative chemical analyzer. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

6. Standalone Performance Study

Yes, standalone performance was done. The studies (imprecision and method correlation) directly assess the performance of the Bayer ADVIA® 1650 Glucose assays in isolation, by comparing its results to a predicate device. This is inherently a standalone performance evaluation of the algorithm/assay without human intervention in the result determination.

7. Type of Ground Truth Used

The ground truth for the method correlation studies was established by measurement on a legally marketed predicate device (Roche Glucose Hexokinase on an Integra system). For the imprecision study, the "ground truth" for the mean glucose level was the determined mean value from the measurements themselves, evaluated against the variability of those measurements.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or "training set sample size." This is typical for a traditional in vitro diagnostic device like a glucose assay evaluated through method comparison and imprecision studies. These types of devices do not typically undergo a development process involving distinct "training" and "test" sets in the way AI/Machine Learning models do. The performance characteristics are derived from direct analytical testing.

9. How Ground Truth for the Training Set was Established

Not applicable, as a distinct training set (in the context of AI/machine learning) is not described or implied for this type of medical device submission. The analytical performance is characterized through direct experimental measurement.

Summary

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SEP 2 9 2004

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Glucose methods for ADVIA® 1650TM

This summary of 510(k) safety and effectiveness information is being submitted in accordance This summary of 910(th) sales) and 1 and 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K642015

1. Intended Use

The Bayer ADVIA 1650 Glucose Oxidase and Glucose Hexokinase II assays are in vitro The Dayer AD TIA 1000 Of to occasion in the sure glucose levels in human cerebrospinal fluid (CSF), serum, plasma, and urine on the ADVIA® 1650 Chemistry System. Such measurements (CDF), seruin, phalma, and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypogleemia, idiopathic hypoglycemia and insulin overdose.

2. Predicate Device

Product Name	ReagentPart #	Calibrator Part #
Roche Glucose Hexokinase	20763020	10759350

Device / Method 3.

Product Name	ReagentPart #/ BAN #	Calibrator Part#/ BAN #
Bayer ADVIA® 1650Glucose Hexokinase	B01-4597-01/04005536	T03-1291-62/09784096
Bayer ADVIA® 1650Glucose Oxidase	B01-4130-01/04903429	T03-1291-62/09784096

Imprecision

ADVIA 1650 GlucoseOxidase		ADVIA 1650 GlucoseHexokinase II		Roche Glucose Hexokinase
Level(mg/dL)	Within-runCV(%)	Level(mg/dL)	Within-runCV(%)	Level(mg/dL)	Within-runCV(%)
58.0	1	60.2	1.2	31	1.6
34.2	1.1	36.9	1.7	59	1.8

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SpecimenType	ComparisonSystem (x)	N	RegressionEquation	Syx	r	Sample Rangemg/dL
Glucose(Oxidase)	Roche(On Integra)	56	$Y = 0.97x + 4.47$	7.6	0.994	37-530
Glucose(Hexokinase)	Roche(On Integra)	55	$Y = 1.03x - 1.25$	6.4	0.987	39-214

Correlation (Y=ADVIA 1650, X=comparison system)

Interfering Substances

Interfering substances are not expected in cerebrospinal fluid samples.

Analytical Range

Glu-HKII: 0- 700 mg/dL Glu-Ox: 0- 750 mg/dL

Carter

7/20/04

Date

Andres Holle Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The logo is black and white.

Public Health Service

SEP 2 9 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Andres Holle Manager, Regulatory Affairs Bayer Healthcare LLC. Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591

K042015 Re:

R042019
Trade/Device Name: Glucose Hexokinase II assay for the ADVIA® 1650 Chemistry System Glucose Oxidase assay for the ADVIA® 1650 Chemistry System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, CFR Dated: July 15, 2004 Received: August 5, 2004

Dear Mr. Holle:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & nowe 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 1 ou may, diereleve, marrer of the Act include requirements for annual registration, listing of general controls proficiouring 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 it may or subject to back of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA can oo louits in there announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be devised alat termination that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any I odoral statutes and regirements, including, but not limited to: registration and listing (21

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and will your to be finding of substantial equivalence of your device to a legally premaince noticate 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, r fou don't on the promotion and advertising of your device, please contact the Office of of quebelle on the preside Evaluation and Safety at (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.

Jean M. Cooper, MS, 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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Indications for Use

510(k) Number (if known): KOL 2015

Device Name: Glucose Hexokinase II assay for the ADVIA® 1650 Chemistry System

Indications For Use:

The Bayer ADVIA® 1650 Glucose Hexokinase II assay is an in vitro diagnosic device The Bayer ADVAN® TUSO Glaoooo Hoxokhabo in human cerebrospinal fluid (CSF), for use in the first for use in the quantitutive actornination on the ADVIA® 1650 Chemistry system. serum, plasma (illinian nopalin), the diagnosis and treatment of carbohydrate Such measurements are about the claghester the clayments, idiopathic hypoglycemia and insulin overdose.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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)

Albert Cert
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and

510(k) K042015

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Glucose Oxidase assay for the ADVIA® 1650 Chemistry System

Indications For Use:

The Bayer ADVIA® 1650 Glucose Oxidase assay is an in vitro diagnostic device for use The Bayer ADVIA® 7000 Glucose in human cerebrospinal fluid (CSF), serum,
in the quantitative determination of glucose in human cerebrospinal fluid (CSF), serum, in the quantitative determination of groups in haman seems . Such measurements are
plasma and urine on the ADVIA® 1650 Chemistry system. Such measurements are plasma and urne on the ADVIA® 1000 Onehabelism disorders including
used in the diagnosis and treatment of carbohydrate and insulin used in the diagnosis and treathent of Sarbonyards in the months and insulin overdose.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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)

Alberto Lutz
Division Sign-Off

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042015

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.