The Bayer ADVIA IMS® Glucose assay is an in vitro diagnostic device for use to measure glucose in human serum, plasma, urine and cerebrospinal fluid (CSF) on the ADVIA IMS® System. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and neonatal hypoglycemia.

Device Description

The ADVIA IMS® Glucose method is based on the combination of hexokinase (HK) and glucose-6-phosphate dehydrogenase (G6PD) for the specific measurement of glucose in serum, plasma, urine and cerebral spinal fluid.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, structured to answer your questions regarding acceptance criteria and the study proving device performance:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the presented performance characteristics. The study demonstrates comparable performance in terms of imprecision and correlation to the predicate device.

Performance Metric	Acceptance Criteria (Implied/Predicate Performance)	Reported Device Performance (ADVIA IMS Glucose)
CSF Imprecision (Within-run CV %)	- Level ~31 mg/dL: 1.6% (Predicate) - Level ~59 mg/dL: 1.8% (Predicate)	- Level 36 mg/dL: 2.1% - Level 60 mg/dL: 2.1%
CSF Imprecision (Total CV %)	- Level ~31 mg/dL: 2.7% (Predicate) - Level ~59 mg/dL: 3.1% (Predicate)	- Level 36 mg/dL: 2.3% - Level 60 mg/dL: 2.2%
CSF Correlation (Regression Equation Slope)	Expected to be close to 1.0 (indicating good agreement with predicate)	0.92
CSF Correlation (Regression Equation Y-intercept)	Expected to be close to 0 (indicating good agreement with predicate)	2.3
CSF Correlation (Syx - Residual Standard Deviation)	Not explicitly stated but lower values indicate better fit	1.9
CSF Correlation (r - Correlation Coefficient)	Expected to be close to 1.0 (indicating strong correlation)	0.997
Analytical Range	Not explicitly stated for predicate in summary, but the predicate likely has a similar range for glucose measurement.	1 mg/dL - 600 mg/dL
Minimum Detectable Concentration	Not explicitly stated for predicate in summary.	1 mg/dL

2. Sample Size and Data Provenance

Test Set Sample Size: 64 CSF samples were used for the CSF correlation study. The sample sizes for the imprecision studies are not explicitly stated as a single number but are implied by the "Within-run CV" and "Total CV" which typically involve multiple runs and replicates.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Their Qualifications for Ground Truth

This information is not applicable and therefore not provided. The study compares the performance of a new in vitro diagnostic device to a legally marketed predicate device, not against human expert interpretation of images or other subjective assessments. The "ground truth" here is the measurement obtained from the predicate device.

4. Adjudication Method for the Test Set

Not applicable. This is a comparison between two quantitative diagnostic devices, not a study involving human interpretation requiring adjudication.

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

No. This study is for an in vitro diagnostic device (glucose assay), not an AI algorithm assisting human readers in diagnostic interpretation. Therefore, an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study

Yes, in a sense. The entire submission describes the standalone performance of the ADVIA IMS Glucose assay in comparison to the predicate device. There is no human-in-the-loop component for the measurement of glucose in this context.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation is the quantitative measurement obtained from the predicate device, the Bayer ADVIA 1650 Glucose Hexokinase II. The study aims to demonstrate substantial equivalence by showing that the new device's measurements correlate strongly with those of the predicate.

8. Sample Size for the Training Set

Not applicable. This is an in vitro diagnostic device based on established biochemical principles (hexokinase and G6PD), not an AI algorithm that requires a "training set" in the machine learning sense. The device is developed and validated through analytical studies, not trained on data.

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

Not applicable, as there is no "training set" for this type of IVD device. The method relies on well-understood chemical reactions.

Summary

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OCT 1 1 2005

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

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

The assigned 510(k) number is: K052/63

1. Intended Use

2. Assay Principle

3. Predicate Device

Product Name	Reagent Ref #	Calibrator Ref #
Bayer ADVIA® 1650Glucose Hexokinase II	04903429	09784096

Device / Method 4.

Product Name	Reagent Ref #	Calibrator Ref #
Bayer ADVIA IMS®Glucose	08594722	09784096

5. CSF Imprecision

ADVIA IMS Glucose			ADVIA 1650 Glucose Hexokinase II
Level(mg/dL)	Within-runCV (%)	TotalCV (%)	Level(mg/dL)	Within-runCV(%)	TotalCV (%)
36	2.1	2.3	31	1.6	2.7
60	2.1	2.2	59	1.8	3.1

6. CSF Correlation (X=ADVIA 1650, Y=ADVIA IMS)

N	RegressionEquation	Syx	r	Sample Rangemg/dL
64	Y = 0.92x + 2.3	1.9	0.997	31-132

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7. Interfering Substances

Interfering substances are not expected in cerebrospinal fluid samples.

8. Analytical Range

1 mg/dL - 600 mg/dL

9. Minimum Detectable Concentration

l mg/dL

10/05/2005__________________________________________________________________________________________________________________________________________________________________ Date

Andres Holle Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 Tel: 914-524-3494

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and wings. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

OCT 1 1 2005

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 10591-5097

Re: K052163

Trade/Device Name: Glucose assay for the ADVIA IMS® System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: August 31, 2005 Received: September 1, 2005

Dear Mr. Holle

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becement in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative) it wasternent date of the Medical Device Amendments, or to commerce pror to May 20, 1978, the oncordance with the provisions of the Federal Food, Drug, de rices that have been receised require approval of a premarket approval application (PMA). and Costicule 71ct (71ct) that the neview, subject to the general controls provisions of the Act. The Tou may, alerefore, mainer of the Act include requirements for annual registration, listing of general controls profitions 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 be subject to subir dadnotial controllations (CFR), Parts 800 to 895. In addition, FDA can be found in Thie 21, becaments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advisod that I Dris issuation that your device complies with other requirements of the Act that I Dri has Indus a deted regulations administered by other Federal agencies. You must or any it cacal statutes and regalaments, including, but not limited to: registration and listing (21 comply with an the Prec 11 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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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 I ou may 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,

Carol C. Benem

Carol C. Benson, M.A. Acting 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):_K0521 63

Device Name: Glucose assay for the ADVIA IMS® System

Indications For Use:

The Bayer ADVIA IMS® Glucose method is for in vitro diagnostic device for use to measure glucose in human serum, plasma (lithium heparin), urine and cerebrospinal fluid (CSF) on the ADVIA IMS® system. Such measurements are used as an aid in the diagnosis, monitoring and treatment of carbohydrate metabolism disorders including diabetes mellitus and neonatal hypoglycemia.

Prescription Use _X (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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K052163

Page 1 of

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.