ADVIA IMS GLUCOSE ASSAY

K052163 · Bayer Healthcare, LLC · CFR · Oct 11, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052163
• Device Name: ADVIA IMS GLUCOSE ASSAY
• Applicant: Bayer Healthcare, LLC
• Product Code: CFR · Clinical Chemistry
• Decision Date: Oct 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

ADVIA IMS® Glucose Assay; quantitative in vitro diagnostic test. Input: human serum, plasma, urine, or cerebrospinal fluid (CSF) samples. Principle: colorimetric endpoint chemistry; hexokinase (HK) catalyzes glucose phosphorylation using ATP; glucose-6-phosphate dehydrogenase (G6PD) catalyzes NAD-mediated oxidation of glucose-6-phosphate to 6-phosphoglucono-δ-lactone, producing NADH. Output: NADH concentration proportional to glucose concentration. Used in clinical laboratory settings; operated by laboratory technicians. Output used by clinicians to diagnose, monitor, and treat carbohydrate metabolism disorders (e.g., diabetes, neonatal hypoglycemia).

Clinical Evidence

No clinical studies performed. Analytical performance established via bench testing. Precision evaluated per CLSI EP5-A (N=64-65, CV 2.1-2.3%). Linearity confirmed 1-600 mg/dL. Method comparison with predicate using 64 CSF samples showed r=0.997, y=0.92x + 2.3 mg/dL. Traceability to CDC reference method via NIST materials.

Technological Characteristics

Enzymatic assay utilizing hexokinase and glucose-6-phosphate dehydrogenase. Analytical range: 1-600 mg/dL. Minimum detectable concentration: 1 mg/dL. Designed for use on the ADVIA IMS System platform.

Indications for Use

Indicated for use as an in vitro diagnostic to measure glucose in human serum, plasma (lithium heparin), urine, and cerebrospinal fluid (CSF) on the ADVIA IMS® system to aid in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders, including diabetes mellitus and neonatal hypoglycemia.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Bayer ADVIA® 1650 Glucose Hexokinase II (k042015)

Submission Summary (Full Text)

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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

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.

#### 2. Assay Principle

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.

#### 3. Predicate Device

| Product Name | Reagent Ref # | Calibrator Ref # |
|--------------------------------------------|---------------|------------------|
| Bayer ADVIA® 1650<br>Glucose Hexokinase II | 04903429 | 09784096 |

#### Device / Method 4.

| Product Name | Reagent Ref # | Calibrator Ref # |
|-----------------------------|---------------|------------------|
| Bayer ADVIA IMS®<br>Glucose | 08594722 | 09784096 |

### 5. CSF Imprecision

| ADVIA IMS Glucose | | | ADVIA 1650 Glucose Hexokinase II | | |
|-------------------|----------------------|-----------------|----------------------------------|---------------------|-----------------|
| Level<br>(mg/dL) | Within-run<br>CV (%) | Total<br>CV (%) | Level<br>(mg/dL) | Within-run<br>CV(%) | Total<br>CV (%) |
| 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 | Regression<br>Equation | Syx | r | Sample Range<br>mg/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: [phone]

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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 [phone]. 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 [phone] or [phone] 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)

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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

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