ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY

K011963 · Bayer Corp. · CFR · Nov 20, 2001 · Clinical Chemistry

Device Facts

• Record ID: K011963
• Device Name: ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
• Applicant: Bayer Corp.
• Product Code: CFR · Clinical Chemistry
• Decision Date: Nov 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Glucose Hexokinase II in vitro diagnostic procedure is intended to measure glucose in human serum, plasma and urine on the Bayer ADVIA® 1650 System. Such measurement is used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.

Device Story

In vitro diagnostic reagent kit for use on Bayer ADVIA 1650 System; measures glucose levels in human serum, plasma, and urine. Utilizes hexokinase enzymatic method; improved formulation over predicate allows for buffer blanking to subtract potential interferences. System processes samples automatically; provides quantitative glucose concentration results. Used in clinical laboratory settings by trained personnel. Output assists clinicians in diagnosing and managing carbohydrate metabolism disorders, including diabetes and various forms of hypoglycemia. Benefits include improved accuracy through interference reduction.

Clinical Evidence

Bench testing only. Imprecision studies showed total CVs ranging from 2.2% to 4.1% across serum and urine samples. Correlation studies (N=194 serum, N=99 urine) demonstrated high agreement with the predicate (R=0.998 for serum, R=0.999 for urine). Interference testing confirmed minimal impact from bilirubin, hemoglobin, and lipids. Analytical range established at 0-700 mg/dL.

Technological Characteristics

In vitro diagnostic reagent; hexokinase enzymatic assay. Dual-aliquot buffer formulation for blanking. Analytical range 0-700 mg/dL. Designed for use on automated Bayer ADVIA 1650 clinical chemistry analyzer.

Indications for Use

Indicated for measurement of glucose in human serum, plasma, and urine to diagnose and treat carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and insulin overdose.

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

• ADVIA 1650 Glucose Hexokinase (K991576)

Submission Summary (Full Text)

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K011963

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Glucose Hexokinase II method for Bayer ADVIA® 1650 System

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: K011963

## 1. Intended Use

The Glucose Hexokinase II in vitro diagnostic procedure is intended to measure glucose in human serum, plasma and urine on the Bayer ADVIA® 1650 System. Such measurement is used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.

#### 2. Predicate Device

| Product Name | Reagent Part # | Calibrator Part # | Predicate Device # |
|-------------------------------|----------------|-------------------|--------------------|
| ADVIA 1650 Glucose Hexokinase | B01-4129-01 | T03-1291-62 | K991576 |

## 3. Device / Method

| Product Name | REF | Calibrator Part # |
|----------------------------------|----------|-------------------|
| ADVIA 1650 Glucose Hexokinase II | 04903429 | T03-1291-62 |

#### Imprecision

| ADVIA 1650 Glu Hex II | | ADVIA 1650 Glucose Hexokinase | | | |
|-----------------------|------------------|-------------------------------|---------------|------------------|-------------|
| Specimen type | Level<br>(mg/dL) | Total CV(%) | Specimen type | Level<br>(mg/dL) | Total CV(%) |
| Serum | 75 | 2.2 | Serum | 77 | 2.4 |
| Serum | 279 | 2.2 | Serum | 279 | 3.3 |
| Urine | 46 | 4.1 | Urine | 42 | 3.5 |
| Urine | 267 | 3.6 | Urine | 285 | 3.6 |

# Correlation (Y=ADVIA 1650 Glucose Hexokinase II, X=ADVIA 1650 Glucose Hexokinase)

| Specimen type | Comparison<br>System (X) | N | Regression Equation | Syx<br>(mg/dL) | R | Sample Range<br>(mg/dL) |
|------------------------|--------------------------|-----|---------------------|----------------|--------|-------------------------|
| Serum | ADVIA 1650 | 194 | Y=1.02x-1.84 | 7.49 | 0.998 | 49.3-589.8 |
| Urine | ADVIA 1650 | 99 | Y=0.97x-7.44 | 5.68 | 0.999 | 0.0-690.8 |
| Plasma(y) vs Serum(x)* | ADVIA 1650 2 | 35 | Y=1.001x+0.088 | 5.33 | 0.9997 | 73.2-623.05 |

*spiked samples used

#### Interfering Substances

| Interfering<br>Substance | Interfering Sub.<br>Conc. (mg/dL) | Glucose<br>(mg/dL) | Effect<br>(% change) |
|--------------------------|-----------------------------------|--------------------|----------------------|
| Bilirubin | 29.1 | 81.32 | 1.05 |
| Hemoglobin | 522 | 80.6 | 0.78 |
| Lipids (Intralipid) | 630 | 80.2 | -4.7 |

#### Analytical Range

Serum/Plasma/Urine: 0 to 700 mg/dL

Nonclinical testing demonstrates that this device is as safe and effective as the predicate device.

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| Package Insert Sections | Glucose Hexokinase assay<br>(predicate device) | Glucose Hexokinase II assay |
|---------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Intended Use | similar | similar |
| Summary | similar | similar |
| Principle | similar | similar |
| Reagents | Assay buffer in single aliquot for<br>reaction | Assay buffer in dual aliquots.<br>Formulation identical; new format<br>allows for blanking. |
| Storage | similar | similar |
| Stability | 25 days | Similar, actual dating TBD |
| Precautions | similar | similar |
| Indications of<br>Deterioration | similar | similar |
| Performance<br>Characteristics | similar | similar |
| Limitations | Blanking was impossible. Assay<br>potentially susceptible to interferences. | Blanking now possible;<br>interference effects eliminated |
| Parameters | similar | similar |

Table of Similarities and Differences between Glucose Hexokinase and Glucose Hexokinase II assay:

The changes in the assay represent improvements and allow for blanking, with an aliquot of buffer, and hence subtraction of any potential interference effects.

Kenneth Cole

9/25/01

Date

Kenneth T. Edds Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 0 2001

Kenneth T. Edds, Ph.D. Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097

Re: k011963

Trade/Device Name: Glucose Hexokinase II Assay for the Advia 1650 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: September 25, 2001 Received: September 26, 2001

Dear Dr. Edds:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared is (a) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreate) to togens and ment 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). and Cosmetic . Its (. 10) and the device, subject to the general controls provisions of the Act. The r ou may, diereleve, mains 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 (PMA), it If your device to such additional controls. Existing major regulations affecting your device can may be subject to back as a substions, Title 21, Parts 800 to 898. In addition, 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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his lotter will and my of substantial equivalence of your device to a legally marketed nouticate 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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, (Jease contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/odrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

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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510(k) Number: K011963

NOV 2 0 2001

Device Name: Glucose Hexokinase II Assay for the Advia 1650

## Indications for Use:

The Glucose Hexokinase II in vitto diagnostic procedure is intended to measure glucose in human serum, The Chaose Irences. In the Bayer Advia 1650 system. Such measurement is used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.

Thomas C. O'Brien

Division Sion-Off Division of Clinical Laboratory Devices K 011963 510(k) Number.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-CounterUse

(Optional Format 1-2-96)