GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)

K031135 · Dade Behring, Inc. · CFR · Jun 2, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031135
• Device Name: GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
• Applicant: Dade Behring, Inc.
• Product Code: CFR · Clinical Chemistry
• Decision Date: Jun 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Glucose Flex® reagent cartridge (GLUC) for the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of glucose in human serum, plasma, urine, and cerebrospinal fluid.

Device Story

In vitro diagnostic reagent cartridge for Dimension clinical chemistry systems; measures glucose in serum, plasma, urine, and cerebrospinal fluid. Uses enzymatic hexokinase/glucose-6-phosphate dehydrogenase method; bichromatic endpoint detection of NADH at 340 and 383 nm. Reagents provided in liquid form. Operated by laboratory personnel in clinical settings. Output provides quantitative glucose concentration; assists clinicians in diagnosing/treating carbohydrate metabolism disorders (e.g., diabetes, hypoglycemia, islet cell carcinoma).

Clinical Evidence

Split-sample comparison between subject device and predicate using clinical patient samples. Sample sizes: 162 serum/plasma, 64 urine, 70 cerebrospinal fluid. Results showed high correlation (r=0.999 for serum/plasma, 1.000 for urine/CSF) and slopes near 1.00, demonstrating equivalent performance.

Technological Characteristics

Enzymatic assay (hexokinase/glucose-6-phosphate dehydrogenase); bichromatic endpoint detection at 340/383 nm; liquid reagent format; designed for use on Dimension clinical chemistry systems.

Indications for Use

Indicated for quantitative measurement of glucose in blood and body fluids to diagnose and treat carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

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

• Dimension® Glucose Method (K860021)

Submission Summary (Full Text)

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'JUN - 2 2003

DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

# Summary of Safety and Effectiveness Information

DADE BEHRING

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.

| Submitter's Name: | Lorraine Piestrak<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|--------------------------|----------------------------------------------------------------------------------|
| Date of Preparation: | April 8, 2003 |
| Name of Product: | Glucose Flex® reagent cartridge (GLUC) |
| FDA Classification Name: | Glucose Test System |
| Predicate Device: | Dimension® Glucose Method (K860021) |

#### Device Description:

Intended Use: The Glucose Flex® reagent cartridge (GLUC) for the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of glucose in human serum, plasma, urine, and cerebrospinal fluid.

## Comparison to Predicate Device:

| Item | GLUC Flex® reagent cartridge | GLU Flex® reagent cartridge |
|---------------|----------------------------------------------------------------|-----------------------------------------------------------------|
| Sample Type | Serum, plasma, urine, and<br>cerebrospinal fluid | Serum, plasma, urine, and<br>cerebrospinal fluid |
| Technology | Enzymatic:<br>Hexokinase- glucose-6<br>phosphate dehydrogenase | Enzymatic:<br>Hexokinase- glucose-6-<br>phosphate dehydrogenase |
| Detection | Bichromatic endpoint<br>measurement- NADH<br>(340 & 383 nm) | Bichromatic endpoint<br>measurement- NADPH<br>(340 & 383 nm) |
| Reaction Time | 120 seconds | 180 seconds |
| Reagents | Liquid | Tablets |

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### Comments on Substantial Equivalence:

Split sample comparison between the GLUC Flex® reagent cartridge on the Dimension® clinical chemistry system and the GLU Flex® reagent cartridge also on the Dimension® clinical chemistry system gave the following correlation statistics, when tested with clinical patient samples:

| Sample Type | Slope | Intercept | Correlation Coefficient | n |
|---------------------|-------|-----------|-------------------------|-----|
| Serum/Plasma | 1.01 | 0.01 | 0.999 | 162 |
| Urine | 1.01 | -1.05 | 1.000 | 64 |
| Cerebrospinal Fluid | 1.00 | -0.54 | 1.000 | 70 |

The Glucose Flex® reagent cartridge (GLUC) is substantially equivalent in Conclusion: principle and performance to the Glucose Flex® reagent cartridge (GLU) assay based on the split sample comparison discussed above.

Lorraine Pestiak

Lorraine Piestrak Regulatory Affairs and Compliance Manager Date: April 8, 2003

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES * USA" is arranged in a circular fashion around the bird image.

JUN - 2 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lorraine Piestrak Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, DE 19714

Re: k031135

Trade/Device Name: Glucose Flex® reagent cartridge (GLUC) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: April 8, 2003 Received: April 9, 2003

Dear Ms. Piestrak:

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 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 general controls provisions 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 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 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 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 practice 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 [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 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### Indications For Use Statement

Device Name: Glucose Flex® reagent cartridge (GLUC)

### Indications for Use:

The Glucose Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure glucose 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.

Dan Cooper

Division Sign-Off

**Division Sign-Off**

Office of In Vitro Diagnostic Device i Evaluation and Safety

Lornanie Pestiace

Lórraine Piestrak Regulatory Affairs and Compliance Manager

April 8, 2003

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 有限制的地球流量是最高质量的需要用品质量发展的机构机构合合同品质量需要

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-counter Use

(Optional format 1-2-96)