GLU

K981185 · Abbott Laboratories · CFR · May 7, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981185
• Device Name: GLU
• Applicant: Abbott Laboratories
• Product Code: CFR · Clinical Chemistry
• Decision Date: May 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Glucose assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the ALCYON 300/300i Analyzer.

Device Story

In vitro diagnostic assay for quantitative glucose measurement in human serum, plasma, urine, or CSF; performed on ALCYON 300/300i Analyzer. Principle: hexokinase (HK) phosphorylates glucose in presence of ATP/magnesium to form glucose-6-phosphate; glucose-6-phosphate dehydrogenase (G-6-PD) oxidizes this to 6-phosphogluconate, reducing NAD to NADH. NADH production measured spectrophotometrically at 340 nm; absorbance increase proportional to glucose concentration. Used in clinical laboratory settings by trained personnel. Output provides quantitative glucose levels to assist clinicians in diagnosing/managing carbohydrate metabolism disorders.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing demonstrating performance characteristics comparable to predicate devices.

Technological Characteristics

In vitro diagnostic clinical chemistry assay. Principle: Hexokinase/G-6-PD enzymatic reaction with spectrophotometric detection at 340 nm. Designed for use on ALCYON 300/300i Analyzer. No specific materials of construction or connectivity standards provided.

Indications for Use

Indicated for the quantitative determination of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) to aid in the diagnosis and treatment of 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

• Roche Cobas Mira Plus Automated Chemistry System Glucose assay (K953847)
• Boehringer Mannheim Glucose/HK assay on the Hitachi 717 Analyzer (K812303)

Submission Summary (Full Text)

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K981185

# CONFIDENTIAL

MAY 7 1998

## 510(k) Summary

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs [phone] Fax [phone]

| Date of Preparation of this Summary: | March 31, 1998 |
|--------------------------------------------------|----------------|
| Device Trade or Proprietary Name: | Glu |
| Device Common/Usual Name or Classification Name: | Glucose |
| Classification Number/Class: | 75CFR/Class II |

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.

The assigned 510(k) number is:

#### Test Description:

Glucose is an in vitro diagnostic assay for the quantitative determination of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF). The Glucose assay is a clinical chemistry assay in which glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PD) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD) to nicotinamide adenine dinucleotide reduced (NADH). One micromole of NADI-Is produced for each micromole of glucose consumed. The NADH produced absorbs light at 340 nm and can be detected spectrophotometrically as an increased absorbance.

Section II Page I

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#### Substantial Equivalence:

The Glucose assay is substantially equivalent to the following devices:

- Roche® Cobas Mira® Plus Automated Chemistry System Glucose assay (K953847) . for the serum application
- Boehringer Mannheim® Glucose/HK assay on the Hitachi® 717 Analyzer . (K812303) for the urine and CSF applications

These assays yield similar Performance Characteristics.

Similarities to Roche:

- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of glucose. .
- Both assays yield similar clinical results. .

Differences to Roche:

- There is a minor difference between the assay range. .
Similarities to Boehringer Mannheim:

- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of glucose. .
- . Both assays yield similar clinical results.

Differences to Boehringer Mannheim:

- · There is a minor difference between the assay range.
### Intended Use:

The Glucose assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the ALCYON 300/300i Analyzer.

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DEPARTMENT OF

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

7 1998 MAY

Mark Littlefield . Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive 75038 Irving, Texas

Re : K981185 Glucose Requlatory Class: II Product Code: CFR March 31, 1998 Dated: Received: April 2, 1998

Dear Mr. Littlefield:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate 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 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, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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 (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Glucose assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the ALCYON 300/300i Analyzer. 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.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. k 181185

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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use_ OR (Per 21 CFR 801.109)

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