GLUCOSE OXIDASE, GLUCOSE

K040974 · Genchem, Inc. · CGA · Dec 27, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040974
• Device Name: GLUCOSE OXIDASE, GLUCOSE
• Applicant: Genchem, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Dec 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The GenChem Glucose Oxidase Reagent is used for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid on the Beckman SYNCHRON CX3 System to aid in the diagnosis of diabetes, liver disease and certain endocrine disorders.

Device Story

GenChem Glucose Reagent is a liquid, ready-to-use enzymatic reagent for the Beckman SYNCHRON CX3 System. It utilizes glucose oxidase to catalyze the reaction of glucose with oxygen, producing gluconic acid and hydrogen peroxide. The system monitors oxygen depletion via a polarographic oxygen electrode; the rate of depletion is proportional to glucose concentration. Used in clinical laboratory settings by trained personnel. Output is a quantitative glucose concentration (mg/dL). Results assist clinicians in diagnosing diabetes, liver disease, and endocrine disorders. The device provides a wider linearity range (0-800 mg/dL) compared to the predicate.

Clinical Evidence

Bench testing only. Precision evaluated per NCCLS EP5-A and EP3-T; linearity per NCCLS EP6-A; analytical specificity per NCCLS EP7-A. Patient comparison study (n=45-81 per specimen type) against predicate reagent showed high correlation (R2=0.999) across serum, plasma, urine, and CSF. Sensitivity documented at 5.0 mg/dL.

Technological Characteristics

Reagent solution containing glucose oxidase and surfactants. Operates via enzymatic glucose oxidase method on Beckman SYNCHRON CX3® Analyzer. Analytical range 5-900 mg/dL. Compatible with heparin, EDTA, sodium fluoride, and potassium oxalate anticoagulants. No software algorithm or connectivity features described.

Indications for Use

Indicated for quantitative glucose determination in serum, plasma, urine, and cerebrospinal fluid to aid in diagnosing diabetes, liver disease, and endocrine disorders in adult patients.

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

• Beckman Glucose Reagent for the CX3 (K761060)

Submission Summary (Full Text)

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# 510(k) SUMMARY K040974

### 1.0 Submitted By:

C.C. Allain, Ph.D. Chief Scientific Officer GenChem, Inc. 471 W. Lambert Road, Ste 107 Brea, CA 92821 Telephone: [phone] FAX: [phone]

#### June 1, 2004 2.0 Date of Preparation:

# Regulatory Information: 3.0

- 3.1 Regulation section:
- 21 CFR § 862.1345, Glucose Oxidase Reagent for Beckman 3.2 Synchron CX3® System
- Clasification : Class II 3.3
- 3.4 Product Code: CGA
- 3.5 Panel: Clinical Chemistry (75)

### 4.0 Device Description:

The Device is a solution containing sufficient Glucose Oxidase, surfactants and other ingredients necessary for optimum system operation on the Beckman CX3® Analyzer.

#### Substantial Equivalence Information: 5.0

- a. Predicate Device Name: Beckman Glucose Reagent for the CX3.
- b. Predicate K Number: K761060
- Comparison with Predicate: Both Reagents are similar in design, function and ﻦ chemical principle as well as ingredient composition and concentration.
- Performance Characteristics: All studies were performed on the Beckman 6.0 CX3 Synchron Analyzer.
- 6.1 Precision/Reproducibility: Within-Day and Day-to-Day precision was determined according to NCCLS EP5-A. Results are summarized below:

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Control sera and spiked urine pools were each assayed in triplicate, two times per day over 10 days on a SYNCHRON CX3® System. Estimates of within run and total imprecision were calculated as described in NCCLS publication EP3-T.

Precision of Glucose Recoveries in (mg/dL)

| Sample | Within Run | | | | Total | |
|---------|------------|-----|-----|-----|-------|-----|
| n | mean | SD | %CV | SD | %CV | |
| Serum1 | 60 | 51 | 0.7 | 1.4 | 1.1 | 2.1 |
| Serum 2 | 60 | 220 | 1.3 | 0.6 | 2.3 | 1.1 |
| Serum 3 | 60 | 387 | 2.3 | 0.6 | 5.1 | 1.3 |
| CSF 1 | 60 | 57 | 0.7 | 1.2 | 1.4 | 2.4 |
| CSF 2 | 60 | 33 | 0.6 | 1.9 | 1.4 | 4.1 |
| Urine 1 | 59 | 24 | 0.7 | 2.9 | 1.4 | 5.8 |
| Urine 2 | 60 | 315 | 3.2 | 1.0 | 5.1 | 1.6 |

Two additional control sera were spiked with glucose and assayed as described above using ORDAC sample dilution.

Precision of ORDAC Glucose Recoveries (mg/dL)

| | Within Run | | | Total | | |
|---------|------------|------|-----|-------|------|-----|
| Sample | n | mean | SD | %CV | SD | %CV |
| Serum 1 | 60 | 557 | 8.1 | 1.5 | 10.0 | 1.8 |
| Serum 2 | 60 | 770 | 7.1 | 0.9 | 11.8 | 1.5 |

### Linearity/assay reportable range: 6.2

Linearity was performed according to NCCLS Guideline EP6-A. Commercially available linearity standards ranging from 0 to 800 mg/dL were analyzed in triplicate on the Beckman SYNCHRON CX3® and the results analyzed by the Least Squares method. The results gave a slope of 1.012 with an intercept of 0.1.97, a standard error of estimate of 6.83 and r2 = 1.000. Samples exceeding these limits should be diluted with normal saline and reanalyzed. Multiply the result by the appropriate dilution factor.

| Specimens | range | Conventional units | SI Units |
|-----------|--------|--------------------|------------------|
| All | Normal | 5 to 450 mg/dL | 0.3 to 25 mmol/L |
| All | ORDAC | 450 to 900 mg/dL | 25 to 50 mmol/L |

#### 6.3 SENSITIVITY:

The sensitivity of this method is 5.0 mg/dL and was documented through the repetitive assay of a diluted serum control. The observed sensitivity limit, calculated as three standard deviations of a 21 replicate within run

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precision study, is 0.255 mg/dL and is below the claimed limit of 5.0 mg/dL.

## Analytical Specificity: 6.4

Determined according to NCCLS EP7-A. Hemoglobin levels up to 500 mg/dL, Bilirubin levels up to 20 mg/dL, and Lipemia levels up to 1800 mg/dL were tested and did not show any adverse effect on a stock sample with a glucose level of 96 mg/dL. Stock solutions of the substance to be tested were prepared at 20x concentrations and 0.5 ml of this stock was placed in a 10 ml volumetric flask and made up to volume with the base pool. The control stock was prepared similarly but with water as the diluent. Heparin, Lithium Heparin, Ammonium Heparin, and EDTA, sodium fluoride and potassium oxalate are acceptable anticoagulants.

# Patient Comparison 7.0

Serum, plasma and CSF specimens, and urine specimens spiked with glucose were collected from adult patients and assayed using GenChem and Beckman glucose reagents on a SYNCHRON CX3® System. Results were compared by least squares linear regression and the following statistics were obtained.

| VALUE | SERUM | PLASMA | URINE | CSF |
|---------------|--------|----------|---------|---------|
| Intercept | -1.2 | 1.0 | -2.1 | 1.0 |
| Slope | 1.011 | 1.000 | 1.012 | 0.973 |
| R2 Value | 0.999 | 0.999 | 0.999 | 0.999 |
| N | 79 | 80 | 81 | 45 |
| Range (mg/dL) | 29-341 | 30 - 350 | 1 - 359 | 3 - 186 |

# Expected Values/ Reference Range: 8.0

The expected values for glucose are listed below. Use these ranges only as guides. Each laboratory should establish its own reference ranges.

| | Reference Ranges3 | | |
|----------------|--------------------|--------------------|--|
| Specimens | Conventional Units | SI Units | |
| Serum/Plasma | 70 - 105 mg/dL | 3.89 - 5.83 mmol/L | |
| Urine (Random) | 1 - 15 mg/dL | 0.1 - 0.8 mmol/L | |
| Urine (Timed) | < 0.5 g/day | < 2.8 mmol/day | |
| CSF | 40 - 70 mg/dL | 2.22 - 3.89 mmol/L | |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 27 2004

C.C. Allain, Ph.D. Chief Scientific Officer GenChem, Inc. 471 W. Lambert Road, Suite 107 Brea, CA 92821

Re: k040974

Trade/Device Name: Glucose Oxidase Reagent Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA Dated: October 15, 2004 Received: October 15, 2004

Dear Dr. Allain:

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) rins leter will and my you w obgen finding of substantial equivalence of your device to a legally preshated 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, r you don't 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 Tou 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/dsma/dsmamain.html.

Sincerely yours,

Sincerely yours,

Cornelia B. Lorke

Cornelia B. Rooks, MA 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: K040974

Device Name: Glucose Oxidase Reagent

Indications For Use:

The GenChem Glucose Oxidase Reagent is for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid on the Beckman SYNCHRON CX3® System to aid in the diagnosis of diabetes, liver disease and certain endocrine disorders.

Prescription Use X_

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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

ffice of In Vitro Diagn Device Evaluation and

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