GENCHEM CREATININE REAGENT

K040976 · Genchem, Inc. · CGX · Dec 27, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040976
• Device Name: GENCHEM CREATININE REAGENT
• Applicant: Genchem, Inc.
• Product Code: CGX · Clinical Chemistry
• Decision Date: Dec 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

The GenChem Creatinine Test Reagent System is intended for the quantitative determination of creatinine in serum, plasma and urine on the Beckman SYNCHRON CX3® System and as an aid in the diagnosis of renal impairment and diseases such as chronic glomerulonephritis, diabetic nephropathy, chronic interstitial nephritis and as an indicator of glomerular filtration rate.

Device Story

GenChem Creatinine Test Reagent is an alkaline picrate-based chemical reagent designed for use on the Beckman SYNCHRON CX3® System. It facilitates the quantitative determination of creatinine levels in serum, plasma, and urine samples. The device operates via colorimetric analysis, consistent with the predicate device's chemical principle. It is intended for clinical laboratory use by trained personnel. Healthcare providers use the resulting creatinine concentration to assess renal function, diagnose renal impairment (e.g., diabetic nephropathy, glomerulonephritis), and estimate glomerular filtration rate. The output provides objective data to support clinical decision-making regarding kidney health and disease management.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated over 30 days (n=60 per serum sample, n=59-60 per urine sample) per NCCLS EP3-T; total %CV ranged from 0.5% to 9.8%. Linearity assessed per NCCLS EP6-A (r=1.00). Analytical specificity tested for hemoglobin, bilirubin, and lipemia per NCCLS EP7-A with no adverse effects. Clinical comparison study (n=80 serum, n=80 plasma, n=79 urine) against the predicate device demonstrated high correlation (slope 0.991-1.000, R2 0.997-1.000).

Technological Characteristics

Alkaline picrate reagent for colorimetric creatinine determination. Designed for use on the Beckman SYNCHRON CX3® System. Analytical method follows standard colorimetric principles. Compatible with heparin and EDTA anticoagulants. No specific materials of construction or software algorithms described; device is a chemical reagent system.

Indications for Use

Indicated for quantitative determination of creatinine in serum, plasma, and urine in adult patients to aid in the diagnosis of renal impairment and diseases including chronic glomerulonephritis, diabetic nephropathy, and chronic interstitial nephritis, and as an indicator of glomerular filtration rate.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Predicate Devices

• Beckman Creatinine Reagent for the CX3 (K915077)

Submission Summary (Full Text)

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DEC 27 2004

# 510(k) SUMMARY K040976

### 1.0 Submitted Bv:

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

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

### 3.0 Regulatory Information:

- 3.1 Regulation section:
- 3.2 21 CFR § 862.1225, Creatinine, Alkaline Picrate, Colorimetry Reagent for Beckman Synchron CX3® System
- 3.3 Clasification : Class II
- 3.4 Product Code: CGX
- 3.5 Panel: Clinical Chemistry (75)

### 4.0 Device Description:

The Device is a Reagent containing alkaline picrate for the determination of creatinine for optimum system operation on the Beckman Synchron CX3® System.

### 5.0 Substantial Equivalence Information:

- a. Predicate Device Name: Beckman Creatinine Reagent for the CX3
- b. Predicate K Number: K915077
- c. Comparison with Predicate: Both Reagents are similar in design, function and chemical principle as well as ingredient composition and concentration.

### Performance Characteristics: All studies were performed on the Beckman CX3 6.0 Synchron Analyzer

### 6.1 Precision/Reproducibility:

Control sera and urine pools were each assayed twice per day in triplicate on a SYNCHRON CX3® System. Data were collected on ten different days over a thirty day

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period. Estimates of within run and total imprecision were calculated as described in NCCLS publication EP3-T.

| Precision of Creatinine Recoveries (mg/dL) | | | | | |
|--------------------------------------------|----|---------------------------|-------------|-----|--|
| | | | | | |
| Sample | n | Within Run<br>mean SD %CV | Total<br>SD | %CV | |
| Serum 1 | 60 | 0.5 0.05 9.8 | 0.05 | 9.8 | |
| Serum 2 | 60 | 4.0 0.02 0.5 | 0.02 | 0.5 | |
| Serum 3 | 60 | 7.4 0.03 0.5 | 0.05 | 0.7 | |
| Urine 1 | 59 | 40.3 0.41 1.0 | 0.56 | 1.4 | |
| Urine 2 | 60 | 222.9 2.29 1.0 | 2.79 | 1.3 | |

## Precision of Creatinine Recoveries (mg/dl )

#### 6.2 Linearity/assay reportable range:

Linearity was performed according to NCCLS Guideline EP6-A. Commercially available linearity standards ranging from 0 to 25.7 mg/dl were analyzed in triplicate on the Beckman CX3® and the results analyzed by the Least Squares method. The results gave a slope of 0.994 with an intercept of -0.05, a standard error of estimate of 0.11 and r = 1.00 and is shown below. Specimens exceeding these limits should be diluted with normal saline and reanalyzed. Multiply the result by the appropriate dilution factor.

| Specimens | Conventional Units | SI Units |
|--------------|--------------------|---------------------|
| Serum/Plasma | 0.2 to 25 mg/dL | 0.2 - 2210 mmol/L |
| Urine | 10 - 400 mg/dL | 0.88 - 35.36 mmol/L |

#### SENSITIVITY: 6.3

The sensitivity of this method is 0.2 mg/dL and is 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 precision study, is 0.01 mg/dL and is below the claimed limit of 0.2 mg/dL.

### 6.4 Analytical Specificity:

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 creatinne level of 1.1 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.

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Heparin, Lithium Heparin Ammonium Heparin, and EDTA are acceptable anticoagulants.

### 7.0 Patient Comparison

Serum and plasma, ranging from 0.4 to 30.4 mg/dl and urine specimens ranging from 12.1to 400 mg/dL were collected from adult patients and assayed for creatinine on a SYNCHRON CX3® System using GenChem and Beckman creatinine reagents. Results were compared by least squares linear regression and the following statistics were obtained:

| VALUE | SERUM | PLASMA | URINE |
|-----------|------------|------------|------------------|
| Intercept | 0.0 | 0.05 | -0.3 |
| Slope | 0.991 | 0.998 | 1.000 |
| R2 Value | 0.997 | 0.998 | 1.000 |
| N | 80 | 80 | 79 |
| Range | 0.4 - 30.4 | 0.4 - 30.4 | 12.1 – 400 mg/dl |

### 8.0 Expected Values

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

Normal Ranges

| Specimens | Conventional Units | SI Units |
|--------------|--------------------|----------------------|
| Serum/Plasma | 0.6 - 1.3 mg/dL | 53 - 115 mmol/L |
| Urine | 11 - 26 mg/day/kg | 97 - 230 mmol/day/kg |

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services-USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 27 2004

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

Re: k040976

Trade/Device Name: GenChem Creatinine Test Reagent Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: CGX 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) 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 vours.

Sincerely yours,

Cornelia B. Parks

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: K040976

Device Name: GenChem Creatinine Test Reagent

Indications For Use:

The GenChem Creatinine Test Reagent System is intended for the quantitative determination of creatinine in serum, plasma and urine on the Beckman SYNCHRON CX3® System and as an aid in the diagnosis of renal impairment and diseases such as chronic glomerulonephritis, diabetic nephropathy, chronic interstitial nephritis and as an indicator of glomerular filtration rate.

Division Sign-Off

Office of In Vitro Diag Device Evaluation an

5100k k040976

Prescription Use X

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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AND/OR

IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)