BUN REAGENT

K040973 · Genchem, Inc. · CDS · Dec 27, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040973
• Device Name: BUN REAGENT
• Applicant: Genchem, Inc.
• Product Code: CDS · Clinical Chemistry
• Decision Date: Dec 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1770
• Device Class: Class 2

Intended Use

The BUN Reagent is to be used for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of renal function and pre renal disease states, such as cardiac decompensation and others.

Device Story

Reagent kit containing urease and surfactants; designed for use on Beckman SYNCHRON CX3® Analyzer. Input: serum, plasma, or urine samples. Principle: enzymatic reaction (urease) followed by conductivity measurement on the CX3 system. Output: quantitative urea nitrogen concentration (mg/dL). Used in clinical laboratory settings by trained technicians. Results assist physicians in assessing renal function and diagnosing pre-renal conditions. Benefits include standardized diagnostic testing for kidney health and related metabolic states.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated over 30 days (n=60 per sample); CVs ranged 0.7%–9.4%. Linearity confirmed 2–300 mg/dL (R=1.00). Sensitivity limit 1.43 mg/dL. Analytical specificity tested against hemoglobin, bilirubin, and lipemia with no adverse effects. Method comparison (n=80 serum/plasma, n=79 urine) against predicate showed high correlation (R² 0.998–1.000, slopes 0.979–0.995).

Technological Characteristics

Reagent formulation containing urease and surfactants. Operates via conductivity measurement on Beckman SYNCHRON CX3® Analyzer. Analytical range 2–300 mg/dL. Compatible with serum, plasma (heparin/EDTA), and urine. No specific materials of construction or software algorithms described beyond standard analyzer integration.

Indications for Use

Indicated for quantitative determination of urea nitrogen in serum, plasma, and urine to aid in diagnosis of renal function and pre-renal disease states (e.g., cardiac decompensation).

Regulatory Classification

Identification

A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Predicate Devices

• Beckman Bun reagent for the CX3 (k761061)

Submission Summary (Full Text)

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DEC 27 2004

# 510(k) SUMMARY K040973

### 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:

### 3.0 Regulatory Information:

- 3.1 Regulation section:
- 3.2 21 CFR § 862.1770, Electrode, Ion Specific, Urea Nitrogen for Beckman Synchron CX3® System
- 3.3 Clasification : Class II
- Product Code: CDS 3.4
- 3.5 Panel: Clinical Chemistry (75)

#### 4.0 Device Description:

The Device is a reagent containing sufficient Urease, surfactants and other ingredients necessary for optimum system operation on the Beckman Synchron CX3® Analyzer.

### 5.0 Substantial Equivalence Information:

- Predicate Device Name: a.
b.

Beckman BUN reagent for the CX3.

c. Predicate K number:

K761061.

Comparison with predicate: The two products have the same intended use, C. utilize the conductivity reactions on the same instrument, have the same analytical range, have the same stability

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

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### Precision/Reproducibility: 6.1

Control sera and diluted urine pools were each assaved twice per day in triplicate on a SYNCHRON CX3® System. Data were collected on ten different days over a thirty day period. Estimates of within run and total imprecision were calculated analogous to the method in NCCLS publication EP3-T.

| Sample | n | mean | Within Run | | | Total Imprecision | |
|---------|----|-------|------------|-----|--|-------------------|-----|
| | | | 1SD | %CV | | 1SD | %CV |
| Serum 1 | 60 | 7.1 | 0.65 | 9.1 | | 0.66 | 9.4 |
| Serum 2 | 60 | 35.4 | 0.62 | 1.8 | | 0.66 | 1.9 |
| Serum 3 | 60 | 63.8 | 0.50 | 0.8 | | 0.80 | 1.3 |
| Urine 1 | 60 | 21.7 | 0.89 | 4.1 | | 0.82 | 3.8 |
| Urine 2 | 60 | 112.2 | 0.75 | 0.7 | | 1.25 | 1.1 |

# Precision of BUN Recoveries in (maN/dL)

### 6.2 Linearity/assay reportable range:

Linearity was performed according to NCCLS Guideline EP6-A. Commercially available linearity standards ranging from 0 to 158 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 0.995 with an intercept of -0.12, a standard error of estimate of 0.49 and re = 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 | Range | Conventional Units | SI Units |
|-----------|--------|--------------------|----------------|
| All | Normal | 2 - 150 mgN/dL | 2-53.6mmol/L |
| All | ORDAC* | 150 - 300 mgN/dL | 53-107.2mmol/L |

### 6.3 SENSITIVITY:

The sensitivity of this method is 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 1.43 mg/dL and is below the claimed limit of 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 BUN level of 15 mg/dL. Stock solutions

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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 are acceptable anticoagulants.

## 7.0

## Patient Comparison

Serum and plasma specimens, and urine specimens diluted with 9 parts normal saline, ranging from 4 to 300 mg/dL were collected from adult patients and assayed for urea nitrogen on a SYNCHRON CX3® System using GenChem and Beckman BUN reagents. Results were compared by least squares linear regression and the following statistics were obtained:

| VALUE | SERUM | PLASMA | URINE |
|-----------|-------|--------|-------|
| Intercept | -0.3 | -0.2 | 0.9 |
| Slope | 0.995 | 0.989 | 0.979 |
| R2 Value | 0.999 | 0.998 | 1.000 |
| N | 80 | 80 | 79 |
| Range | 4-300 | 4-300 | 6-142 |

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is simple and monochromatic.

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: k040973

Trade/Device Name: Electrode, Ion Specific, Urea Nitrogen (BUN) Reagent Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Product Code: CDS 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 yours.

Cornelia B. Lorks

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: K040973

Device Name: Electrode, Ion Specific, Urea Nitrogen (BUN) Reagent

Indications For Use:

The BUN Reagent is to be used for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of renal function and pre renal disease states, such as cardiac decompensation and others.

Alberto Salsi

Office of In Vitro Diagnost Device Evaluation an

510k K040973

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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