HICHEM BUN REAGENT

K992847 · Elan Holdings, Inc. · LFP · Oct 14, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992847
• Device Name: HICHEM BUN REAGENT
• Applicant: Elan Holdings, Inc.
• Product Code: LFP · Clinical Chemistry
• Decision Date: Oct 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1770
• Device Class: Class 2

Intended Use

HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems. Urea nitrogen results are used in the treatment of numerous renal and metabolic diseases. This reagent is intended for professional use only.

Device Story

HiChem® BUN Reagent is an in vitro diagnostic reagent for quantitative urea nitrogen measurement; used on Beckman® SYNCHRON CX® and CX® DELTA clinical chemistry systems. The reagent facilitates chemical analysis of serum, plasma, or urine samples; results assist clinicians in diagnosing and monitoring renal and metabolic conditions. Operated by laboratory professionals in clinical settings; the system processes samples and provides numerical urea nitrogen concentrations. The device benefits patients by providing diagnostic data for managing kidney function and metabolic health.

Clinical Evidence

Bench testing only. Precision studies (n=60 per sample) evaluated within-run and total imprecision across serum and urine pools, showing CVs comparable to the predicate. Method comparison studies (n=160 serum/plasma; n=79 urine) using least squares linear regression demonstrated high correlation (r=0.999 and r=1.000 respectively) against the predicate reagent.

Technological Characteristics

In vitro diagnostic chemical reagent for urea nitrogen quantification. Designed for use on automated Beckman® SYNCHRON CX® and CX® DELTA clinical chemistry analyzers. Utilizes standard clinical chemistry analytical principles for BUN determination. No specific materials of construction or software algorithms described beyond standard reagent-based diagnostic chemistry.

Indications for Use

Indicated for the quantitative determination of urea nitrogen in serum, plasma, and urine for professional use in the treatment of renal and metabolic diseases.

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

• SYNCHRON® CX® Systems BUN Reagent Kit (product no. 443350)

Submission Summary (Full Text)

{0}------------------------------------------------

K992847

OCT 14 1999

élan diagnostics

Image /page/0/Picture/3 description: The image shows the logo for "élan". The logo features a stylized letter "e" formed by several parallel lines that curve around to create the shape. To the left of the "e", there are a few short, horizontal lines that resemble the tail of a comet or a stylized wing. Below the symbol, the word "élan" is written in a sans-serif font, with an acute accent over the "e".

Summary of 510(k) Safety and Effectiveness Information

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.

HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems. The HiChem® BUN Reagent Kit is substantially equivalent to the SYNCHRON® CX® Systems BUN Reagent Kit, product no. 443350, manufactured by Beckman Coulter, Inc.

The effectiveness of the BUN Reagent Kit is shown by the following studies.

Precision:

Control sera and diluted urine pools were each assayed twice per day in triplicate using both HiChem® and Beckman® BUN reagents on a SYNCHRON CX® DELTA 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 described in NCCLS publication EP3-T.

Precision of BUN Recoveries (mgN/dL)

| Sample | n | mean | HiChem® Reagent | | Beckman® Reagent | | | | | |
|---------|----|-------|-------------------|-------------------|------------------|--------------|-------------------|-------------------|--------------|--------------|
| | | | Within Run<br>1SD | Within Run<br>%CV | Total<br>1SD | Total<br>%CV | Within Run<br>1SD | Within Run<br>%CV | Total<br>1SD | Total<br>%CV |
| Serum 1 | 60 | 7.1 | 0.65 | 9.1% | 0.66 | 9.4% | 0.65 | 9.1% | 0.60 | 8.4% |
| Serum 2 | 60 | 35.4 | 0.62 | 1.8% | 0.66 | 1.9% | 0.53 | 1.5% | 0.57 | 1.6% |
| Serum 3 | 60 | 63.8 | 0.50 | 0.8% | 0.80 | 1.3% | 0.72 | 1.1% | 0.76 | 1.2% |
| Urine 1 | 60 | 21.7 | 0.89 | 4.1% | 0.82 | 3.8% | 0.62 | 2.9% | 0.63 | 2.9% |
| Urine 2 | 60 | 112.2 | 0.75 | 0.7% | 1.25 | 1.1% | 0.82 | 0.7% | 1.31 | 1.2% |

Two control sera were spiked with urea and assayed as described above using ORDAC sample dilution. Precision of ORDAC BUN Recoveries (mgN/dL)

| Sample | n | mean | 1SD | %CV | 1SD | %CV | n | mean | 1SD | %CV | 1SD | %CV |
|---------|----|------|------|------|------|------|----|-------|------|------|------|------|
| Serum 1 | 60 | 179 | 1.18 | 0.7% | 2.58 | 1.4% | 60 | 180.0 | 1.18 | 0.7% | 2.17 | 1.2% |
| Serum 2 | 60 | 258 | 1.91 | 0.7% | 3.55 | 1.4% | 60 | 262.4 | 1.75 | 0.7% | 2.78 | 1.1% |

{1}------------------------------------------------

## Patient Comparison

Serum and plasma specimens, and urine specimens diluted with 9 parts normal saline, were collected from adult patients and ാലിവി and plasma specifically, and anno opennance and Beckman® and Beckman® BUN reagents. Results were compared by least squares linear regression and the following statistics were obtained.

## Serum/Plasma Comparison

HiChem® = -0.3 mgN/dL + 0.987 x Beckman® Reagent

range = 4 - 126 mgN/dL r = 0.999 n = 160

Urine Comparison

HiChem® = 0.9 mgN/dL + 0.979 x Beckman® Reagent range = 6 - 142 mgN/dL r = 1.000 n = 79

Wynn Jordan

Wynn Stocking Manager of Regulatory Affairs Elan Diagnostics

20 August, 1999

{2}------------------------------------------------

Image /page/2/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 a wavy line representing water beneath it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 4 1999

Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 231 North Puente Street Brea. California 92821

Re: · K992847

> Trade Name: HiChem® BUN Reagent Regulatory Class: II Product Code: LFP Dated: August 20, 1999 Received: August 24, 1999

Dear Mr. Stocking:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 regulations.

{3}------------------------------------------------

## 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 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 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 general 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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

{4}------------------------------------------------

510(k) Number (if known):

K993847

Device Name:

HiChem® BUN Reagent

Indications For Use:

HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems.

Urea nitrogen results are used in the treatment of numerous renal and metabolic diseases.

This reagent is intended for professional use only.

Respectfully,

Wynn Stocking

Regulatory Affairs Manager Elan Diagnostics

20 August, 1999

Sean Cooper
(Division Sign-Off)
Division of Climate

Division of
510(k) Number: K971284

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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)

510(k) Notification, HiChem® BUN Reagent Elan Diagnostics, Brea, California

20 August, 1999 page 52 of 52