BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT

K033056 · Diamond Diagnostics, Inc. · CDS · Jan 30, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033056
• Device Name: BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT
• Applicant: Diamond Diagnostics, Inc.
• Product Code: CDS · Clinical Chemistry
• Decision Date: Jan 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1770
• Device Class: Class 2

Intended Use

The BUN Reagent for Beckman Synchron CX® & CX® Delta Systems is intended for in vitro diagnostic use for the quantitative determination of blood urea nitrogen (BUN) in serum, plasma, and urine on Beckman Synchron CX® & CX® Delta Analyzers. BUN measurements are useful in the diagnosis and treatment of certain renal and metabolic diseases.

Device Story

Reagent kit for quantitative urea nitrogen (BUN) measurement; used on Beckman Synchron CX and CX Delta analyzers. Input: serum, plasma, or urine samples. Principle: enzymatic conductivity method; Beckman conductivity electrode measures rate of increase in conductivity, proportional to BUN concentration. Output: BUN concentration values (mg/dL). Used in clinical laboratory settings by trained technicians. Results assist physicians in diagnosing and monitoring renal and metabolic diseases. Reagent serves as a direct replacement for OEM-manufactured reagents.

Clinical Evidence

Bench testing only. Precision evaluated per NCCLS EP5-A (N=80 per control). Linearity/recovery assessed across 3-150 mg/dL range. Method comparison performed against predicate using 66 serum and 40 urine samples (r² > 0.99). Functional sensitivity established at 3 mg/dL.

Technological Characteristics

Liquid reagent; Jack Bean Urease (120 U/mL), salts, buffer, preservative. Enzymatic conductivity rate sensing principle. Compatible with Beckman Synchron CX/CX Delta systems. No specific software/connectivity; relies on host instrument for processing and ORDAC function.

Indications for Use

Indicated for patients requiring quantitative BUN measurement in serum, plasma, or urine to assist in the diagnosis and treatment of renal and metabolic diseases. No specific age or gender restrictions; intended for laboratory use.

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 PN 443350 BUN Reagent (K942676, K864236)

Submission Summary (Full Text)

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K033056
Page 2 of 4

JAN 3 0 2004

## 510(k) Summary for Mission Diagnostic BUN Reagent for Beckman Synchron CX® & CX® Delta Systems

#### Submitter's Name & Address 1.

Mission Diagnostics 331 Fiske St Holliston MA 01746 FAX: [phone]

Contact Person: Linda Stundtner QA/RA Manager

508-429-0450

3003656721 Establishment Registration Number:

Date of Preparation:

Jan 19, 2004

### 2. Identification of the Device:

| Proprietary/Trade name: | BUN Reagent for Beckman Synchron CX & Delta Instrument |
|-------------------------|--------------------------------------------------------|
| Common or usual name | BUN Reagent |
| Classification name: | Urea Nitrogen test system |
| Device Classification | II |
| Regulation Number: | 21 CFR § 862.1345 |
| Panel: | Chemistry (75) |
| Product Code: | CGA |

- Mission manufactures reagents intended to serve as direct replacements to like named products . manufactured by Original Equipment Manufactures (OEM)
#### Predicate Device: 3.

- Mission claims substantial equivalence to the OEM Reagent listed below: .
### Substantial Equivalence Table of Product PN & Trade Names

| Mission Product | OEM Equivalent |
|------------------------|--------------------|
| BK-443350D BUN Reagent | 443350 BUN Reagent |

- The predicate reagent, Beckman PN 443350, is encompassed in the 510(k)'s K942676 & . K864236 cleared 11/02/1994 & 12/31/1986 respectively.
### 4. Device Description:

- Urea nitrogen concentration is determined by an enzymatic conductivity method employing a . Beckman Conductivity Electrode. Electronic circuits determine the rate of increase in conductivity, which is directly proportional to the concentration of BUN in the sample.
### Intended Use:

- Mission BUN Reagent is intended for the quantitative determination of urea nitrogen in . serum, plasma, and urine on Beckman Synchron CX & Delta Analyzers.
- BUN measurements are used in the diagnosis and treatment of certain renal and . metabolic diseases.

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- The original equipment manufacturer (OEM) of the instruments and the predicate reagents . which are necessary for the continued operation and use of the instruments.
- Mission uses a similar composition, description and packaging as that used by the OEM in its t products, as shown in the packaging section of this submission.

### 5. Performance Characteristics:

Precision and correlation data are collected per:

- SOP23-01-02 Performance Study Protocol for 510(k) Submission .
### Precison and Correlation are summarized below:

Precision data was collected following the guidelines of NCCLS Guideline EP5-A

- Samples were run for 20 days, 2 runs per day, 2 observations per run on an instrument ● operated according to the manufacturers instructions. The following data was obtained:

| | N | Test<br>Mean<br>mg/dL | Swr<br>within run<br>sd | % CV | ST<br>Total<br>sd | %CV |
|-----------------|----|-----------------------|-------------------------|------|-------------------|-----|
| Serum Control 1 | 80 | 13 | 0.7 | 5.5 | 0.7 | 5.8 |
| Serum Control 2 | 80 | 48 | 1.3 | 2.7 | 3.1 | 6.5 |
| Urine Control 1 | 80 | 58 | 1.2 | 2.1 | 1.9 | 3.3 |
| Urine Control 2 | 80 | 63 | 1.9 | 2.9 | 2.6 | 4.0 |

Method Comparison of Mission BUN Reagent to Beckman Reagent following the guidelines of NCCLS Guideline EP9-A2 was conducted.

Serum samples were spiked or diluted and run in triplicate and tested with each reagent, Mission BUN Reagent and Beckman BUN Reagent in separate calibrated runs. Recoveries of individual observations were compared by least squares regression. The following statistics were obtained:

Mission = 0.892 x Beckman + 1.22 Range = 4 to 87 mg/dL; r2 = 0.997; df = 65; n = 66; Sqxx) = 1.30 mg/dL

Urine controls_were spiked or diluted and run in triplicate and tested with each reagent, Mission BUN Reagent and Beckman BUN Reagent in separate calibrated runs. Recoveries of individual observations were compared by least squares regression. The following statistics were obtained:

Mission = 0.923 x Beckman + 1.054 Range = 4 to 100 mg/dL; r2 = 0.996; df = 41; n = 40; S(yx) = 1.70 mg/dL

Recovery to Expected Values was evaluated for each matrix; serum & urine. Dilutions of the respective matrices were made and measured with Mission and Beckman reagent.

- Pooled Serum was spiked to an expected value of 200 mg/dL by adding urea gravimetrically. Dilutions . were made using the spiked serum, serum, and/or Human serum albumin (HmSA).
- Urine recovery samples were made by mixing Urine Control 2 (expected value = 300 mg/dL), Urine . Control 1 (expected value = 135 mg/dL), and/or Normal saline.

% Recovery = (Measured/expected) x100 was calculated for both Mission and Beckman. Mission and Beckman exhibited similar recoveries across the range of values in all matrices. See table below:

| Matrix | Range of Conc. Expected, mg/dL | Reagent | Range of average % Recovery | Overall Mean Recovery |
|--------|--------------------------------|---------|-----------------------------|-----------------------|
| Serum | 81.0 – 7.5 mg/dL | Mission | 82 – 106 | 97 |
| Serum | 81.0 – 7.5 mg/dL | Beckman | 94 – 111 | 105 |
| Urine | 100 – 10.5 mg/dL | Mission | 85.7 – 103.8 | 97.6 |
| Urine | 100 – 10.5 mg/dL | Beckman | 93.3 – 110 | 101.2 |

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Functional sensitivity was evaluated on dilutions of serum samples made from a starting serum of I uncilentif oncentration of 13.7 mg/dL; and dilutions of 1:3, 1:5.1:11 and a zero. Dilutions were tested as 4 samples per run over 5 calibrated runs.

- The lowest level where the % CV was less than 20% was with the dilution at an expected . value of 3 mg/dL BUN which measured/recovered as:
- 3 mg/dL with Mission reagent .
- . 5 mg/dL with Beckman reagent.

The CX Delta reports BUN values to the whole number.

| | | Mission Reagent | | | | Beckman Reagent | | | |
|----------|----------------------|-----------------|------|----|-------|-----------------|------|----|------|
| Dilution | Expected value mg/dL | Mean | sd | N | %CV | Mean | sd | N | %CV |
| 1 | 13.7 | 14.1 | 0.60 | 20 | 4.3 | 15.1 | 1.52 | 20 | 10.1 |
| 2 | 4.6 | 5.1 | 0.22 | 20 | 4.4 | 6.4 | 0.50 | 20 | 7.9 |
| 3 | 2.7 | 3.1 | 0.22 | 20 | 7.3 | 4.6 | 0.50 | 20 | 10.9 |
| 4 | 0.7 | 1.0 | 0.56 | 20 | 56.2 | 3.0 | 0.97 | 20 | 32.4 |
| 5 | 0.0 | 0.5 | 0.71 | 2 | 141.4 | NA | NA | 0 | NA |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Linda M. Stundtner QA/RA Manager Diamond Diagnostics Mission Diagnostics Division 331 Fiske St. Holliston. MA 01746

JAN \$ 0 2004

k033056 Re:

Trade/Device Name: Mission Diagnostic BUN Reagent for Beckman Synchron CX & CX® Delta Systems

Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Product Code: CDS Dated: December 22, 2003 Received: December 24, 2003

Dear Ms. Stundtner:

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 ror woo waver 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 If your de roo is one 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 r reaso of a reade 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 or unly 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,

Jean M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. 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 (if known): ____________________________________________________________________________________________________________________________________________________

Device Name Mission Diagnostic BUN Reagent for Beckman Synchron CX & CX Delta Systems

Indications For Use:

- Mission BUN Reagent is intended for in vitro diagnostic use for the quantitative deterningtion of . Mission BON Reagent is thenaculer in the allaghesis and urine on Beckman Synchron CX & CX® Delta Analyzers.
- BUN measurements are useful in the diagnosis and treatment of certain renal and metabolic � diseases

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Carol C. Benam for Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) k033056