CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS

K033058 · Diamond Diagnostics, Inc. · CGX · Jan 30, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033058
• Device Name: CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
• Applicant: Diamond Diagnostics, Inc.
• Product Code: CGX · Clinical Chemistry
• Decision Date: Jan 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

Mission Creatinine Reagent Kit is for the quantitative determination of creatinine in serum, plasma, or urine on the Beckman Synchron CX® & CX® Delta Systems. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in renal dialysis, and as a calculation basis for measuring other urine analytes.

Device Story

Reagent kit for quantitative creatinine determination in serum, plasma, or urine; designed for use on Beckman Synchron CX and CX Delta systems. Principle of operation: Jaffe reaction; sample mixed with alkaline picric reagent to form red-colored complex. Device measures differential absorbance at 520 nm and 560 nm at 25.6 seconds post-addition. Output is creatinine concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing/treating renal disease and managing dialysis. Benefits include providing diagnostic data for renal function assessment.

Clinical Evidence

Bench testing only. Precision evaluated per NCCLS EP5-A (20 days, 2 runs/day, 2 observations/run); %CV for serum ranged 4.4-8.9%, urine 0.8-12.3%. Method comparison (n=71 serum, n=45 urine) against predicate showed high correlation (r2=0.998 serum, r2=0.999 urine). Recovery studies confirmed accuracy across concentration ranges. Functional sensitivity evaluated via dilution series.

Technological Characteristics

Alkaline picric acid reagent system. Photometric sensing at 520 nm and 560 nm. Designed for automated clinical chemistry analyzers (Beckman Synchron CX/CX Delta). Reagents are liquid-stable, intended as direct replacements for OEM formulations.

Indications for Use

Indicated for quantitative determination of creatinine in serum, plasma, or urine for diagnosis and treatment of renal diseases and renal dialysis.

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 Synchron CX Creatinine Reagent (443340)

Submission Summary (Full Text)

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K033058

JAN § 0 2004

# 510(k) Summary for Mission Diagnostic Creatinine Reagents on Beckman Synchron CX® & CX® Delta Systems

| 1. Submitter's Name & Address | Mission Diagnostics<br>331 Fiske St<br>Holliston MA 01746<br>FAX: [phone] |
|------------------------------------|--------------------------------------------------------------------------------|
| | Contact Person: |
| | Linda Stundtner<br>QA/RA Manager<br>508-429-0450 |
| | |
| | |
| | |
| | |
| Establishment Registration Number: | 3003656721 |
| Date of Preparation: | Jan 19, 2009 |
| 2. Identification of the Device: | |
| Proprietary/Trade name: | Creatinine Reagent Kit for Beckman Synchron CX®<br>& CX® Delta Systems |
| Common or usual name | Creatinine Reagent, Alkaline Picric Reagent |
| Classification name: | Creatinine test system |
| Device Classification | II |
| Regulation Number: | 21 CFR § 862.1225 |

Chemistry (75)

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

Panel:

Product Code:

- Mission claims substantial equivalence to the OEM Reagents listed below: .
CGX

# Substantial Equivalence Table of Product PN's & Trade Names

| Mission Product | | OEM Equivalent | |
|-----------------|----------------------|----------------|----------------------|
| BK-443340D | Creatinine Reagent - | 443340 | Creatinine Reagent - |
| BK-443340AD | Alkaline Buffer | 443340 | Alkaline Buffer |
| BK-443340BD | Picric Acid | 443340 | Picric Acid |

### 4. Device Description:

- Creatinine is determined by mixing a sample with the alkaline picric reagent, Creatinine from . the sample combines with the reagent to produce a red-colored complex. Absorbance readings are taken at both 520 nm and 560 nm at 25.6 seconds after sample addition. The differential absorbance is a direct measure of the concentration of Creatinine in the sample.
- Intended Use: .
- Mission Creatinine Reagent is for the quantitative determination of Creatinine in serum, . plasma or urine on the Beckman Synchron CX® & CX® Delta.
- Creatinine measurements are used in the diagnosis and treatment of renal diseases, in . renal dialysis, and as a calculation basis for measuring other urine analytes.

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- The reagents are intended for use in place of predicate devices. .
- 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 . 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 Mean<br>mg/dL | Swr<br>within run sd | % CV | ST<br>Total sd | %CV |
|-----------------|----|--------------------|----------------------|------|----------------|------|
| Serum Control 1 | 80 | 1.6 | 0.07 | 4.4 | 0.14 | 8.4 |
| Serum Control 2 | 80 | 6.9 | 0.10 | 1.5 | 0.62 | 8.9 |
| Urine Control 1 | 80 | 89 | 0.7 | 0.8 | 10.9 | 12.3 |
| Urine Control 2 | 80 | 217 | 2.2 | 1.0 | 9.5 | 4.4 |

Method Comparison of Mission Creatinine 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 Creatinine Reagent and Beckman Creatinine Reagent in separate calibrated runs. Recoveries of individual observations were compared by least squares regression. The following statistics were obtained:

Mission = 1.000 x Beckman + 0.003 Range = 0.2 to 11.8 mg/dL; r2 = 0.998; df = 70; n = 71; S(yx) = 0.13 mg/dL

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

Mission = 0.988 x Beckman + 0.634 Range = 10 to 400 mg/dL; r2 = 0.999; df = 44; n = 45; S(yx) = 3.17 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 10 mg/dL by adding Creatinine 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 = 400 mg/dL), Urine . Control 1 (expected value = 90 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:

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| Matrix | Range of Conc.<br>Expected, mg/dL | Reagent | Range of average %<br>Recovery | Overall Mean<br>Recovery |
|--------|-----------------------------------|---------|--------------------------------|--------------------------|
| Serum | 9.04 - 0.20 mg/dL | Mission | 85.7 - 105.3 | 98.5 |
| Serum | 9.04 - 0.20 mg/dL | Beckman | 93.4 - 114.3 | 104.2 |
| Urine | 400 - 10 mg/dL | Mission | 87 - 102.1 | 96 |
| Urine | 400 - 10 mg/dL | Beckman | 83 - 102.9 | 96.2 |

Functional sensitivity was evaluated on dilutions of serum samples made from a starting serum of an approximately concentration of 0.9 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 0.9 mg/dL Creatinine which measured/recovered as:
- 0.6 mg/dL with Mission reagent .
- . 0 8 mg/dL with Beckman reagent.

The CX Delta reports Creatinine values to 0.1 mg/dL.

| Dilution | Expected value mg/dL | Mission Reagent | | | | Beckman Reagent | | | |
|----------|----------------------|-----------------|------|----|-------|-----------------|------|----|-------|
| | | Mean | sd | N | %CV | Mean | sd | N | %CV |
| 1 | 0.90 | 0.57 | 0.07 | 20 | 12.9 | 0.79 | 0.06 | 20 | 7.0 |
| 2 | 0.30 | 0.18 | 0.04 | 20 | 25.4 | 0.22 | 0.06 | 20 | 28.0 |
| 3 | 0.18 | 0.08 | 0.04 | 20 | 51.3 | 0.11 | 0.03 | 20 | 28.0 |
| 4 | 0.04 | 0.04 | 0.05 | 5 | 136.9 | 0.00 | 0.00 | 2 | NA |
| 5 | 0.00 | 0.11 | 0.11 | 9 | 94.9 | 0.09 | 0.09 | 11 | 103.8 |

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Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the edge. Inside the circle is a symbol consisting of three stylized, curved lines that resemble a person or a flame. The seal appears to be a logo or emblem, possibly representing a government agency or organization related to health and human services.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 5 0 2004

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

2

k033058 Re:

Trade/Device Name: Mission Diagnostic Creatinine Reagent for Beckman Synchron CX

& Delta Analyzers Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: CGX 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 for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimer 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 of any I ecolul statutes and regisments, 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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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, US, DVM.

Yean 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 Creatinine Reagent for Beckman Synchron CX & Delta Analyzers

Indications For Use:

- Mission Creatinine Reagent Kit is for the quantitative determination of creatinine in serum, . Mission Creathine Reagent Kit is for the qualificano assimilar
plasma, or urine on the Beckman Synchron CX® & CX® Delta Systems.
- Creatinine measurements are used in the diagnosis and treatment of renal diseases, in . Creatinine measuremonts are acculation basis for measuring other urine analytes.

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

510(k) k033058

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