GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS

K033055 · Diamond Diagnostics, Inc. · CGA · Jan 30, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033055
• Device Name: GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
• Applicant: Diamond Diagnostics, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jan 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Mission Glucose Reagent is intended for the quantitative determination of glucose in serum, plasma, cerebrospinal fluid (CSF), and urine on the Beckman Synchron CX® & CX® Delta Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

Device Story

Reagent for quantitative glucose determination in serum, plasma, CSF, and urine; used on Beckman Synchron CX® and CX® Delta systems. Operates via oxygen rate method; Beckman oxygen electrode measures rate of oxygen consumption, which is directly proportional to glucose concentration in sample. Used in clinical laboratory settings by trained personnel. Output is a numerical glucose value (mg/dL) displayed by the host instrument. Healthcare providers use results to diagnose and manage carbohydrate metabolism disorders. Benefits include accurate glucose monitoring for clinical decision-making.

Clinical Evidence

No clinical studies were performed. Evidence is based on bench testing, including precision/reproducibility (N=18 to 80 per sample type), linearity (0.6–25 mmol/L), and method comparison against the predicate. Method comparison studies (N=50 serum, 57 urine, 36 CSF) showed high correlation (r² ≥ 0.997) and regression slopes near 1.0. Functional sensitivity is 10 mg/dL (CV < 20%).

Technological Characteristics

Quantitative electrochemical assay; oxygen rate method using an oxygen electrode. Reagent composition: 590 U/mL glucose oxidase, 10% denatured alcohol, 0.04 mol/L potassium iodide, buffers, ammonium molybdate, and preservatives. Form factor: 500 mL liquid reagent. Designed for use with Beckman Synchron CX®/CX® Delta Systems. Complies with NCCLS EP5-A and EP9-A2 guidance.

Indications for Use

Indicated for quantitative glucose determination in serum, plasma, CSF, and urine for patients with carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Beckman PN 443355 (K942676, K864236)

Submission Summary (Full Text)

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

| Mission Diagnostics<br>331 Fiske St<br>Holliston MA 01746<br>FAX: [phone] | | Linda Stundtn<br>QA/RA Manag<br>508-429-0450 |
|--------------------------------------------------------------------------------|--|----------------------------------------------|
|--------------------------------------------------------------------------------|--|----------------------------------------------|

| Establishment Registration Number: | 3003656721 |
|------------------------------------|--------------|
| Date of Preparation: | Jan 16, 2004 |

2. Identification of the Device:

| Proprietary/Trade name: | Glucose Reagent for Beckman Synchron<br>CX® & CX® Delta Systems |
|-------------------------|-----------------------------------------------------------------|
| Common or usual name | Glucose Reagent |
| Classification name: | Glucose test system |
| Device Classification | II |

Mission manufactures reagents intended to serve as direct replacements to like named products . manufactured by Original Equipment Manufactures (OEM)

21 CFR § 862.1345

Chemistry (75)

## 3. Predicate Device:

Panel:

Regulation Number:

Product Code:

- Mission claims substantial equivalence to the OEM Reagent listed below: .
CGA

## Substantial Equivalence Table of Product PN & Trade Names

| | Mission Product | OEM Equivalent | |
|------------|-----------------|----------------|-----------------|
| BK-443355D | Glucose Reagent | 443355 | Glucose Reagent |

- The predicate reagent, Beckman PN 443355, is encompassed in the 510(k)'s K942676 & ● K864236 cleared 11/02/1994 & 12/31/1986 respectively.
#### 4. Device Description:

- Glucose concentration is determined by an oxygen rate method employing a Beckman Oxygen . Electrode Electronic circuits determine the rate of oxygen consumption, which is directly proportional to the concentration of glucose in the sample45
## Intended Use:

- Mission Glucose Reagent is intended for the quantitative determination of glucose in serum, . plasma, cerebrospinal fluid (CSF) and urine on Beckman Synchron CX® & CX® Delta Systems.
- Glucose measurements are used in the diagnosis and treatment of carbohydrate . metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.

133055

## Contact Person:

Linda Stundtner anager 0450

JAN S 0 2004

Submitter's Name & Address

1.

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- All CX® & CX® Delta Systems that measure glucose utilize the same measurement method . and reagent.
- The original equipment manufacturer (OEM) of the instruments and the predicate reagents . are necessary for the continued operation and use of the instruments.
- The reagent is intended for use on equivalent OEM 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<br>Mean<br>mg/dL | Swr<br>within<br>run sd | % CV | ST<br>Total<br>sd | %CV |
|-----------------|----|-----------------------|-------------------------|------|-------------------|------|
| CSF Control 1 | 80 | 59 | 0.8 | 1.3 | 3.8 | 6.3 |
| CSF Control 2 | 80 | 30 | 1.5 | 5.0 | 3.0 | 10.1 |
| Serum Control 1 | 80 | 89 | 2.1 | 2.3 | 6.0 | 6.7 |
| Serum Control 2 | 80 | 308 | 2.2 | 0.1 | 21.7 | 7.0 |
| Urine Control 1 | 80 | 45 | 1.0 | 2.3 | 2.3 | 5.1 |
| Urine Control 2 | 80 | 287 | 2.4 | 0.8 | 14.4 | 5.0 |

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

Mission = 1.038 x Beckman - 2.31 Range = 0 to 900 mg/dL; r2 = 0.998; df = 49; n = 50; S(vx) = 9.00 mg/dL

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

Mission = 1.022 x Beckman + 1.067 Range = 1 to 293 mg/dL; r2 = 0.998; df = 56; n = 57; Sq(x) = 2.85 mg/dL

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

Mission = 1.014 x Beckman =0.920 Range = 8 to 118 mg/dL; r2 = 0.997; df = 35; n = 36; S((x) = 1.68 mg/dL

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

- Pooled Serum was spiked to an expected value of 950 mg/dL by adding glucose 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 = 50 mg/dL), and/or Normal saline.
- CSF recovery samples were made by mixing CSF Control 2 (expected value = 100 mg/dL), CSF . Control 1 (expected value = 50 mg/dL), and/or Human Serum Albumin.

% 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.<br>Expected, mg/dL | Reagent | Range of average %<br>Recovery | Overall Mean<br>Recovery |
|--------|-----------------------------------|---------|--------------------------------|--------------------------|
| Serum | 835 - 30 mg/dL | Mission | 83.3 - 115.4 | 103 |
| Serum | 835 - 30 mg/dL | Beckman | 83.3 - 117.5 | 103 |
| Urine | 300 - 10 mg/dL | Mission | 88 - 120 | 101 |
| Urine | 300 - 10 mg/dL | Beckman | 87 - 110 | 97 |
| CSF | 100 - 25mg/dL | Mission | 88 - 98 | 94 |
| CSF | 100 - 25mg/dL | Beckman | 88 - 100 | 95 |

Functional sensitivity was evaluated on dilutions of serum samples made from a starting serum of an approximately concentration of 42.5 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 9 mg/dL Glucose which measured/recovered as:
- 10 mg/dL with Mission reagent .
- . 8 mg/dL with Beckman reagent.

The CX Delta reports Glucose values to the whole number.

| Dilution | Expected value mg/dL | Mission Reagent | | | | Beckman Reagent | | | |
|----------|----------------------|-----------------|------|----|------|-----------------|------|----|-------|
| | | Mean | sd | N | %CV | Mean | sd | N | %CV |
| 1 | 43 | 41.9 | 1.52 | 20 | 3.6 | 40.5 | 0.83 | 20 | 2.0 |
| 2 | 14 | 14.7 | 0.75 | 20 | 5.1 | 13.3 | 0.64 | 20 | 4.8 |
| 3 | 9 | 9.8 | 0.95 | 20 | 9.7 | 8.2 | 0.37 | 20 | 4.5 |
| 4 | 2 | 3.6 | 1.35 | 20 | 37.6 | 2.1 | 0.55 | 20 | 26.3 |
| 5 | 0 | 2.0 | 0.65 | 20 | 32.4 | 0.5 | 0.51 | 20 | 113.4 |

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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 stripes extending from its body, representing health and human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the logo.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 5 0 2004

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

k033055 Re:

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

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA 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 use based in 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, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, allere, mass 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 device 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 I least be devilsed that I Dr bration that your device complies with other requirements of the Act that I Dri has made a aoved regulations administered by other Federal agencies. You must or any I ederal banales and states and mot 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.
MC, MS 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 Glucose Reagent for Beckman Synchron CX® & CX® Delta Systems

Indications For Use:

- Mission Glucose Reagent is intended for in vitro diagnostic use for the quantitative determination . Mission Glucose in serum, plasma, cerebrospinal fluid (CSF) and urine on Beckman Synchron CX® & CX® Delta Systems.
- Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism . Oldoose meader omromo are esellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

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. NM
**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033055

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