UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)

K131189 · Beckman Coulter, Inc. · CFR · Apr 17, 2014 · Clinical Chemistry

Device Facts

• Record ID: K131189
• Device Name: UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
• Applicant: Beckman Coulter, Inc.
• Product Code: CFR · Clinical Chemistry
• Decision Date: Apr 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

UniCel DxC SYNCHRON Systems Glucose reagent (GLUH), when used in conjunction with UniCel® DxC 600/800 SYNCHRON System(s) and SYNCHRON Systems AQUA CAL 1 and 3, is intended for the quantitative determination of glucose concentration in human serum. plasma, urine or cerebrospinal fluid (CSF). 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

In vitro diagnostic reagent kit for quantitative glucose measurement in human serum, plasma, urine, or CSF. Operates on UniCel DxC 600/800 SYNCHRON analyzers using a timed endpoint spectrophotometric method. Reagent contains hexokinase, glucose-6-phosphate dehydrogenase, ATP, and NAD+. Hexokinase catalyzes phosphorylation of glucose to glucose-6-phosphate; G6PDH oxidizes this to 6-phosphogluconate, reducing NAD+ to NADH. NADH production is measured spectrophotometrically. Used in clinical laboratory settings by trained personnel. Output is glucose concentration (mg/dL), used by clinicians to diagnose and manage carbohydrate metabolism disorders. Benefits include accurate, automated glucose quantification for patient monitoring and diagnostic decision-making.

Clinical Evidence

Bench testing only. Precision studies (within-run and total imprecision) conducted per CLSI EP5-A2 using serum, urine, and CSF pools (n=80 per sample type). Linearity verified per CLSI EP6-A (5-700 mg/dL). Method comparison against predicate (k883181) showed high correlation (R=1.000) across all sample types. Interference testing confirmed no significant bias (<10%) for common substances (hemoglobin, bilirubin, etc.). No clinical trials performed.

Technological Characteristics

Spectrophotometric, timed endpoint assay. Reagents: Hexokinase (2.0 KIU/L), G6PDH (3.0 KIU/L), ATP (3.8 mmol/L), NAD+ (2.7 mmol/L). Analytical range: 5-700 mg/dL. Automated system integration with UniCel DxC 600/800 analyzers. Calibration traceable to NIST SRM 917a. Complies with CLSI guidelines for precision (EP5-A2), linearity (EP6-A), and interference (EP7-A2).

Indications for Use

Indicated for quantitative glucose determination in human serum, plasma, urine, or CSF to aid in diagnosis/treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal/idiopathic hypoglycemia, and pancreatic islet cell carcinoma. Prescription use only.

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

• SYNCHRON Systems LX and UniCel DxC GLU reagent (k883181)

Reference Devices

• SYNCHRON Systems AQUA CAL 1 and 3 (k965240)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized circular graphic to the left of the company name. The company name is written in a bold, sans-serif font, with "BECKMAN" on the top line and "COULTER" on the bottom line.

## Summary of Safety & Effectiveness UniCel DxC SYNCHRON Systems Glucose (GLUH) reagent

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

#### 1.0 Submitted By:

Yvette Lloyd Consultant Beckman Coulter, Inc. 250 S. Kraemer Blvd Mail Stop: E1.SE.01 Brea, CA 92821 Phone: [phone] FAX: [phone] email: [e-mail]

#### 2.0 Date Submitted:

April 4, 2014

#### 3.0 Device Name(s):

3.1 Proprietary Names UniCel DxC SYNCHRON Systems Glucose reagent (GLUH)

#### 3.2 Classification Name

Glucose test system (21 CFR 862.1345, Product Code CFR)

#### 4.0 Predicate Devices:

| CANDIDATE | PREDICATE (K#) | Classification<br>— Regulation | Classification<br>Panel | Product<br>Code |
|-------------------------------------------|----------------------------------------|--------------------------------|----------------------------|-----------------|
| UniCel DxC<br>SYNCHRON<br>Systems<br>GLUH | Beckman Coulter GLU<br>assay (K883181) | Class II<br>862.1345 | 75 (Clinical<br>Chemistry) | CFR |

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#### 5.0 Description:

## Reagent:

GLUH reagent is used to measure the glucose concentration by a timed endpoint method. In the reaction, hexokinase (HK) catalyses the transfer of a phosphate group from adenosine triphosphate (ATP) to glucose to form adenosine diphosphate (ADP) and glucose-6phosphate. The glucose-6-phosphate is then oxidized to 6-phosphogluconate with the concomitant reduction of ß-nicotinamide adenine dinucleotide (NAD) to reduced ßnicotinamide adenine dinucleotide (NADH) by the catalytic action of glucose-6-phosphate dehydrogenase (G6PDH).

The UniCel® DxC 600/800 SYNCHRON System(s) automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 100 parts reagent. The system monitors the change in absorbance at 340 nanometers. This change in absorbance is directly proportional to the concentration of glucose in the sample and is used by the System to calculate and express glucose concentration.

The GLUH uses the following chemical reaction scheme:

| Glucose + ATP | <span style="float:left">HK</span> <span style="float:right">glucose-6-phosphate + ADP</span> |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Glucose-6-phosphate + NAD ⁺ | <span style="float:left">G6PDH</span> <span style="float:right">6-phosphogluconate + NADH + H⁺</span> |

#### 6.0 Intended Use:

INTENDED USE

UniCel DxC SYNCHRON Systems Glucose reagent (GLUH), when used in conjunction with UniCel® DxC 600/800 SYNCHRON System(s) and SYNCHRON Systems AQUA CAL 1 and 3, is intended for the quantitative determination of glucose concentration in human serum. plasma, urine or cerebrospinal fluid (CSF).

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.

#### 7.0 Comparison to Predicate(s):

The following tables show the similarities and differences between the modified device and the predicate device identified in Section 4.0 of this summary.

| Characteristics | UniCel DxC<br>SYNCHRON<br>Systems GLUH<br>Reagent | SYNCHRON Systems LX and UniCel DxC GLU<br>reagent (K883181) | List of design inputs that are different between the two reagent devices | | |
|---------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Intended Use | Same | Intended for the quantitative determination of<br>glucose using serum, plasma, urine, or CSF as a<br>sample type. | UniCel DxC SYCNHRON Systems<br>GLUH Reagent | SYNCHRON Systems LX and UniCel<br>DxC GLU'reagent (K883181) | |
| Clinical<br>indications | Same | Glucose measurements are used in the diagnosis<br>and treatment of carbohydrate metabolism<br>disorders including diabetes mellitus, neonatal<br>hypoglycemia, idiopathic hypoglycemia, and<br>pancreatic islet cell carcinoma. | Calibrator used | SYNCHRON Systems AQUA CAL 1<br>SYNCHRON Systems AQUA CAL 3<br>(K071277) | SYNCHRON MultiCal (K110251) |
| Methodology | Same | Timed endpoint method | Calibrator Stability<br>(opened) | 30 days | 20 days |
| Reaction<br>principle | Same | $ Glucose + ATP → glucose-6-phosphate + ADP Glucose-6-phosphate + NAD+ → 6-phosphogluconate + NADH + H+ $ | Interferences | | |
| Fundamental<br>Technology | Same | Spectrophotometric detection | Bilirubin | 24 mg/dL | 24 mg/dL |
| System use | Same (NOTE:<br>GLUH is only<br>applied to the DxC<br>600/800 systems) | For use on clinical chemistry analyzers | Hemoglobin | 500 mg/dL | 400 mg/dL |
| Analytic Range | Same | 5-700 mg/dL | Lipemia | Low pool: Serum index = >6 (3+) (Human<br>lipemia)<br>Mid/High Pool: Serum index = 10(4+)<br>(Human Lipemia) | 400 mg/dL (4+) (Intralipid) |
| Reagent | Same | SYNCHRON Systems Glucose reagent,<br>REAGENT CONSTITUENTS:<br>Adenosine Triphosphate, 3.8 mmol/L; NAD+, 2.7<br>mmol/L; Hexokinase, 2.0 KIU/L; Glucose-6-<br>phosphate dehydrogenase, 3.0 KIU/L;<br>Also non-reactive chemicals necessary for optimal<br>system performance. | Ascorbic Acid | 6.0 mg/dL | 3.0 mg/dL |
| Reference<br>Intervals | Same | Sample type range<br>Serum/plasma 74-106 mg/dL<br>Urine 1-15 mg/dL<br>Urine (timed) <0.5g/24 hours<br>CSF 40-70 mg/dL | Urea | 500 mg/dL | 500 mg/dL |
| Sample Storage<br>and Stability | Same | Serum/plasma<br>1. 8 hours at +20°C to +25°C<br>2. 48 hours at +2°C to +8°C<br>3. > 48 hours at ≤ -15 to -20°C<br><br>Serum/plasma<br>1. 1 freeze/thaw cycle (when stored at -15 to -<br>20°C) | Uric Acid | 40 mg/dL | 20 mg/dL |
| Linearity | Same | Analytical range = 5-700mg/dL, with sample dilution<br>using saline for samples exceeding the high end of<br>the linear range. | EDTA | 16 mg/dL | 8 mg/dL |
| Sample type | Same | Serum/plasma, CSF, urine | Creatinine | 40 mg/dL | 30 mg/dL |
| Within run<br>Precision Claims | Same | SD - 2.0 mg/dL<br>CV - 2.0% | Anticoagulant | Lithium Heparin, Sodium Heparin,<br>Potassium Oxalate/Sodium Fluoride | Ammonium Heparin, Lithium Heparin,<br>Sodium Heparin, Potassium<br>Oxalate/Sodium Fluoride |
| Total Precision<br>Claims | Same | SD - 3.0 mg/dL<br>CV - 3.0% | Sensitivity | ≤5 mg/dL | <5mg/dL |
| Reagent On<br>Board Stability | Same | 30 days | | | |
| Calibration<br>stability | Same | 14 days | | | |
| Within lot<br>calibration | Same | 90 days | | | |

## List of design inputs that are same/similar between the two reagent devices

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#### 8.0 Summary of Non-clinical Performance Data:

A series of studies were performed to evaluate the following non-clinical performance characteristics for the GLUH Reagent: method comparison, anticoagulant, precision, sensitivity, linearity, interferences, sample stability, sample dilution, reagent stability, reference range, and calibration stability experiments.

#### Method Comparison

Methods comparison experiments were designed using CLSI Procedure EP9-A2: "Method Comparison and Bias Estimation Using Patients Samples". The patient correlation studies were conducted using the SYNCHRON Glucose (GLU) (Method X) and the candidate UniCel DxC SYNCHRON Systems Glucose (GLUH) (Method Y) for serum and CSF matrices. Patient correlation studies were conducted using the SYNCHRON modular Glucose (GLUCm) (Method X) and the candidate Beckman Coulter UniCel DxC SYNCHRON Systems Glucose (GLUH) (Method Y) for urine samples. A minimum of 100 samples were tested for each matrix.

| Platform | Sample | Slope | Intercept | R | N |
|-------------------|--------|-------|-----------|-------|-----|
| UniCel DxC<br>600 | Serum | 0.982 | -1.02 | 1.000 | 120 |
| UniCel DxC<br>800 | Serum | 0.999 | -1.60 | 1.000 | 120 |
| UniCel DxC<br>600 | CSF | 0.978 | 1.25 | 1.000 | 100 |
| UniCel DxC<br>800 | CSF | 1.002 | -0.61 | 1.000 | 100 |

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| UniCel DxC<br>600 | Urine | 0.989 | 2.08 | 1.000 | 117 |
|-------------------|-------|-------|------|-------|-----|
| UniCel DxC<br>800 | Urine | 0.973 | 2.86 | 1.000 | 117 |

## Anticoagulant Studies

Anticoagulant experiments were designed using CLSI Procedure EP14-A2: "Evaluation of Matrix Effects: Approved Guidelines - Second Edition". For each anticoagulant tested, paired plasma and serum samples from healthy volunteers were drawn. Over 50 patient specimens with glucose concentrations spanning the analytical range were obtained and tested internally.

| DxC600 | | |
|---------------------------------------|----|-------------------------------|
| Anticoagulant | N | Deming Regression<br>Analysis |
| Sodium Heparin | 79 | $y= 0.983 + 0.849, R= 0.999$ |
| Lithium Heparin | 79 | $y= 0.994 + 0.393, R= 0.999$ |
| Sodium Fluoride/<br>Potassium Oxalate | 79 | $y= 0.995 + 1.007, R= 0.999$ |
| DxC800 | | |
| Anticoagulant | N | Deming Regression<br>Analysis |
| Sodium Heparin | 58 | $y= 0.998 - 0.172, R= 0.999$ |
| Lithium Heparin | 58 | $y= 1.02 - 2.476, R= 1.000$ |
| Sodium Fluoride/<br>Potassium Oxalate | 58 | $y= 1.012 - 0.302, R= 0.999$ |

#### Precision

Precision studies were conducted in accordance with CLSI EP5-A2. Multiple levels of samples were tested 4 times a day for 20 days. The user of a UniCel DxC 600/800 SYNCHRON System(s) should expect the instrument to produce imprecision values less than or equal to the claimed maximum performance limits (S.D. or % CV). The claimed within run SD is 2.0 mo/dL, and the claimed total SD is 3.0 mg/dL. The claimed within run %CV is 2.0, and the claimed total %CV is 3.0. The changeover value is 100.0 mg/dL.

| Type of Imprecision | SAMPLE TYPE | SAMPLE | No. Systems | No. Data Points | GLUH<br>GRAND<br>MEAN<br>(mg/dL) | SD | %CV |
|---------------------|-------------|-----------|-------------|-----------------|----------------------------------|-----|-----|
| Within Run DxC 600 | Serum | Control 1 | 1 | 80 | 43 | 0.7 | 1.6 |
| | Serum | Control 2 | 1 | 80 | 219 | 2.3 | 1.0 |
| | Serum | Control 3 | 1 | 80 | 390 | 5.7 | 1.5 |
| | Serum | Pool 1 | 1 | 80 | 9 | 0.3 | 3.6 |
| | Serum | Pool 2 | 1 | 80 | 101 | 1.1 | 1.1 |
| | Serum | Pool3 | 1 | 80 | 660 | 6.4 | 1.0 |
| | Urine | Pool 1 | 1 | 80 | 10 | 0.3 | 3.2 |
| | Urine | Pool 2 | 1 | 80 | 95 | 0.9 | 1.0 |
| | Urine | Pool 3 | 1 | 80 | 670 | 5.2 | 0.8 |
| | CSF | Pool 1 | 1 | 80 | 11 | 0.3 | 3.0 |

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| | CSF | Pool 2 | 1 | 80 | 100 | 1.3 | 1.2 |
|---------------|-------|-----------|-----|----|-----|------|-------|
| | CSF | Pool3 | 1 | 80 | 677 | 7.0 | 1.0 |
| Total DxC 600 | Serum | Control 1 | 1 | 80 | 43 | 0.8 | 1 9 |
| | Serum | Control 2 | 1 | 80 | 219 | 2.6 | 1.2 |
| | Serum | Control 3 | l | 80 | 390 | ર. ક | 1.7 |
| | Serum | Pool 1 | 1 | 80 | 9 | 0.6 | ਟ: ਰੇ |
| | Serum | Pool 2 | 1 | 80 | 101 | 1.6 | 1.6 |
| | Serum | Pool3 | 1 | 80 | ୧୧୦ | 8.4 | 1.3 |
| | Urine | Pool 1 | l | 80 | 10 | 0.6 | 5.7 |
| | Urine | Pool 2 | - J | 80 | વેટ | 1.4 | 1.5 |
| | Urine | Pool 3 | 1 | 80 | 670 | 6.1 | 0.9 |
| | CSF | Pool 1 | 1 | 80 | 11 | 0.6 | 5.3 |
| | CSF | Pool 2 | 1 | 80 | 109 | 1.6 | 1.5 |
| | CSF | Pool3 | 1 | 80 | 677 | 8.6 | 1.3 |

| Type of Imprecision | SAMPLE TYPE | SAMPLE | No. Systems | No. Data Points | GLUH GRAND<br>MEAN (mg/dL) | SD | %CV |
|---------------------|-------------|-----------|-------------|-----------------|----------------------------|-----|-----|
| Within Run DxC 800 | Serum | Control 1 | 1 | 80 | 43 | 0.5 | 1.2 |
| | Serum | Control 2 | 1 | 80 | 219 | 2.7 | 1.2 |
| | Serum | Control 3 | 1 | 80 | 389 | 6.3 | 1.6 |
| | Serum | Pool 1 | 1 | 80 | 9 | 0.3 | 3.2 |
| | Serum | Pool 2 | 1 | 80 | 101 | 1.1 | 1.1 |
| | Serum | Pool3 | 1 | 80 | 662 | 7.5 | 1.1 |
| | Urine | Pool 1 | 1 | 80 | 10 | 0.3 | 3.0 |
| | Urine | Pool 2 | 1 | 80 | 94 | 1.2 | 1.2 |
| | Urine | Pool 3 | 1 | 80 | 668 | 7.9 | 1.2 |
| | CSF | Pool 1 | 1 | 80 | 11 | 0.3 | 2.3 |
| | CSF | Pool 2 | 1 | 80 | 108 | 1.1 | 1.0 |
| | CSF | Pool3 | 1 | 80 | 680 | 6.7 | 1.0 |
| Total DxC 800 | Serum | Control 1 | 1 | 80 | 43 | 0.7 | 1.7 |
| | Serum | Control 2 | 1 | 80 | 219 | 3.5 | 1.6 |
| | Serum | Control 3 | 1 | 80 | 389 | 7.2 | 1.9 |
| | Serum | Pool 1 | 1 | 80 | 9 | 0.3 | 3.6 |
| | Serum | Pool 2 | 1 | 80 | 101 | 1.2 | 1.2 |
| | Serum | Pool3 | 1 | 80 | 662 | 9.4 | 1.4 |
| | Urine | Pool 1 | 1 | 80 | 10 | 0.4 | 3.7 |
| | Urine | Pool 2 | 1 | 80 | 94 | 1.3 | 1.3 |
| | Urine | Pool 3 | 1 | 80 | 668 | 8.1 | 1.2 |
| | CSF | Pool 1 | 1 | 80 | 11 | 0.4 | 3.6 |
| | CSF | Pool 2 | 1 | 80 | 108 | 1.7 | 1.6 |
| | CSF | Pool3 | 1 | 80 | 680 | 8.1 | 1.2 |

.

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## Analytical Sensitivity (Limits of detection)

Limit of blank (LoB), limit of detection (LoD), and Limit of Quantitation (LoQ) data analyses were performed in accordance with the CLSI EP17-A2 guideline. Multiple urine, CSF and serum pools were run over multiple days to establish and verify the analytical sensitivity claims. The claimed LoB, LoD and LoQ values are ≤5mg/dL.

| | Serum | CSF | Urine |
|-----|--------------|--------------|--------------|
| LoB | 0.19 mg/dL | 0.17 mg/dL | 0.19 mg/dL |
| | 0.011 mmol/L | 0.009 mmol/L | 0.011 mmol/L |
| LoD | 1.74 mg/dL | 1.68 mg/dL | 1.78 mg/dL |
| | 0.097 mmol/L | 0.093 mmol/L | 0.099 mmol/L |
| LoQ | 3.78 mg/dL | 3.67 mg/dL | 3.69 mg/dL |
| | 0.210 mmol/L | 0.204 mmol/L | 0.205 mmol/L |

#### Linearity

The study followed CLSI EP-6A. The testing involves running multiple replicates of the pools over the range of the assav. The concentration Recovery error and %Recovery error were calculated for each sample tested. The recovered concentrations verses the Target concentrations are curve fit with first, second, and third order polynomials. The residual differences for each level between the first order (linear) and the better fitting higher order (second or third polynomial) known as the Nonlinearity Differences are calculated. The data substantiates GLUH test is linear between 5 and 700 mg/dL.

The following are the final linear equations obtained for each matrix:

#### DxC 600

Serum: y= 1.01016x + 1.0881 CSF: y = 1.0075x + 1.5157 Urine: y= 1.0011x + 0.4464

#### DxC 800

Serum: y=1.0035x + 2.1977 CSF: v = 1.0081x + 1.5778 Urine: y= 0.9991x -+ 1.068

#### Interferences

Interference studies were designed from CLSI Guideline EP7-A: "Interference Testing in Clinical Chemistry - Approved Guideline" and used to assess common or known substances which could interfere with the UniCel DxC SYNCHRON Systems GLUH assay. The experiment involves adding potential interfering substances to patient serum pools to determine the magnitude of the effect. A properly operating UniCel DxC 600/800 SYNCHRON System(s) should exhibit interference values less than or equal to: ± 6 mg/dL or 10%, with a crossover value of 60 mg/dL.

| Low Level Glucose Pool | | | | | |
|-------------------------|-------------------|----------------------------|-------------------|----------------------|----------------|
| Substance | Source | Maximum<br>Level<br>Tested | Target<br>(mg/dL) | Recovered<br>(mg/dL) | %<br>recovery* |
| Hemoglobin | RBC<br>hemolysate | 500<br>mg/dL | 45.3 | 43.7 | 96.5 |
| Bilirubin | Bovine | 24 mg/dL | 43.4 | 42.5 | 97.9 |
| Lipemia | Human | (3+) | 46.4 | 45 | 97 |
| Serum Index = 6 | | | | | |
| Ascorbic Acid | NA | 6.0 mg/dL | 43.7 | 43.8 | 100.2 |
| Urea | NA | 500 mg/dL | 54.7 | 55.2 | 100.9 |
| Uric Acid | NA | 40 mg/dL | 42.9 | 44.4 | 103.5 |
| EDTA | NA | 16 mg/dL | 43.6 | 43.4 | 99.5 |
| Creatinine | NA | 40 mg/dL | 45.2 | 44.4 | 98.2 |
| Mid Level Glucose Pool | | | | | |
| Substance | Source | Maximum Level Tested | Target (mg/dL) | Recovered (mg/dL) | % recovery* |
| Hemoglobin | RBC hemolysate | 500 mg/dL | 171.5 | 169.1 | 98.6 |
| Bilirubin | Bovine | 24 mg/dL | 168.7 | 167.9 | 99.5 |
| Lipemia | Human | (4+)<br>Serum Index =>10 | 189.1 | 184.6 | 97.6 |
| Ascorbic Acid | NA | 6.0 mg/dL | 167.7 | 166.4 | 99.2 |
| Urea | NA | 500 mg/dL | 207.1 | 208.9 | 100.9 |
| Uric Acid | NA | 40 mg/dL | 166.8 | 168.4 | 101 |
| EDTA | NA | 16 mg/dL | 167 | 168.1 | 100.7 |
| Creatinine | NA | 40 mg/dL | 173.8 | 173.4 | 99.8 |
| High Level Glucose Pool | | | | | |
| Substance | Source | Maximum Level Tested | Target (mg/dL) | Recovered (mg/dL) | % recovery* |
| Hemoglobin | RBC hemolysate | 500 mg/dL | 410.7 | 406.1 | 98.9 |
| Bilirubin | Bovine | 24 mg/dL | 407.2 | 404.8 | 99.4 |
| Lipemia | Human | (4+)<br>Serum Index =>10 | 461.7 | 453.1 | 98.1 |
| Ascorbic Acid | NA | 6.0 mg/dL | 396.2 | 394.6 | 99.6 |
| Urea | NA | 500 mg/dL | 476 | 477.4 | 100.3 |
| Uric Acid | NA | 40 mg/dL | 397.1 | 405 | 102 |
| EDTA | NA | 16 mg/dL | 402.6 | 404.4 | 100.4 |
| Creatinine | NA | 40 mg/dL | 409.4 | 411.5 | 100.5 |

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Listings of drugs, diseases and other pre-analytical variables known to affect glucose measurements when analyzing Serum, Urine and CSF are described in References (1,2,3). Visually turbid urine specimens should be centrifuged prior to analysis.

## References:

1. Young, D. S., Effects of Drugs on Clinical Laboratory Tests, 5th Edition, AACC Press, Washington, D. C. (2000).

2. Friedman, R. B., Young, D. S.,Effects of Disease on Clinical Laboratory Tests, 4th Edition, AACC Press, Washington, D.C. (2001).

.

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3. Young, D. S., Effects of Preanalytical Variables on Clinical Laboratory Tests, 3rd Edition, AACC Press, Washington, D. C. (2007).

## Sample dilution

The objective of this testing is to determine and verify the appropriate sample diluent to use when diluting out of range samples using the UniCel DxC SYNCHRON Systems Glucose (GLUH) reagent. Saline was chosen as the appropriate diluent. There was no issue or effect observed when verifying saline as an appropriate sample diluent.

#### Reagent stability

The UniCel DxC SYNCHRON Systems Glucose (GLUH) Reagent was tested to verify the onboard stability claim on the UniCel DxC 600/800 SYNCHRON System(s) family of Clinical Chemistry analyzers. The performance assessment involves assaying multiple levels of pooled sera at regular intervals throughout the testing period. The assay was calibrated at 14 day intervals. To be considered acceptable, recovered values must fall within the expected ranges. The testing establishes that the GLUH reagent is stable on board for 30 days.

#### Reference range

Samples reference intervals are based on published literature references.

| Sample | Literature reference |
|---------------|----------------------|
| Serum/Plasma | 74-106 mg/dL |
| Urine | 1-15 mg/dL |
| Urine (timed) | <0.5g/24 hours |
| CSF | 40-70 mg/dL |

#### Literature References

Tietz, N. W., ed., Fundamentals of Clinical Chemistry, 6th Edition, W. B. Saunders; Philadelphia. PA (2007).

Pagana, K D and Pagana, T J, Mosby's Manual of Diagnostic and Laboratory Tests 3rd Edition , Mosby Inc., St Louis, MO (2006).

#### 9.0 Conclusion:

The data for the UniCel DxC SYNCHRON Systems Glucose Reagent (GLUH), in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to the currently cleared SYNCHRON Systems Glucose Reagent (GLU, K883181). Equivalence is demonstrated through method comparison, anticoagulant, precision, sensitivity, linearity, interferences, sample stability, sample dilution, reagent stability, reference range, and calibration stability experiments.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

April 17, 2014

BECKMAN COULTER, INC. YVETTE LLOYD 250 S. KRAEMER ST BREA CA 92821

Re: K131189

Trade/Device Name: UniCel DxC SYNCHRON Systems Glucose Reagent (GLUH) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CFR Dated: April 11, 2014 Received: April 14, 2014

Dear Ms. Lloyd:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2—Ms. Lloyd

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/defauit.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincercly yours,

# Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K131189

#### Device Name

UniCel DxC SYNCHRON Systems Glucose Reagent (GLUH)

## Indications for Use (Describe)

UniCel DxC SYNCHRON Systems Glucose Reagent (GLUH), when used in conjunction with UniCel DxC 600/800 SYNCHRON System(s) and SYNCHRON Systems AQUA CAL 1 and 3, is intended for the quantitative determination of glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF).

Glucose measurements are used in the diagnosis and treatment of carbohydrate including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

... ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘ : . FOR FDA USE ONLY ... Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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