GLUCOSE

K060383 · Abbott Laboratories · CFR · May 5, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060383
• Device Name: GLUCOSE
• Applicant: Abbott Laboratories
• Product Code: CFR · Clinical Chemistry
• Decision Date: May 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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.

Device Story

In vitro diagnostic assay for quantitative glucose measurement in human serum, plasma, urine, or CSF; utilizes hexokinase/G-6-PDH enzymatic methodology; hexokinase phosphorylates glucose in presence of ATP/magnesium to produce G-6-P; G-6-PDH oxidizes G-6-P to 6-phosphogluconate, reducing NAD to NADH; NADH production measured spectrophotometrically at 340 nm; used on AEROSET and ARCHITECT c8000 systems; operated by laboratory professionals; output provides quantitative glucose concentration; results assist clinicians in diagnosing/managing carbohydrate metabolism disorders.

Clinical Evidence

Bench testing only. Precision studies (CLSI EP5-A/EP10-A) performed on AEROSET and ARCHITECT systems; total %CV ranged from 0.80% to 2.15%. Linearity verified across 5-800 mg/dL (serum) and 1-800 mg/dL (urine/CSF). Interference testing confirmed acceptable recovery (±6% serum, ±10% urine) for common substances (bilirubin, hemoglobin, triglycerides, etc.). Method comparison (n=102 serum, 41 urine, 52 CSF) against predicate showed high correlation (r > 0.999).

Technological Characteristics

Liquid, ready-to-use single reagent kit. Contains NAD (5.0 mg/mL), G-6-PDH (3,000 U/L), Hexokinase (15,000 U/L), ATP 2Na (9.0 mg/mL). Sensing principle: spectrophotometric absorbance at 340 nm. Analyzers: Abbott AEROSET and ARCHITECT c8000. Calibration stability: 30 days. Shelf-life: 12 months.

Indications for Use

Indicated for quantitative measurement of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) to aid in the diagnosis and treatment of 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

• Glucose/HK on the Hitachi 917 Analyzer (k953847)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k060383

B. Purpose for Submission:
New device

C. Measurand:
Glucose

D. Type of Test:
Quantitative enzymatic assay based on Hexokinase/G-6-PDH methodology

E. Applicant:
Abbott Laboratories

F. Proprietary and Established Names:
Glucose Reagent

G. Regulatory Information:
1. Regulation section:
21 CFR §862.1345, Hexokinase, Glucose
2. Classification:
Class II
3. Product code:
CFR
4. Panel:
75 (Chemistry)

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H. Intended Use:

1. Intended use(s):

See Indications for use.

2. Indication(s) for use:

A glucose test system is a device intended to measure glucose quantitatively in blood and other bodily 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.

3. Special conditions for use statement(s):

For Prescription use only.

4. Special instrument requirements:

Abbott AEROSET® and Abbott ARCHITECT® c8000®

I. Device Description:

The Glucose reagent is supplied as a liquid, ready-to-use, single reagent kit which contains:

Ref 3L82-20, R1 10 x 55 mL – estimated test per kit: 9,000
Ref 3L82-40, R1 10 x 90 mL – estimated test per kit: 15,000

| Reactive Ingredients | Concentration |
| --- | --- |
| NAD | 5.0 mg/mL |
| G-6-PDH | 3,000 U/L |
| Hexokinase | 15,000 U/L |
| ATP 2Na | 9.0 mg/mL |

The calibrator recommended for this assay was cleared under k981706.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Glucose/HK on the Hitachi 917 Analyzer

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2. Predicate 510(k) number(s):

k953847

3. Comparison with predicate:

| Assay Characteristics | New Device Glucose (k060383) | Glucose/HK on Hitachi 917 Analyzer (k032377) |
| --- | --- | --- |
| Analyte Measured | Carbon Dioxide | Carbon Dioxide |
| Intended Use | The Glucose assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF). | The Glucose assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF). |
| Assay Principle | Glucose is phosphorylated by Hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD) to nicotinamide adenine dinucleotide reduced (NADH). One micromole of NADH is produced for each micromole of glucose consumed. The NADH produced absorbs light at 340 nm and can be detected spectrophotometrically as an increased absorbance | Glucose is phosphorylated by Hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD) to nicotinamide adenine dinucleotide reduced (NADH). One micromole of NADH is produced for each micromole of glucose consumed. The NADH produced absorbs light at 340 nm and can be detected spectrophotometrically as an increased absorbance |
| Detection of Analyte | Endpoint | Endpoint |
| Samples | Serum, plasma, urine, or cerebrospinal fluid (CSF) | Serum, plasma, urine, or cerebrospinal fluid (CSF) |
| Assay Range | Serum/ Plasma: 5 to 800 mg/dL Urine/CSF: 1 to 800 mg/dL | Serum/ Plasma: 2 to 750 mg/dL Urine/CSF: 2 to 750 mg/dL |
| Analysis Medium | Aqueous solution | Aqueous solution |
| Use of Calibrators | Yes | Yes |
| Use of Controls | Yes | Yes |

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K. Standard/Guidance Document Referenced (if applicable):

EP5-A2 CLSI: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline, Second Edition 2004

EP6-A CLSI: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline Evaluation of Matrix Effects; Approved Guideline, Second Edition 2003

EP7-P CLSI: Interference Testing in Clinical Chemistry; Approved Guideline. Vol 6, No. 13, 1986

EP9-A CLSI: Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. Vol. 15, No. 17, 1995

L. Test Principle:

Glucose is phosphorylated by Hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD) to nicotinamide adenine dinucleotide reduced (NADH). One micromole of NADH is produced for each micromole of glucose consumed. The NADH produced absorbs light at 340 nm and can be detected spectrophotometrically as an increased absorbance

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Serum Application:

The sponsor conducted a total precision study in accordance with CLSI EP5-A for each component of variation (between-day, between-run, and within-run) per protocol. Two control levels (Level 1 and Level 2) at normal and abnormal analyte concentrations were tested. These controls were evaluated over 20 days, two runs per day, and two replicates per run. Precision was reported as the total %CV. Serum precision results are summarized in the below table.

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AEROSET Serum Precision

| Control | | Level 1 | Level 2 |
| --- | --- | --- | --- |
| N | | 80 | 80 |
| Mean (mg/dL) | | 82.28 | 292.19 |
| Within Run | SD | 0.59 | 1.50 |
| | %CV | 0.72 | 0.51 |
| Between Run | SD | 0.57 | 3.84 |
| | %CV | 0.69 | 1.31 |
| Between Day | SD | 0.30 | 0.00 |
| | %CV | 0.36 | 0.00 |
| Total | SD | 0.87 | 4.12 |
| | %CV | 1.06 | 1.41 |

ARCHITECT Serum Precision

| Control | | Level 1 | Level 2 |
| --- | --- | --- | --- |
| N | | 80 | 80 |
| Mean (mg/dL) | | 79.58 | 281.26 |
| Within Run | SD | 1.58 | 1.83 |
| | %CV | 1.98 | 0.65 |
| Between Run | SD | 0.67 | 2.62 |
| | %CV | 0.84 | 0.93 |
| Between Day | SD | 0.00 | 2.80 |
| | %CV | 0.00 | 0.99 |
| Total | SD | 1.71 | 4.24 |
| | %CV | 2.15 | 1.51 |

## Urine and CSF Applications:

The sponsor also conducted a five day precision study in accordance with CLSI EP10-A. This study was intended to supplement data obtained from the twenty-day serum precision study and provides a limited assessment of the performance of the assay with the urine and CSF matrices. Two control levels (Level 1 and Level 2) at normal and abnormal analyte concentrations were tested for the urine and CSF applications. These controls were evaluated over five days, two runs per day, and five replicates per run. Precision was reported as the total $\% \mathrm{CV}$. Urine and CSF precision results are summarized in the below tables.

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AEROSET Urine Precision

| Control | | Level 1 | Level 2 |
| --- | --- | --- | --- |
| N | | 50 | 50 |
| Mean (mg/dL) | | 29.86 | 305.94 |
| Within Run | SD | 0.30 | 2.12 |
| | %CV | 0.99 | 0.69 |
| Between Run | SD | 0.40 | 3.55 |
| | %CV | 1.33 | 1.16 |
| Between Day | SD | 0.00 | 0.00 |
| | %CV | 0.00 | 0.00 |
| Total | SD | 0.49 | 4.13 |
| | %CV | 1.66 | 1.35 |

ARCHITECT Urine Precision

| Control | | Level 1 | Level 2 |
| --- | --- | --- | --- |
| N | | 50 | 50 |
| Mean (mg/dL) | | 29.37 | 300.66 |
| Within Run | SD | 0.25 | 2.28 |
| | %CV | 0.85 | 0.76 |
| Between Run | SD | 0.16 | 0.76 |
| | %CV | 0.54 | 0.25 |
| Between Day | SD | 0.00 | 0.00 |
| | %CV | 0.00 | 0.00 |
| Total | SD | 0.30 | 2.40 |
| | %CV | 1.01 | 0.80 |

AEROSET CSF Precision

| Control | | Level 1 | Level 2 |
| --- | --- | --- | --- |
| N | | 50 | 50 |
| Mean (mg/dL) | | 60.40 | 28.98 |
| Within Run | SD | 0.57 | 0.41 |
| | %CV | 0.95 | 1.41 |
| Between | SD | 0.74 | 0.27 |

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| Run | %CV | 1.23 | 0.92 |
| --- | --- | --- | --- |
| Between Day | SD | 0.00 | 0.00 |
| | %CV | 0.00 | 0.00 |
| Total | SD | 0.94 | 0.49 |
| | %CV | 1.55 | 1.69 |

ARCHITECT CSF Precision

| Control | | Level 1 | Level 2 |
| --- | --- | --- | --- |
| N | | 50 | 50 |
| Mean (mg/dL) | | 59.25 | 28.45 |
| Within Run | SD | 0.46 | 0.20 |
| | %CV | 0.78 | 0.70 |
| Between Run | SD | 0.43 | 0.27 |
| | %CV | 0.72 | 0.94 |
| Between Day | SD | 0.00 | 0.00 |
| | %CV | 0.00 | 0.00 |
| Total | SD | 0.63 | 0.33 |
| | %CV | 1.07 | 1.17 |

# b. Linearity/assay reportable range:

To determine the linear range of analyte concentrations of the Glucose assay on the AEROSET and ARCHITECT c8000 Systems the sponsor assayed ten samples at various concentrations spanning the desired linear range of the assay with four replicates per concentration. At least one level was included which exceeded the desired linear range. The percent recovery for each sample was determined by dividing the mean observed result by the expected value. The sponsor's acceptance criteria were the acceptable difference between the observed result and expected value be within $\pm 6\%$ or $\pm 1\mathrm{mg / dL}$ , whichever is greater, for serum; and $\pm 10\%$ or $\pm 1\mathrm{mg / dL}$ , whichever is greater, for urine.

Serum linearity results are presented in the tables below.

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Glucose - Serum
AEROSET Linearity

| Mean Conc. (mg/dL) | Expected Conc. (mg/dL) | % Recovery |
| --- | --- | --- |
| 899.853 | 864.506 | 104.09 |
| 804.023 | 778.055 | 103.34 |
| 720.345 | 691.605 | 104.16 |
| 532.258 | 518.704 | 102.61 |
| 432.253 | 432.253 | 100.00 |
| 336.563 | 345.802 | 97.328 |
| 162.675 | 172.901 | 94.086 |
| 86.935 | 86.451 | 100.56 |
| 41.320 | 43.225 | 95.592 |
| 8.703 | 8.645 | 100.66 |
| 4.553 | 4.323 | 105.32 |
| 2.700 | 2.161 | 124.93 |

Glucose - Serum
ARCHITECT Linearity

| Mean Conc. (mg/dL) | Expected Conc. (mg/dL) | % Recovery |
| --- | --- | --- |
| 897.031 | 876.5 | 102.35 |
| 812.504 | 788.9 | 103.00 |
| 714.763 | 701.3 | 101.92 |
| 534.571 | 526.1 | 101.62 |
| 438.236 | 438.5 | 99.946 |
| 340.989 | 350.9 | 97.183 |
| 165.448 | 175.7 | 94.180 |
| 87.741 | 88.07 | 99.624 |
| 42.090 | 44.27 | 95.071 |
| 8.746 | 9.232 | 94.738 |
| 4.591 | 4.852 | 94.628 |
| 2.601 | 2.662 | 97.716 |

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The data presented indicate acceptable linearity over the claimed measuring range (5 to 800 mg/dL) for serum.

Urine linearity results are presented in the tables below.

Glucose – Urine
AEROSET Linearity

| Mean Conc. (mg/dL) | Expected Conc. (mg/dL) | % Recovery |
| --- | --- | --- |
| 881.710 | 841.3 | 104.81 |
| 785.773 | 757.1 | 103.78 |
| 702.290 | 673.0 | 104.35 |
| 541.753 | 504.8 | 107.33 |
| 420.628 | 420.6 | 100.00 |
| 330.135 | 336.5 | 98.108 |
| 162.968 | 168.3 | 96.860 |
| 82.800 | 84.13 | 98.424 |
| 40.370 | 42.06 | 95.976 |
| 8.118 | 8.413 | 96.493 |
| 4.045 | 4.206 | 96.166 |
| 2.080 | 2.103 | 98.900 |
| 0.918 | 0.841 | 109.06 |

Glucose – Urine
ARCHITECT Linearity

| Mean Conc. (mg/dL) | Expected Conc. (mg/dL) | % Recovery |
| --- | --- | --- |
| 895.497 | 858.000 | 104.37 |
| 801.910 | 772.200 | 103.85 |
| 706.534 | 686.400 | 102.93 |
| 549.767 | 514.800 | 106.79 |
| 429.000 | 429.000 | 100.00 |
| 339.807 | 343.200 | 99.011 |
| 166.934 | 171.600 | 97.281 |
| 84.825 | 85.800 | 98.864 |

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| Mean Conc. (mg/dL) | Expected Conc. (mg/dL) | % Recovery |
| --- | --- | --- |
| 41.618 | 42.900 | 97.012 |
| 8.205 | 8.580 | 95.629 |
| 3.928 | 4.290 | 91.559 |
| 2.043 | 2.145 | 95.222 |
| 0.733 | 0.858 | 85.456 |

The data presented indicate acceptable linearity of urine over the claimed measuring range (1 to $800\mathrm{mg / dL}$ ) for urine/ CSF.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The reagent calibration stability was determined by the recovery method of Glucose reagent. Fresh reagent was calibrated with fresh calibrators on Day 0. Control material and a prepared test sample near the linear high were analyzed on Day 0, 1, 7, 14, 15, 21, 28, 29, 32, and 33. The sponsor's acceptance criteria were the target for $\%$ recovery was 94 to $106\%$ of the Day 0 results. All test points up to and including Day 33 met the target for $\%$ recovery. The resulting calibration stability claim is 30 days.

The reagent open onboard stability was also determined by the recovery method on multiple lots of Glucose reagent. Fresh reagent was calibrated with fresh calibrators on Day 0. Control material and a prepared test sample near the linear high were analyzed on Day 0, 1, 7, 14, 15, 21, 28, 29, 32 and, 33. The open onboard stability claim is 30 days. The sponsor claims a product shelf-life/expiration of 12 months. Protocols and acceptance criteria were reviewed.

# d. Detection limit:

The sponsor determined the functional sensitivity of the Glucose assay based on the Limit Of Quantitation (LOQ) on the AEROSET and the ACHITECT c8000 Systems. To determine the LOQ, test levels near the linear low for the Glucose assay were run in replicates of 10, on three instruments, two runs per instrument. The limit of quantitation was defined as the lowest concentration of analyte which has imprecision less than or equal to $20\%$ CV. The sponsor's internal verification study supported an LOQ of $5.0~\mathrm{mg / dL}$ (0.278 mmol/L) for the serum application and $1.0~\mathrm{mg / dL}$ (0.056 mmol/L) for the urine/CSF application. The LOD testing for Glucose was performed using a study design based on CLSI EP17-A. An internal verification study by the sponsor supported an LOD of $2.5~\mathrm{mg / dL}$ (0.139 mmol/L) for the serum application, and $1.0~\mathrm{mg / dL}$ (0.056 mmol/L) for the urine/CSF application. The proportions of false positives $(\alpha)$ and false negatives $(\beta)$ were less than $5\%$ and the limit of blank (LOB) was $0.33~\mathrm{mg / dL}$ .

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# e. Analytical specificity:

The sponsor conducted interference studies to evaluate any interference in the Glucose assay caused by bilirubin, hemoglobin, and triglyceride (Intralipid) for serum samples on the AEROSET and ARCHITECT c8000 Systems. For urine samples, testing for interference was performed using hydrochloric acid, sodium fluoride, acetic acid, ascorbate, boric acid, nitric acid, protein, sodium carbonate, and sodium oxalate. Interferents which may falsely elevate or reduce the concentration of an analyte were tested per the work instruction protocol for Glucose. Human serum samples (reference) at two glucose concentrations (Medical Decision Level 1 and 2) and urine samples (reference) were spiked with various levels of interferents.

According to the sponsor, four replicates of each interferent level and four replicates of reference sample were run. The percent recovery was determined by dividing the mean result of each interferent sample by the mean result of the reference sample. The sponsor's acceptance criteria were the level of interference was considered acceptable if there was no more than $\pm 6\%$ difference between the interferent result and the reference result (serum) or no more than $\pm 10\%$ difference between the interferent result and the reference result (urine). Testing was performed using the AEROSET System.

The tables below summarize the results for serum samples, at each decision level, and urine samples, respectively, indicating the highest interferent level at which the percent interference was within $\pm 6\%$ for serum and $\pm 10\%$ for urine.

Glucose - Serum Interfering Substances - Medical Decision Level 1

| Interfering Substance | Interfering Substance Concentration | Target (mg/dL) | Observed (% of Target) |
| --- | --- | --- | --- |
| Bilirubin | 30 mg/dL | 83.1 | 99.89 |
| | 60 mg/dL | 83.1 | 100.11 |
| Hemoglobin | 1,000 mg/dL | 78.2 | 95.59 |
| | 2,000 mg/dL | 78.2 | 91.74 |
| Intralipid | 1,000 mg/dL | 81.0 | 98.21 |
| | 2,000 mg/dL | 81.0 | 97.84 |

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Glucose - Serum
Interfering Substances – Medical Decision Level 2

| Interfering Substance | Interfering Substance Concentration | Target (mg/dL) | Observed (% of Target) |
| --- | --- | --- | --- |
| Bilirubin | 30 mg/dL | 126.3 | 100.66 |
| | 60 mg/dL | 126.3 | 101.14 |
| Hemoglobin | 1,000 mg/dL | 118.3 | 98.29 |
| | 2,000 mg/dL | 118.3 | 96.03 |
| Intralipid | 1,000 mg/dL | 119.1 | 99.70 |
| | 2,000 mg/dL | 119.1 | 99.58 |

Glucose - Urine
Interfering Substances

| Interfering Substance | Interfering Substance Concentration | Target (mg/dL) | Observed (% of Target) |
| --- | --- | --- | --- |
| Hydrochloric Acid (6 N) | 2.5 ml/dL | 16.140 | 101.81 |
| Sodium Fluoride | 400 mg/dL | 16.293 | 100.12 |
| Acetic Acid (8.5 N) | 6.25 ml/dL | 15.948 | 105.55 |
| Ascorbate | 200 mg/dL | 14.995 | 99.53 |
| Boric Acid | 250 mg/dL | 16.050 | 99.58 |
| Nitric Acid (6 N) | 5.0 ml/dL | 15.860 | 105.47 |
| Protein | 50 mg/dL | 15.968 | 102.16 |
| Sodium Carbonate | 1.25 g/dL | 15.930 | 100.86 |
| Sodium Oxalate | 60 mg/dL | 15.705 | 103.87 |

f. Assay cut-off:
Not applicable for this type of device.

2. Comparison studies:
a. Method comparison with predicate device:
The sponsor performed comparative performance studies using the AEROSET® and

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ARCHITECT® c8000® Systems compared to the Glucose/HK assay on the Hitachi 917 Analyzer. The study was conducted in accordance with CLSI EP9-A2 by testing 102 serum samples, 41 urine samples, and 52 CSF samples using each method. A total of 3 serum samples, 12 urine samples, and 12 CSF samples were spiked with NIST SRM917 to generate high analytical levels. A linear regression was performed comparing the results for each method. The ranges of samples tested were as follows - 13.3 to 663.9 mg/dL (Serum), 13.3 to 663.9 mg/dL (Urine), and 10.5 to 697.7 mg/dL (CSF).

Serum application:

| | AEROSET vs. Hitachi | ARCHITECT vs. Hitachi | AEROSET vs. ARCHITECT |
| --- | --- | --- | --- |
| N | 102 | 102 | 102 |
| Y - Intercept | -5.50 | -4.54 | 0.85 |
| Correlation Coefficient | 0.9995 | 0.9993 | 0.9996 |
| Slope | 1.09 | 1.06 | 0.97 |

Urine application:

| | AEROSET vs. Hitachi | ARCHITECT vs. Hitachi | AEROSET vs. ARCHITECT |
| --- | --- | --- | --- |
| N | 41 | 41 | 41 |
| Y - Intercept | -1.35 | -2.67 | -1.36 |
| Correlation Coefficient | 0.9998 | 0.9998 | 0.9999 |
| Slope | 1.09 | 1.04 | 0.96 |

CSF application:

| | AEROSET vs. Hitachi | ARCHITECT vs. Hitachi | AEROSET vs. ARCHITECT |
| --- | --- | --- | --- |
| N | 52 | 52 | 52 |
| Y - Intercept | -4.29 | -3.89 | 0.22 |
| Correlation Coefficient | 0.9998 | 0.9997 | 0.9998 |
| Slope | 1.09 | 1.04 | 0.95 |

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b. Matrix comparison:

Ten (10) subjects were tested using each of the collection tubes to be evaluated. The serum tube used for the baseline was the only glass tube; all other specimen tubes were plastic. Data were analyzed for statistical differences between different tube types. The sponsor's acceptance criteria were acceptability of each anticoagulant is based on a difference of less than $\pm 6\%$ difference between the mean values of all samples/ replicates for each tube type in question and the plain glass serum tube.

Testing was performed using the AEROSET System. The table below summarizes the results of the specimen tube study.

Glucose Specimen Tube - Data Summary

| | | Differences | | | Percent Differences | | | Recoveries | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Substance | N | Mean | Min | Max | Mean | Min | Max | Mean | Min | Max |
| Li Hep Plasma | 15 | 3.000 | -1.602 | 7.330 | 3.362 | -1.538 | 8.043 | 103.36 | 98.462 | 108.04 |
| Li Hep PST | 15 | 4.468 | 0.250 | 8.798 | 4.696 | 0.292 | 11.030 | 104.70 | 100.29 | 111.03 |
| Na Hep Plasma | 15 | 3.334 | 0.302 | 8.355 | 3.533 | 0.318 | 8.812 | 103.53 | 100.32 | 108.81 |
| EDTA Plasma | 15 | 5.205 | 1.135 | 9.283 | 5.421 | 1.325 | 10.820 | 105.42 | 101.32 | 110.82 |
| NaFl/Potassium Oxalate Plasma | 14 | 1.210 | -1.597 | 3.463 | 1.238 | -2.078 | 3.469 | 101.24 | 97.922 | 103.47 |
| SST Serum | 15 | 3.104 | 1.285 | 7.590 | 3.127 | 1.352 | 6.378 | 103.13 | 101.35 | 106.38 |

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable.

b. Clinical specificity:

Not applicable.

c. Other clinical supportive data (when a. and b. are not applicable):

4. Clinical cut-off:

Not applicable.

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5. Expected values/Reference range:

The sponsor’s claimed Expected values/ Reference range were derived from literature.

The sponsor states that the American Diabetes Association recommends use of a fasting glucose concentration of 109 mg/dL (6.0 mmol/L) as the upper limit of “normal.” Population reference ranges in various texts and publications may differ.

Serum/ Plasma

| Fasting | Range (mg/dL) | Range (mmol/L) |
| --- | --- | --- |
| Cord | 45 to 96 | 2.50 to 5.33 |
| Premature | 20 to 60 | 1.11 to 3.33 |
| Neonate | 30 to 60 | 1.67 to 3.33 |
| Newborn, 1 day | 40 to 60 | 2.22 to 3.33 |
| Newborn, > 1 day | 50 to 80 | 2.78 to 4.44 |
| Child | 60 to 100 | 3.33 to 5.55 |
| Adult | 70 to 105 | 3.89 to 5.83 |
| > 60 years | 80 to 115 | 4.44 to 6.38 |
| > 70 years | 83 to 110 | 4.61 to 6.10 |
| Urine | | |
| | Range | Range |
| Random | 1 to 15 mg/dL | 0.1 to 0.8 mmol/L |
| 24 hour | < 0.5 g/day | < 2.8 mmol/day |

Cerebrospinal Fluid

| | Range | Range |
| --- | --- | --- |
| Infant, Child | 60 to 80 | 3.33 to 4.44 |
| Adult | 40 to 70 | 2.22 to 3.89 |

24 Hour Urinary Excretion

To convert results from mg/dL to g/day (24 hour urinary excretion)

Where:
V = 24 hour urine volume (mL)

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c = analyte concentration (mg/dL)

24 hour excretion = [(V x c) ÷ 100,000] mmol/day

To convert results from mmol/L to mmol/day (24 hour urinary excretion)

Where:
V = 24 hour urine volume (mL)
c = analyte concentration (mmol/L)

24 hour excretion = [(V x c) ÷ 1000] mmol/day

The sponsor recommends that each laboratory determine its own reference range based upon its particular locale and population characteristics.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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