← Product Code [CGA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA) · K100187

# EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT (K100187)

_Medica Corp. · CGA · May 5, 2010 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K100187

## Device Facts

- **Applicant:** Medica Corp.
- **Product Code:** [CGA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA.md)
- **Decision Date:** May 5, 2010
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1345
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry
- **Attributes:** Pediatric

## Indications for Use

The EasyRA Glucose Trinder (GLU-T) Reagent is for the measurement of glucose in serum and plasma using the "EasyRA chemistry analyzer". Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. For in vitro diagnostic use only The EasyRA Glucose Hexokinase (GLU-H) Reagent is for the measurement of glucose in serum and plasma using the "EasyRA chemistry analyzer". Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. For in vitro diagnostic use only

## Device Story

EasyRA Glu-T and Glu-H reagents are quantitative photometric assays for glucose measurement on the EasyRA chemistry analyzer. This submission adds plasma (Na-Heparin or NaF/K oxalate) as an acceptable sample matrix to previously cleared serum-only assays. The device uses enzymatic reactions: Glu-T uses glucose oxidase/peroxidase to produce a quinoneimine dye measured at 520 nm; Glu-H uses hexokinase/glucose-6-phosphate dehydrogenase to produce NADH measured spectrophotometrically. The analyzer calculates glucose concentration by comparing sample absorbance to calibrator absorbance. Used in clinical laboratory settings by trained personnel. Output assists clinicians in diagnosing and managing metabolic disorders.

## Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance characteristics typical for glucose test systems.

## Technological Characteristics

Reagents for glucose measurement using Trinder (glucose oxidase/peroxidase) and Hexokinase enzymatic methods. Designed for use on the EasyRA chemistry analyzer. In vitro diagnostic use only.

## Regulatory 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.

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

1 of 7

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

A. 510(k) Number:
k100187

B. Purpose for Submission:
This submission is for the addition of plasma as a matrix for two cleared glucose assays EasyRa Glu-T Reagent k070057 and EasyRa Glu-H Reagent k092506

C. Measurand:
Glucose

D. Type of Test:
Quantitative Photometric Assays

E. Applicant:
Medica Corp.

F. Proprietary and Established Names:
EasyRA Glu-T Reagent, EasyRA Glu-H Reagent

G. Regulatory Information:

1. Regulation section:
21CFR862.1345-Glucose test system.

2. Classification:
Class II

3. Product code:
CFR - Hexokinase, Glucose
CGA - Glucose Oxidase, Glucose

4. Panel:
Chemistry (75)

H. Intended Use:

1. Intended use(s):
See indication(s) for use below

2. Indication(s) for use:
The EasyRA Glucose Trinder (GLU-T) Reagent is for the measurement of glucose in serum and plasma using the "EasyRA chemistry analyzer". Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.

{1}

For in vitro diagnostic use only

The EasyRA Glucose Hexokinase (GLU-H) Reagent is for the measurement of glucose in serum and plasma using the "EasyRA chemistry analyzer". Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.

For in vitro diagnostic use only

3. Special conditions for use statement(s): For prescription use
4. Special instrument requirements: EasyRA chemistry analyzer (k070057)

I. Device Description:

GLUCOSE-Trinder (Glu-T)

Phosphate Buffer, pH 7.4 13.8 mmol/L
Phenol 10 mmol/L
4-Aminoantipyrine 0.3 mmol/dL
Glucose oxidase • 10,000 U/L
Peroxidase • 700 U/L

The reagent is ready to use supplied in wedges each contain a usable volume of 39 mL of reagent.

GLUCOSE-Hexokinase (Glu-H)

Glucose Buffer Reagent (R1):
TRIS Buffer (pH 7.8) 80 mmol/L
Nicotinamide Adenine Dinucleotide (NAD) 1.7 mmol/L
Adenosine Triphosphate (ATP) 1.7 mmol/L
Magnesium 4 mmol/L

Glucose Enzyme Reagent (R2):
Magnesium 4 mmol/L
Hexokinase > 1.5 KU/L
Glucose-6-phosphate dehydrogenase > 1.5 KU/L

The reagent is ready to use supplied in wedges each contain a usable volume of 29 mL of R1 reagent and 6 mL of R2 reagent

J. Substantial Equivalence Information:

2 of 7

{2}

1. Predicate device name(s):

EasyRA Glu-T Reagent k070057, EasyRA Glu-H Reagent k092506

2. Comparison with predicate:

|  Similarities and differences  |   |   |
| --- | --- | --- |
|  Item | The EasyRA Glucose Trinder (GLU-T) Reagent – Candidate Device | EasyRA Glu-T Reagent k070057-Predicate  |
|  Intended use | For the measurement of glucose using the "EasyRA chemistry analyzer". | Same  |
|  Reagents | Glucose trinder reagents | Same  |
|  Analyzer used | EasyRA chemistry analyzer | Same  |
|  Sample matrix | Serum and Plasma | Serum  |
|  Similarities and differences  |   |   |
| --- | --- | --- |
|  Item | The EasyRA Glucose Hexokinase (GLU-H) Reagent – Candidate Device | EasyRA Glu-H Reagent k092506 -Predicate  |
|  Intended use | For the measurement of glucose using the "EasyRA chemistry analyzer". | Same  |
|  Reagents | Glucose hexokinase reagent | Same  |
|  Analyzer used | EasyRA chemistry analyzer | Same  |
|  Sample matrix | Serum and Plasma | Serum  |

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

CLSI - Method Comparison and Bias Estimation Using Patient Samples - EP09-A2
CLSI - Evaluation of Precision Performance of Clinical Chemistry Devices - EP05-A2

# L. Test Principle:

GLUCOSE-Trinder (Glu-t)

The enzymatic endpoint reaction, based on the early work of Trinder and the later method of Burrin is as follows:

{3}

![img-0.jpeg](img-0.jpeg)

The quinoneimine dye component is measured spectrophotometrically at an absorbance peak of  $520~\mathrm{nm}$ . The rate of the formation of the dye is directly proportional to the Glucose in the sample. After completion of the assay the Medica EasyRA Chemistry Analyzer calculates the Glucose concentration from the ratio of the absorbance of the unknown sample to the absorbance of the calibrator, multiplied by the calibrator value.

GLUCOSE- Hexokinase (Glu-h)

This method uses hexokinase to phosphorylate glucose as follows:

Hexokinase/Mg++

D-glucose + ATP -Glucose-6-P + ADP

Glucose-6-P dehydrogenase

Glucose-6-P + NAD+ -6-Phosphogluconate + NADH + H+

After completion of the assay the Medica EasyRA Chemistry Analyzer calculates the Glucose concentration from the ratio of the absorbance of the unknown sample to the absorbance of the calibrator, multiplied by the calibrator value.

# M. Performance Characteristics (if/when applicable):

# 1. Analytical performance:

# a. Precision/Reproducibility:

Serum Precision was provided in k070057 and k092506

Precision studies were performed in conjunction with the matrix comparison study. Duplicate plasma and serum samples from the matrix studies were calculated for average SD for 3 partitioned bins covering the ranges tested. The average SD in each of the 3 bins for both plasma and serum are comparable. Results are summarized below:

|  GLU-T Summary of Precision Studies using Na-Heparin  |   |   |   |
| --- | --- | --- | --- |
|  Analytical Range | Low | Medium | High  |
|   |  10 - 100 | 100 - 150 | 150 - 400  |
|  Mean (all samples) | 76.2 | 117.4 | 284.4  |
|  No. of samples | 36 | 19 | 12  |
|  No. of replicates | 2 | 2 | 2  |
|  |   |   |   |
|  Serum SD | 0.80 | 1.43 | 3.16  |
|  GLU-T Summary of Precision Studies using NaF/K oxalate  |   |   |   |
| --- | --- | --- | --- |
|  Analytical Range | Low | Medium | High  |
|   |  10 - 100 | 100 - 150 | 150 - 400  |
|  Mean (all samples) | 78.5 | 114.1 | 321.3  |
|  No. of samples | 25 | 14 | 7  |
|  No. of replicates | 2 | 2 | 2  |
|  |   |   |   |
|  Serum SD | 0.97 | 1.28 | 2.27  |

{4}

|  Serum CV | 1.0% | 1.2% | 1.1%  |
| --- | --- | --- | --- |
|  |   |   |   |
|  Plasma SD | 0.98 | 1.57 | 2.61  |
|  Plasma CV | 1.3% | 1.3% | 0.92%  |
|  Serum CV | 1.2% | 1.1% | 0.71%  |
| --- | --- | --- | --- |
|  |   |   |   |
|  Plasma SD | 0.91 | 1.24 | 2.55  |
|  Plasma CV | 1.2% | 1.1% | 0.79%  |
|  GLU-H Summary of Precision Studies using Na-Heparin  |   |   |   |
| --- | --- | --- | --- |
|  Analytical Range | Low | Medium | High  |
|   |  10 - 100 | 100 - 150 | 150 - 600  |
|  Mean (all samples) | 75.3 | 119.6 | 246.8  |
|  No. of samples | 40 | 16 | 9  |
|  No. of replicates | 2 | 2 | 2  |
|  |   |   |   |
|  Serum SD | 0.89 | 1.1 | 1.8  |
|  Serum CV | 1.2% | 0.92% | 0.73%  |
|  |   |   |   |
|  Plasma SD | 0.86 | 0.77 | 2.7  |
|  Plasma CV | 1.1% | 0.65% | 1.1%  |
|  GLU-H Summary of Precision Studies using NaF/K oxalate  |   |   |   |
| --- | --- | --- | --- |
|  Analytical Range | Low | Medium | High  |
|   |  10 - 100 | 100 - 150 | 150 - 600  |
|  Mean (all samples) | 78.8 | 116.4 | 245.5  |
|  No. of samples | 29 | 10 | 5  |
|  No. of replicates | 2 | 2 | 2  |
|  |   |   |   |
|  Serum SD | 0.90 | 0.89 | 1.18  |
|  Serum CV | 1.1% | 0.77% | 0.48%  |
|  |   |   |   |
|  Plasma SD | 0.88 | 1.34 | 1.84  |
|  Plasma CV | 1.1% | 1.2% | 0..75%  |

# b. Linearity/assay reportable range:

Provided in k070057 and k092506

Due to potential dilution effect on plasma matrix verses serum matrix the applicant conducted extended range recovery for Na-Heparined plasma using a dilution factor of 2 at 3 high ranges:

GLU-T

|   | Range | Estimate (mg/dL) | Manual Diluted Sample calculated (mg/dL) | EasyRA Rerun extended range (mg/dL) | % recovery  |
| --- | --- | --- | --- | --- | --- |
|  High | 670 - 800 | 755 | 753 | 766 | 101.7%  |
|  Medium | 530 - 670 | 600 | 684 | 671 | 98.1%  |
|  Low | 400 - 530 | 425 | 498 | 494 | 99.1%  |

GLU-H

|   | Range | Estimate (mg/dL) | Manual Diluted Sample calculated (mg/dL) | EasyRA Rerun extended range (mg/dL) | % recovery  |
| --- | --- | --- | --- | --- | --- |
|  High | 1000 - 1200 | 1150 | 1108 | 1113 | 100.4%  |
|  Medium | 800 - 1000 | 900 | 956 | 950 | 99.4%  |
|  Low | 600 - 800 | 650 | 679 | 693 | 102.1%  |

c. Traceability, Stability, Expected values (controls, calibrators, or methods): Provided in k070057 and k092506
d. Detection limit: Provided in k070057 and k092506
e. Analytical specificity: Provided in k070057 and k092506

{5}

f. Assay cut-off: Provided in k070057 and k092506

2. Comparison studies:

a. Method comparison with predicate device: Provided in k070057 and k092506

b. Matrix comparison: The following tables list the data obtained in a comparison of matched serum (x) and plasma (y) samples using the Medica Reagents for Glu-T and Glu-H on the Medica EasyRA Chemistry Analyzer. Some samples are spiked or diluted in order to cover the hard-to-find sample range. The data analysis below represents a single plasma determination vs. the average of two replicate serum values.

Medica Reagents for Glu-T

|  Sodium Heparin as Anticoagulant |   | Sodium fluoride Potassium Oxalate as Anticoagulant  |   |
| --- | --- | --- | --- |
|  Number of Samples | 65 | Number of Samples | 44  |
|  Range of Samples | 9 to 396 mg/dL | Range of Samples | 9 to 393 mg/dL  |
|  Slope | 0.9844 | Slope | 0.9954  |
|  y Intercept | 1.648 | y Intercept | 1.498  |
|  Correlation Coefficient Regression Equation | 0.997 Y = 0.9844·X + 1.648 | Correlation Coefficient Regression Equation | 0.9954 Y = 0.9954·X + 1.498  |

Medica Reagents for Glu-H

|  Sodium Heparin as Anticoagulant |   | Sodium fluoride Potassium Oxalate as Anticoagulant  |   |
| --- | --- | --- | --- |
|  Number of Samples | 57 | Number of Samples | 46  |
|  Range of Samples | 10 to 515 mg/dL | Range of Samples | 11 to 570 mg/dL  |
|  Slope | 0.9948 | Slope | 0.9985  |
|  y Intercept | -0.3733 | y Intercept | -0.0375  |
|  Correlation Coefficient | 0.9979 | Correlation Coefficient | 0.9979 Regression  |
|  Regression Equation: | y = 0.9948·X - 0.3733 | Regression Equation. | y = 0.9985·X - 0.0375  |

Duplicate plasma and serum samples from the above studies were calculated for average SD for 3 partitioned bins covering the ranges tested. The average SD in each of the 3 bins for both plasma and serum are comparable.

{6}

The sponsor claimed that Na heparin and Na F/K oxalate are acceptable anticoagulant to use.

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): Not Applicable

4. Clinical cut-off: Not Applicable

5. Expected values/Reference range: Provided in k070057 and k092506

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.

7 of 7

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K100187](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K100187)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com