DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)

K033851 · Hypoguard USA, Inc. · JIL · Mar 2, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033851
• Device Name: DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)
• Applicant: Hypoguard USA, Inc.
• Product Code: JIL · Clinical Chemistry
• Decision Date: Mar 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2

Indications for Use

DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative measurement of glucose and ketones in urine. They are intended for both professional and over-the-counter use.

Device Story

Plastic strips coated with dry reagents; used for qualitative/semi-quantitative detection of glucose and ketones in urine. Principle: chemical reaction between urine analyte and dry reagent causing visual color change. Operation: dip-and-read or midstream collection; visual comparison against color chart. Used in professional settings or home by patients. Output: color-coded concentration level. Clinical utility: aids diagnosis/management of diabetes, metabolic disorders, and ketosis; enables patient self-monitoring.

Clinical Evidence

Clinical data provided to support over-the-counter use. Study compared performance between home users and professional users, demonstrating that home users obtain accuracy substantially equivalent to professional users.

Technological Characteristics

Plastic strips with dry reagent pads. Sensing principle: colorimetric chemical reaction between reagent and specific analyte (glucose or ketone). Visual readout via color chart. No electronic components or software.

Indications for Use

Indicated for qualitative and semi-quantitative measurement of glucosuria and ketonuria in patients. Used for diagnosis and treatment of carbohydrate metabolism disorders (diabetes mellitus, hypoglycemia, hyperglycemia) and acidosis/ketosis, and for monitoring patients on ketogenic diets or with diabetes.

Regulatory Classification

Identification

A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

Predicate Devices

• DiaScreen® Reagent Strips for Urinalysis (K033851)

Submission Summary (Full Text)

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

A. 510(k) Number:
k033851

B. Analyte:
Urinary Glucose, Urinary Ketones

C. Type of Test:
Qualitative and semi-quantitative

D. Applicant:
Hypoguard USA, Inc.

E. Proprietary and Established Names:
DiaScreen® Reagent Strips for Urinalysis

F. Regulatory Information:
1. Regulation section:
21 CFR § 862.1340; 21 CFR § 862.1435
2. Classification:
Class II, Class I
3. Product Code:
JIL; JIN
4. Panel:
75 Clinical Chemistry

G. Intended Use:
1. Intended Use
DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative measurement of glucose and ketones in urine. They are intended for both professional and over-the-counter use.

2. Indication(s) for use:
DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative measurement of glucosuria (glucose in urine). These measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative measurement of ketones in urine. Identification of ketones is

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used in the diagnosis and treatment of acidosis or ketosis and for monitoring patients on ketogenic diets and patients with diabetes.

3. Special condition for use statement(s):
This submission is for an over-the-counter version of the previously cleared professional use device for glucose and ketones. Consumers can perform the test using the midstream technique or the dip and read technique.

4. Special instrument Requirements:
N/A

H. Device Description:
The DiaScreen® Reagent Strips for Urinalysis consist of a plastic strip coated with one or more dry reagents, each specific for a particular analyte. This submission included three configurations: one to detect glucose, one to detect ketones, and one to detect both. When saturated with urine, the dry reagents change color in a chemical reaction with their associated analyte. The reagent blocks are read visually against a color chart.

I. Substantial Equivalence Information:

1. Predicate device name(s):
DIA SCREEN® 10 Way Reagent Strips for Urinalysis

2. Predicate K number(s):
K961375

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analytes | Glucose and/or Ketones | Glucose and/or Ketones
plus up to eight other
analytes |
| Methodology | Same | Dry Reagents with Visual
Color Change |
| Measurement
Range | Same | Ketones: Neg, Trace, 15,
40, 80, 160
Glucose: Neg, 50, 100,
250, 500, 1000 |
| Sample Size | Same | Sufficient Volume to Cover
Reagent Blocks When
Dipped |
| Read Time | Same | 60 seconds |
| Differences | | |
| Item | Device | Predicate |
| Intended Use | Professional and Over the
Counter Use | Professional Use Only |

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| Sample Application | Dip and Read OR Midstream | Dip and Read |
| --- | --- | --- |

J. Standard/Guidance Document Referenced (if applicable):
None referenced

K. Test Principle:
The glucose test is based on a sequential enzyme reaction. First, glucose oxidase catalyzes the formation of gluconic acid and hydrogen peroxide from the oxidation of glucose. A second enzyme, peroxidase, catalyzes the reaction of hydrogen peroxide with a potassium iodide chromogen to oxidize the chromogen to colors ranging from blue-green to brown.

The ketone test is based on a reaction between acetoacetic acid in the urine with nitroprusside in the dry reagent. The color of the reagent pad ranges from tan for no reaction (negative result) through pink and purple for a positive result. The sponsor states that acetone and beta-hydroxybutyric acid make no significant contribution to the reaction.

L. Performance Characteristics (if/when applicable):
1. Analytical performance: The previous submission (K961375) included dry reagents for up to ten analytes and was intended for professional use only. Performance data for glucose and ketones for that submission are briefly summarized here.

a. Precision/Reproducibility:
The data demonstrated adequate reproducibility between masked operators and between different strip lots.

b. Linearity/assay reportable range:
The data demonstrated a linear relationship between spiked-in values and the semi-quantitative readings for glucose and ketones.

c. Traceability (controls, calibrators, or method):
N/A

d. Detection limit:
Sensitivity was demonstrated to the lowest reporting block

e. Analytical specificity:
For ketones, L-Dopa and 2-Mercaptoethane at 15 mg/dL were observed to cause a positive bias. For glucose, ascorbic acid at 50 mg/dL and acetoacetic acid at 40 mg/dL were observed to cause a false negative result. It was also observed that a high specific gravity could cause a negative bias for glucose.

f. Assay cut-off:
N/A

2. Comparison studies:
a. Method comparison with predicate device:

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In the previous submission (K961375) two lots of the device were compared with the predicate. For glucose and ketones, 100% of the readings were within 1 color block of the predicate.

In this submission, the sponsor demonstrated that untrained consumers, after reading the proposed package insert, could use the test correctly and achieve results comparable to trained professional users. A discrepant result was defined as a consumer reading more than one color block away from the professional reading. The overall agreement for both ketones and glucose was 341 out of 346 or 98.6% agreement.

The study consisted of two parts. The first part of the study compared glucose and ketone results between consumers and professionals on synthetic urine using the dip and read method. Samples were tested for both glucose and ketones and were a mixture of positives and negatives.

Results were as follows for n = 104

| Analyte | Same Color Block | Within +/- One Color Block |
| --- | --- | --- |
| Glucose | 77% | 98% |
| Ketones | 69% | 97% |

When broken down by concentration, the following was observed (discrepant results in large bold type):

n = 104

| Glucose mg/dL - Professional | 1000 | 1 | | | | | 7 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | 500 | | | | 2 | 7 | |
| | 250 | | | 1 | 11 | 1 | |
| | 100 | | | 6 | 4 | | |
| | 50 | 2 | 6 | | | | |
| | Neg | 43 | 12 | | 1 | | |
| | | Neg | 50 | 100 | 250 | 500 | 1000 |

Glucose mg/dL – Consumers

n = 104

| Ketones mg/dL - Professional | 160 | | | | 2 | 5 | 6 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | 80 | | | | 5 | 2 | 2 |
| | 40 | | 1 | 4 | 2 | | |
| | 15 | | 4 | 8 | | | |
| | 5 | 12 | 2 | | | | |
| | Neg | 49 | | | | | |
| | | Neg | 5 | 15 | 40 | 80 | 160 |

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# Ketones mg/dL – Consumers

There were five discrepant results using the dip and read method reported by four participants (one participant had a discrepant result for both glucose and ketones).

The second part of the study compared glucose and ketone results between consumers and professionals using the midstream method. Because this part of the study used unaltered clinical samples and because of the difficulty in obtaining positive samples, some of the samples (Site 1, n = 42) were employees of the sponsored who had been prescreened and were known to be positive. The remaining samples (Site 2, n = 27) were not prescreened and were obtained from the general public. Consumers conducted their own midstream test and collected a urine sample in a specimen cup for professional testing by the dip and read method immediately afterward.

Overall results were as follows:

| | Site 1 (n = 42) | | Site 2 (n = 27) | |
| --- | --- | --- | --- | --- |
| Analyte | Same Color Block | Within +/- One Color Block | Same Color Block | Within +/- One Color Block |
| Glucose | 100% | 100% | 100% | 100% |
| Ketones | 95% | 100% | 93% | 100% |

When broken down by concentration, the following was observed:

Site 1 (n = 42)

| Glucose mg/dL - Professional | 1000 | | | | | | 3 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | 500 | | | | | 4 | |
| | 250 | | | | 3 | | |
| | 100 | | | 1 | | | |
| | 50 | | | | | | |
| | Neg | 31 | | | | | |
| | | Neg | 50 | 100 | 250 | 500 | 1000 |

Glucose mg/dL – Consumers

Site 2 (n = 27)

| Glucose mg/dL - Professional | 1000 | | | | | | 2 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | 500 | | | | | | |
| | 250 | | | | | | |
| | 100 | | | | | | |
| | 50 | | | | | | |
| | Neg | 25 | | | | | |
| | | Neg | 50 | 100 | 250 | 500 | 1000 |

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# Glucose mg/dL - Consumers

Site 1 (n = 42)

| Ketones mg/dL - Professional | 160 | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | 80 | | | | | | |
| | 40 | | | | 2 | | |
| | 15 | | 1 | 1 | | | |
| | 5 | 1 | 5 | | | | |
| | Neg | 32 | | | | | |
| | | Neg | 5 | 15 | 40 | 80 | 160 |

Ketones mg/dL – Consumers

Site 2 (n = 27)

| Ketones mg/dL - Professional | 160 | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | 80 | | | | | | |
| | 40 | | | 1 | 2 | | |
| | 15 | | | | | | |
| | 5 | 1 | | | | | |
| | Neg | 23 | | | | | |
| | | Neg | 5 | 15 | 40 | 80 | 160 |

Ketones mg/dL - Consumers

There were no discrepant results using the midstream method.

The sponsor also required a Test Interpretation Exit Questionnaire to assess the participants' ability to understand the information presented in the labeling. Questions were asked concerning the relationship between blood and urine glucose levels, the presence of glucose or ketones in the urine and how it relates to diet, and the significance of large amounts of ketones and/or glucose in the urine. Overall, greater than 96% of participants answered all questions correctly. The question regarding the significance of large amounts of ketones and/or glucose in the urine was answered correctly by 100% of the participants.

b. Matrix comparison:
N/A

3. Clinical studies:
a. Clinical sensitivity:
N/A
b. Clinical specificity:
N/A
c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off:
N/A

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5. Expected values/Reference range: N/A

**M. Conclusion:**

Based upon the information provided for the file, I recommend that the over-the-counter version of the DiaScreen® Reagent Strips for Urinalysis be found substantially equivalent to the predicate device.