DIA SCREEN 10 WAY REAGENT STRIPS
Device Facts
| Record ID | K961375 |
|---|---|
| Device Name | DIA SCREEN 10 WAY REAGENT STRIPS |
| Applicant | Genesis Labs, Inc. |
| Product Code | JIL · Clinical Chemistry |
| Decision Date | Jun 18, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1340 |
| Device Class | Class 2 |
Indications for Use
The DIA SCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semiquantitative urinalysis. DIA SCREEN® Reagent Strips have been developed to allow health care professionals to test semiquantitatively for patient urine levels of specific gravity, ketone, glucose, protein, blood, nitrite, pH, ascorbic acid, bilirubin, and urobilinogen by visual comparison with a color chart.
Device Story
Disposable plastic reagent strips for semiquantitative urinalysis; used by healthcare professionals in clinical settings. Input: fresh, well-mixed, uncentrifuged urine. Operation: dip strip into urine; visual comparison of reagent color changes against provided color chart. Output: semiquantitative levels of specific gravity, ketone, glucose, protein, blood, nitrite, pH, ascorbic acid, bilirubin, and urobilinogen. No laboratory equipment required. Results assist clinicians in patient assessment and diagnostic decision-making.
Clinical Evidence
Independent laboratory evaluation conducted at University of Minnesota. Study compared two lots of DIA SCREEN strips against Ames Multistix 10 SG and Behring Rapignost using fresh, uncentrifuged urine samples (n=58). Discrepant results were resolved using standard confirmatory methods (e.g., refractometer, microscopic evaluation, pH meter). Results showed 96.5% agreement within one color block for all analytes across both lots.
Technological Characteristics
Plastic strips with affixed chemical reagent pads. Reagents include sodium nitroprusside, glucose oxidase, peroxidase, tetrabromphenol blue, 3,3',5,5'-tetramethylbenzidine, and various diazonium salts. Visual read-only; no electronic components. Storage: 15-30°C, protected from moisture/light. Disposable.
Indications for Use
Indicated for health care professionals to perform semiquantitative urinalysis on patient urine samples to detect specific gravity, ketone, glucose, protein, blood, nitrite, pH, ascorbic acid, bilirubin, and urobilinogen.
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
Reference Devices
- Ames Multistix 10 SG
- Behring Rapignost
- Boehringer Mannheim Chemstrip
- Acetest (Ames)
- Urispec Reagent Strip (Henry Schein)
- Ictotest (Ames)
Submission Summary (Full Text)
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JUN 18 1996
K.961375
# Summary of Safety and Effectiveness
April 4, 1996
The following information is provided as a summary of safety and effectiveness information for the DIA SCREEN® Reagent Strip System.
[a] Common Name: Visual Reagent Test Strip for Urinalysis
Trade/Proprietary Name: DIA SCREEN® Reagent Strips, in many different configurations with as many different product codes. DIA SCREEN® is the registered trademark of Dia-Screen Incorporated, a wholly owned subsidiary of Genesis Labs, Inc.
[b] Establishment Registration Number 2183670
Genesis Labs, Inc.
5182 West 76th Street
Minneapolis, MN 55439-2904
[c] Contact Person: Bert Walter
[d] Intended Use
The DIA SCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semiquantitative urinalysis. DIA SCREEN® Reagent Strips have been developed to allow health care professionals to test semiquantitatively for patient urine levels of specific gravity, ketone, glucose, protein, blood, nitrite, pH, ascorbic acid, bilirubin, and urobilinogen by visual comparison with a color chart.
[e] Product Description
DIA SCREEN® Reagent Strips are plastic strips to which are affixed reagent areas. Several product configurations are included with this submission, but all configurations are limited to one, some or all of the following tests: specific gravity, ketone, glucose, protein, blood, nitrite, pH, ascorbic acid, bilirubin, and urobilinogen.
The reagent test areas on the DIA SCREEN® Reagent Strips are ready to use upon removal from the bottle and the entire reagent strip is disposable after use. The strips are to be read visually, requiring no additional laboratory equipment for testing.
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The directions must be followed exactly. Accurate timing is essential to provide optimal results. The reagent strips must be kept in the original bottle containing the desiccant with the cap tightly closed to maintain reagent activity. To obtain optimal results, it is necessary to use fresh, well-mixed, uncentrifuged urine.
Dia-Screen Corporation, a subsidiary of Genesis Labs, Inc., has previously received determinations of substantial equivalence for complete lines of urine reagent strips which have been marketed under the Bioscan (K940043) and DIA SCREEN (K952971) label.
The DIA SCREEN® Reagent Strips will be manufactured by Genesis Labs for distribution by Dia-Screen. The intended use of the strips which are the subject of this new premarket notification is exactly the same as the strips which were reviewed previously (K940043 and K952971).
[f] Substantial Equivalence
The intended use of the strips which are the subject of this new premarket notification is exactly the same as the strips which were reviewed previously (K940043 and K952971).
The design and function of the new DIA SCREEN® Reagent Strips are the same as the design and function of both the Bioscan and DIA SCREEN Reagent Strips which have been previously reviewed under premarket notifications K940043 and K952971.
The DIA SCREEN® Reagent Strips for Urinalysis are substantially equivalent to Ames Multistix 10 SG, Behring Rapignost, Bioscan and Boehringer Mannheim Chemstrip urine test strip systems (90% of all observations are within one color block).
Characteristics of the Ames Multistix 10 SG and Behring Rapignost systems are compared with the DIA SCREEN® system in the following table:
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| Strip Name | This 510 (k)
DIA SCREEN®
DIA SCREEN® | Previous 510 (k)
DIA SCREEN®
DIA SCREEN® | Ames Multistix 10 SG
Ames | Rapignost
Behring |
| --- | --- | --- | --- | --- |
| Distributor
Reagents for: | | | | |
| Specific
Gravity | Bromthymol blue
Detergent | NA | Bromthymol blue
Poly (methyl vinyl-ether
maleic anhydride | NA |
| Ketone | Sodium nitroprusside | Sodium nitroprusside | Sodium nitroprusside
Buffer | Sodium nitroprusside
Glycine
Buffer |
| Glucose | Glucose oxidase
Peroxidase
Potassium iodide | Glucose oxidase
Peroxidase
Potassium iodide | Glucose oxidase
Peroxidase
Potassium iodide
Buffer | Glucose oxidase
Peroxidase
Tolidine hydrochloride
Buffer |
| Protein | Tetrabromphenol blue
Citric acid | Tetrabromphenol blue
Citric acid | Tetrabromphenol blue
Buffer | Tetrabromphenol blue
Buffer |
| Blood | 2,5 Dimethylhexane-
2,5-dihydroperoxide
3,3',5,5'-
Tetramethylbenzidine | NA | Diisopropylbenzene-
dihydroperoxide
3,3',5,5'-
Tetramethylbenzidine | Cumene hydroperoxide
Tetramethylbenzidine
dihydrochloride
Buffer |
| Nitrite | Hydroxy(3)-1,2,3-
tetrahydrobenzo-(h)quinoline
p-Arsanilic acid | NA | p-Arsanilic acid
1,2,3,4-Tetrahydro-
benzo(h)quinoline-3-ol
Buffer | 4-Arsanilic acid
N-(Naphthyl)-
ethylenediammonium
Dihydrochloride
Buffer |
| pH | Bromthymol blue
Methyl red | NA | Bromthymol blue
Methyl red | Bromthymol blue
Cresol red
Methyl red |
| Ascorbic Acid | Phosphomolybdic acid | | | 2,6-Dichloro-phenol-
indophenol
Buffer salts |
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| Strip Name | This 510 (k)
DIA SCREEN®
DIA SCREEN® | Previous 510 (k)
DIA SCREEN®
DIA SCREEN® | Ames Multistix 10 SG
Ames | Rapignost
Behring |
| --- | --- | --- | --- | --- |
| Distributor
Reagents for: | | | | |
| Bilirubin | 2,4 Dichlorobenzene-diazonium salt | NA | 2,4-Dichloroaniline-diazonium salt
Buffer | 2,4-Dichlorobenzene-diazonium salt
Buffer |
| Urobilinogen | Dimethylaminobenzaldehyde | NA | Diethylaminobenzaldehyde | Fluorodiazoniumtetrafluoroborate
Buffer |
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| Strip Name
Distributor | This 510 (k)
DIA SCREEN®
DIA SCREEN® | Previous 510 (k)
DIA SCREEN
DIA SCREEN | N - Multistix
Ames | Rapignost
Behring |
| --- | --- | --- | --- | --- |
| Packaged with
Desiccant | Yes | Yes | Yes | Yes |
| Control Available | Yes | Yes | Yes | Yes |
| Time required to
read strips | 30 to 60 seconds | 60 seconds | 30 to 60 seconds | 60 seconds |
| Storage | Between 15 - 30 °C (59°-86° F). Do Not Store in refrigerator or freezer. Do not expose to moisture, heat or light. | Between 15 - 30 °C (59°-86° F). Do Not Store in refrigerator or freezer. Do not expose to moisture, heat or light | Between 15°- 30° C (59°-86° F) Do Not Store in Direct Sunlight | Between 15 - 30° C (59°- 86° F). Do Not Store in refrigerator or freezer. Do not expose to moisture, heat or light. |
| 510 (k)
Expected Values: | This submission | K952971 | --- | --- |
| Specific Gravity | Random urines vary from 1.001-1.035. Twenty-four hour urines from normal adults with normal diets and fluid intake will have a specific gravity of 1.016-1.022 | NA | Random urines vary from 1.001-1.035. Twenty-four hour urines from normal adults with normal diets and fluid intake will have a specific gravity of 1.016-1.022 | NA |
| Ketone | Should not be detected in normal urine. | Should not be detected in normal urine. | Normal specimens yield negative results. | Should not be detected in normal urine |
| Glucose | None found in normal urine. Concentrations of 100 mg/dL may be considered abnormal. | None found in normal urine. Concentrations of 100 mg/dL may be considered abnormal. | None found in normal urine. Concentration of 100 mg/dL may be considered abnormal. | None found in normal urine. Concentrations of 100 mg/dL may be considered abnormal. |
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| Strip Name
Distributor
Expected values: | This 510 (k)
DIA SCREEN®
DIA SCREEN® | Previous 510 (k)
DIA SCREEN®
DIA SCREEN® | Ames Multistix 10 SG
Ames | Rapignost
Behring |
| --- | --- | --- | --- | --- |
| Protein | Normal specimens ordinarily contain some protein (0-4 mg/dL). Persistent results of trace or higher indicate significant proteinuria. | Normal specimens ordinarily contain some protein (0-4 mg/dL). Persistent results of trace or higher indicate significant proteinuria. | Normal specimens ordinarily contain some protein (0-4 mg/dL). A color matching any “+” block indicates significant proteinuria | Normal specimens ordinarily contain some protein (0-4 mg/dL). Persistent results of 30 mg/dL or higher indicate significant proteinuria |
| Blood | The practical detection limit of this test is 5 to 10 erythrocytes per microliter of urine | NA | The significance of the trace reaction may vary among patients. Clinical judgment is required | The practical detection limit of this test is 5 to 10 erythrocytes per microliter of urine |
| Nitrite | Any degree of pink color after 30 seconds indicates clinically significant bacteria | NA | Normally, no nitrite is detectable in urine | Concentrations between .05 and 0.1 mg/dL produce a pink color, indicating significant bacteria |
| pH | Normal urine has a pH of 6 and urine pH values generally range from 5 to 8 | NA | Both the normal and abnormal pH range is from 5 to 9 pH units | Normal urine has a pH of 6 and urine pH values generally range from 5 to 9 |
| Ascorbic Acid | Urinary excretion of ascorbic acid can result from the intake of vitamin C | NA | NA | Any color change after 60 seconds indicates a positive result |
| Bilirubin | No bilirubin is detectable in urine of healthy persons | NA | Normally, no bilirubin is detectable in healthy persons | No bilirubin is detectable in urine of healthy persons |
| Urobilinogen | Normal range is 0.1 to 1.0 mg/dL | NA | Normal range is 0.1 to 1.0 Ehrlich units per 100 mL | Normal range is 0.5 to 1.0 mg/dL |
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Clinical Laboratory Evaluation of DIA SCREEN® Strips
The DIA SCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip intended for use as an in-vitro diagnostic aid using urine specimens. DIA SCREEN® Reagent Strips have been developed to allow health care professionals to semiquantitatively determine levels of specific gravity, ketone, glucose, protein, blood, nitrite, pH, ascorbic acid, bilirubin, and urobilinogen in patient urine by visual comparison with a color chart of each concentration range. No additional reagents or laboratory equipment are required. These reagent strips are packaged in a plastic vial containing a desiccant. The test strips must be maintained tightly capped in the plastic vial to assure reagent activity. The directions-for-use must be followed exactly.
An independent laboratory evaluation of the new DIA SCREEN® Reagent Strips for Urinalysis was conducted under the direction of Nancy Brunzel, C.L.S., M.T., at the University of Minnesota Department of Medical Technology. The purpose of the laboratory evaluation was to establish the performance of the DIA SCREEN® Reagent Strip for Urinalysis when compared to "510 (k) approved" marketed urinalysis strip systems.
The study consisted of comparing the performance of two (2) manufactured lots of DIA SCREEN® Reagent Strips with one (1) lot of a marketed product (Ames Multistix 10 SG and Behring Rapignost).
Fresh urine samples were obtained at the medical facility. The comparison strips, Ames Multistix 10 SG and Behring Rapignost strips, and abnormal urine controls were furnished by Dia-Screen. When data between the two products did not agree within one color block, an alternate procedure (see table below) was used to test the sample.
| Analyte | Confirmation Test | Manufacturer |
| --- | --- | --- |
| Specific Gravity | Refractometer | NA |
| Ketone | Acetest | Ames |
| Glucose | Chemstrip Reagent Strip | Boehringer Mannheim |
| Protein | SSA | NA |
| Blood | Microscopic Evaluation | NA |
| Nitrite | Microscopic Evaluation | NA |
| pH | pH Meter | NA |
| Ascorbic Acid | Urispec Reagent Strip | Henry Schein |
| Bilirubin | Ictotest | Ames |
| Urobilinogen | Chemstrip Reagent Strip | Boehringer Mannheim |
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Fresh, well-mixed, and uncentrifuged urine from a mixed patient population was reacted with the DIA SCREEN® Reagent Strips and the results were read by visual comparison with the DIA SCREEN® color chart. Results of these readings were compared to results measured by Multistix 10 SG and Rapignost Strips.
A summary of the data obtained from the clinical evaluation described above is provided in the following tables (pages 9 and 10):
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# DIA SCREEN versus Ames and Rapignost Clinical Correlation
Tables I and II present the percentage of responses for the indicated lots of the DIA SCREEN and Ames and Rapignost Reagent Strips that are within the same color block and that are within plus or minus one color block. Table III presents a similar analysis for the two lots of the DIA SCREEN Reagent Strips.
Table I. DIA SCREEN Lot 00226A versus Ames Lot D397095 and Rapignost Lot 633962A
| Specific Gravity | Same Color Block | | Within 1 Color Block | |
| --- | --- | --- | --- | --- |
| | 24/58 | 41.4% | 53/58 | 91.4% |
| Ketone | 52/58 | 89.6% | 58/58 | 100% |
| Glucose | 46/58 | 79.3% | 58/58 | 100% |
| Protein | 41/57 | 71.9% | 57/57 | 100% |
| Blood | 45/58 | 77.6% | 53/58 | 91.4% |
| Nitrite | 56/57 | 98.2% | 57/57 | 100% |
| pH | 23/58 | 39.6% | 58/58 | 100% |
| Ascorbic Acid | 46/57 | 80.7% | 56/57 | 98.2% |
| Bilirubin (lot 0306A) | 44/48 | 91.7% | 46/48 | 95.8% |
| Urobilinogen | 49/54 | 90.7% | 50/54 | 92.6% |
Table II. DIA SCREEN Lot 00226B versus Ames Lot D397095 and Rapignost Lot 633962A
| Specific Gravity | Same Color Block | | Within 1 Color Block | |
| --- | --- | --- | --- | --- |
| | 25/58 | 43.1% | 52/58 | 89.6% |
| Ketone | 51/58 | 87.9% | 58/58 | 100% |
| Glucose | 49/58 | 84.5% | 58/58 | 100% |
| Protein | 43/57 | 75.4% | 57/57 | 100% |
| Blood | 46/58 | 79.3% | 53/58 | 91.4% |
| Nitrite | 56/57 | 98.2% | 57/57 | 100% |
| pH | 27/58 | 46.5% | 58/58 | 100% |
| Ascorbic Acid | 49/57 | 86.0% | 57/57 | 100% |
| Bilirubin (lot 0306B) | 44/48 | 91.7% | 46/48 | 95.8% |
| Urobilinogen | 49/54 | 90.7% | 50/54 | 92.6% |
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Table III. DIA SCREEN Lot 00226A versus DIA SCREEN Lot 00226B
| Specific Gravity | Same Color Block | | Within 1 Color Block | |
| --- | --- | --- | --- | --- |
| | 54/58 | 93.1% | 58/58 | 100% |
| Ketone | 57/58 | 98.3% | 58/58 | 100% |
| Glucose | 55/58 | 94.8% | 58/58 | 100% |
| Protein | 55/57 | 96.5% | 57/57 | 100% |
| Blood | 57/58 | 98.3% | 58/58 | 100% |
| Nitrite | 57/57 | 100% | 57/57 | 100% |
| pH | 52/58 | 89.6% | 58/58 | 100% |
| Ascorbic Acid | 54/57 | 94.7% | 56/57 | 98.2% |
| Bilirubin (lots 0306A/B) | 48/48 | 100% | 48/48 | 100% |
| Urobilinogen | 54/54 | 100% | 54/54 | 100% |
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# DIA SCREEN versus Ames and Rapignost Clinical Correlation
Adjusted to use confirmatory test results for discrepant results.
Tables IV and V present the percentage of responses of the DIA SCREEN strip within one color block of the Ames and Rapignost Test Strips or the confirmatory test method when discrepancies of greater than one color block arose. 96.5% agreement within one color block was obtained for all analytes.
Table IV. DIA SCREEN Lot 00226A versus Ames Lot D397095 and Rapignost Lot 633962A
| Specific Gravity | Within 1 Color Block | |
| --- | --- | --- |
| | 55/58 | 96.5% |
| Ketone | 58/58 | 100% |
| Glucose | 58/58 | 100% |
| Protein | 57/57 | 100% |
| Blood | 57/58 | 98.3% |
| Nitrite | 57/57 | 100% |
| pH | 58/58 | 100% |
| Ascorbic Acid | 56/57 | 98.2% |
| Bilirubin (lot 0306A) | 48/48 | 100% |
| Urobilinogen | 54/54 | 100% |
Table V. DIA SCREEN Lot 00226B versus Ames Lot D397095 and Rapignost Lot 633962A
| Specific Gravity | Within 1 Color Block | |
| --- | --- | --- |
| | 55/58 | 96.5% |
| Ketone | 58/58 | 100% |
| Glucose | 58/58 | 100% |
| Protein | 57/57 | 100% |
| Blood | 57/58 | 98.3% |
| Nitrite | 57/57 | 100% |
| pH | 58/58 | 100% |
| Ascorbic Acid | 57/57 | 100% |
| Bilirubin (lot 0306B) | 48/48 | 100% |
| Urobilinogen | 54/54 | 100% |
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