(70 days)
Not Found
No
The device description and performance studies indicate a simple dip-and-read test strip with visual interpretation, with no mention of AI or ML.
No
This device is a diagnostic tool used to semiquantitatively test patient urine for various levels, not to treat or alleviate a medical condition.
Yes
Explanation: The device is described as a "dip-and-read test strip for semiquantitative urinalysis" used by "health care professionals to test semiguantitatively for patient urine levels of specific gravity, ketone, glucose, protein, blood, nitrite, pH, ascorbic acid, billirubin, and urobilinogen." The results are then compared "by visual comparison with a color chart." This process of testing patient samples and generating data for medical professionals to interpret aligns with the definition of a diagnostic device, as it provides information used to identify or monitor medical conditions.
No
The device is a physical reagent strip for urinalysis, requiring visual comparison with a color chart, and does not involve any software component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "semiguantitative urinalysis" and allows "health care professionals to test semiguantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, nitrite, pH, ascorbic acid, billirubin, and urobilinogen". This involves testing a sample (urine) taken from the human body to provide information about a patient's health status.
- Device Description: It describes "plastic strips to which are affixed reagent areas" that react with urine. This is a common format for IVD test strips.
- Performance Studies: The document details clinical laboratory evaluations using fresh urine samples from a mixed patient population to compare the device's performance to predicate devices. This type of testing is characteristic of IVD validation.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, or tissues, taken from the human body to detect diseases, conditions, or infections. The DIA SCREEN® Reagent Strip clearly fits this definition.
N/A
Intended Use / 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 semiguantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, nitrite, pH, ascorbic acid, billirubin, and urobilinogen by visual comparison with a color chart.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care professionals; In-Vitro Diagnostic Aid
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Fresh urine samples were obtained at the medical facility from a mixed patient population. The comparison strips, Ames Multistix 10 SG and Behring Rapignost strips, and abnormal urine controls were furnished by Dia-Screen. Results of these readings were compared to results measured by Multistix 10 SG and Rapignost Strips. When data between the two products did not agree within one color block, an alternate confirmatory procedure was used to test the sample. Sample size was generally around 58 per analyte, with some exceptions (e.g., 57 for protein, ascorbic acid, and nitrite; 48 for bilirubin; 54 for urobilinogen).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The study consisted of comparing the performance of two (2) manufactured lots of DIA SCREEN® Reagent Strips (Lot 00226A and Lot 00226B, plus Lot 0306A/B for Bilirubin) with one (1) lot of a marketed product (Ames Multistix 10 SG Lot D397095 and Behring Rapignost Lot 633962A).
The evaluation measured the percentage of responses that were within the same color block and within plus or minus one color block for each analyte. Fresh, well-mixed, and uncentrifuged urine from a mixed patient population was reacted with the DIA SCREEN® Reagent Strips and results were read by visual comparison with the DIA SCREEN® color chart. Discrepant results (greater than one color block) were subject to confirmatory testing.
Key results:
DIA SCREEN Lot 00226A vs. Ames/Rapignost:
- Same Color Block agreement ranged from 39.6% (pH) to 98.2% (Nitrite).
- Within 1 Color Block agreement ranged from 91.4% (Specific Gravity, Blood) to 100% (Ketone, Glucose, Protein, Nitrite, pH).
DIA SCREEN Lot 00226B vs. Ames/Rapignost:
- Same Color Block agreement ranged from 43.1% (Specific Gravity) to 98.2% (Nitrite).
- Within 1 Color Block agreement ranged from 89.6% (Specific Gravity) to 100% (Ketone, Glucose, Protein, Nitrite, pH, Ascorbic Acid).
DIA SCREEN Lot 00226A vs. DIA SCREEN Lot 00226B (Intra-device variability):
- Same Color Block agreement ranged from 89.6% (pH) to 100% (Nitrite, Bilirubin, Urobilinogen).
- Within 1 Color Block agreement was 100% for most analytes, with Specific Gravity at 93.1%, Ascorbic Acid at 98.2%.
Adjusted results using confirmatory tests for discrepant results led to:
- DIA SCREEN Lot 00226A vs. Ames/Rapignost (adjusted): Within 1 Color Block agreement ranged from 96.5% (Specific Gravity) to 100% (Ketone, Glucose, Protein, Nitrite, pH, Bilirubin, Urobilinogen).
- DIA SCREEN Lot 00226B vs. Ames/Rapignost (adjusted): Within 1 Color Block agreement ranged from 96.5% (Specific Gravity) to 100% (Ketone, Glucose, Protein, Nitrite, pH, Ascorbic Acid, Bilirubin, Urobilinogen).
Overall, 96.5% agreement within one color block was obtained for all analytes when adjusted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement within the same color block and within one color block of a reference device or confirmatory test.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1340 Urinary glucose (nonquantitative) test system.
(a)
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.(b)
Classification. Class II.
0
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.
-
Common Name: Visual Reagent Test Strip for Urinalysis (a)
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. -
Establishment Registration Number 2183670 [b]
Genesis Labs, Inc. 5182 West 76th Street Minneapolis, MN 55439-2904 -
Contact Person: Bert Walter (c)
-
Intended Use [d]
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 semiguantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, nitrite, pH, ascorbic acid, billirubin, and urobilinogen by visual comparison with a color chart.
- Product Description [e]
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.
1
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., previously received determinations of substantial has 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).
- Substantial Equivalence ്രി
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:
2
| Strip Name
Distributor
Reagents for: | This 510 (k)
DIA SCREEN®
DIA SCREEN® | Previous 510 (k)
DIA SCREEN®
DIA SCREEN® | Ames Multistix 10 SG
Ames | Rapignost
Behring |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | NA | NA | 2,6-Dichloro-phenol-
indophenol
Buffer salts |
| | This 510 (k) | Previous 510 (k) | | |
| Strip Name | DIA SCREEN® | DIA SCREEN® | Ames Multistix 10 SG | Rapignost |
| Distributor | DIA SCREEN® | DIA SCREEN® | Ames | Behring |
| 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 | Fluorodiazoniumtetra- fluoroborate
Buffer |
| | This 510 (k) | Previous 510 (k) | N - Multistix | Rapignost |
| Strip Name | DIA SCREEN® | DIA SCREEN | Ames | Behring |
| Distributor | DIA SCREEN® | DIA SCREEN | Ames | 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) | This submission | K952971 | | |
| Expected Values: | | | | |
| 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. |
| 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 |
ﻤﺠﻌ
3
ﺳﺴ
4
5
ﺳﻌﻪ
6
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 |
7
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):
8
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.
DIA SCREEN Lot 00226A versus Ames Lot D397095 and Table I. Rapignost Lot 633962A
| Same Color Block | ||
|---|---|---|
| Specific Gravity | 24/58 | 41.4% |
| Ketone | 52/58 | 89.6% |
| Glucose | 46/58 | 79.3% |
| Protein | 41/57 | 71.9% |
| Blood | 45/58 | 77.6% |
| Nitrite | 56/57 | 98.2% |
| pH | 23/58 | 39.6% |
| Ascorbic Acid | 46/57 | 80.7% |
| Bilirubin (lot 0306A) | 44/48 | 91.7% |
| Urobilinogen | 49/54 | 90.7% |
| Within 1 Color Block | |
|---|---|
| 53/58 | 91.4% |
| 58/58 | 100% |
| 58/58 | 100% |
| 57/57 | 100% |
| 53/58 | 91.4% |
| 57/57 | 100% |
| 58/58 | 100% |
| 56/57 | 98.2% |
| 46/48 | 95.8% |
| 50/54 | 92.6% |
Table II. DIA SCREEN Lot 00226B versus Ames Lot D397095 and Rapignost Lot 633962A
| Same Color Block | Within 1 Color Block | ||||
|---|---|---|---|---|---|
| Specific Gravity | 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% |
9
Table III. DIA SCREEN Lot 00226A versus DIA SCREEN Lot 00226B
| Same Color Block | |||||
|---|---|---|---|---|---|
| Specific Gravity | 54/58 | 93.1% | Within 1 Color Block | ||
| Ketone | 57/58 | 98.3% | ୧୫।୧୫ | 100% | |
| Glucose | 55/58 | 94.8% | 58/58 | 100% | |
| Protein | 55/57 | 96.5% | 100% | ||
| Blood | 57/58 | 98.3% | 57157 | 100% | |
| Nitrite | 57/57 | 100% | ടുക്കു | 100% | |
| pH | 52/58 | 89.6% | 57157 | 100% | |
| Ascorbic Acid | 54/57 | 94.7% | 58158 | 100% | |
| Bilirubin (lots 0306A/B) | 48/48 | 100% | 56/57 | 98.2% | |
| Urobilinogen | 54/54 | 100% | 48/48 | 100% | |
| 54/54 | 100% |
10
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.
DIA SCREEN Lot 00226A versus Ames Lot D397095 and Table IV. Rapignost Lot 633962A
| Within 1 Color Block | ||
|---|---|---|
| Specific Gravity | 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% |
DIA SCREEN Lot 00226B versus Ames Lot D397095 and Table V. Rapignost Lot 633962A
| Within 1 Color Block | |
|---|---|
| Specific Gravity | 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% |