(70 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device is considered substantially equivalent to existing marketed products, with the primary acceptance criterion being a high degree of correlation with these predicate devices and confirmatory tests. The general acceptance criterion for this device, which is a visual reagent test strip, is established through comparison to predicate devices, where "90% of all observations are within one color block."
| Analyte (Test) | Acceptance Criteria (Agreement within 1 Color Block with Predicate Devices or Confirmatory Test) | DIA SCREEN Lot 00226A Performance | DIA SCREEN Lot 00226B Performance |
|---|---|---|---|
| Specific Gravity | ≥ 90% | 96.5% | 96.5% |
| Ketone | ≥ 90% | 100% | 100% |
| Glucose | ≥ 90% | 100% | 100% |
| Protein | ≥ 90% | 100% | 100% |
| Blood | ≥ 90% | 98.3% | 98.3% |
| Nitrite | ≥ 90% | 100% | 100% |
| pH | ≥ 90% | 100% | 100% |
| Ascorbic Acid | ≥ 90% | 98.2% | 100% |
| Bilirubin | ≥ 90% | 100% | 100% |
| Urobilinogen | ≥ 90% | 100% | 100% |
All analytes meet or exceed the "90% of all observations are within one color block" criterion when adjusted for confirmatory test results.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The number of urine samples varied slightly by analyte, but generally the study used:
- 58 samples for Specific Gravity, Ketone, Glucose, Blood, and pH.
- 57 samples for Protein, Nitrite, and Ascorbic Acid.
- 48 samples for Bilirubin.
- 54 samples for Urobilinogen.
- Data Provenance: The study used fresh urine samples obtained at the medical facility (University of Minnesota Department of Medical Technology where the evaluation was conducted). This indicates prospective data collection from a clinical setting within the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of individuals who performed the visual readings or those who conducted the confirmatory tests as "experts" in the sense of specialized clinical diagnosticians establishing ground truth.
However, the study was conducted "under the direction of Nancy Brunzel, C.L.S., M.T., at the University of Minnesota Department of Medical Technology."
- Qualifications of Nancy Brunzel: C.L.S., M.T. (Certified Laboratory Scientist, Medical Technologist). These qualifications indicate expertise in clinical laboratory procedures and analysis.
- Implication for "Experts": While not explicitly stated how many readers were involved, it's reasonable to infer that the visual readings were performed by competent laboratory personnel, likely medical technologists or similar professionals, under Ms. Brunzel's supervision. The "ground truth" was established not solely by visual reading but significantly by confirmatory reference methods when discrepancies arose (see point 7).
4. Adjudication Method for the Test Set
The primary "adjudication" or reconciliation method was a confirmatory testing strategy.
- The study compared two lots of DIA SCREEN® strips against Ames Multistix 10 SG and Behring Rapignost strips.
- "When data between the two products did not agree within one color block, an alternate procedure (confirmation test)" was used.
- This implies a 2-way comparison (DIA SCREEN vs. Predicate) with a third, independent, and typically more accurate confirmatory method acting as the adjudicator for discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
- This device is a visual dip-and-read non-AI based test strip. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here. The study focuses on the performance of the DIA SCREEN® strips themselves against predicate devices and confirmatory tests, as read apparently by trained laboratory personnel.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
- No, a standalone (algorithm only) performance study was not done.
- This device relies on visual comparison with a color chart by a human reader. It is not an automated or AI-driven diagnostic system; it explicitly states "by visual comparison with a color chart" and "requiring no additional laboratory equipment for testing."
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the test set was established using a combination of:
- Predicate device results: Initial comparison was made against Ames Multistix 10 SG and Behring Rapignost.
- Confirmatory (Reference) laboratory methods: For any discrepancies (results not within one color block) between the DIA SCREEN® strips and the predicate devices, a specific, established confirmatory test was employed. Examples include:
- Specific Gravity: Refractometer
- Ketone: Acetest
- Glucose: Chemstrip Reagent Strip (from Boehringer Mannheim)
- Protein: SSA (Sulfosalicylic Acid test)
- Blood: Microscopic Evaluation
- Nitrite: Microscopic Evaluation
- pH: pH Meter
- Ascorbic Acid: Urispec Reagent Strip (from Henry Schein)
- Bilirubin: Ictotest
- Urobilinogen: Chemstrip Reagent Strip (from Boehringer Mannheim)
This multi-faceted approach, heavily relying on established reference methods for discrepant results, serves as a strong form of ground truth.
8. The Sample Size for the Training Set
The document describes a clinical evaluation study (which serves as the "test set" in this context) but does not explicitly mention a separate "training set" for the DIA SCREEN® Reagent Strips. This is common for predicate-based 510(k) submissions, especially for visual assays. The implicit "training" for such devices often comes from the established clinical utility of the predicate devices and the internal development and quality control processes of the manufacturer to ensure the strips produce expected reactions.
9. How the Ground Truth for the Training Set Was Established
As no specific training set is mentioned in the provided text, the method for establishing its ground truth is also not described. The focus of this 510(k) submission is on demonstrating substantial equivalence through a direct comparison study (test set) against already established and approved predicate devices.
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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.
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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., 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:
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| Strip NameDistributorReagents for: | This 510 (k)DIA SCREEN®DIA SCREEN® | Previous 510 (k)DIA SCREEN®DIA SCREEN® | Ames Multistix 10 SGAmes | RapignostBehring |
|---|---|---|---|---|
| SpecificGravity | Bromthymol blueDetergent | NA | Bromthymol bluePoly (methyl vinyl-ethermaleic anhydride | NA |
| Ketone | Sodium nitroprusside | Sodium nitroprusside | Sodium nitroprussideBuffer | Sodium nitroprussideGlycineBuffer |
| Glucose | Glucose oxidasePeroxidasePotassium iodide | Glucose oxidasePeroxidasePotassium iodide | Glucose oxidasePeroxidasePotassium iodideBuffer | Glucose oxidasePeroxidaseTolidine hydrochlorideBuffer |
| Protein | Tetrabromphenol blueCitric acid | Tetrabromphenol blueCitric acid | Tetrabromphenol blueBuffer | Tetrabromphenol blueBuffer |
| Blood | 2,5 Dimethylhexane-2,5-dihydroperoxide3,3',5,5'-Tetramethylbenzidine | NA | Diisopropylbenzene-dihydroperoxide3,3',5,5'-Tetramethylbenzidine | Cumene hydroperoxideTetramethylbenzidinedihydrochlorideBuffer |
| Nitrite | Hydroxy(3)-1,2,3-tetrahydrobenzo-(h)quinolinep-Arsanilic acid | NA | p-Arsanilic acid1,2,3,4-Tetrahydro-benzo(h)quinoline-3-olBuffer | 4-Arsanilic acidN-(Naphthyl)-ethylenediammoniumDihydrochlorideBuffer |
| pH | Bromthymol blueMethyl red | NA | Bromthymol blueMethyl red | Bromthymol blueCresol redMethyl red |
| Ascorbic Acid | Phosphomolybdic acid | NA | NA | 2,6-Dichloro-phenol-indophenolBuffer 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 saltBuffer | 2,4-Dichlorobenzene- diazonium saltBuffer |
| Urobilinogen | Dimethylaminobenzaldehyde | NA | Diethylaminobenzaldehyde | Fluorodiazoniumtetra- fluoroborateBuffer |
| 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 withDesiccant | Yes | Yes | Yes | Yes |
| Control Available | Yes | Yes | Yes | Yes |
| Time required toread strips | 30 to 60 seconds | 60 seconds | 30 to 60 seconds | 60 seconds |
| Storage | Between 15 - 30 °C (59°-86° F). Do Not Store inrefrigerator or freezer. Donot expose to moisture,heat or light. | Between 15 - 30 °C(59°-86° F). Do NotStore in refrigerator orfreezer. Do not exposeto moisture, heat orlight | Between 15°- 30° C (59°-86° F) Do Not Store in DirectSunlight | Between 15 - 30° C (59°- 86°F). Do Not Store inrefrigerator or freezer. Donot expose to moisture, heator light. |
| 510 (k) | This submission | K952971 | ||
| Expected Values: | ||||
| Specific Gravity | Random urines vary from1.001-1.035. Twenty-fourhour urines from normaladults with normal dietsand fluid intake will havea specific gravity of1.016-1.022 | NA | Random urines vary from1.001-1.035. Twenty-fourhour urines from normaladults with normal diets andfluid intake will have aspecific gravity of 1.016-1.022 | NA |
| Ketone | Should not be detected innormal urine. | Should not be detectedin normal urine. | Normal specimens yieldnegative results. | Should not be detected innormal urine |
| Glucose | None found in normalurine. Concentrations of100 mg/dL may beconsidered abnormal. | None found in normalurine. Concentrationsof 100 mg/dL may beconsidered abnormal. | None found in normal urine.Concentration of 100 mg/dLmay be consideredabnormal. | None found in normal urine.Concentrations of 100 mg/dLmay be consideredabnormal. |
| Strip NameDistributorExpected values: | This 510 (k)DIA SCREEN®DIA SCREEN® | Previous 510 (k)DIA SCREEN®DIA SCREEN® | Ames Multistix 10 SGAmes | RapignostBehring |
| Protein | Normal specimensordinarily contain someprotein (0-4 mg/dL).Persistent results of traceor higher indicatesignificant proteinuria. | Normal specimensordinarily containsome protein (0-4mg/dL). Persistentresults of trace orhigher indicatesignificant proteinuria. | Normal specimens ordinarilycontain some protein (0-4mg/dL). A color matchingany "+" block indicatessignificant proteinuria | Normal specimens ordinarilycontain some protein (0-4mg/dL). Persistent results of30 mg/dL or higher indicatesignificant proteinuria |
| Blood | The practical detectionlimit of this test is 5 to 10erythrocytes per microliterof urine | NA | The significance of the tracereaction may vary amongpatients. Clinical judgmentis required | The practical detection limitof this test is 5 to 10erythrocytes per microliter ofurine |
| Nitrite | Any degree of pink colorafter 30 secondsindicates clinicallysignificant bacteria | NA | Normally, no nitrite isdetectable in urine | Concentrations between .05and 0.1 mg/dL produce apink color, indicatingsignificant bacteria |
| pH | Normal urine has a pH of6 and urine pH valuesgenerally range from 5 to8 | NA | Both the normal andabnormal pH range is from 5to 9 pH units | Normal urine has a pH of 6and urine pH valuesgenerally range from 5 to 9 |
| Ascorbic Acid | Urinary excretion ofascorbic acid can resultfrom the intake of vitaminC | NA | NA | Any color change after 60seconds indicates a positiveresult |
| Bilirubin | No bilirubin is detectablein urine of healthypersons | NA | Normally, no bilirubin isdetectable in healthypersons | No bilirubin is detectable inurine of healthy persons |
| Urobilinogen | Normal range is 0.1 to 1.0mg/dL | NA | Normal range is 0.1 to 1.0Ehrlich units per 100 mL | Normal range is 0.5 to 1.0mg/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.
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% |
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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% |
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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.
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% |
§ 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.