DIASCREEN REAGENT STRIPS

K971976 · Dia-Screen Corp. · LJX · Jun 17, 1997 · Hematology

Device Facts

• Record ID: K971976
• Device Name: DIASCREEN REAGENT STRIPS
• Applicant: Dia-Screen Corp.
• Product Code: LJX · Hematology
• Decision Date: Jun 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7675
• Device Class: Class 1

Intended Use

The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip and is intended for use as an in vitro diagnostic aid using urine specimens. The strip contains solid phase reagent areas affixed to a plastic strip and is provided in a dry reagent format. The strip provides qualitative and semi-quantitative tests for specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart for each concentration range. No additional reagents and laboratory equipment are required. The reagent strips are packaged in a plastic vial containing a desiccant. The test strips must be kept tightly capped in the vial to assure reagent reactivity. The directions must be followed exactly and it is necessary to use fresh, well-mixed, uncentrifuged urine for optimal results.

Device Story

DIASCREEN® Reagent Strips are plastic strips with affixed dry reagent test areas for urinalysis. Used by healthcare professionals in clinical settings; no additional laboratory equipment required. Input: fresh, well-mixed, uncentrifuged patient urine. Operation: dip-and-read method; reagent areas react with urine analytes; color change occurs. Output: visual comparison of strip color against a provided color chart. Healthcare providers interpret results to assess patient urine levels of specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen. Results aid in clinical decision-making for patient health status. Benefit: provides rapid, semi-quantitative diagnostic information for urinalysis.

Clinical Evidence

Clinical laboratory evaluation conducted at Wichita State University compared two lots of DIASCREEN® strips against Bayer Multistix 10 SG using fresh urine samples. Results showed high correlation: 66-79% of results were in the same color block and 100% were within one color block for analytes including specific gravity, leukocyte, pH, blood, and nitrite. Bench testing confirmed performance consistency between lots.

Technological Characteristics

Plastic strips with dry reagent pads. Reagents include bromothymol blue, methyl red, sodium nitroprusside, glucose oxidase, peroxidase, potassium iodide, tetrabromphenol blue, 2,5-dimethylhexane-2,5-dihydroperoxide, 3,3',5,5'-tetramethylbenzidine, p-arsanilic acid, and diazonium salts. Visual read format; no energy source; no software. Storage: 15-30°C, protected from moisture/light.

Indications for Use

Indicated for health care professionals to perform semi-quantitative urinalysis on patient urine samples to detect specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen. No specific age or gender restrictions noted.

Regulatory Classification

Identification

A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.

Predicate Devices

• Bayer Multistix 10 SG
• Behring Rapignost
• Bioscan (K940043, K943008)
• DIASCREEN® (K952971, K961375)
• Boehringer Mannheim Chemstrip

Reference Devices

• Schein Urispec Reagent Strips

Submission Summary (Full Text)

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K971976

# JUN 17 1997

## Summary of Safety and Effectiveness

### May 27, 1997

The following information is provided as a summary of safety and effectiveness information for the DIASCREEN® Reagent Strip System.

- Common Name: Visual Reagent Test Strip for Urinalysis (a]
Trade/Proprietary Name: DIASCREEN® Reagent Strips, in many different configurations with as many different product codes. is the registered trademark of Dia-Screen DIASCREEN® Corporation.

- Establishment Registration Number: 9010673 [b]
Chung Do Pharmaceutical Co., Ltd. 312 Gaju-Dong Jin Hae-City Kyung Sang Nam-Do, 645-500 Korea.

- Vicki Frawley Contact Person: [c]
- [d] Intended Use

The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semi-quantitative urinalysis. DIASCREEN® Reagent Strips have been developed to allow health care professionals to test semi-quantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart.

- Product Description [e]
DIASCREEN® Reagent Strips are plastic strips to which are affixed reagent test 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, leukocytes, nitrite, pH, bilirubin, and urobilinogen.

The reagent test areas on the DIASCREEN® Reagent Strips are ready to use upon removal from the bottle and the entire reagent

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strip is disposable after use. The strips are to be read visually, requiring no additional laboratory equipment for testing.

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.

The DIASCREEN® Reagent Strips will be manufactured in Korea by Chunq Do Pharmaceutical CO., Ltd. of Seoul. Korea. They will be marketed in the United States by Dia-Screen Corporation. Dia-Screen is the exclusive United States distributor for Chung Do.

Dia-Screen Corporation has previously submitted 510k's on behalf of Chung Do Pharmaceutical Co., Ltd and Bioscan Instruments, Inc.(now defunct) under Dia-Screen Corporation's former name, Genesis Labs Inc. These are K940043 and K943008. In addition, Dia-Screen Corporation, which is a FDA registered facility, has received two 510k's for its own manufactured urine reagent strips. They are K961375 and K952971.

The intended use of the strips that are the subject of this new premarket notification is exactly the same as the Bioscan (K940043, K943008) and DIASCREEN® (K952971, K961375) strips which were reviewed previously.

#### Substantial Equivalence િય

The intended use of the strips which are the subject of this new pre-market notification is exactly the same as the strips which were reviewed previously (K940043, K943008, K952971, K961375),

The design and function of the new DIASCREEN® Reagent Strips are the same as the design and function of both the Bioscan and DIASCREEN® Reagent Strips which have been previously reviewed under pre-market notifications K940043, K943008. K952971, and K961375.

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The DIASCREEN® Reagent Strips for Urinalysis are substantially equivalent to Bayer Multistix 10 SG, Behring Rapignost, Bioscan, and Boehringer Mannheim Chemstrip urine test strip systems.

Characteristics of the Bayer Multistix 10 SG and the Bioscan systems are compared with the DIA SCREEN® system in the following table:

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| | This 510 (k) | Prevoius 510 (k) | Bayer Multistix 10 SG |
|---------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Strip Name | DIASCREEN® | Bioscan | Bayer |
| Distributor | Dia-Screen | Dia-Screen | Bayer |
| Reagents for: | | | |
| Specific | Bromothymol blue | Bromthymol blue | Bromthymol blue |
| Gravity | Methyl red | Methyl vinyl ether/ | Poly (methyl vinyl-ether<br>maleic anhydride) |
| | Polyvinyl phosphate | maleic acid copolymer | |
| Leukocyte | 2-Phenylthiazole amino<br>acid ester<br>Diazonium salt | Not offered | Derivatized pyrrole amino<br>acid ester<br>Diazonium salt<br>Buffer |
| Ketones | Sodium nitroprusside | Sodium nitroprusside | Sodium nitroprusside<br>Buffer |
| Glucose | Glucose oxidase<br>Peroxidase<br>Potassium iodide | Glucose oxidase<br>Peroxidase<br>Potassium iodide | Glucose oxidase<br>Peroxidase<br>Potassium iodide<br>Buffer |
| Protein | Tetrabromphenol blue<br>Citric acid<br>Trisodium citrate | Tetrabromphenol blue<br>Citric acid<br>Trisodium citrate | Tetrabromphenol blue<br>Buffer |
| Blood | 2,5 Dimethylhexane-<br>2,5-dihydroperoxide<br>3,3',5,5'-<br>Tetramethylbenzidine | 2,5 Dimethylhexane-<br>2,5-dihydroperoxide<br>3,3',5,5'-<br>Tetramethylbenzidine | Diisopropylbenzene-<br>dihydroperoxide<br>3,3',5,5'-<br>Tetramethylbenzidine |

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| Strip Name<br>Distributor<br>Reagents for: | This 510 (k)<br>DIASCREEN®<br>Dia-Screen | Prevoius 510 (k)<br>Bioscan<br>Dia-Screen | Bayer Multistix 10 SG<br>Bayer |
|--------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------|
| Nitrite | p-Arsanilic acid<br>N-(1-naphthyl)ethylene<br>diamine | p-Arsanilic acid<br>N-(1-naphthyl)ethylene<br>diamine | p-Arsanilic acid<br>1,2,3,4-Tetrahydro-<br>benzo(h)quinoline-3-ol<br>Buffer |
| pH | Bromthymol blue<br>Methyl red | Bromthymol blue<br>Methyl red | Bromthymol blue<br>Methyl red |
| Bilirubin | 2,4 Dichlorobenzene-<br>diazonium salt<br>Oxalic acid | 2,4 Dichlorobenzene-<br>diazonium salt<br>Oxalic acid | 2,4-Dichloroaniline-<br>diazonium salt<br>Buffer |
| Urobilinogen | 4-methoxybenzene-<br>diazonium salt<br>Citric acid | 4-methoxybenzene-<br>diazonium salt<br>Citric acid | Diethylaminobenzaldehyde |

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| Strip Name<br>Distributor | This 510 (k)<br>DIA SCREEN® | Previous 510 (k)<br>Bioscan | Multistix 10 SG |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Distributor | Dia-Screen | Dia-Screen | Bayer |
| Packaged with<br>Desiccant | Yes | Yes | Yes |
| Control Available | Yes | Yes | Yes |
| Time required to<br>read strips | 10 to 120 seconds | 60 seconds | 30 to 120 seconds |
| Storage | Between 15 - 30 °C (59°-<br>86° F). Do Not Store in<br>refrigerator or freezer. Do<br>not expose to moisture,<br>heat or light. | Between 15 - 30 °C (59°-<br>86° F). Do Not Store in<br>refrigerator or freezer. Do<br>not expose to moisture,<br>heat or light | Between 15°- 30° C (59°-<br>86° F) Do Not Store in<br>Direct Sunlight |

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| | This 510 (k) | Previous 510 (k) | Multistix 10 SG |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Strip Name | DIA SCREEN® | Bioscan | |
| Distributor | Dia-Screen | Dia-Screen | Bayer |
| Expected Values: | | | |
| Specific Gravity | Random urines vary from<br>1.001-1.035. Twenty-four<br>hour urines from normal<br>adults with normal diets<br>and fluid intake will have<br>a specific gravity of<br>1.016-1.022 | Random urines vary from<br>1.001-1.035. Twenty-four<br>hour urines from normal<br>adults with normal diets<br>and fluid intake will have<br>a specific gravity of<br>1.016-1.022 | Random urines vary from<br>1.001-1.035. Twenty-four<br>hour urines from normal<br>adults with normal diets<br>and fluid intake will have<br>a specific gravity of<br>1.016-1.022 |
| Ketones | Should not be detected in<br>normal urine. | Should not be detected in<br>normal urine. | Normal specimens yield<br>negative results. |
| Glucose | None found in normal<br>urine. Concentrations of<br>100 mg/dL may be<br>considered abnormal. | None found in normal<br>urine. Concentrations of<br>100 mg/dL may be<br>considered abnormal. | None found in normal<br>urine. Concentration of<br>100 mg/dL may be<br>considered abnormal. |
| Protein | Normal specimens<br>ordinarily contain some<br>protein (0-4 mg/dL).<br>Persistent results of trace<br>or higher indicate<br>significant proteinuria. | Normal specimens<br>ordinarily contain some<br>protein (0-4 mg/dL).<br>Persistent results of trace<br>or higher indicate<br>significant proteinuria. | Normal specimens<br>ordinarily contain some<br>protein (0-4 mg/dL). A<br>color matching any "+"<br>block indicates significant<br>proteinuria |

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| Strip Name<br>Distributor | This 510 (k)<br>DIA SCREEN®<br>Dia-Screen | Previous 510 (k)<br>Bioscan<br>Dia-Screen | Multistix 10 SG<br>Bayer |
|---------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Expected Values: | | | |
| Blood | The practical detection<br>limit of this test is 5 to 10<br>erythrocytes per microliter<br>of urine | The practical detection<br>limit of this test is 5 to 10<br>erythrocytes per microliter<br>of urine | The significance of the<br>trace reaction may vary<br>among patients. Clinical<br>judgement is required |
| Nitrite | Any degree of pink color<br>after 30 seconds<br>indicates clinically<br>significant bacteria | Any degree of pink color<br>after 30 seconds indicates<br>clinically significant<br>bacteria NA | Normally, no nitrite is<br>detectable in urine |
| pH | Normal urine has a pH of<br>6 and urine pH values<br>generally range from 5 to<br>8 | Normal urine has a pH of<br>6 and urine pH values<br>generally range from 5 to<br>8NA | Both the normal and<br>abnormal pH range is<br>from 5 to 9 pH units |
| Bilirubin | No bilirubin is detectable<br>in urine of healthy<br>persons | No bilirubin is detectable<br>in urine of healthy<br>persons | Normally, no bilirubin is<br>detectable in healthy<br>persons |
| Urobilinogen | Normal range is 0.1 to 1.0<br>mg/dL | N Normal range is 0.1 to<br>1.0 mg/dL A | Normal range is 0.1 to<br>1.0 Ehrlich units per 100<br>ml |

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## Clinical Laboratory Evaluation of DIASCREEN® Strips

The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip intended for use as an in-vitro diagnostic aid using urine specimens. DIASCREEN® Reagent Strips have been developed to allow health care professionals to semi-quantitatively determine levels of specific gravity, ketone, alucose, protein, blood, leukocytes, nitrite, pH, 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 DIASCREEN® Reagent Strips for Urinalysis was conducted under the direction of James Jackson MT(ASCP) CLS, Ph.D. at Wichita State University Department of Medical Technology. The purpose of the laboratory evaluation was to establish the performance of the leukocyte and specific gravity tests and to evaluate the pH, nitrite and blood for placement adjacent to these tests on the DIASCREEN® Reagent Strip for Urinalysis when compared to a "510 (k) approved" marketed urinalysis strip svstem.

The study consisted of comparing the performance of two (2) manufactured lots of DIASCREEN® Reagent Strips with the marketed product (Bayer Multistix 10 SG).

Fresh urine samples were obtained at the medical facility. The comparison strips. Baver Multistix 10 SG Reagent Strips, Schein Urispec Reagent Strips(for ascorbic acid detection), Boehringer Manneheim Corporation CHEMSTRIP Reagent Strips(for confirmatory testing), normal 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 |
| Leukocyte | Microscopic Evaluation<br>CHEMSTRIP | NA<br>Boehringer Mannheim |
| pH | pH Meter | NA |
| Blood | Microscopic Evaluation<br>CHEMSTRIP<br>Ascorbic Acid Test/Urispec | NA<br>Boehringer Mannheim<br>Henry Schein |
| Nitrite | Microscopic Evaluation<br>CHEMSTRIP | NA<br>Boehringer Mannheim |

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Fresh, well-mixed, and uncentrifuged urine from a mixed patient population was reacted with the DIASCREEN® Reagent Strips and the results were read by visual comparison with the DIASCREEN® color chart. Results of these readings were compared to results measured by Multistix 10 SG Reagent Strips.

A summary of the data obtained from the clinical evaluation described above is provided in the following tables.

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## DIASCREEN® versus Bayer Clinical Correlation

Tables I and II present the percentage of responses for the indicated lots of the DIASCREEN® and Bayer 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 DIASCREEN® Reagent Strips.

DIASCREEN® Lot 1 versus Bayer Lot D639066 or 6K30C Table I.

| | Same Color Block | |
|------------------|------------------|------|
| Specific Gravity | 39/53 | 74% |
| Leukocyte | 42/53 | 79% |
| pH | 37/53 | 70% |
| Blood | 49/53 | 92% |
| Nitrite | 53/53 | 100% |

| Within 1 Color Block | |
|----------------------|------|
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |

DIASCREEN® Lot 2 versus Bayer Lot D639066 or 6K30C Table II.

| | Same Color Block | |
|------------------|------------------|------|
| Specific Gravity | 35/53 | 66% |
| Leukocyte | 43/53 | 81% |
| pH | 35/53 | 66% |
| Blood | 44/53 | 83% |
| Nitrite | 53/53 | 100% |

| Within 1 Color Block | |
|----------------------|------|
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |

### DIASCREEN® Lot 1 versus DIASCREEN® Lot 2 Table III.

| | Same Color Block | |
|------------------|------------------|------|
| Specific Gravity | 48/53 | 91% |
| Leukocyte | 47/53 | 89% |
| pH | 49/53 | 92% |
| Blood | 52/53 | 98% |
| Nitrite | 53/53 | 100% |

| Within 1 Color Block | |
|----------------------|------|
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |

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Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black against a white background. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 17 1997

John Murray President and Chief Executive Officer Dia-Screen Corporation -----5182 West 76th Street Minneapolis, Minnesota ਦ ਦੇ ਕੇ ਤੇ ਰ

K971976 Re : DIASCREEN® 10 Way Reagent Strips for Urinalysis (In Duplicate) Regulatory Class: I & II Product Code: LJX, JNA, KQO May 27, 1997 Dated: Received: May 29, 1997

Dear Mr. Murray:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 0(k) Number (if known): | K971976 |
|-------------------------|--------------------------|
| Device Name: | DIASCREEN Reagent Strips |
| Indications For Use: | |

The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip
and is intended for use as an *in vitro* diagnostic aid using urine specimens.
The strip contains solid phase reagent areas affixed to a plastic strip and is
provided in a dry reagent format.

The strip provides qualitative and semi-quantitative tests for specific gravity,
ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and
urobilinogen by visual comparison with a color chart for each concentration
range. No additional reagents and laboratory equipment are required. The
reagent strips are packaged in a plastic vial containing a desiccant. The

test strips must be kept tightly capped in the vial to assure reagent
reactivity. The directions must be followed exactly and it is necessary to use
fresh, well-mixed, uncentrifuged urine for optimal results.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)

Page 1 of 1

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <i>Veronica Calvin for Di Montgomery</i> |
|---------------|------------------------------------------|
| | (Division Sign-Off) |
| | Division of Clinical Laboratory Devices |
| 510(k) Number | K971976 |

| Prescription Use<br>(21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|--------------------------------------|----|--------------------------------------------------|
|--------------------------------------|----|--------------------------------------------------|

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