DIASCREEN REAGENT STRIPS
Device Facts
| Record ID | K981555 |
|---|---|
| Device Name | DIASCREEN REAGENT STRIPS |
| Applicant | Chronimed, Inc. |
| Product Code | LJX · Hematology |
| Decision Date | Jun 1, 1998 |
| 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 disposable plastic strips with affixed solid-phase reagent areas for urinalysis. The device is used by healthcare professionals in clinical settings. The operator dips the strip into a fresh, well-mixed, uncentrifuged urine sample and compares the resulting color changes on the reagent pads against a provided color chart. This visual comparison provides semi-quantitative results for ten analytes: specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen. The device requires no additional laboratory equipment. Results assist clinicians in diagnosing or monitoring conditions related to urinary tract health, such as pyuria or metabolic status. Proper storage in a sealed vial with desiccant is required to maintain reagent activity.
Clinical Evidence
Two independent clinical laboratory evaluations compared the DIASCREEN leukocyte test performance against the Bayer Multistix 10 SG. Evaluation One (Wichita State University) tested two lots of DIASCREEN strips; 90% of results were in the same color block and 100% were within ±1 color block of the predicate. Evaluation Two (Technovations Inc.) showed 85% of results in the same color block and 96% within ±1 color block. No other clinical data provided.
Technological Characteristics
Plastic strips with solid-phase reagent pads. Reagents include diazonium salts, glucose oxidase, peroxidase, potassium iodide, and various pH indicators. Visual read-only; no electronic components. Storage: 15-30°C, protected from moisture/light. Shelf-stable with desiccant. No software or energy source.
Indications for Use
Indicated for use by healthcare professionals as an in vitro diagnostic aid for semi-quantitative urinalysis in patients requiring assessment of specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen levels.
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
- Bioscan (K940043)
- DIASCREEN (K952971)
- DIASCREEN (K961375)
- DIASCREEN (K943008)
- DIASCREEN (K971976)
- Bayer Multistix 10 SG Reagent Strips
Related Devices
- K993850 — URINALYSIS REAGENT STRIPS (10 PARAMETERS) · International Newtech Development, Inc. · Jan 3, 2000
- K971976 — DIASCREEN REAGENT STRIPS · Dia-Screen Corp. · Jun 17, 1997
- K961375 — DIA SCREEN 10 WAY REAGENT STRIPS · Genesis Labs, Inc. · Jun 18, 1996
Submission Summary (Full Text)
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## Summary of Safety and Effectiveness
## April 22, 1998
The following information is provided as a summary of safety and effectiveness information for the DIASCREEN® Reagent Strip System. The reagent strips which are the subject of this pre-market notification contain one new reagent area for leukocytes in urine. The other nine reagent areas have been previously reviewed.
- Common Name: Visual Reagent Test Strip for Urinalysis (al
Trade/Proprietary Name: DIASCREEN® Reagent Strips, in many different configurations with as many different product codes. DIASCREEN® the registered trademark of Dia-Screen is Corporation.
- [b] Establishment Registration Number: 2183670
Chronimed Inc. Bury Drive Eden Prairie, MN 55346
- Contact Person: lcl
Vicki Frawley 5182 West 76th Street Minneapolis. MN 55439 Phone: (612) 835-3446 ext. 17 Fax: (612) 835-9406
- [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.
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#### Product Description lel
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 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.
Corporation has previously received Dia-Screen determination of substantial equivalence for complete lines of reagent strips for urinalysis which have been marketed under the Bioscan label (K940043) and the DIASCREEN® label (K952971. K961375). The intended use of the strips that are the subject of this new premarket notification is exactly the same as the Bioscan (K940043) and DIASCREEN® (K952971, K961375) strips which were reviewed previously.
Chronimed Inc. purchased Dia-Screen Corporation on March The DIASCREEN® Reagent Strips will 16. 1998. be manufactured by Chronimed Inc. for distribution by Chronimed Inc.
#### [f] Substantial Equivalence
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. K971976).
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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, K961375, and K971976.
Ship ... ..
The DIASCREEN® Reagent Strips for Urinalysis are substantially equivalent to the previous line of DIASCREEN® Reagent Strips (K943008, K961375) and the Bayer Multistix 10 SG Reagent Strips for Urinalysis. The new reagent area for leukocytes in urine on the DIASCREEN® Reagent Strips is substantially equivalent to the reagent area for leukocytes in urine on the Bayer Multistix 10 SG reagent strips.
Characteristics of the Bayer Multistix 10 SG system and the previous DIASCREEN® system are compared with the subject DIASCREEN® system in the following table.
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| Strip Name<br>Distributor | This 510 (k)<br>DIASCREEN®<br>Dia-Screen | Prevoius 510 (k)<br>DIASCREEN®<br>Dia-Screen | Bayer Multistix 10 SG<br>Bayer |
|---------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Reagents for: | | | |
| Leukocyte | 2-(3-Methoxyphenyl)-4-<br>thiazol<br>Diazonium salt | Not offered | Derivatized pyrrole amino<br>acid ester<br>Diazonium salt<br>Buffer |
| Specific<br>Gravity | Bromothymol blue<br>Methyl red<br>Polyvinyl phosphate | Bromthymol blue<br>Detergent | Bromthymol blue<br>Poly (methyl vinyl-ether<br>maleic anhydride) |
| 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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| | This 510 (k) | Prevoius 510 (k) | |
|---------------|----------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Strip Name | DIASCREEN® | DIASCREEN® | Bayer Multistix 10 SG |
| Distributor | Dia-Screen | Dia-Screen | Bayer |
| Reagents for: | | | |
| Nitrite | p-Arsanilic acid<br>Hydroxy(3)-1,2,3-<br>tetrahydrobenzo(h)quinoline | p-Arsanilic acid<br>Hydroxy(3)-1,2,3-<br>tetrahydrobenzo(h)quinoline | 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>Sulfasalicylic acid | 2,4 Dichlorobenzene-<br>diazonium salt | 2,4-Dichloroaniline-<br>diazonium salt<br>Buffer |
| Urobilinogen | 4-methoxybenzene-<br>diazonium salt<br>Metaphosphoric acid | Dimethylaminobenzaldede | Diethylaminobenzaldede |
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| Strip Name<br>Distributor | This 510 (k)<br>DIA SCREEN®<br>Dia-Screen | Previous 510 (k)<br>DIA SCREEN®<br>Dia-Screen | Multistix 10 SG<br>Bayer |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Packaged with<br>Desiccant | Yes | Yes | Yes |
| Control Available | Yes | Yes | Yes |
| Time required to<br>read strips | 30 to 120 seconds | 30-60 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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| Strip Name<br>Distributor | This 510 (k)<br>DIA SCREEN®<br>Dia-Screen | Previous 510 (k)<br>DIA SCREEN®<br>Dia-Screen | Multistix 10 SG<br>Bayer |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Expected Values: | | | |
| Leukocyte | Normally no leukocytes<br>are detected in urine.<br>Individually observed<br>trace results may be of<br>questionable clinical<br>significance. Positive<br>results found in random<br>specimens from females<br>may be due to vaginal<br>contamination. | Not applicable. | Normal urine specimens<br>generally yield negative<br>results. Positive results<br>(small or greater) are<br>clinically significant.<br>However, trace results<br>observed repeatedly may<br>be clinically significant/<br>Positive and repeated<br>trace results indicate the<br>need for testing of the<br>patient and/or urine<br>specimen according to<br>medically accepted<br>procedures for pyuria.<br>Positive results may be<br>found with random<br>specimens from females<br>due to contamination by<br>vaginal discharge |
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| Strip Name | This 510 (k)<br>DIA SCREEN® | Previous 510 (k)<br>DIA SCREEN® | Multistix 10 SG<br>Bayer |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Distributor<br>Expected Values: | Dia-Screen | Dia-Screen | Bayer |
| Leukocyte | Normally no leukocytes<br>are detected in urine.<br>Individually observed<br>trace results may be of<br>questionable clinical<br>significance. Positive<br>results found in random<br>specimens from females<br>may be due to vaginal<br>contamination. | Not applicable. | Normal urine specimens<br>generally yield negative<br>results. Positive results<br>(small or greater) are<br>clinically significant.<br>However, trace results<br>observed repeatedly may<br>be clinically significant/<br>Positive and repeated<br>trace results indicate the<br>need for testing of the<br>patient and/or urine<br>specimen according to<br>medically accepted<br>procedures for pyuria.<br>Positive results may be<br>found with random<br>specimens from females<br>due to contamination by<br>vaginal discharge. |
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| Strip Name<br>Distributor<br>Expected Values: | This 510 (k)<br>DIA SCREEN®<br>Dia-Screen | Previous 510 (k)<br>DIA SCREEN®<br>Dia-Screen | Multistix 10 SG<br>Bayer |
|-----------------------------------------------|-------------------------------------------|-----------------------------------------------|-----------------------------|
| Specific Gravity | Random urines vary from | Random urines vary from | Random urines vary from |
| | 1.001-1.035. Twenty-four | 1.001-1.035. Twenty-four | 1.001-1.035. Twenty-four |
| | hour urines from normal | hour urines from normal | hour urines from normal |
| | adults with normal diets | adults with normal diets | adults with normal diets |
| | and fluid intake will have | and fluid intake will have | and fluid intake will have |
| | a specific gravity of | a specific gravity of | a specific gravity of |
| | 1.016-1.022 | 1.016-1.022 | 1.016-1.022 |
| Ketones | Should not be detected in | Should not be detected in | Normal specimens yield |
| | normal urine. | normal urine. | negative results. |
| Glucose | None found in normal | None found in normal | None found in normal |
| | urine. Concentrations of | urine. Concentrations of | urine. Concentration of |
| | 100 mg/dL may be | 100 mg/dL may be | 100 mg/dL may be |
| | considered abnormal. | considered abnormal. | considered abnormal. |
| Protein | Normal specimens | Normal specimens | Normal specimens |
| | ordinarily contain some | ordinarily contain some | ordinarily contain some |
| | protein (0-4 mg/dL). | protein (0-4 mg/dL). | protein (0-4 mg/dL). A |
| | Persistent results of trace | Persistent results of trace | color matching any "+" |
| | or higher indicate | or higher indicate | block indicates significant |
| | significant proteinuria. | significant proteinuria. | proteinuria |
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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, leukocyte, ketone, glucose, protein, blood, 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.
Two independent laboratory evaluations of the DIASCREEN® Urine Leukocyte Test were conducted. The purpose of the laboratory evaluations was to establish the performance of the leukocyte test when compared to a "510(k) approved" marketed urinalysis strip system.
Clinical Evaluation One was under the direction of James Jackson, MT(ASCP) CLS, Ph.D. at Wichita State University Department of Medical Technology (Site 1). The study consisted of comparing the performance of two (2) manufactured lots of DIASCREEN® Leukocyte Reagent Strips with the marketed product (Baver Multistix 10 SG).
Fresh urine samples were obtained at the medical facility. The comparison strips, Bayer Multistix 10 SG Reagent Strips, were furnished by Dia-Screen.
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.
Clinical Evaluation Two was conducted under the direction of Mvron Rapkin. Technovations Inc. at two clinical sites. Reagent strips and urine samples were handled as described above.
A summary of the data obtained from the two clinical evaluations follows. Table I presents the percentage of responses of the DIASCREEN® Strips that are within the same color block and that are within plus or minus one color block of Baver Leukocyte results. Table II presents a similar analysis for two lots of the DIASCREEN® Reagent Strips tested during Clinical Evaluation One. The data used to compile these tables is presented for each evaluation in charts where the shaded region represents the within plus or minus one color block range.
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# DIASCREEN® versus Bayer Clinical Correlation
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### DIASCREEN® Lot 1 versus Bayer Multistix Table I.
| | Same Color Block | | Within 1 Color Block | |
|----------------------|------------------|-----|----------------------|------|
| Evaluation One-Lot 1 | 35/39 | 90% | 39/39 | 100% |
| Evaluation One-Lot 2 | 35/39 | 90% | 39/39 | 100% |
| Evaluation Two | 237/279 | 85% | 268/279 | 96% |
### DIASCREEN® Lot 1 versus DIASCREEN® Lot 2 Table II.
| ----------<br>Evaluation One- | Same Color Block | | Within 1<br>Color Block | |
|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------|---------------------------------------------------------------------------|
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Page_1 of 1
510(k) Number (if known); \$69 x 155
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | <span></span> ✓ | OR | Over-The-Counter Use______ |
|----------------------|-----------------|----|----------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K981555 |
|---------------|---------|
|---------------|---------|
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**NT OF HEALT**
Image /page/12/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
JUN 11 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Vicki Frawley . Chronimed Inc. 5182 West 76th Street Minneapolis, Minnesota ਦੇ ਦੇ ਤੇ ਰ
Re: K981555 DIASCREEN® Leukocyte Reagent Strip for Urinalysis Requlatory Class: II Product Code: LJX Dated: April 22, 1998 Received: May 1, 1998
Dear Ms. Frawley:
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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 (770) 488-7655.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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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Page == 1 = of i
510(k) Number (if known); 40 9 3 15 55
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)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-----------------------------------------------------------------------|
| Prescription Use | <div style="display:flex; align-items:center;"> <span>✓</span> </div> |
| (Per 21 CFR 801.109) | |
| | OR |
| | Over-The-Counter Use ______ |
| | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K981555 |
|---------------|---------|
|---------------|---------|
