Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple dip-and-read test strip with visual comparison to a color chart, and the summary explicitly states "No additional reagents and laboratory equipment are required" and "The strips are to be read visually, requiring no additional laboratory equipment for testing." There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI/ML.

Therapeutic

No.
This device is for in vitro diagnostic use to semi-quantitatively analyze urine specimens, not for treating a condition or disease.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "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."

SaMD (Software as a Medical Device)

No

The device is a physical reagent strip for urinalysis that is read visually. It is not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "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."

This statement directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

LJX, JNA, KQO

Device Description

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.

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

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

Independent laboratory evaluation of two (2) manufactured lots of DIASCREEN® Reagent Strips was conducted at Wichita State University Department of Medical Technology, comparing their performance to a "510 (k) approved" marketed urinalysis strip system (Bayer Multistix 10 SG). Fresh urine samples were obtained at a medical facility. When data between the two products did not agree within one color block, an alternate procedure using confirmation tests (Refractometer for Specific Gravity, Microscopic Evaluation/CHEMSTRIP for Leukocyte, pH Meter for pH, Microscopic Evaluation/CHEMSTRIP/Ascorbic Acid Test/Urispec for Blood, Microscopic Evaluation/CHEMSTRIP for Nitrite) was used to test the sample. Fresh, well-mixed, and uncentrifuged urine from a mixed patient population.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical Laboratory Evaluation of DIASCREEN® Strips: The study compared two manufactured lots of DIASCREEN® Reagent Strips with Bayer Multistix 10 SG.
Sample size: 53 urine samples.
Performance was measured by comparing the percentage of responses within the same color block and within plus or minus one color block between DIASCREEN® and Bayer strips, and between the two DIASCREEN® lots.

Key Results:
DIASCREEN® Lot 1 versus Bayer Lot D639066 or 6K30C (53 samples):

Specific Gravity: 74% same color block, 100% within 1 color block.
Leukocyte: 79% same color block, 100% within 1 color block.
pH: 70% same color block, 100% within 1 color block.
Blood: 92% same color block, 100% within 1 color block.
Nitrite: 100% same color block, 100% within 1 color block.

DIASCREEN® Lot 2 versus Bayer Lot D639066 or 6K30C (53 samples):

Specific Gravity: 66% same color block, 100% within 1 color block.
Leukocyte: 81% same color block, 100% within 1 color block.
pH: 66% same color block, 100% within 1 color block.
Blood: 83% same color block, 100% within 1 color block.
Nitrite: 100% same color block, 100% within 1 color block.

DIASCREEN® Lot 1 versus DIASCREEN® Lot 2 (53 samples):

Specific Gravity: 91% same color block, 100% within 1 color block.
Leukocyte: 89% same color block, 100% within 1 color block.
pH: 92% same color block, 100% within 1 color block.
Blood: 98% same color block, 100% within 1 color block.
Nitrite: 100% same color block, 100% within 1 color block.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K940043, K943008, K952971, K961375

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

Regulation Number and Section

§ 864.7675 Leukocyte peroxidase test.

(a)
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.(b)
Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Summary

0

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

1

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.

2

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:

3

	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
maleic anhydride)
	Polyvinyl phosphate	maleic acid copolymer
Leukocyte	2-Phenylthiazole amino
acid ester
Diazonium salt	Not offered	Derivatized pyrrole amino
acid ester
Diazonium salt
Buffer
Ketones	Sodium nitroprusside	Sodium nitroprusside	Sodium nitroprusside
Buffer
Glucose	Glucose oxidase
Peroxidase
Potassium iodide	Glucose oxidase
Peroxidase
Potassium iodide	Glucose oxidase
Peroxidase
Potassium iodide
Buffer
Protein	Tetrabromphenol blue
Citric acid
Trisodium citrate	Tetrabromphenol blue
Citric acid
Trisodium citrate	Tetrabromphenol blue
Buffer
Blood	2,5 Dimethylhexane-
2,5-dihydroperoxide
3,3',5,5'-
Tetramethylbenzidine	2,5 Dimethylhexane-
2,5-dihydroperoxide
3,3',5,5'-
Tetramethylbenzidine	Diisopropylbenzene-
dihydroperoxide
3,3',5,5'-
Tetramethylbenzidine

4

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

1

ાં

ﺇ

5

| Strip Name
Distributor | This 510 (k)
DIA SCREEN® | Previous 510 (k)
Bioscan | Multistix 10 SG |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Distributor | Dia-Screen | Dia-Screen | Bayer |
| Packaged with
Desiccant | Yes | Yes | Yes |
| Control Available | Yes | Yes | Yes |
| Time required to
read strips | 10 to 120 seconds | 60 seconds | 30 to 120 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 |

t

6

	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
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	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	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
Ketones	Should not be detected in
normal urine.	Should not be detected in
normal urine.	Normal specimens yield
negative results.
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.
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

l

(

SS and E Page 7

7

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

8

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
CHEMSTRIP	NA
Boehringer Mannheim
pH	pH Meter	NA
Blood	Microscopic Evaluation
CHEMSTRIP
Ascorbic Acid Test/Urispec	NA
Boehringer Mannheim
Henry Schein
Nitrite	Microscopic Evaluation
CHEMSTRIP	NA
Boehringer Mannheim

9

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.

10

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%

11

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.

12

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 requlation (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 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 (800) 638-2041 or (301) 443-6597 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

13

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)

	Veronica Calvin for Di Montgomery
	(Division Sign-Off)
	Division of Clinical Laboratory Devices
510(k) Number	K971976

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

--------------------------------------	----	--------------------------------------------------

.

:

・・

...