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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k061559 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k061559

B. Purpose for Submission:
Clearance of a new device

C. Measurand:
Urinary Glucose, Occult Blood, Leukocytes, pH, Nitrite, Protein, Ketones,
Urobilinogen, Bilirubin, Specific Gravity and Ascorbic Acid

D. Type of Test:
Qualitative and semi-quantitative urine tests

E. Applicant:
ACON Laboratories, Inc.

F. Proprietary and Established Names:
ACON

Urinalysis Reagent Strips

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1340 Urinary Glucose (Non-Quantitative) Test System
21 CFR § 862.1115 Urinary Bilirubin and its Conjugates (Non-Quantitative) Test
System
21 CFR § 862.1435 Ketones (Non-Quantitative) Test System
21 CFR § 864.6550 Occult Blood Test
21 CFR § 862.1550 Urinary pH (Non-Quantitative) Test System
21 CFR § 862.1645 Urinary Protein or Albumin (Non-Quantitative) Test System
21 CFR § 862.1785 Urinary Urobilinogen (Non-Quantitative) Test System
21 CFR § 862.1510 Nitrite (Non-Quantitative) Test System
21 CFR § 864.7675 Leukocyte Peroxidase Test
21 CFR § 862.1095 Ascorbic Acid Test System

2. Classification:
Class II: Urinary Glucose and Occult Blood

Class I: Urinary Leukocytes, Urinary pH, Nitrite, Urinary Protein, Ketones,
Urinary Urobilinogen, Urinary Bilirubin, Specific Gravity and Ascorbic Acid

3. Product code:
JIL
Urinary Glucose (non-quant.) test system
JIO
Blood, Occult, Colorimetric, in urine

1 LJX Test,
Urine
Leukocyte
CEN Urinary,
pH
(non-quant.)
JMT Nitrite (urinary, non-quant.) test system
JIR
Protein or Albumin (urinary, non-quant.) test system
JIN
Ketones (urinary, non-quant.) test system
CDM Urinary Urobilinogen (non-quant.) test system
JJB
Urinary Bilirubin & its conjugates (urinary, non-quant.) test system
JMA Acid, Ascorbic, 2, 4-Dinitrophenylhydrazine (Spectrophotometric)

4. Panel:
Chemistry (75)
Hematology (82)


H. Intended Use:
1. Intended use(s):
The ACON Urinalysis Reagent Strips are for the qualitative and semi-quantitative
detection of one or more of the following analytes in urine: glucose, bilirubin,
ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen,
nitrite, leukocytes and ascorbic acid. It is intended for professional use only.

2.

Indication(s) for use:
The ACON Urinalysis Reagent Strips (Urine) are for the qualitative and semi-
quantitative for detection of one or more of the following analytes in urine:
Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH,
Protein, Urobilinogen, Nitrite, Leukocytes and Ascorbic Acid.

The ACON Urinalysis Reagent Strips (Urine) are for single use in professional
near-patient (point-of-care) and centralized laboratory locations. The strips are
intended for use in screening at-risk patients to assist diagnosis in the following
areas:

Kidney function
Urinary track infections
Carbohydrate metabolism (e.g. diabetes mellitus)
Liver function
Acid-base balance
Urine concentration

The results can be used along with other diagnostic information to rule out certain
disease states and to determine if microscopic analysis is needed. The test is to be
read visually. It is intended for professional use only.

3. Special conditions for use statement(s):
For prescription use

4.

Special instrument requirements:

2 Not applicable. The device is a visually read single-use device.

I. Device
Description:
The ACON Urinalysis Reagent Strips are urine test strips of which glucose, bilirubin,
ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leukocyte
reagent pads are affixed onto the plastic strips. The reagent pads react with the urine
and provide a visible color reaction. Results are obtained by direct comparison of the
test strip with the color blocks printed on the bottle label. The product is packaged
with a drying agent in a plastic bottle. The entire reagent strip is disposable when the
disposal directions are followed exactly. Laboratory instrumentation is not required.
These tests are intended for professional use with human urine.

J. Substantial Equivalence Information:
1. Predicate device name(s):

Bayer Multistix 10 SG Reagent Strips for Urinalysis

2. Predicate 510(k) number(s):
k905396

3. Comparison with predicate:

Similarities
Item
Device
Predicate
Intended Use
Professional use in point-
of-care urine testing
Same
Target Population
Patients of physicians,
hospitals, and clinics
Same
Intended Specimen
Urine
Same
Material Provided
Plastic strips affixed with
several separate reagent
areas.
Same
Visual read test time
Varies from 30 Seconds to
2 Minutes
Same
Glucose Methodology
Same
Same
Bilirubin Methodology
Same
Same
Ketone Methodology
Same
Same
Specific Gravity
Methodology
Same

Same
Blood Methodology
Same
Same
pH Methodology
Same

Same
Protein Methodology
Same
Same
Urobilinogen
Methodology
Same

Same
Nitrite Methodology
Same
Same
Leukocyte Methodology Same
Same


3
Differences
Item
Device
Predicate
Ascorbic Acid
Methodology
This test involves
decolorization of
Tillmanns reagent. The
presence of ascorbic acid
causes the color of the
test field to change from
blue-green to orange.
This test is not included
on Bayer test strip.
Storage
2 to 30ºC
15 to 30ºC


K. Standard/Guidance Document Referenced (if applicable):
None were identified by the applicant.


L. Test Principle:
Glucose: This test is based on the enzymatic reaction that occurs between glucose
oxidase, peroxidase and chromogen. Glucose if first oxidized to produce gluconic
acid and hydrogen peroxide in the presence of glucose oxidase. The hydrogen
peroxide reacts with potassium iodide chromogen in the presence of peroxidase. The
extent to which the chromogen is oxidized determines the color which is produced,
ranging from green to brown. Low amounts of glucose are normally excreted in urine.
Glucose concentrations as low as 100 mg/dL, read at either 10 or 30 seconds, may be
considered abnormal if results are consistent. At 10 seconds, results should be
interpreted qualitatively. For semi-quantitative results, read at 30 seconds only.

Bilirubin: This test is based on azo-coupling reaction of bilirubin with diazotized
dichloroaniline in a strongly acidic medium. Varying bilirubin levels will produce a
pinkish-tan color proportional to its concentration in urine. In normal urine, no
bilirubin is detectable by even the most sensitive methods. Even trace amounts of
bilirubin require further investigation. Atypical results (colors different from the
negative or positive color blocks shown on the color chart) may indicate that
bilirubin-derived bile pigments are present in the urine specimen, and are possibly
masking the bilirubin reaction.

Ketone: This test is based on ketones reacting with nitroprusside and acetoacetic acid
to produce a color change ranging from light pink for negative results to a darker pink
or purple color for positive results. Ketones are normally not present in urine.
Detectable ketone levels may occur in urine during physiological stress conditions
such as fasting, pregnancy and frequent strenuous exercise. In starvation diets, or in
other abnormal carbohydrate metabolism situations, ketones appear in the urine in
excessively high concentration before serum ketones are elevated.

Specific Gravity: This test is based on the apparent pKa change of certain pretreated
polyelectrolytes in relation to ionic concentration. In the presence of an indicator,

4 colors range from deep blue-green in urine of low ionic concentration to green and
yellow-green in urine of increasing ionic concentration. Randomly collected urine
may vary in specific gravity from 1.003-1.035. Twenty-four hour urine from healthy
adults with normal diets and fluid intake will have a specific gravity of 1.016-1.022.
In cases of severe renal damage, the specific gravity is fixed at 1.010, the value of the
glomerular filtrate.

Blood: This test is based on the peroxidase-like activity of hemoglobin which
catalyzes the reaction of cumene-hydroperoxide and 3,3',5,5'-tetramethylbenzidine.
The resulting color ranges from orange to green to dark blue. Any green spots or
green color development on the reagent area within 60 seconds is significant and the
urine specimen should be examined further. Blood is of