ACON U120 URINE ANALYZER, MODEL U111-101

K070929 · ACON Laboratories, Inc. · KQO · Jul 30, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070929
• Device Name: ACON U120 URINE ANALYZER, MODEL U111-101
• Applicant: ACON Laboratories, Inc.
• Product Code: KQO · Clinical Chemistry
• Decision Date: Jul 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2900
• Device Class: Class 1

Indications for Use

The ACON™ U120 Urine Analyzer is intended for use in conjunction with the ACON Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract.

Device Story

The ACON™ U120 Urine Analyzer is a reflectance photometer used in professional clinical settings. It processes urine samples applied to ACON Urinalysis Reagent Strips. The device uses an LED light source and a photosensitive diode sensor to measure the intensity and color of light reflected from the reagent areas of the strip after a one-minute incubation. The analyzer operates in single or continuous test modes, providing semi-quantitative or qualitative results for 11 analytes. Results are displayed on an LCD, printed via an internal printer, or transmitted via an RS-232C port. The device aids healthcare providers in evaluating general health and monitoring metabolic or urinary tract conditions. Calibration is performed automatically using a white calibration circle on the strip holder.

Clinical Evidence

No clinical data. Performance was established via bench testing, including precision/reproducibility studies (n=900 per analyte), sensitivity validation (n=135 per analyte), and method comparison studies against the predicate device using patient samples and spiked samples across the reportable range for each analyte.

Technological Characteristics

Reflectance photometer; photosensitive diode detection; RS232C and 25-pin parallel ports; internal heat-sensitive printer; 220V/110V AC power; dimensions 27.1 x 26.5 x 14.8 cm; weight 2.6 kg. Operates 0-40°C.

Indications for Use

Indicated for professional, in vitro diagnostic use to detect analytes in urine (Glucose, Bilirubin, Ketone, Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes, Ascorbic Acid, Nitrite) for health evaluation and monitoring of metabolic, systemic, kidney, endocrine, or urinary tract diseases.

Regulatory Classification

Identification

An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

Predicate Devices

• Bayer Clinitek Status Urine Chemistry Analyzer (k031947)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k070929

B. Purpose for Submission:
New submission for the ACON™ U120 Urine Analyzer for the use with ACON Laboratories previously cleared urine strips, ACON Urinalysis Reagent Strips k061559.

C. Measurand:
Glucose, Blood, Leukocytes, Specific Gravity, pH, Nitrite, Protein, Ketone, Urobilinogen, Ascorbic Acid and Bilirubin in urine

D. Type of Test:
Qualitative

E. Applicant:
ACON Laboratories, Inc.

F. Proprietary and Established Names:
ACON™ U120 Urine Analyzer

G. Regulatory Information:

1. Regulation section:
21 CFR § 862.2900 Automated urinalysis system
21 CFR § 862.1340 Urinary glucose (nonquantitative) test system
21 CFR § 864.6550 Occult blood test
21 CFR § 864.7675 Leukocyte peroxidase test
21 CFR § 862.2800 Refractometer for clinical use
21 CFR § 862.1550 Urinary pH (nonquantitative) test system
21 CFR § 862.1510 Nitrite (nonquantitative) test system
21 CFR § 862.1645 Urinary protein or albumin (nonquantitative) test system
21 CFR § 862.1435 Ketones (nonquantitative) test system
21 CFR § 862.1785 Urinary urobilinogen (nonquantitative) test system

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21 CFR § 862.1115 Urinary bilirubin and its conjugates (nonquantitative) test system
21 CFR § 862.1095 Ascorbic Acid test system

2. Classification:

Class II; Urinary glucose (nonquantitative) test system and Occult blood test

Class I; Leukocyte peroxidase test, Refractometer for clinical use, Urinary pH (nonquantitative) test system, Nitrite (nonquantitative) test system, Urinary protein or albumin (nonquantitative) test system, Ketones (nonquantitative) test system, Urinary urobilinogen (nonquantitative) test system and Urinary bilirubin and its conjugates (nonquantitative) test system, Automated urinalysis system and Ascorbic Acid test system

3. Product code:

KQO, JIL, JIO, LJX, JRE, CEN, JMT, JIR, JIN, CDM. JJB AND JMA, respectively

4. Panel:

75 Chemistry and 81 Hematology

H. Intended Use:

1. Intended use(s):

See Indications for use below.

2. Indication(s) for use:

The ACON™ U120 Urine Analyzer is intended for use in conjunction with the ACON Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract.

3. Special conditions for use statement(s):

For prescription use only

4. Special instrument requirements:

ACON™ U120 Urine Analyzer

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I. Device Description:

The analyzer is composed of an internal Processor with memory, mechanical unit, liquid crystal display (LCD), photoelectric scanning unit, power system, keyboard, 25 pin parallel external printer port, internal printer and standard RS-232C port.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Bayer Clinitek Status Urine Chemistry Analyzer, Bayer Healthcare, LLC

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

k031947

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Specimen | Urine | Same |
| Methodology | Reflectance Photometer | Same |
| Strip Incubation Time | 1 minute | Same |
| Line Leakage Current | <0.5 mA | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Parameters Detected | Leukocytes, Nitrite, Blood (Occult), Glucose, Protein, Ketone, Specific Gravity, pH, Bilirubin, Urobilinogen and Ascorbic Acid | Leukocytes, Nitrite, Blood (Occult), Glucose, Albumin, Protein, Creatinine, Ketone, Specific Gravity, pH, Bilirubin, Urobilinogen and hCG |
| Strips or Cassette to be Used | ACON Urinalysis Reagent Strips | Bayer Urinalysis Strips or hCG Cassette |
| Detection | Photosensitive diode | CCD |
| Throughput | Single Test Mode: 40 tests/hour, Continuous Test Mode: 120 test/hour | 60 test/hour |
| Memory | Last 500 results | 200 results |

K. Standard/Guidance Document Referenced (if applicable):

IE/CEN 61326

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L. Test Principle:

The U120 Urine Analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip. Using a light emitting diode (LED) as the light source and a photodiode as a light sensor, the optical system reads the color change in the urine test strips after a sample is applied.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

The precision evaluation included 10 replications on two levels of controls, using three instruments and three lot numbers. The contingency table 2x2 is applied to evaluate the total agreement, in term of percentage, on each parameter. The expected values of the control material were used to determine the agreement between the samples.

| Urine analyte | Expected values
Control level I and II | Expected result(s)
determined by
Comparator Method | Acon U120 results | % Agreement
with expected results | n |
| --- | --- | --- | --- | --- | --- |
| GLU | Neg | Negative | Negative | 100 | 900 |
| GLU | 250 - ≥ 2000 | 500 | 500 | 100 | 900 |
| BILI | Neg | Negative | Negative | 100 | 900 |
| BILI | Mod. - Large | Large | Large | 100 | 900 |
| KET | Neg | Negative | Negative | 100 | 900 |
| KET | 5 – 40 | 40 | 15 | 100 within 1
color block | 900 |
| SG | 1.010 - 1.020 | 1.020 | 1.020 | 100 | 900 |
| SG | 1.015 – 1.025 | 1.015 | 1.015 | 100 | 900 |
| BLO | Neg | Negative | Negative | 100 | 900 |
| BLO | Mod. - Large | Large | Large | 100 | 900 |
| pH | 5.0 – 6.0 | 5.0 | 5.0 | 100 | 900 |
| pH | 6.5 – 7.5 | 7.0 | 7.0 | 100 | 900 |
| PRO | Neg | Negative | Negative | 100 | 900 |
| PRO | 30 - ≥ 300 | 300 | 300 | 100 | 900 |
| URO | 0.2 – 1.0 | 0.2 | 0.2 | 100 | 900 |
| URO | 4.0 – 8.0 | 8.0 | 8.0 | 100 | 900 |
| NIT | Neg | Negative | Negative | 100 | 900 |
| NIT | Positive | Positive | Positive | 100 | 900 |
| LEU | Neg | Negative | Negative | 100 | 900 |
| LEU | Small - Large | Large | Large | 100 | 900 |
| ASC | Neg | Negative | Negative | 100 | 900 |

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The urinalysis controls did not contain ascorbic acid; the sponsor used one ascorbic acid standard positive solution, 20 mg/dL. Test was performed as above.

| Urine analyte | Expected values
Ascorbic Acid Standard | Expected result(s) determined by
Comparator Method | Acon U120 results | % Agreement with expected results | n |
| --- | --- | --- | --- | --- | --- |
| ASC | 20 | N/A | 20 | 100 | 900 |

b. Linearity/assay reportable range:

See the Method Comparison section 2.a below

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Previously cleared k061559

d. Detection limit:

The sensitivity of the assay when read by the ACON U120 Urine Analyzer was validated by spiking positive urine samples of known concentrations for each analyte. These positive samples of each analyte were then diluted to the lowest "positive" concentrations indicated on the ACON color chart. For each analyte, aliquots of the lowest positive samples were further diluted to 80%, 60% of the originals with negative urine. Each urine sample was tested with three lots of the ACON Urinalysis Reagent Strips on three analyzers. For three consecutive days, each sample was tested 15 times per day. A total of 135 strips were used for each concentration tested (3 analyzers x 3 days x 5 strips x 3 lots = 135 strips). The minimum sensitivity level for each analyte of the ACON Urinalysis Reagent Strips when read by the analyzer is defined by the sponsor as the lowest level at which over 55% of the test results are positive when the diluted positive samples for an analyte of known concentrations were tested. The results of each analyte sensitivity pad are summarized below.

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| Analyte | Detection Range of ACON U120 Urine Analyzer | Minimum Sensitivity |
| --- | --- | --- |
| Glucose | 0, 100, 250, 500 &1,000 mg/dL | 80 mg/dL |
| Bilirubin | 0, 1, 2 & 4 mg/dL | 0.8 mg/dL |
| Ketone | 0, 5, 15, 40 & 80 mg/dL | 4 mg/dL |
| Blood | 0, 10, 25, 80 & 200 Cells/μL | 5 Cells/μL |
| Protein | 0, 15, 30, 100 & 300 mg/dL | 12 mg/dL |
| Urobilinogen | 0.2, 1, 2, 4 & 8 mg/dL | 0.8 mg/dL |
| Nitrite | Negative, Positive | 0.05 mg/dL |
| Leukocyte | 0, 15, 70, 125 & 500 Cells/μL | 12 Cells/μL |
| Ascorbic Acid | 0, 10, 20 & 40 mg/dL | 8 mg/dL |
| pH | 5, 5.5, 6, 6.5, 7.0, 7.5, 8.0, 8.5 & 9.0 | 5 |
| Specific Gravity | 1.000, 1.005, 1.010, 1.015, 1.020, 1.025 & 1.030 | 1.000 |

e. Analytical specificity:

Previously cleared k061559

f. Assay cut-off:

See detection limit section M.1.d above

# 2. Comparison studies:

a. Method comparison with predicate device:

Patient samples were tested in three Point of Care settings on both the Acon U120 analyzer and Bayer Clinitek Status using the respective reagent strips for each system. Spiked samples covering the range of each analyte were tested in-house by the sponsor.

Glucose:

| U120 | ≥1,000 | 500 | 250 | 100 | 0 (Neg) |
| --- | --- | --- | --- | --- | --- |
| Predicate | | | | | |
| ≥1,000 | 45 | | | | |
| 500 | | 43 | 3 | | |
| 250 | | | 41 | 4 | |
| 100 | | | | 47 | 2 |
| 0 (Neg) | | | 1 | 5 | 163 |
| Total | 45 | 43 | 45 | 56 | 165 |
| % Agreement (Exactly Match) | 100 | 100 | 91 | 84 | 99 |
| % Agreement (±1 Color Block) | 100 | 100 | 98 | 100 | 100 |

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Bilirubin:

| U120 | 4 (+++) | 2 (++) | 1 (+) | 0 (Neg) |
| --- | --- | --- | --- | --- |
| Predicate | | | | |
| +++ | 44 | 1 | | |
| ++ | | 44 | 3 | 1 |
| + | | | 46 | 10 |
| 0 (Neg) | | 1 | 4 | 155 |
| Total | 44 | 46 | 53 | 166 |
| % Agreement (Exactly Match) | 100 | 96 | 87 | 93 |
| % Agreement (±1 Color Block) | 100 | 98 | 100 | 99 |

Ketone:

| U120 | 80 | 40 | 15 | 5 | 0 (Neg) |
| --- | --- | --- | --- | --- | --- |
| Predicate | | | | | |
| 80 | 45 | 1 | | | |
| 40 | | 45 | | | |
| 15 | | | 43 | 6 | |
| 5 | | | | 55 | 13 |
| 0 (Neg) | | | | 5 | 141 |
| Total | 45 | 46 | 43 | 66 | 154 |
| % Agreement (Exactly Match) | 100 | 98 | 100 | 83 | 92 |
| % Agreement (±1 Color Block) | 100 | 100 | 100 | 100 | 100 |

SG:

| U120 | 1.030 | 1.025 | 1.020 | 1.015 | 1.010 | 1.005 | 1.000 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Predicate | | | | | | | |
| 1.030 | 85 | 4 | | | | | |
| 1.025 | 7 | 59 | 2 | 2 | | | |
| 1.020 | 5 | 14 | 50 | 6 | 1 | | |
| 1.015 | | 5 | 4 | 53 | 1 | | |
| 1.010 | | | 3 | 3 | 45 | 1 | |
| ≤1.005 | | | | | 4 | 45 | 45 |
| Total | 97 | 82 | 59 | 64 | 51 | 46 | 45 |
| % Agreement (Exactly Match) | 88 | 72 | 85 | 83 | 88 | 98 | 100 |
| % Agreement (±1 Color Block) | 95 | 94 | 95 | 97 | 98 | 100 | 100 |

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Blood:

| U120 | +++ | ++ | + | +/- | 0 (Neg) |
| --- | --- | --- | --- | --- | --- |
| Predicate | | | | | |
| +++ | 48 | 1 | | | |
| ++ | | 47 | | | 1 |
| + | | 4 | 48 | 3 | 1 |
| +/- | | | 1 | 49 | 19 |
| 0 (Neg) | | | | | 132 |
| Total | 48 | 52 | 49 | 52 | 153 |
| % Agreement (Exactly Match) | 100 | 90 | 98 | 94 | 86 |
| % Agreement (±1 Color Block) | 100 | 100 | 100 | 100 | 99 |

pH:

| U120 | 9.0 | 8.5 | 8.0 | 7.5 | 7.0 | 6.5 | 6.0 | ≤5.5 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Predicate | | | | | | | | |
| 8.5 | 45* | 43 | 3 | 1 | | | | |
| 8.0 | | | 42 | 3 | 1 | 1 | | |
| 7.5 | | | 1 | 47 | 2 | | | 1 |
| 7.0 | | | | 1 | 51 | 6 | 1 | 5 |
| 6.5 | | | | | 1 | 42 | 4 | 7 |
| 6.0 | | | 1 | | | | 45 | 22 |
| ≤5.5 | | | | | | 2 | 1 | 110 |
| Total | 45 | 43 | 47 | 52 | 55 | 51 | 51 | 145 |
| % Agreement (Exactly Match) | 100 | 100 | 89 | 90 | 93 | 82 | 88 | 76 |
| % Agreement (±1 Color Block) | 100 | 100 | 98 | 98 | 98 | 94 | 98 | 91 |

*The highest pH detection range of the predicate, Bayer Clinitek Analyzer, is 8.5.

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Protein:

| U120 | ≥300 | 100 | 30 | 15 | 0 (Neg) |
| --- | --- | --- | --- | --- | --- |
| Predicate | | | | | |
| ≥300 | 47 | | | | |
| 100 | 1 | 45 | 4 | | |
| 30 | | | 46 | 11 | 8 |
| 15 | | | 1 | 51 | 12 |
| 0 (Neg) | | | | 6 | 122 |
| Total | 48 | 45 | 51 | 68 | 142 |
| % Agreement (Exactly Match) | 98 | 100 | 90 | 75 | 86 |
| % Agreement (±1 Color Block) | 100 | 100 | 100 | 100 | 94 |

Urobilinogen:

| U120 | 8 | 4 | 2 | 1 | 0 (Neg) |
| --- | --- | --- | --- | --- | --- |
| Predicate | | | | | |
| 8 | 45 | | | | |
| 4 | | 45 | | | |
| 2 | | 6 | 39 | | |
| 1 | | | | 41 | 11 |
| 0 (Neg) | | | | 2 | 165 |
| Total | 45 | 51 | 39 | 43 | 176 |
| % Agreement (Exactly Match) | 100 | 88 | 100 | 95 | 94 |
| % Agreement (±1 Color Block) | 100 | 100 | 100 | 100 | 100 |

Nitrite:

| U120 | Positive | Negative |
| --- | --- | --- |
| Predicate | | |
| Positive | 137 | 5 |
| Negative | 1 | 166 |
| Total | 138 | 171 |
| % Agreement (Exactly Match) | 99 | 97 |
| % Agreement (±1 Color Block) | 100 | 100 |

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Leukocyte:

| U120 | 500 | 125 | 70 | 15 | 0 (Neg) |
| --- | --- | --- | --- | --- | --- |
| Predicate | | | | | |
| 500 (+++) | 48 | | | | |
| 125 (++) | | 45 | | | |
| 70 (+) | | 1 | 46 | 1 | |
| 15 (Trace) | | 1 | 2 | 51 | 4 |
| 0 (Neg) | | | 1 | 10 | 144 |
| Total | 48 | 47 | 49 | 62 | 148 |
| % Agreement (Exactly Match) | 100 | 96 | 94 | 82 | 97 |
| % Agreement (±1 Color Block) | 100 | 98 | 98 | 100 | 100 |

b. Matrix comparison:

Not applicable. The device is only intended for measurements with urine samples.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):

Not applicable

4. Clinical cut-off:

Not applicable

5. Expected values/Reference range:

Previously cleared k061559

N. Instrument Name:

Acon U120 Urine Analyzer

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O. System Descriptions:

1. Modes of Operation:
Single and continuous testing mode

2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X or No ☐

3. Specimen Identification:
Manual Patient ID entry

4. Specimen Sampling and Handling:
Single Step or Continuous Test Modes the strip is manual dip and the strip is place on the strip holder.

5. Calibration:
The reflectance of the white calibration circle located on the top of the strip holder is tested when the instrument is first turned on and with each test strip.

6. Quality Control:
Recommendations for testing quality control are provided in the labeling as follows: users should follow federal, state and local requirements for quality control testing.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

R. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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