CLINITEK ADVANTUS, MODEL 1420

K063276 · Bayer Healthcare, LLC · JIL · Dec 28, 2006 · Clinical Chemistry

Device Facts

• Record ID: K063276
• Device Name: CLINITEK ADVANTUS, MODEL 1420
• Applicant: Bayer Healthcare, LLC
• Product Code: JIL · Clinical Chemistry
• Decision Date: Dec 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2

Indications for Use

The CLINITEK Advantus™ Urinalysis analyzer is a semi-automated, bench top analyzer. It is designed to read Bayer® Reagent Strips for Urinalysis, such as, MULTISTIX® 10 SG and MULTISTIX PRO® Reagent Strips. This analyzer is intended for the measurement of the following: Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Specific Gravitv, and Urobilinogen, Tests performed using the CLINITEK Advantus™ are intended for in vitro diagnostic use.

Device Story

Semi-automated benchtop urinalysis analyzer; reads Bayer reagent strips (e.g., MULTISTIX 10 SG, MULTISTIX PRO). Input: reagent strips with urine samples. Operation: reflectance spectrophotometer measures color/intensity of reflected light from reagent areas; automated push-bar mechanics move strips through incubation/read station; internal thermal printer outputs results. Used in clinical settings by laboratory personnel. Features integrated touch screen for data entry, LIS/HIS communication, and automated calibration per strip. Benefits: standardized, automated urine chemistry analysis; assists diagnosis of metabolic/renal/hepatic conditions.

Clinical Evidence

Performance demonstrated via internal laboratory evaluations and clinical setting studies. Testing confirmed substantial equivalence to predicate devices. Software verification and validation activities, including requirements specifications and hazard analysis, were performed to ensure device performance.

Technological Characteristics

Reflectance spectrophotometer; benchtop form factor. Components: system optics, push-bar mechanics, barcode reader, integrated color touch screen. Connectivity: LIS/HIS system integration. Calibration: automated per strip. Software: utilizes reagent-specific algorithms and performance parameters.

Indications for Use

Indicated for use by clinicians to measure urine analytes (Bilirubin, Blood, Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Specific Gravity, Urobilinogen) to assist in diagnosing kidney function, urinary tract infections, metabolic disorders, and liver function.

Regulatory Classification

Identification

A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

Predicate Devices

• CLINITEK 500 (CLINITEK family internal filing)
• CLINITEK 200+ (K926359)

Submission Summary (Full Text)

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

A. 510(k) Number:
k063276

B. Purpose for Submission:
New device

C. Measurand:
Urinary Glucose, Blood, Creatinine, Bilirubin, Ketones, Leukocyte, Nitrite, pH, Protein, Specific Gravity and Urobilinogen

D. Type of Test:
Qualitative and semi-Quantitative

E. Applicant:
Bayer HealthCare, LLC

F. Proprietary and Established Names:
Bayer CLINITEK Advantus

G. Regulatory Information:

1. Regulation section:
21 CFR §862.1340 – Urinary glucose (non-quantitative) test system
21 CFR §864.6550 – Occult blood test
21 CFR §862.1225 – Creatinine 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 §864.7675 – Leukocyte peroxidase test
21 CFR §862.1510 – Nitrite (non-quantitative) test system
21 CFR §862.1550 – Urinary pH (non-quantitative) test system
21 CFR §862.1645 – Urinary protein or albumin (non-quantitative) test system
21 CFR §862.2800 – Refractometer for clinical use

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21 CFR §862.1785 – Urinary urobilinogen (non-quantitative) test system
21 CFR §862.2900 – Automated urinalysis system

2. Classification:
Class II (glucose, blood and creatinine) and the remainder are Class I.

3. Product code:
Class II: JIL, JIO and JFY
Class I: JJB, JIN, LJX, JMT, CEN, JIR, JRE, CDM and KQO

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 CLINITEK Advantus Urinalysis analyzer is a semi-automated, benchtop analyzer. It is designed to read Bayer Reagent Strips for Urinalysis, such as, MULTISTIX 10 SG and MULTISTIX PRO Reagent Strips.

This analyzer is intended for the measurement of the following: Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Specific Gravity and Urobilinogen. These measurements are used to assist diagnosis in the following areas:
- Kidney Function
- Urinary tract infections
- Metabolic disorders (e.g. diabetes mellitus)
- Liver Function

Tests performed using the CLINITEK Advantus are intended for in vitro diagnostic use.

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

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4. Special instrument requirements:

CLINITEK Advantus

I. Device Description:

The Clinitek Advantus Urinalysis analyzer is a semi-automated, bench top analyzer. It is designed to read Bayer Reagent Strips, such as Multistix 10 SG or Multistix PRO Reagent Strips.

The analyzer is a reflectance spectrophotometer that analyzes the color and intensity of the light reflected from the reagent area and reports the results. The analyzer can determine and report the color of the urine. The user can enter the clarity for each specimen. Calibration is performed automatically each time a reagent strip is run.

The analyzer has a touch screen display, printer, push bar and fixed platform which consist of strip loading station, incubation/read station and waste bin.

During testing a reagent strip is manually dipped into a urine sample then placed on the strip loading station. The push bar moves the strip to the incubation/read station, where it is tested. When testing is complete, the strip is dropped into the waste bin and the results are printed.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Bayer Clinitek 200+ and 500+(current generation instrument)

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

k926359

3. Comparison with predicate:

| Similarities/Differences | | | |
| --- | --- | --- | --- |
| Item | Device | Predicate 1 | Predicate 2 |
| Specimen Type | Urine | Same | Same |
| Reported Output | Bilirubin, blood (occult), creatinine, glucose, ketone, leukocyte, nitrite, pH, protein, specific gravity, urobilinogen and protein-to creatinine ratio | Same | Same |

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| Similarities/Differences | | | |
| --- | --- | --- | --- |
| Intended Use | The analyzer is a semi-automated, bench top instrument designed to read Bayer Reagent strips for Urinalysis, such as Multistix 10 SG and Bayer Multistix PRO reagent strips | Same | Same (with k992257) |
| Calibration method | Performed automatically at each strip reading using dark current and white reflectance strip | Same | Performed automatically when the analyzer is powered on, using white reflectance strip |
| Data storage | 500 patients results, 200 Quality control | Same | 200 patient results |
| Print Out | Fixed Head Printer – Roll | Same | Moving Head Printer -Roll |
| Entered Parameter | Urine color, Urine clarity, Patient ID, Operator ID and microscopic results | Urine color, Urine clarity, Patient ID and Operator ID | Patient ID |
| User interface | Color LCD display | Mono color Graphical user interface | Vacuum fluorescent display |

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

IEC 61010-1/2001; Safety requirements for electrical equipment for measurement, control, and laboratory use-Part 1: General requirements.

IEC 61010-2-081/2001; Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-081: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes.

EN 61010-2-101/2002; Safety requirements for electrical equipment for measurement, control, and laboratory use. Particular requirements In Vitro diagnostic (IVD) medical equipment.

EN 61326-2-6/2005; Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic 9IVD) medical equipment.

L. Test Principle:

Previously cleared under Multistix urine test strips k905396 and k992257

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Fresh urine samples from normal adults were prepared by spiking with various analytes to the desired concentration. The samples were tested using three lots of the Multistix 10SG and three lots of the Multistix Pro 10LS strips on nine Clinitek Advantus and nine Clinitek 500 instruments. Six replicates were performed on each instrument.

| Urine analyte | Contrived/Spiked level | Expected result(s) determined by fitness for use requirements | % Agreement with expected results | | n |
| --- | --- | --- | --- | --- | --- |
| | | | CLINITEK Advantus | CLINITEK 500 | |
| BIL | 0 mg/dL | Negative | 100 | 99.8 | 486 |
| BIL | 0.8 mg/dL | Small & Moderate | 99.6 | 99.6 | 486 |
| BLO | 0 mg/dL | Negative | 100 | 100 | 486 |
| BLO | 0.062 mg/dL | Small | 98.6 | 100 | 486 |
| CRE | 50 mg/dL | 50 mg/dL | 93.8 | 98.8 | 162 |
| CRE | 200 mg/dL | 200 mg/dL | 99.4 | 93.2 | 162 |
| GLU | 0 mg/dL | Negative | 100 | 100 | 486 |
| GLU | 100 mg/dL | 100 mg/dL | 100 | 100 | 486 |
| GLU | 250 mg/dL | 100 & 250 mg/dL | 100 | 100 | 486 |
| GLU | 1000 mg/dL | 500 & ≥1000 mg/dL | 99.6 | 100 | 486 |
| KET | 0 mg/dL | Negative | 100 | 100 | 486 |
| KET | 10 mg/dL | Trace & 15 mg/dL | 100 | 100 | 486 |
| KET | 40 mg/dL | 40 & ≥80 mg/dL | 95.1 | 98.8 | 486 |
| LEU | 0 cells/μL | Negative | 98.1 | 96.3 | 486 |
| LEU | 42 cells/μL | Small 7 Moderate | 97.3 | 95.3 | 486 |
| NIT | 0 mg/dL | Negative | 100 | 100 | 486 |
| NIT | 0.15 mg/dL | Positive | 100 | 100 | 486 |
| pH | 6 | 5 ~ 6 | 100 | 100 | 486 |
| pH | 7 | 6 ~ 7 | 99.6 | 100 | 486 |
| pH | 8 | 7 ~ 8 | 100 | 100 | 486 |
| PRO | 0 mg/dL | Negative | 100 | 100 | 486 |
| PRO | 30 mg/dL | 30 mg/dL | 99.8 | 100 | 486 |
| PRO | 500 mg/dL | ≥300 mg/dL | 100 | 99.8 | 486 |
| SG | 1.004-1.006 | ≤1.005 & 1.010 | 99.3 | 100 | 810 |

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| Urine analyte | Contrived/Spiked level | Expected result(s) determined by fitness for use requirements | % Agreement with expected results | | n |
| --- | --- | --- | --- | --- | --- |
| | | | CLINITEK Advantus | CLINITEK 500 | |
| SG | 1.022-1.024 | 1.020 & 1.025 | 100 | 100 | 810 |
| URO | 1 mg/dL | 0.2 & 1.0 mg/dL | 100 | 100 | 486 |
| URO | 4 mg/dL | 2.0 & 4.0 mg/dL | 100 | 100 | 486 |

b. Linearity/assay reportable range:

Previously cleared

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

Previously cleared

d. Detection limit:

Previously cleared

e. Analytical specificity:

Previously cleared

f. Assay cut-off:

Previously cleared

2. Comparison studies:

a. Method comparison with predicate device:

The comparison was performed by using the MULTISIX 10SG and Bayer MULTISTIX PRO Reagent strips. Patient samples were tested on all analyzers as well as visually read. The data was analyzed in a tabular format and it was divided into two levels of percentage agreement (exact and within one level agreement):

| Test | Comparative Method | Product | N | % Exact Agreement | % Within one level Agreement |
| --- | --- | --- | --- | --- | --- |
| Bilirubin | Clinitek 200+ | 10SG | 2352 | 94.2 | 99.9 |
| | Clinitek 500 | 10SG | 2344 | 95.7 | 99.9 |
| | Lab Method | 10SG | 1612 | 90.4 | 94.8 |

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| Test | Comparative Method | Product | N | % Exact Agreement | % Within one level Agreement |
| --- | --- | --- | --- | --- | --- |
| | Visual | 10SG | 2297 | 89.2 | 99.2 |
| Blood | Clinitek 200+ | Both | 4710 | 84.5 | 99.6 |
| | Clinitek 500 | Both | 4692 | 86.3 | 99.9 |
| | Lab Method | Both | 2966 | 41.9 | 64.5 |
| | Visual | Both | 4695 | 71.8 | 97.7 |
| Creatinine | Clinitek 200+ | PRO10LS | 2358 | 81.0 | 99.8 |
| | Clinitek 500 | PRO10LS | 2348 | 83.1 | 100 |
| | Lab Method | PRO10LS | 2358 | 72.9 | 99.5 |
| | Visual | PRO10LS | 2332 | 43.5 | 95.6 |
| Glucose | Clinitek 200+ | Both | 4710 | 91.7 | 99.9 |
| | Clinitek 500 | Both | 4692 | 94.0 | 99.8 |
| | Lab Method | Both | 4712 | 91.3 | 99.8 |
| | Visual | Both | 4706 | 90.2 | 99.6 |
| Ketone | Clinitek 200+ | Both | 4710 | 88.7 | 99.9 |
| | Clinitek 500 | Both | 4692 | 93.8 | 100 |
| | Visual | Both | 4699 | 85.6 | 99.6 |
| Leukocyte | Clinitek 200+ | Both | 4710 | 82.5 | 99.6 |
| | Clinitek 500 | Both | 4692 | 87.5 | 99.9 |
| | Lab Method | Both | 2950 | 58.8 | 82.4 |
| | Visual | Both | 4675 | 79.8 | 98.8 |
| Nitrite | Clinitek 200+ | Both | 4710 | 94.3 | 100 |
| | Clinitek 500 | Both | 4692 | 93.7 | 100 |
| | Visual | Both | 4684 | 93.4 | 99.9 |
| pH | Clinitek 200+ | Both | 4710 | 46.7 | 90.1 |
| | Clinitek 500 | Both | 4692 | 73.7 | 97.0 |
| | Lab Method | Both | 4712 | 62.2 | 97.2 |
| | Visual | Both | 4680 | 61.8 | 90.2 |
| Protein | Clinitek 200+ | 10SG | 2352 | 88.1 | 100 |
| | Clinitek 200+ | PRO10LS | 2358 | 90.5 | 99.3 |
| | Clinitek 500 | 10SG | 234 | 91.8 | 100 |
| | Clinitek 500 | PRO10LS | 2348 | 93.1 | 99.6 |
| | Lab Method Albumin | 10SG | 2346 | 72.3 | 96.4 |
| | Lab Method Total Protein & Alb | PRO10LS | 2350 | 82.0 | 97.0 |
| | Lab Method Total Protein | 10SG | 2354 | 75.6 | 98.7 |
| | Visual | 10SG | 2350 | 76.5 | 99.2 |
| | Visual | PRO10LS | 2353 | 72.2 | 93.5 |
| P:C | Clinitek 200+ | PRO10LS | 2205 | 83.0 | 96.6 |
| | Clinitek 500 | PRO10LS | 2224 | 89.8 | 97.0 |
| | Lab Method | PRO10LS | 2219 | 79.9 | 94.0 |

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The urine color was also compared. Patient samples were tested on the analyzers and read visually. The results are presented in the tables below. Shaded boxes indicate exact agreement.

| | Comparative Method - Visual | Total |
| --- | --- | --- |
| Color-less | YLW | Orange | Red | GRN | BRN | Other |
| Clinitek Advantus | | 454 | 3156 | 672 | 17 | 8 | 25 | 3 |
| YLW | n |
| % | 99.3 | 93.3 | 87.3 | 42.5 | 100 | 58.1 | 75.0 |
| Orange | n | | 136 | 81 | 3 | | 6 | |
| % | | 4.0 | 10.5 | 7.5 | | 14.0 | |
| RED | n | | 10 | 2 | 12 | | 7 | |
| % | | 0.3 | 0.3 | 30.0 | | 16.3 | |
| GRN | n | 3 | 20 | 4 | | | | |
| % | 0.7 | 0.6 | 0.5 | | | | |
| BRN | n | | 60 | 11 | 8 | | 5 | 1 |
| % | | 1.8 | 1.4 | 20.0 | | 11.6 | 25.0 |
| Total | | 457 | 3382 | 770 | 40 | 8 | 43 | 4 |
| | Comparative Method - Clinitek 500 | | | | | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | YLW | Orange | Red | GRN | BRN | | Other |
| Clinitek Advantus | | 4111 | 57 | 18 | 8 | 75 | 4269 | |
| YLW | n | | | | | | | |
| | % | 96.6 | 25.9 | 40.9 | 80.0 | 70.8 | 92.1 | |
| ORANGE | n | 59 | 160 | | | 5 | 224 | |
| | % | 1.4 | 72.7 | | | 4.7 | 4.8 | |
| RED | n | 7 | | 21 | | 3 | 31 | |
| | % | 0.2 | | 47.7 | | 2.8 | 0.7 | |
| GRN | n | 25 | | | 2 | | 27 | |
| | % | 0.6 | | | 20.0 | | 0.6 | |

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| BRN | n | 52 | 3 | 5 | | 23 | 83 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | % | 1.2 | 1.4 | 11.4 | | 21.7 | 1.8 |
| Total | | 4254 | 220 | 44 | 10 | 106 | 4634 |

b. Matrix comparison:

Not applicable

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:

Previously cleared

5. Expected values/Reference range:

Previously cleared

N. Instrument Name:

CLINITEK Advantus Urinalysis Analyzer

O. System Descriptions:

1. Modes of Operation:

Single sample application

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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:

Alpha-Numeric keyboard, barcode reader or the operator and create a worklist.

4. Specimen Sampling and Handling:

The Bayer reagent strip is manually dipped into a urine sample then placed on the fixed platform for testing. All steps that follow are automatically controlled by the instrument’s software.

5. Calibration:

Dark current, White reflectance strip

6. Quality Control:

Periodic Positive and Negative control recommendation per laboratory requirements. Up to 200 QC results are stored in the instrument.

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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