← Product Code [KQO](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO) · K101852

# CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT (K101852)

_Iris International Inc., A Division of Iris Iris I · KQO · Mar 23, 2011 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO/K101852

## Device Facts

- **Applicant:** Iris International Inc., A Division of Iris Iris I
- **Product Code:** [KQO](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO.md)
- **Decision Date:** Mar 23, 2011
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2900
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Indications for Use

The iChem®VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem®VELOCITY™ Urine Chemistry Strips. The iChem®VELOCITY™ can be used as a stand alone-system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity. iChem®VELOCITY™ strips are intended for use only with the iChem®VELOCITY™ analyzer. In particular they are not intended for visual reading. The iChem® VELOCITY™ test strips are not intended for visual reading. The iChem®VELOCITY™ is not intended to be used as a Point of Care (POC) analyzer. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChem® VELOCITY™ are intended for clinical laboratory use and in vitro diagnostic use only.

## Device Story

Fully automated, computer-controlled urine chemistry analyzer; processes urine samples via automated probe aspiration and dispensing onto reagent strips. System utilizes fixed-time end-point reflectance photometry (three LEDs and CMOS camera) to measure color changes on reagent pads; electronic refractometer assembly measures specific gravity; optical absorbance/scattering methods determine color and clarity. Used in clinical laboratories; operated by trained personnel. Output includes quantitative specific gravity, semi-quantitative chemistry results, and qualitative color/clarity data. Integrated into iRICELL™ configuration with iQ200 Series systems. Results aid clinicians in diagnosing metabolic, renal, urinary, and liver conditions. Includes CalChek kit for performance monitoring.

## Clinical Evidence

Bench testing only. Precision evaluated over 20 non-consecutive runs using negative, low, and high positive pools (N=540 per level). Method comparison performed against iChem 100 analyzer and Atago PEN Refractometer using clinical urine samples. Results showed high concordance (exact agreement and +/- 1 color block agreement) across all analytes. Interference testing conducted for common substances (e.g., ascorbic acid, glucose, hemoglobin) to define limitations.

## Technological Characteristics

Fully automated analyzer; CMOS digital camera for reflectance photometry; electronic refractometer for specific gravity. Reagent strips use enzymatic/colorimetric reactions. Connectivity: Standalone or integrated with iQ200 Series (iRICELL™). Calibration: Quarterly using CalChek strips. Software: Computer-controlled. Materials: CalChek reagents (glycerol, salts, food dyes, preservatives).

## Regulatory 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

- iChem 100 Urine Chemistry Analyzer and iChem 10SG strips
- IRISpec Gravity Control 1™ and IRISpec Gravity Control 2™ ([K960054](/device/K960054.md))
- Arkray Check Strips ([K013783](/device/K013783.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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

A. 510(k) Number:
k101852

B. Purpose for Submission:
New Device

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

D. Type of Test:
Qualitative and semi-quantitative

E. Applicant:
Iris Diagnostics

F. Proprietary and Established Names:
iChem®VELOCITY™ Automated Urine Chemistry System
iChem®VELOCITY™ Chemistry Strips.
iChem®VELOCITY™ Cal Chek Kit

G. Regulatory Information:
1. Regulation section:

|  Classification Name | Product Code | Device Class | Regulation Number  |
| --- | --- | --- | --- |
|  Urinary glucose (non-quantitative) test system | JIL | II | 21 CFR§862.1340  |
|  Occult blood test | JIO | II | 21 CFR§864.6550  |
|  Urinary urobilinogen (non-quantitative) test system | CDM | I | 21 CFR§862.1785  |
|  Urinary bilirubin and its conjugates (non-quantitative) | JJB | I | 21 CFR§862.1115  |

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|  test system |  |  |   |
| --- | --- | --- | --- |
|  Ketones (non-quantitative test system) | JIN | I | 21 CFR§862.1435  |
|  Urinary protein or albumin (non-quantitative) test system | JIR | I | 21 CFR§862.1645  |
|  Nitrite (non-quantitative) test system | JMT | I | 21 CFR§862.1510  |
|  Leukocyte peroxidase test | LJX | I | 21 CFR§864.7675  |
|  Urinary pH (non-quantitative) test system | CEN | I | 21 CFR§862.1550  |
|  Refractometer for Clinical Use | JRE | I | 21 CFR§862.2800  |
|  Ascorbic Acid Test System | JMA | I | 21 CFR§862.1095  |
|  Automated Urinalysis System | KQO | I | 21 CFR§862.2900  |

4. Panel:

(75) Clinical Chemistry and (81) Hematology

H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indication(s) for use:

The iChem®VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem®VELOCITY™ Urine Chemistry Strips. The iChem®VELOCITY™ can be used as a stand alone-system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity. iChem®VELOCITY™ strips are intended for use only with the iChem®VELOCITY™ analyzer. In particular they are not intended for visual reading. The iChem® VELOCITY™ test strips are not intended for visual reading. The iChem®VELOCITY™ is not intended to be used as a Point of Care (POC) analyzer.

These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChem® VELOCITY™ are intended for clinical laboratory use and in vitro diagnostic use only.

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iChem® VELOCITY™ CalChek Kit

iChem® VELOCITY™ CalChek Kit is a set of assayed and unassayed in vitro diagnostic controls for monitoring performance of the iChem® VELOCITY™ urine chemistry analyzer.

The controls include assayed liquid controls for the monitoring of the specific gravity measurement module, and unassayed liquid color and clarity controls for the monitoring of color and clarity measurements. The kit also includes a set of assayed reflectance strips for the monitoring of reflectance measurements. These measurements monitored by these controls are part of an automated urine chemistry analyzer used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function.

3. Special conditions for use statement(s):

Prescription use only

4. Special instrument requirements:

iChem® VELOCITY™ automated urine chemistry system

I. Device Description:

The iChem® VELOCITY™ is a fully automated, computer-controlled urine chemistry analyzer intended for use only with the iChem® VELOCITY™ Chemistry strips for the measurement of ten urine chemistry analytes from the chemistry strip plus the measurement of specific gravity using an electronic refractometer assembly and the qualitative measurement of color and clarity by optical absorbance and scattering methods. A Cal Check kit is included that contains SG Calchek, Color CalCheks and Clarity CalCheks in a liquid ready to use form.

J. Substantial Equivalence Information:

1. Predicate device name(s):

iChem 100 Analyzer 10SG strips

IRISSpec Gravity Control™ 1, 2 and Arkray Check Strips

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

k060280

k013783

3. Comparison with predicate:

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|  Similarities and Differences  |   |   |
| --- | --- | --- |
|  Item | iChem VELOCITY Urine Chemistry system (Proposed Device) | iChem 100 Analyzer and 10SG strips (k060280) (Predicate Device)  |
|  Intended Use | Intended for the in vitro measurement of multiple analytes | Same  |
|  Anaylzer | Automated urine analyzer | Semi-automated urine analyzer  |
|  Analyte | specific gravity, glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid, nitrites, color and clarity | glucose (GLU), Protein (PRO), bilirubin (BIL), urobilinogen (URO), pH, blood (BLD), ketones (KET), nitrite (NIT), leukocytes (LEU), specific gravity (SG) and color  |
|  Specimen | Urine | Same  |
|  Chemistry Strips | For use with iChem Velocity test strips only | For use with IChem 10 SG multi-parameter test strips  |
|  Design | Uses fixed-time end-point reflectance for all chemistry determinations. | Same  |
|  Similarities and Differences  |   |   |
| --- | --- | --- |
|  Item | iChem VELOCITY Calchek Kit (Proposed Device) | IRISSpec Gravity Control1™ and IRISSpec Gravity Control 2™ k013783  |
|  Intended Use | Assayed and Unassayed QC materials for monitoring of urine chemistry specific gravity, color and clarity measurements. The kit also includes a set of assayed reflectance strips for the monitoring of reflectance measurements on the iChem VELOCITY Urine Analyzer. | Same  |
|  Analytes | Specific Gravity at three levels | Specific Gravity at two levels  |
|  Usage | Vial is intended for one time use only. | Contents dispensed for multiple uses.  |
|  Packaging-container | 10 mL Vacutainers | 500 mL glass container  |
|  Form | Liquid, ready to use | Same  |
|  Composition | Glycerol, salts, food dyes, preservatives, dissolved in deionized water. No biological material. | Salts, food coloring, glycerin, stabilizers, preservative in deionized  |

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|  Similarities and Differences  |   |   |
| --- | --- | --- |
|  Item | iChem VELOCITY Calchek Kit (Proposed Device) | IRISSpec Gravity Control1™ and IRISSpec Gravity Control 2™ k013783  |
|   |  | water.  |
|  Storage | 20-28°C | Dark, dry place (2-8°C)  |
|  Stability | Open Vial Stability: Single one time use. Closed Vial stability: 1 year | Open Vial Stability: 30 days. Closed Vial stability: 1 year  |
|  Item | IRIS Reflectance CalCheks (Proposed Device) | Arkray Check Strips (k013783)  |
| --- | --- | --- |
|  Composition | Munsell paper of various reflectances laminated by mylar foil. | One plain mylar foil, one laminate.  |
|  Reflectance acceptance ranges | Programmed into instrument | Same  |
|  Reusable | No | Yes, until results are out of range  |
|  Shelf-life | 1 year | Not specified  |
|  Storage Temperature | 18-25°C | 20-28°C  |

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

CEN 13640 Stability Testing of In Vitro Diagnostic Reagents; 2002

EP12-A2 User Protocol for Evaluation of Qualitative Test Performance; January 2008

EP7-A2 Interference Testing in Clinical Chemistry

L. Test Principle:

The iChem® VELOCITY™ is an automatic chemistry system performing measurements of urine and chemical constituents utilizing test strips read by wavelength reflectance and specific gravity using the refractive index.

Reflectance photometry analyzes the intensity and color of light reflected from the reagent areas of a urinalysis test strip. Using three LEDs and one black and white complementary metal oxide semiconductor camera (CMOS), the optical system reads the color change in the urine strips after a sample is applied.

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The measurement of the ten analytes on the iChem® VELOCITY™ chemistry strip is based on optical measurement of percent reflectance of visible light flashed on reagent pads that undergo a color development reaction proportional to the analyte concentration. The sensor is a complementary metal-oxide semiconductor (CMOS) digital camera assembly.

**Glucose**- Two step enzymatic reaction using glucose oxidase, peroxidase and a chromogen. Glucose oxidase catalyzes the formation of gluconic acid and hydrogen peroxide via the oxidation of glucose. Peroxidase then catalyzes the reaction of hydrogen peroxide with a chromogen via the oxidation of chromogen to colors ranging between green to gray-blue.

**Occult Blood**- pseudo-enzymatic test containing organic peroxide and a chromogen. The peroxidase effect of hemoglobin and myoglobin causes a color change to green.

**Urobilinogen**- based on the coupling reaction of urobilinogen with a stable diazonium salt in buffer. A pink to red color proportional to the urobilinogen concentration is generated.

**pH**- this test contains a mixed indicator which assures a marked change in color between pH 5 and pH 9.

**Nitrite**- This test is based on modified Griess reaction in which Nitrite in the urine reacts with amide to form a diazonium compound. The subsequent coupling reaction yields a pink color in the presence of nitrite.

**Specific Gravity**- Specific gravity is physically determined by refractometry in the urine chemistry system and is not analyzed by strip chemistry.

**Leukocyte Peroxidase**- enzymatic test pad containing an indoxyl ester and a diazonium salt. Granulocyte esterases react with indoxyl ester and diazonium salt to generate a violet color.

**Ascorbic Acid**- This test is based on Tilman’s reaction in which the presence of ascorbic acid leads to the decolorization of the test pad from gray-blue to orange.

**Ketones**- based on Legal’s method in which the test pad contains sodium nitroprusside and glycine in an alkaline medium. A violet color proportional to methylketone is generated.

**Protein**- based on the “protein error” of pH indicators on the green color developed from the presence of protein.

**Bilirubin**- based on the coupling of bilirubin with diazonium salt in an acidic medium. A pinkish tan color proportional to bilirubin concentration is generated.

## M. Performance Characteristics (if/when applicable):

1. **Analytical performance:**

a. **Precision/Reproducibility**:

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Repeatability (within run and day-to-day) precision of the iChem VELOCITY automated urine chemistry system was evaluated using a negative urine pool which was spiked at the lowest positive level and the highest positive level. Three replicate tubes of each level (negative, low positive, and high positive) were analyzed on three iChem Velocity analyzers with three lots of iChem VELOCITY Urine Chemistry Strips for 20 non-consecutive runs/days. The within-run precision is calculated as an average direct agreement for the 20 runs over the 3 replicate for all instruments and strip lots. The day-to-day precision is calculated as an average direct agreement of all  $20\mathrm{1}^{\mathrm{st}}$  replicates of each run for all instruments and strip lots. All concentrations for all tests had  $100\%$  agreement at +/- one color block.

Example: 3 replicates (1 negative sample + 2 positive samples) x 3 instruments x 3 strip lots x 20 runs = 540 replicates

Precision: Day-to-Day

|  Analyte | Level | Unit | Direct Agreement (%) | ±1 block Agreement (%) | N  |
| --- | --- | --- | --- | --- | --- |
|  BILIRUBIN | 0 | mg/dL | 100 | 100 | 180  |
|  UROBILINOGEN | 0 | mg/dL | 100 | 100 | 180  |
|  KETONES | 0 | mg/dL | 99.8 | 100 | 180  |
|  ASCORBIC ACID | 0 | mg/dL | 100 | 100 | 180  |
|  GLUCOSE | 0 | mg/dL | 100 | 100 | 180  |
|  PROTEIN | 0 | mg/dL | 100 | 100 | 180  |
|  BLOOD | 0 | mg/dL | 100 | 100 | 180  |
|  pH | 5 | - | 100 | 100 | 180  |
|  NITRITE | 0 | mg/dL | 100 | 100 | 180  |
|  LEUKOCYTES | 0 | WBC/μL | 100 | 100 | 180  |

Level II:

|  Analyte | Level | Unit | Direct Agreement (%) | ± 1 block Agreement (%) | N  |
| --- | --- | --- | --- | --- | --- |
|  BILIRUBIN | 2 | mg/dL | 95.2 | 100 | 180  |
|  UROBILINOGEN | 2 | mg/dL | 96.1 | 100 | 180  |
|  KETONES | 5 | mg/dL | 100 | 100 | 180  |
|  ASCORBIC ACID | 20 | mg/dL | 96.1 | 100 | 180  |
|  GLUCOSE | 50 | mg/dL | 97.2 | 100 | 180  |
|  PROTEIN | 30 | mg/dL | 98.9 | 100 | 180  |
|  BLOOD | 0.03 | mg/dL | 97.2 | 100 | 180  |
|  pH | 7 | - | 100 | 100 | 180  |
|  NITRITE | Pos. | mg/dL | 99.4 | 100 | 180  |
|  LEUKOCYTES | 25 | WBC/μL | 96.1 | 100 | 180  |

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Level III:

|  Analyte | Level | Unit | Direct Agreement (%) | ± 1 block Agreement (%) | N  |
| --- | --- | --- | --- | --- | --- |
|  BILIRUBIN | 4 | mg/dL | 100 | 100 | 180  |
|  UROBILINOGEN | 4 | mg/dL | 100 | 100 | 180  |
|  KETONES | 80 | mg/dL | 100 | 100 | 180  |
|  ASCORBIC ACID | 40 | mg/dL | 99.4 | 100 | 180  |
|  GLUCOSE | 500 | mg/dL | 100 | 100 | 180  |
|  PROTEIN | 500 | mg/dL | 100 | 100 | 180  |
|  BLOOD | 1.0 | mg/dL | 98.9 | 100 | 180  |
|  pH | 9 | - | 97.8 | 100 | 180  |
|  NITRITE |  |  |  |  |   |
|  LEUKOCYTES | 500 | WBC/μL | 100 | 100 | 180  |

## Precision: Within Run

Level I:

|  Analyte | Level | Unit | Direct Agreement (%) | ± 1 block Agreement (%) | N  |
| --- | --- | --- | --- | --- | --- |
|  BILIRUBIN | 0 | mg/dL | 100 | 100 | 540  |
|  UROBILINOGEN | 0 | mg/dL | 100 | 100 | 540  |
|  KETONES | 0 | mg/dL | 100 | 100 | 540  |
|  ASCORBIC ACID | 0 | mg/dL | 100 | 100 | 540  |
|  GLUCOSE | 0 | mg/dL | 100 | 100 | 540  |
|  PROTEIN | 0 | mg/dL | 100 | 100 | 540  |
|  BLOOD | 0 | mg/dL | 100 | 100 | 540  |
|  pH | 5 | - | 100 | 100 | 540  |
|  NITRITE | 0 | mg/dL | 100 | 100 | 540  |
|  LEUKOCYTES | 0 | WBC/μL | 100 | 100 | 540  |

Level II:

|  Analyte | Level | Unit | Direct Agreement (%) | ± 1 block Agreement (%) | N  |
| --- | --- | --- | --- | --- | --- |
|  BILIRUBIN | 2 | mg/dL | 96.1 | 100 | 540  |
|  UROBILINOGEN | 2 | mg/dL | 96.3 | 100 | 540  |
|  KETONES | 5 | mg/dL | 99.4 | 100 | 540  |
|  ASCORBIC ACID | 20 | mg/dL | 97.6 | 100 | 540  |
|  GLUCOSE | 50 | mg/dL | 95.6 | 100 | 540  |
|  PROTEIN | 30 | mg/dL | 98.9 | 100 | 540  |
|  BLOOD | 0.03 | mg/dL | 97.8 | 100 | 540  |
|  pH | 7 | - | 100 | 100 | 540  |
|  NITRITE | Pos. | mg/dL | 99.4 | 100 | 540  |
|  LEUKOCYTES | 25 | WBC/μL | 96.3 | 100 | 540  |

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Level III:

|  Analyte | Level | Unit | Direct Agreement (%) | ± 1 block Agreement (%) | N  |
| --- | --- | --- | --- | --- | --- |
|  BILIRUBIN | 4 | mg/dL | 100 | 100 | 540  |
|  UROBILINOGEN | 4 | mg/dL | 100 | 100 | 540  |
|  KETONES | 80 | mg/dL | 99.4 | 100 | 540  |
|  ASCORBIC ACID | 40 | mg/dL | 99.8 | 100 | 540  |
|  GLUCOSE | 500 | mg/dL | 100 | 100 | 540  |
|  PROTEIN | 500 | mg/dL | 100 | 100 | 540  |
|  BLOOD | 1.0 | mg/dL | 98 | 100 | 540  |
|  pH | 9 | - | 97.6 | 100 | 540  |
|  NITRITE |  |  |  |  |   |
|  LEUKOCYTES | 500 | WBC/μL | 100 | 100 | 540  |

b. Linearity/assay reportable range:

Please see the method comparison section 2.a below and detection limit 2.d. below.

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

IRISpec CA/CB/CC controls previously cleared under (k072640) are to be used with the iChem® VELOCITY™ automated urine chemistry system and iChem® VELOCITY™ test strips.

Traceability

The IChem Velocity CalChek reagents are traceable to the following:

|  Consumable | Reference Instrument | Traceability  |
| --- | --- | --- |
|  SG Calchek | Atago Model SUR-NE refractometer | The Atago Model SUR-NE refractometer is calibrated annually to an outside calibration laboratory certified to ISO/IEC 17025  |
|  Color CalCheks | Shimatzu model 1601 spectrophotometer | The Shimatzu spectrophotometer is calibrated annually to an outside calibration laboratory certified to ISO/TEC 17025  |
|  Clarity CalCheks | Hanna HI 93414 Turbidity Meter | AMCO® Turbidity 1000 and AMCO® Turbidity 4000 Turbidity Standards, which are components of the Clarity Cal Cheks, are NIST traceable standards.  |

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# Stability

Real Time, open vial and accelerated stability protocols were reviewed and found to be acceptable. The iChem® VELOCITY™ CalChek Reagents are for single use only and have an open vial stability for up to 8 hours, with a single repeat, and a shelf-life of 1 year when stored at 18°C to 25°C (65°F-77°F).

# Value Assignment

SG Color Cal Cheks- NaCl and/or Glycerol are added gravimetrically to deionized water to obtain values that span the range of the assay on the instrument. Comparison testing was performed on three lots of proposed CalChek control material and compared with human urine spiked with NaCl. Testing was performed in triplicate on the iChem® VELOCITY™. No significant measurement differences were found.

SG Color Cal Cheks- varying amounts of food color are blending to achieve desired shades of colorless, straw, normal yellow and amber. The correct color absorbance values are verified by a spectrophotometer at 450, 550, and 650 nm.

Clarity CalCheks-varying amounts of food coloring and AMCO® turbidity standards are added to deionized water to achieve the desired clarity of slightly cloudy, cloudy and turbid. The achieved clarity is verified by nephrometric turbidity units obtained from a turbidity meter.

An example of the CalChek reagent values are as follows:

|  CalChek# | CalChek Name  |
| --- | --- |
|  1 | SG 1.002  |
|  2 | SG 1.030  |
|  3 | SG 1.060  |
|  4 | Colorless  |
|  5 | Straw  |
|  6 | Yellow  |
|  7 | Amber  |
|  8 | Slightly-Cloudy  |
|  9 | Cloudy  |
|  10 | Turbid  |

# d. Detection limit:

The sensitivity of the iChem® VELOCITY™ Urine Chemistry Strips was evaluated by spiking negative urine pools with known quantities of analytes. The analytes were spiked at the middle of each positive color block as well as between the negative and the first positive color block. Multiple samples were tested for each concentration. The prepared samples were then assayed on three iChem® VELOCITY™ analyzers. Sensitivity was defined as the lowest concentration that will yield ≥ 67% positive results.

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|  Analyte (Unit of Measure) | Sensitivity  |
| --- | --- |
|  Bilirubin (mg/dL) | 1.8  |
|  Urobilinogen (mg/dL) | 1.6  |
|  Ketones (mg/dL) | 3.0  |
|  Ascorbic Acid (mg/dL) | 17  |
|  Glucose (mg/dL) | 20  |
|  Protein (mg/dL) | 20  |
|  Blood (Hemoglobin) (mg/dL | 0.02  |
|  Nitrite (mg/dL) | 0.04  |
|  Leukocytes (WBC/μL) | 15  |

# e. Analytical specificity:

Negative urine was spiked one at a time with the possible interfering substances with concentrations listed in the following table. Each urine sample was tested with 5 replicates using an iChem® VELOCITY™ instrument and strips. Possible interference was determined when a difference of one color pad in any of the five replicates for the particular test analyte compared to either the negative (specificity) or analyte-spiked positive sample (interference).

The following potentially interfering substances at concentrations indicated were added to the urine. The noted interferences are stated in the labeling.

|  Interfering Substance | Interfering Substance Conc. (mg/dL) | Negative Urine With Spiked Substances  |
| --- | --- | --- |
|  Acetoacetate | 250 | Positive with Ketone. Negative for others  |
|  Ammonium Chloride | 200 | All Negative  |
|  Albumin | 1000 | Positive with Protein. Negative for others. Increased SG  |
|  Ascorbic Acid | >300 | Positive for Ascorbic. False negative bilirubin, ↓glucose, hemoglobin and nitrite  |
|  Bilirubin | 4 | Positive for Bilirubin and Urobilinogen.  |

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|   |  | Negative for others  |
| --- | --- | --- |
|  Calcium Chloride | 80 | All negative  |
|  Citric Acid | 65 | All negative. Lowered pH  |
|  Creatinine | 600 | All negative. Increased SG.  |
|  D (+) Glucose | 4100 | Positive for Glucose. Negative for others. Increased SG  |
|  Glycine | 450 | All negative. Increased SG  |
|  Hemoglobin | 5 | Positive for blood. Negative for others.  |
|  Potassium chloride | 1200 | All negative. Increase SG  |
|  Sodium Chloride | 1800 | All negative. Increased SG  |
|  Oxalic Acid | 70 | All Negative. Lowered pH  |
|  Sodium Nitrate | 0.3 | All negative  |
|  Sodium Nitrite | 10 | Positive for nitrite. Negative for others.  |
|  Sodium Phosphate | 500 | All negative. Increased SG  |
|  Urea | 4000 | All negative. Increased SG  |
|  D(+) Galactose | 0.5 | All negative  |
|  Beta-Lactose | 1 | All negative  |
|  2-mercaptoethanesulphonate (MESNA) | Up to 1140 | False positive for glucose, ketone, and ascorbic acid. All others negative.  |
|  Cephalosporin | 60 | May ↓ leukocyte esterase reading All others negative  |
|  Boric Acid | 1000 | May ↓ leukocytes esterase reading. All others negative.  |
|  Tetracycline | 1.5 | All negative  |
|  D | 1.5 | Positive for D  |
|  D | 1.5 | Positive for D  |
|  D | 1.5 | Positive for D  |

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f. Assay cut-off:

Not applicable

## 2. Comparison studies:

a. Method comparison with predicate device:

A method comparison study was performed using a single replicate of each clinical specimen between a single lot or reagent test strips and the iChem 100 analyzer with a single lot of iChem 10SG reagent strips. A minimum of 50 clinical samples were analyzed for the first positive color block above the negative. No spiked samples were used. For the second and successive color blocks above the lowest color block a minimum of 40 clinical samples were analyzed. Clinically positive spiked samples were used when insufficient numbers of high concentration samples were not available.

Ascorbic Acid

|  iChemVELOCITY (mg/dL) | 40 |  |  | 40  |
| --- | --- | --- | --- | --- |
|   |  20 | 1 | 47 |   |
|   |  0 | 326 | 2 |   |
|   |   | 0 | 20 | 40  |
|  iChem 100 (mg/dL)  |   |   |   |   |
|  Exact Agreement |  | 99.7% | 95.9% | 100%  |
|  Agreement +/- 1 Grade |  | 100% | 100% | 100%  |

Bilirubin

|  iChemVELOCITY (mg/dL) | 4 |  |  | 40  |
| --- | --- | --- | --- | --- |
|   |  2 | 2 | 36 |   |
|   |  0 | 338 |  |   |
|   |   | 0 | 2 | 4  |
|  iChem 100 (mg/dL)  |   |   |   |   |
|  Exact Agreement |  | 99.4% | 100% | 100%  |
|  Agreement +/- 1 Grade |  | 100% | 100% | 100%  |

{13}

14

# Blood

|  iChemVELOCITY (mg/dL) | 1.0 |  |  |  | 38  |
| --- | --- | --- | --- | --- | --- |
|   |  0.2 |  | 4 | 34 | 2  |
|   |  0.03 |  | 50 | 2 |   |
|   |  0 | 300 |  |  |   |
|   |   | 0 | 0.030 | 0.2 | 1.0  |
|  iChem 100 (mg/dL)  |   |   |   |   |   |
|  Exact Agreement |  | 100% | 92.6% | 94.4% | 95%  |
|  Agreement +/- 1 Grade |  | 100% | 100% | 100% | 100%  |

# Glucose

|  iChemVELOCITY (mg/dL) | 500 |  |  |  | 37  |
| --- | --- | --- | --- | --- | --- |
|   |  150 |  |  | 34 | 4  |
|   |  50 |  | 48 | 22 |   |
|   |  0 | 300 |  |  |   |
|   |  | 0 | 50 | 150 | 500 - 1000  |
|  iChem 100 (mg/dL)  |   |   |   |   |   |
|  Exact Agreement |  | 100% | 100% | 60.7%* | 90.2%  |
|  Agreement +/- 1 Grade |  | 100% | 100% | 100% | 100%  |

*The sponsor states in the labeling, this discrepancy is due to the reflectance border separating 50 from 150 mg/dL. This design concept results in reduced concordance at the 50/150 border.

{14}

# Ketones

|  iChemVELOCITY (mg/dL) |  |  |  |  |   |
| --- | --- | --- | --- | --- | --- |
|   |  80 |  |  |  | 11  |
|   |  20 |  | 2 | 20 |   |
|   |  5 | 1 | 28 |  |   |
|   |  0 | 19 |  |  |   |
|   |   | 0 | 25 | 100 | 300  |
|  iChem 100 (mg/dL)  |   |   |   |   |   |
|  Exact Agreement |  | 95% | 93.3% | 100% | 100%  |
|  Agreement +/- 1 Grade |  | 100% | 100% | 100% | 100%  |

# Leukocytes

|  iChemVELOCITY (mg/dL) | 500 |  |  |  |  | 40  |
| --- | --- | --- | --- | --- | --- | --- |
|   |  |   |   |   |   |   |
|   |  75 |  | 5 | 11 |  |   |
|   |  25 | 4 | 62 | 4 |  |   |
|   |  0 | 323 | 5 |  |  |   |
|   |   | 0 | 25 | 75 |  | 500  |
|  iChem 100 (mg/dL)  |   |   |   |   |   |   |
|  Exact Agreement |  | 98.8% | 86.1% | 73.3% |  | 100%  |
|  Agreement+=-/- 1 Grade |  | 100% | 100% | 100% |  | 100%  |

# Nitrite

|  iChemVELOCITY (mg/dL) | Pos |  | 48  |
| --- | --- | --- | --- |
|   |  0 | 324 | 2  |
|   |   | 0 | 0.1  |
|  iChem 100 (mg/dL)  |   |   |   |
|  Exact Agreement |  | 100% | 96.0%  |
|  Agreement +/- 1 Grade |  | 100% | 100%  |

{15}

pH

|  iChemVELOCITY (mg/dL) | 9 |  |  |  |  | 10  |
| --- | --- | --- | --- | --- | --- | --- |
|   |  8 |  |  |  | 8 |   |
|   |  7 |  |  | 10 | 2 |   |
|   |  6 | 3 | 7 |  |  |   |
|   |  5 | 10 |  |  |  |   |
|   |   | 5 | 6 | 7 | 8 | 9  |
|  iChem 100 (mg/dL)  |   |   |   |   |   |   |
|  Exact Agreement |  | 76.9% | 100% | 100% | 80% | 100%  |
|  Agreement +/- 1 Grade |  | 100% | 100% | 100% | 100% | 100%  |

Protein

|  iChemVELOCITY (mg/dL) | 500 |  |  |  | 35  |
| --- | --- | --- | --- | --- | --- |
|   |  100 |  | 5 | 38 | 2  |
|   |  30 |  | 46 |  |   |
|   |  0 | 324 |  |  |   |
|   |   | 0 | 30 | 100 | 500  |
|  iChem 100 (mg/dL)  |   |   |   |   |   |
|  Exact Agreement |  | 100% | 90.2% | 100% | 94.6%  |
|  Agreement +/- 1 Grade |  | 100% | 100% | 100% | 100%  |

Urobilinogen

|  iChemVELOCITY (mg/dL) | 4 |  | 3 | 35  |
| --- | --- | --- | --- | --- |
|   |  2 |  | 47 | 2  |
|   |  0 | 366 |  |   |
|   |   | 0 | 2 | 4  |
|  iChem 100 (mg/dL)  |   |   |   |   |
|  Exact Agreement |  | 100% | 94% | 95%  |
|  Agreement +/- 1 Grade |  | 100% | 100% | 100%  |

Specific Gravity was analyzed by comparing iChem®VELOCITY™ to the ATAGO PEN Refractometer. Values ranged from 1.000 to 1.060 in increments of 0.005 SG units. A total of 240 specimens natural urine samples were analyzed.

{16}

S.G. semi-quatitative Concordance iChemVELOCITY vs Atago PEN Refractometer

|  iChemVELOCITY | 1.060 |  |  |  |  |  |  |  |  |  |  |  | 20  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  1.055 |  |  |  |  |  |  |  |  |  |  | 20 |   |
|   |  1.050 |  |  |  |  |  |  |  |  |  | 20 |  |   |
|   |  1.045 |  |  |  |  |  |  |  |  | 20 |  |  |   |
|   |  1.040 |  |  |  |  |  |  |  | 20 |  |  |  |   |
|   |  1.035 |  |  |  |  |  |  | 20 |  |  |  |  |   |
|   |  1.030 |  |  |  |  |  | 19 |  |  |  |  |  |   |
|   |  1.025 |  |  |  |  | 20 | 1 |  |  |  |  |  |   |
|   |  1.020 |  |  |  | 19 |  |  |  |  |  |  |  |   |
|   |  1.015 |  |  | 20 | 1 |  |  |  |  |  |  |  |   |
|   |  1.010 |  | 20 |  |  |  |  |  |  |  |  |  |   |
|   |  1.005 | 20 |  |  |  |  |  |  |  |  |  |  |   |
|   | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 | 1.035 | 1.040 | 1.045 | 1.050 | 1.055 | 1.060 |   |
|   |  Atago PEN Refractometer  |   |   |   |   |   |   |   |   |   |   |   |   |
|  Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20  |
|  Agreement: |  |  |  |  |  |  |  |  |  |  |  |  |   |
|  Exact | 100% | 100% | 100% | 95% | 100% | 95% | 100% | 100% | 100% | 100% | 100% | 100% | 100%  |
|  ± 1 Grade | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100%  |

b. Matrix comparison:

Not applicable. The device is for urine samples only.

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:

Complete details of the expected analyte values are provided in the labeling.

N. Instrument Name:

iChem®VELOCITY™ Automated Urine Chemistry System

{17}

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:
Bar Code Reader and Manual numeric entry

4. Specimen Sampling and Handling:
The iChem® VELOCITY™ Urinalysis Test system can analyze multiple samples. Test strips are dispensed from the strip provider module, and places face up on the strip conveyer system. The sample probe mixes the specimen, then aspirates an aliquot of urine from the sample tube and dispenses the sample onto each reagent pad.

5. Calibration:
The instrument uses the accompanying five Cal Chek strips to perform a calibration reflectance check. The five Cal Chek strips have fixed calibration values with no lot specific values. Cal Chek strips are single use only. The sponsor recommends that the device be calibrated on a quarterly basis.

6. Quality Control:
Recommendations for testing quality control are provided in the labeling. The condition and accuracy of the system can be checked by performing control measurements using urine control CA/CB/CC. The iChem® VELOCITY™ supports the use of three control solutions (CA, CB, and CC) to validate the positive responses for each urine chemistry.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
None.

Q. Proposed Labeling:

{18}

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.

19

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO/K101852](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KQO/K101852)

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