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. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChemVELOCITY 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.

The 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.

Device Description

The proposed device is a fully automated, computer-controlled urine chemistry analyzer intended for use only with iChemVelocity 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, respectively.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study data for the iChem VELOCITY Automated Urine Chemistry System:

The provided 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device (iChem 100 Urine Chemistry Analyzer and iChem 10SG strips) for regulatory clearance. It describes the device, its intended use, and compares its design, materials, safety, and electromagnetic compatibility with the predicate.

Crucially, the 510(k) summary does not include detailed acceptance criteria or a dedicated study section proving the device meets specific performance criteria beyond asserting "substantial equivalence." This is a common practice in 510(k) applications, where extensive performance data (like clinical trial results with predefined acceptance criteria) might not be explicitly summarized in the public document if the device is deemed substantially equivalent based on similarity to an already cleared device and analytical performance tests.

However, we can infer some "acceptance criteria" from the comparison section and general principles of diagnostic device performance. The study described is an analytical performance comparison to the predicate device, not a human reader study or a standalone clinical effectiveness study in the typical sense.

Here's an attempt to answer your questions based on the available information:

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence Claim)

Since explicit acceptance criteria for performance are not listed, we can infer that the device's performance was deemed acceptable if it was substantially equivalent to the predicate device, the iChem 100 Analyzer and 10SG strips, for all analytes and measurements. The "Reported Device Performance" below refers to the general claim of equivalence, as specific numerical performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) are not provided in this summary.

Acceptance Criteria (Inferred from Substantial Equivalence Goal)	Reported Device Performance (Inferred from 510(k) Clearance)
Equivalence in Intended Use: The iChem VELOCITY's intended use should be comparable to or encompass that of the predicate device.	The iChem VELOCITY's intended use is for automating urine chemistry analysis with specific strips, producing quantitative (SG), semi-quantitative (glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones, ascorbic acid), and qualitative (nitrites, color, clarity) results, aiding in diagnosis of metabolic disorders, kidney/liver function, and UTIs. This is consistent with the predicate's purpose, with a broader scope for some analytes like ascorbic acid.
Similar Design Principles: The operational and measurement principles should be consistent with the predicate.	The device "uses similar well-proven design methods as predicate." It employs well-proven chemistry strip methods, optical absorbance, and scattering for analyte determination and physical properties of urine. Uses LED illumination and a CMOS image sensor for specific gravity and chemistry strip readings, and flowcell absorbance for color, similar to the predicate's principles, albeit with technological updates.
Comparable Material Characteristics: The materials used, especially for chemistry strips, should be functionally equivalent.	"Materials are generally same as predicate." Chemistry strip compositions are "very similar," although some pads (glucose, pH) in the iChem VELOCITY strips are noted as "more hydrophobic" compared to the predicate's 10 SG strips. This difference was presumably found acceptable.
Meeting Safety and EMC Standards: The device must comply with relevant safety and electromagnetic compatibility (EMC) standards.	Certified to UL61010-1, CAN/CSA C22.2 #61010-1, IEC 61010-1, CENELEC EN61010-1, IEC61010-2-101, and CENELEC EN 61010-2-81 (Safety). Tested and certified to CENELEC EN 61326-1 EMC and CENELEC EN 61326-2-6 EMC (EMC). This demonstrates compliance with current standards.
Performance Equivalence for Analyte Detection: The device should produce results for each analyte that are functionally equivalent to the predicate.	The 510(k) clearance implies that the performance of the iChem VELOCITY for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones, ascorbic acid, specific gravity, nitrites, color, and clarity was found to be sufficiently similar to the predicate device to warrant clearance. No specific performance metrics (e.g., sensitivity, specificity, agreement rates) are provided in this summary.

Study Information (Based on 510(k) Summary)

Given the nature of a 510(k) for substantial equivalence, the "study" described is primarily an analytical performance comparison against a predicate device, rather than a full clinical trial.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated within this 510(k) summary. For a device like this, the "test set" would typically refer to a range of urine samples (both normal and abnormal, prepared or clinical) used for analytical validation across the measurement range of each analyte.
- Data Provenance: Not explicitly stated. For a device manufactured by an US-based company (Iris Diagnostics, Chatsworth, CA), it is highly likely that the testing and data generation occurred in the United States, usually at the manufacturer's facility or an associated clinical/analytical laboratory. The summary does not specify if the data was retrospective or prospective, but analytical performance studies often involve prospective collection or preparation of samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For this type of analytical device (measuring chemical properties of urine), the "ground truth" for the test set would typically be established by established reference methods or highly accurate laboratory analyzers, not necessarily by "experts" in the human interpretation sense (like radiologists). If visual assessments were part of a comparison (e.g., for color/clarity in early development stages), then trained laboratory personnel would likely be involved.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable/not specified. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) where there's subjectivity and potential for disagreement among readers. For an automated chemistry analyzer, the comparison would be against a quantitative or semi-quantitative reference method, or the predicate device's output.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an automated urine chemistry system, not an AI-assisted diagnostic tool that aids human readers in interpreting complex data. Its function is to perform the measurements directly.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Yes, the fundamental "performance" of this device is inherently standalone. It is an automated system ("algorithm only" in a broader sense of automation) that performs measurements without direct human real-time intervention for each test. The summary explicitly states: "iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading." This clearly indicates it functions as a standalone system without human-in-the-loop for reading the strips themselves.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth Type: While not explicitly detailed, for an analytical chemistry system, the ground truth would typically be established by reference laboratory methods (e.g., established gold standard chemical assays, refractometry for specific gravity) or by agreement with the predicate device's measurements on a diverse set of samples. The objective is to demonstrate that the new device measures the analytes accurately and consistently.
The sample size for the training set:
- Training Set Sample Size: Not applicable/not specified in this summary. This document describes a medical device seeking 510(k) clearance, which would typically rely on pre-defined chemical reactions and optical detection methods, rather than machine learning algorithms requiring explicit "training sets" in the modern AI sense. While some internal calibration or parameter optimization (which could be loosely termed "training") would have occurred during development, it's not a "training set" in the context of deep learning or statistical model training that would be detailed in this type of regulatory submission in 2011.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as no explicit training set in the AI sense is described. For calibration or development, ground truth would have been established through controlled experiments using known concentrations of analytes and reference methods.

In summary, the provided document is a 510(k) summary demonstrating "substantial equivalence," not a detailed clinical study report. It highlights the device's technical comparability and regulatory compliance (safety, EMC) with a previously cleared device. Detailed performance metrics with specific acceptance criteria and the methodologies for establishing ground truth for test and training sets (especially in the context of AI/ML) are typically more extensively covered in PMA submissions or in supporting documentation that is not part of this public summary.

Summary

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510(k) Summary

10 852

MAR 2 3 2011

Applicant: Iris Diagnostics, a Division of IRIS International Inc 9172 Eton Avenue Chatsworth, CA 91311 (818) 709-1244 David W. Gates, Ph.D. VP Quality Assurance and Regulatory Affairs

I. iChem VELOCITY Automated Urine Chemistry System

Proprietary and Established Names:

Proprietary names: iChem® VELOCITY™ Automated Urine Chemistry System and iChem VELOCITY™ Chemistry Strips.

Common names: Automated Urinalysis System, Urinary Test System (non-quantitative).

Regulation Section:	Code	Test
21 CFR § 862.2900	KQO	Automated Urinalysis System
21 CFR § 862.1340	JIL	Urinary Glucose (Non Quantitative) Test System
21 CFR § 864.6550	JIO	Occult Blood test
21 CFR § 862.1785	CDM	Urinary Urobilinogen (Non-Quantitative)
21 CFR § 862.1550	CEN	Urinary pH (Non-Quantitative) Test System
21 CFR § 862.1510	JMT	Nitrite (Non-Quantitative) Test System
21 CFR § 862.2800	JRE	Refractometer for Clinical Use
21 CFR § 864.7675	LJX	Leukocyte Peroxidase Test
21 CFR § 862.1095	JMA	Ascorbic Acid Test System
21 CFR § 862.1435	JIN	Ketones (Non-Quantitative) Test System
21 CFR § 862.1645	JIR	Urinary Protein or Albumin (Non-Quant.) Test System
21 CFR § 862.1115	JJB	Urinary Bilirubin and its conjugates (Non-Quantitative)Test System

Classification names: Automated Urinalysis System; Urinary Test Systems (Non Quantitative); Refractometer for Clinical Use

Class II: Urinary Glucose and Occult Blood

Class I: Automated Urinalysis System, Urinary Urobilinogen, Urinary pH, Ketones, Urinary Protein, Urinary Bilirubin, Nitrite, Leukocyte Peroxidase, Ascorbic Acid, Refractometer.

Indication 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. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not

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intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.

Devices to which substantial equivalence is claimed

iChem 100 Urine Chemistry Analyzer and iChem 10SG strips

Description of the proposed device:

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Device	ProposediChem VELOCITY,iChem VELOCITY strips	PredicateiChem 100 Analyzer10SG strips
Intended use	The iChem®VELOCITY™automated urine chemistrysystem is an in vitro diagnosticdevice used to automate theurine chemistry analysis profileusing iChem®VELOCITY™Urine Chemistry Strips. TheiChem VELOCITY can beused as a stand alone-system,as well as in an iQ®200 Seriessystem, a configuration giventhe proprietary nameiRICELL™ as it is designed tobe hardware and softwarecompatible with iQ200 Seriessystems. It producesquantitative results for specificgravity, semi-quantitativeresults for glucose, blood,leukocyte esterase, bilirubin,urobilinogen, pH, protein,ketones and ascorbic acid;and qualitative results fornitrites, color and clarity.iChemVELOCITY strips areintended for use only with theiChemVELOCITY analyzer. Inparticular they are notintended for visual reading.The iChem VELOCITY teststrips are not intended forvisual reading. TheiChemVELOCITY is notintended to be used as a Pointof Care (POC) analyzer.These measurements areused to aid in the diagnosis ofmetabolic disorders, kidneyfunction anomalies, urinarytract infections, and liverfunction. Tests performedusing the iChem VELOCITYare intended for clinicallaboratory use and in vitrodiagnostic use only.	The iChem100 is a semi-automated urine analyzerintended for the in vitromeasurement of the followinganalytes: glucose (GLU),protein (PRO), bilirubin (BIL),urobilinogen (URO), pH, blood(BLD), ketones (KET), nitrite(NIT), leukocytes (LEU),specific gravity (SG) and color.
	1. Uses similar well-provendesign methods as predicate.	1. Uses well-proven chemistrystrip methods, and opticalabsorbance and scattering fordetermination of analytes inand physical properties ofurine.
	2. Same as predicate	2. Is capable of stand-alone,as well as joint operation withan Iris iQ200 Series System.
	3. Same as predicate	3. Tests for the concentrationof ascorbic acid in urine.
	4. Same as predicate	4. Uses fixed-time end-pointreflectance for all chemistrydeterminations.
Design	5. Same as predicate	5. LED's with three differentwavelengths are used toilluminate the test strips formeasurement. It utilizes a(CMOS) image sensor thatcaptures a color image of eachof the test pads. The CMOSimage sensor is able tophotograph almost the wholelength (100mm) of the urinetest strip and all of its width.
	6. Urine color is measured bythe absorbance of white lightthrough a flowcell containingurine. Intensities of RGBwavelengths are measuredwith a solid-statephotodetector array.	6. Urine color is measuredfrom the color compensation .pad on the iChem 10 SG strip
	7. Specific gravity is measuredby determining the refractiveindex of the specimen.	7. Specific Gravity ismeasured using a test padthat contains a detergent andBromthymol blue that indicatesthe presence of ionicconstituents in the urine bychanging color from green toyellow. The test pad forspecific gravity is impregnatedwith a reddish dye so that thecolor produced isyellow-brown tan.
Materials	D.C. by an internal switching mode power supply	VD.C. by an external power converter.
	Materials are generally same as predicate	Commodity materials and purchased components used in most bench top laboratory instruments, i.e. aluminum frames, thermoplastic enclosures and various molded parts; switching mode power supplies, solder-plated printed circuit board assemblies, programmable and general purpose microprocessors, discrete wire harnesses, flat flexible cables etc.
Safety	The proposed device has been certified to comply with latest applicable safety standards for U.S., Canada, and the European Union, including CB Scheme Certificate and Report.Specifically, these include UL61010-1, CAN/CSA C22.2 #61010-1, IEC 61010-1, CENELEC EN61010-1, IEC61010-2-101, and CENELEC EN 61010-2-81	The predicate device was tested to U.S. (U.L.) Part 1: General Requirements, UL61010A-1, First Edition. and to the Canadian Standards for Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use; Part 1: General Requirements, CAN/CSA-C22.2 No. 1010.1-92, First Edition.It was also tested to the European/International versions of those norms IEC 61010-1/ EN 61010-1: 2001 "Safety requirements for electrical equipment for measurement, control, and laboratory use: Part I General requirements"
ElectromagneticCompatibility	The proposed device has been tested and certified to CENELEC EN 61326-1 EMC requirements-general and CENELEC EN 61326-2-6 EMC requirements-particular requirements for IVD medical equipment.	Was tested and certified to IEC61326-1:1997+A1 1998+A2:2001
Chemistry strips	1. The iChem VELOCITY is intended for use only with Iris VELOCITY chemistry strips2. Analyte detection chemistry composition very similar	1. The iChem100 is intended for use only with the iChem 10 SG multi-parameter test strips.2. Analyte detection pads for glucose and pH are more hydrophobic.

(

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ll. iChem VELOCITY CalChek Kit

Proprietary and Established Names:

Proprietary name: iChem VELOCITY CalChek Kit

Classification name: Quality control material (assayed and unassayed).

Common name: Urinalysis controls

Regulation Section:	Code	Test
21 CFR § 862.1660	JJX	Single (Specified) Analyte Controls (Assayed AndUnassayed)

Class I: Single (Specified) Analyte Controls, Assayed.

Unclassified: Urinary Color, Urinary Clarity (Turbidity)

Device to which substantial equivalence is claimed

IRISpec Gravity Control 1 ™ and IRISpec Gravity Control 2™ File No. K960054

Arkray Check Strips K013783

Description of the proposed device:

iChem VELOCITY CalChek Reagents are a set of buffer-based solutions intended for the in vitro monitoring of specific gravity, color and clarity.

Intended Use:

The 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 liguid 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.

Comparison of the proposed device with the predicate device

Comparison	iChem VELOCITY SpecificGravity Calcheks(Proposed Device)	IRISpec Gravity Control 1™IRISpec Gravity Control 2™(Predicate Devices)
Composition	Glycerol, salts, food dyes,preservative, dissolved in deionizedwater. No biological material.	Salts, foodcoloring,glycerin,stabilizers,preservative in deionized water
Form	Same as predicate	Liquid, ready to use

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Preservatives	Yes	Yes
Storage	20-28°C (68-82°F)	Dark, dry place (2-8C)
Stability-closed vial	1 year	1 year
Stability-open vial	Single use	30 days
S.G. Cal value -low	1.002 ± 0.002	NA
S.G. Cal value-med	1.030 ± 0.002	1.025 ± 0.001
S.G. Cal value-high	1.060 ± 0.002	1.060 ± 0.001
Intended use	Assayed QC materials formonitoring of urine chemistryspecific gravity on the iChemVELOCITY Urine Analyzer.	For IVD use in the operation ofIRIS Urinalysis workstations
Analytes	SG at three levels	Specific Gravity at two levels
Usage	Vial is intended for one time use	Contents dispensed for multipleuses
Packaging-container	10 mL Vacutainers	500 ml. glass container

Comparison	IRIS Reflectance Calchecks(Proposed Device)	Arkray Check Strips(Predicate Devices)

Composition	Munsell paper of variousreflectances laminated to mylar foil	One plain mylar foil, onelaminate
No. sets per package	Same as predicate	2
Reflectance acceptanceranges	Same as predicate	Programmed into instrument
Packaging	Same as predicate	Clear polystyrene cylindricaltube with press-on stopper
No. of strips/set	5	2
Distinct reflectance values	89.8%,72.3%,39.4%, 19.4%,5.8%,	White (90-110%), gray (~30-40)
Measurement wavelengths	472,525,630nm	430,500,565,635,760 nm
Reusable	No	Yes, until results are out ofrange
Shelf-life	1 year	Not specified
Storage temperature	18-25°C	20-28° C
Package Insert	P/N 300-1226	No

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Image /page/7/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles a stylized human figure or bird in flight. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

HAR 2 3 2011

IRIS International Inc. c/o Mr. David Gates 9172 Eton Avenue Chatsworth, CA 91311

Re: K101852

Trade Name: iChem® VELOCITY™ Automated Urine Chemistry System iChem® VELOCITY™ Chemistry Strips iChem® VELOCITY™ CalChek Kit Regulation Number: 21 CFR §862.1340 Regulation Name: Urinary Glucose (non-quantitative test system) Regulatory Class: Class II Product Codes: JIL, CDM, JJB, JIN, JIR, JMT, LJX, CEN, JIO, JRE, JMA, KQO Dated: March 2, 2011 Received: March 4, 2011

Dear Mr. Gates:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 –

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

CJC.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): K101852

Device Names:

iChem® VELOCITY TM Urine Chemistry System

Indication 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 qlucose. blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.

X Prescription Use __ (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K10/852

11 - 10 - 12 - 11 -

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Indications for Use

KI01852 510(k) Number (if known):

Device Names:

iChem® VELOCITY ™ CalChek Kit

Indication For Use:

The 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.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k/0/852

・・・・・

Regulation Number and Section

§ 862.2900 Automated urinalysis system.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.