IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE

K093861 · Iris International, Inc. · LKM · Feb 5, 2010 · Hematology

Device Facts

• Record ID: K093861
• Device Name: IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
• Applicant: Iris International, Inc.
• Product Code: LKM · Hematology
• Decision Date: Feb 5, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5200
• Device Class: Class 2

Intended Use

The iQ® 200 Analyzer/System is intended for the automated analysis of urine specimens.

Device Story

iQ® 200 Analyzer/System; automated urine microscopy analyzer. Modification: addition of iQ® Lamina Cradle accessory. Function: tracks reagent consumption; provides visual warning flags and audio alerts for reagent levels. Used in clinical laboratories; operated by laboratory personnel. Output: automated microscopy results; reagent status alerts. Benefit: ensures reagent availability; prevents analysis interruption.

Clinical Evidence

No clinical tests were performed with the addition of the Lamina Cradle. Bench testing only.

Technological Characteristics

Automated urine microscopy analyzer; accessory (Lamina Cradle) added for reagent tracking. Sensing principle: automated detection of reagent consumption. Connectivity: integrated system. Software: firmware for reagent monitoring and alert generation.

Indications for Use

Indicated for routine urinalysis in patients undergoing clinical evaluation, physical exams, or monitoring for metabolic, systemic, renal, or urinary tract disease/dysfunction, infection, carcinoma, or therapy effectiveness. Used for analysis of urine chemistry, specific gravity, and formed sediment elements.

Regulatory Classification

Identification

An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.

Predicate Devices

• iQ® 200 Analyzer/System (K022774)

Submission Summary (Full Text)

{0}------------------------------------------------

### International Remote Imaging Systems, Inc.

9162 Eton Avenue, Chatsworth, CA 91311 800-776-4747 818-709-1244 FAX [phone]

FEB - 5 2010

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## 510(k) SUMMARY

# 510(k) Submission: K093861

## iQ®200 System with Lamina Cradle

# General Information

| Date of Submission: | 12/03/2009 |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name of Device: | iQ®200 System with Lamina Cradle |
| Common Name of Device: | Automated Urinalysis System |
| Classification Name: | Automated Urinalysis System,<br>21 CFR 862.2900, Class I<br>Microscope, 21 CFR 862.3600, Class I<br>Automated cell counter (Urine particle counter),<br>21 CFR 864.5200, Class II |
| Submitter's Name: | Ellen A. Johnston<br>Sr. Quality Engineer<br>Iris Diagnostics,<br>Division of International Remote Imaging Systems, Inc.<br>9162 Eton Avenue, Chatsworth, CA 91311 |
| Description of Cradle: | The iQ Lamina Cradle is a new accessory to be used with the iQ<br>Series of Urine Microscopy Analyzers (K022774). The iQ Lamina<br>Cradle is connected to the iQ Series via a 5V DC USB bus, and is<br>under software control of the desktop computer that is part of the<br>iQ Series. The cradle contains a RFID transceiver and antenna. In<br>simple terms, it recognizes a legitimate IRIS RFID tag embedded<br>in the container label of each 7 liter iQ Lamina Bottle. The<br>software tracks the consumption of iQ Lamina. Visual warning<br>and error messages are displayed as flags in the system software.<br>Audio alerts are communicated through the cradle's speaker. The<br>tracking will alert the operator when a bottle is empty or when a<br>bottle not containing an Iris RFID chip is being used. |
| Intended Use: | The iQ 200 System is an in-vitro diagnostic device used to<br>automate the complete urinalysis profile, including urine test strip<br>chemistry panel and microscopic sediment analysis. Optionally,<br>the iQ 200 Analyzer can be used as a stand-alone unit, or the<br>results from the iQ 200 Analyzer can be combined with other urine |
| | chemistry results received from an LIS. It produces quantitative or<br>qualitative counts of all formed sediment elements present in urine,<br>including cells, casts, crystals, and organisms. A competent<br>human operator can set criteria for auto-reporting and flagging<br>specimens for review. All instrument analyte image decisions may<br>be reviewed and overridden by a trained technologist. |
| Substantial Equivalence<br>To Predicate Devices: | The iQ 200 System is substantially equivalent under Section<br>510(k) of the Food, Drug, and Cosmetic Act to The Yellow IRIS<br>Urinalysis Workstation with CHEMSTRIP Reader, the IRIS Flow<br>Microscope, the 900UDx Urine Pathology System, the 939UDx<br>Urine Pathology System, and the Sysmex UF-100. The product<br>codes are LKM, Urine Particle Counter, and KQO, Automated<br>Urinalysis System. |
| Summary of Technological<br>Characteristics: | The iQ 200 System provides automatic sample handling for<br>automated intelligent microscopy and automatic analyte<br>classification for improved data reporting, presentation and<br>management. Specimens are aspirated by an auto sampler rather<br>than poured manually. Each image is analyzed and assigned a<br>classification by an auto analyte recognition algorithm. Using<br>these classifications and the known observation volume,<br>microscopic analyte concentrations may be automatically reported.<br>If results from a specimen are not auto reported, microscopic<br>examination results are displayed on an independent computer<br>Workstation. Operators can then confirm or modify analyte<br>classification and release reports off-line for enhanced<br>convenience, obviating the need to process a second aliquot for<br>review. Chemistry results from the companion ARKRAY<br>AUTION MAX AX-4280 are automatically consolidated by the<br>Computer Workstation for display and reporting. |
| Performance Studies: | Not applicable to the addition of Lamina Cradle |
| Conclusions Drawn<br>From Clinical Tests: | No clinical tests were performed with the addition of the Lamina<br>Cradle. |

{1}------------------------------------------------

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

FEB 0 5 2010

IRIS International, Inc. c/o Ms. Ellen Johnston, Sr. Quality Engineer 9172 Eton Avenue Chatsworth, CA 91311

Re: k093861

Trade/Device Name: iQ® 200 System with iQ® Lamina Cradle Regulation Number: 21 CFR 864.5200 Regulation Name: Automated Cell Counter Regulatory Class: Class II Product Code: LKM, KQO Dated: January 7, 2010 Received: February 1, 2010

Dear Ms. Johnston:

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 class II (Special Controls), 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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

{3}------------------------------------------------

Page 2 - Ms. Ellen Johnston

predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Kerek R. Si

jar

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

#### Indications for Use

510(k) Number (if known): K093861

Device Name: iQ 200 System with Lamina Cradle

Indications for Use:

The iQ 200 System is intended for analysis of urine chemistry, specific gravity, and formed sediment elements, which constitutes typical routine urinalysis.

Urinalysis is ordered by physicians as a screening procedure for detection of possible abnormal metabolic or systemic disease, indicated by chemical composition of urine, and of potential renal or urinary tract disease or dysfunction, indicated by urine concentration and by the nature and distribution of urinary formed elements. Urine profile testing is commonly employed in the initial clinical evaluation of patients admitted for hospital care or undergoing physical examinations.

Routine urinalysis is also indicated in diagnosis of patients with possible renal or urinary tract infection, carcinoma, or other injury, as well as for monitoring the status and effectiveness of drug, radiation, or dietary therapy, and of post-surgical or posttherapeutic recovery.

The information produced by the iQ 200 System concerning the composition of patient urines is ordered at the discretion of the physician, and is part of a larger body of laboratory and other test results available to assist the physician in health assessments or differential diagnoses. Routine urinalysis findings are always subject to judgment and interpretation by physicians relative to the patient's overall clinical presentation and history.

August 20, 2002 Harvey Kasdan

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
|-------------------------------------------------------------------|
|-------------------------------------------------------------------|

Division Sign-Off

Office of In Vitro Diagnostic
Device Evaluation and Safety