CYBOW READER, MODELS 300 & 720

K102188 · DFI Co., Ltd. · KQO · Aug 9, 2011 · Clinical Chemistry

Device Facts

• Record ID: K102188
• Device Name: CYBOW READER, MODELS 300 & 720
• Applicant: DFI Co., Ltd.
• Product Code: KQO · Clinical Chemistry
• Decision Date: Aug 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2900
• Device Class: Class 1

Intended Use

The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry analyzers are semiautomated analyzers intended to be used with CYBOW 11 and CYBOW 10 Reagent Strips as a test system to semi-quanititatively or qualitatively measure the specified analytes in urine as follows: glucose, urobilinogen, pH, ketone, occult blood, protein, bilirubin, ascorbic acid, nitrite, leukocyte, and specific gravity. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry test systems are intended for prescription and in vitro diagnostic use only.

Device Story

Semi-automated urine chemistry analyzers (Reader 300/720) process urine samples via CYBOW 11/10 reagent strips; reflectance photometry measures color intensity changes on strip pads. LED light source and contact image sensor (CIS) module capture optical data. Analyzers provide semi-quantitative/qualitative results for 11 analytes. Used in clinical settings by trained operators; samples collected in clean containers. Output displayed on device or printed; aids clinical decision-making for renal/metabolic disorders. Optional barcode reader for specimen ID. Reader 720 includes automated waste disposal; Reader 300 requires manual strip removal.

Clinical Evidence

Bench testing only. Precision evaluated using two levels of control materials across three sites (n=90 per level). Method comparison performed against predicate using clinical urine samples. Sensitivity defined as 95% detection of trace/positive results. Interference testing conducted for medically relevant concentrations of substances. No clinical diagnostic studies performed.

Technological Characteristics

Reflectance photometer; uses color image sensor for optical detection. Analyzes CYBOW 11 and 10 reagent strips. System includes internal printer. Software-based image analysis for color evaluation. Semiautomated operation.

Indications for Use

Indicated for semi-quantitative or qualitative measurement of urine analytes (glucose, urobilinogen, pH, ketone, occult blood, protein, bilirubin, ascorbic acid, nitrite, leukocyte, specific gravity) to aid in evaluation of renal, urinary, and metabolic disorders. For prescription, in vitro diagnostic use.

Regulatory Classification

Identification

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

Predicate Devices

• Clinitek 200+, 500 (K926359)

Submission Summary (Full Text)

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K102188

#### 510(k) SUMMARY AUG - 9 2011

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

Submitter Information: DFI Co., Ltd 542-1, Daman-ri, Jinrye-myun, Kimhae-city, Gyung-nam, (621-880), Korea

Contact Person: Ho Dong, Yang Onbix Corporation #708 Le-Meilluer Town, 837-19 Yeuksam-dong Gangnam-gu, Seoul, Korea Tel: *82-2-566-3360 / Fax: *82-2-6280-3360 Email: [e-mail]

#### Aug 05, 2011 Date Summary Prepared:

#### Device Name:

| Trade Name(s): | CYBOW Reader 300, CYBOW Reader 720 |
|----------------------|-------------------------------------------------------|
| Classification Name: | Urinalysis system |
| Panel: | clinical chemistry |
| Product code: | KQO, JIL, JIO, CDM, CEN, JIN, JIR, JJB, JMA, JMT, LJX |

# Predicate Device Information:

K926359 / Clinitek 200+, 500

# Device Description:

CYBOW Reader 300, 720 are reflectance photometer. The strip is illuminated by white light, and there flected light from the strip is detected by a color Image Sensor. The RGB signals are digitized, and this digitized image is evaluated by the processor. The intelligent image analyzer SW locates the strip and the pads, and based on these color data the parameter values are determined. The results with the date and time of the measurement as well as the sequence number and the ID are stored and printed out by the internal printer.

### Intended Use:

The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry analyzers are semiautomated analyzers intended to be used with CYBOW 11 and CYBOW 10 Reagent Strips as a test system to semi-quanititatively or qualitatively measure the specified analytes in urine as follows: glucose, urobilinogen, pH, ketone, occult blood, protein, bilirubin, ascorbic acid, nitrite, leukocyte, and specific gravity. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry test systems are intended for prescription and in vitro diagnostic use only.

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# Comparison to Predicate Device(s):

This device is equivalent to the predicate devices in its intended use and technological characteristics, including:

- * indications for use
- * technological characteristics
- * performance properties

# Non-Clinical Study performance

Non-Clinical study was conducted on the CYBOW Reader 300 and CYBOW Reader 720 such as;

- 1. Analytical performance
precision / reproducibility linearity / assay reportable range, detection

limit, analytical specificity / limitation of test,

- 2. Comparison study Method comparison with predicate device, clinical study
The evaluation followed "Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (2002) NCCLS, EP9A.

Three independent laboratory evaluations of the New Device and Predicative Device were conducted. One evaluation one was Samsung Hospital (Site A, sample number: 255samples), the other was Authoritative local university hospital at national Univ.of Pusan) (Site B, sample number: 280samples) and another was Authoritative local university hospital (Hospital at national Univ.of Dong Ai) (Site C, sample number: 332samples) for 20days. Three operators, reflective of the intended users of the devices, performed the testing at each site

# Conclusion

Based on the information provided in this summary we conclude that CYBOW Reader 300 & 720 Urinalysis system are safe and effective and substantially equivalent to the predicate device K926359.

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Public Health Service

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized graphic of a bird-like figure, possibly representing a human profile, with flowing lines suggesting movement or flight. The overall design is simple and monochromatic.

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

AUG 0 9 2011

DFI Co., Ltd c/o Mr. Ho Dong Yang CEO. Onbix Corporation #821 Samil Plaza, 837-26 Yeuksam-dong Gangnam-gu, Seoul Republic of Korea, 135-937

Re: k102188

Trade/Device Name: CYBOW Reader 300 and CYBOW Reader 720 Urine Chemistry Analyzers Regulation Number: 21 CFR §862. 1340 Regulation Name: Urinary glucose (non-quantitative) system Regulatory Class: Class II Product Code: JIL, JIO, CDM, CEN, JIN, JIR, JJB, JMT, JRE, LJX, JMA, KQO Dated: July 20, 2011 Received: July 26, 2011

Dear Mr. Yang:

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).

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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 [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,

C.C.

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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# Indications for Use Form

510(k) Number (if known):

CYBOW Reader 300 / CYBOW Reader 720 Device Name:

Indications for Use:

The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry analyzers are semi-automated analyzers intended to be used with CYBOW 11 and CYBOW 10 Reagent Strips as a test system to semi-quanititatively or qualitatively measure the specified analytes in urine as follows: glucose, urobilinogen, pH, ketone, occult blood, protein, bilirubin, ascorbic acid, nitrite, leukocyte, and specific gravity. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry test systems are intended for prescription and in vitro diagnostic use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C)

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

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

Buth Chesler

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

K102188

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