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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the DFI Co., Ltd's CYBOW Reader 300 and CYBOW Reader 720 urine chemistry analyzers. It describes the device, its intended use, and indicates substantial equivalence to a predicate device based on non-clinical studies.

However, the summary does not explicitly state specific acceptance criteria (e.g., performance thresholds like sensitivity, specificity, accuracy targets) for the device. Instead, it broadly states that non-clinical studies for analytical performance (precision, linearity, reportable range, detection limit, analytical specificity/limitation) and comparison studies were conducted. The conclusion is that the device is "safe and effective and substantially equivalent" to the predicate, implying that its performance met unstated internal criteria for equivalence.

Additionally, the document does not provide the detailed results of the device performance for direct comparison against any acceptance criteria. It only mentions that a "Comparison study Method comparison with predicate device, clinical study" was performed according to NCCLS EP9A guidelines.

Given these limitations, I will extract and infer information from the provided text to fulfill the request as best as possible.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria are not explicitly stated in the provided 510(k) summary. The document only mentions that analytical performance and comparison studies were conducted to demonstrate substantial equivalence to the predicate device.

Inferred Acceptance Criteria (based on the context of a 510(k) submission for substantial equivalence):

Analytical Performance: Performance (precision, reproducibility, linearity, assay reportable range, detection limit, analytical specificity/limitation) should be comparable to or not worse than the predicate device.
Method Comparison: Agreement with the predicate device should be within acceptable clinical and analytical limits, as defined by standard guidelines like NCCLS EP9A.

Reported Device Performance:
The document states that a "Non-Clinical study was conducted on the CYBOW Reader 300 and CYBOW Reader 720" including "Analytical performance" and a "Comparison study Method comparison with predicate device, clinical study."
The conclusion is that the device is "safe and effective and substantially equivalent" to the predicate, implying that the performance met unstated criteria. No specific numerical performance results (e.g., correlation coefficients, bias, accuracy rates) are provided in this summary.

Acceptance Criteria (Inferred)	Reported Device Performance
Analytical Performance: Comparable to or not worse than predicate device for:	Analytical performance studies were conducted including precision/reproducibility, linearity/assay reportable range, detection limit, and analytical specificity/limitation of test. The conclusion states the device is "safe and effective and substantially equivalent" to the predicate, implying these criteria were met. No specific performance data is provided.
- Precision / Reproducibility
- Linearity / Assay Reportable Range, Detection Limit
- Analytical Specificity / Limitation of Test

Method Comparison: Agreement with predicate device within acceptable clinical/analytical limits (per NCCLS EP9A).	Comparison study was conducted: "Method comparison with predicate device, clinical study" following "Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (2002) NCCLS, EP9A." The conclusion of "substantial equivalence" suggests acceptable agreement. No specific comparison data is provided.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- Site A (Samsung Hospital): 255 samples
- Site B (Authoritative local university hospital at national Univ. of Pusan): 280 samples
- Site C (Authoritative local university hospital at national Univ. of Dong Ai): 332 samples
- Total Samples (across three sites): 867 samples (assuming these are distinct samples rather than samples per parameter, which is typical for method comparison studies)
Data Provenance:
- Country of Origin: Based on the names of the hospitals (Samsung Hospital, National Univ. of Pusan, National Univ. of Dong Ai) and the submitter's address (Kimhae-city, Gyung-nam, Korea; Seoul, Korea), the data originated from South Korea.
- Retrospective or Prospective: The document implies prospective collection for the purpose of the study. It states, "Three independent laboratory evaluations of the New Device and Predicative Device were conducted... for 20 days." And also, "Three operators, reflective of the intended users of the devices, performed the testing at each site." This strongly suggests the samples were run during this 20-day study period, rather than being historical retrospective data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts or a specific ground truth establishment process for the test set in the way one might see for imaging or diagnostic interpretation devices.

For a urine chemistry analyzer comparing to a predicate, the "ground truth" for the test set is typically established by the measurement results from the predicate device itself, or a recognized reference method if one exists and is specified (which is not the case here).

Therefore:

Number of Experts: Not applicable in the context of this type of comparison study, as the ground truth is the predicate device's measurement.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method. This is expected for a method comparison study of a quantitative/semi-quantitative analyte measurement device. The comparison method typically involves statistical analysis (e.g., regression, bias plots) between the new device's readings and the predicate device's readings, rather than a human adjudication process for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Was an MRMC study done? No. The study described is a method comparison study between an automated device and a predicate device, focusing on analytical performance and agreement on patient samples. While "Three operators, reflective of the intended users of the devices, performed the testing at each site," this is to assess reproducibility and routine use, not a multi-reader (human interpretation) comparative effectiveness study of diagnostic accuracy.
Effect Size of Human Readers Improvement with AI vs. Without AI: Not applicable, as this was not an AI-assisted human interpretation study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone study was done. The CYBOW Reader 300 and CYBOW Reader 720 are described as "reflectance photometer" devices with "intelligent image analyzer SW" that "locates the strip and the pads, and based on these color data the parameter values are determined." The non-clinical studies, including analytical performance and method comparison, evaluate the performance of these devices in a standalone manner (the algorithm/system itself, without human interpretation of the final result). The human operators are involved in running the device and handling samples, but the "performance" directly refers to the device's measured output.

7. The Type of Ground Truth Used

For the comparison study, the ground truth was the measurement results from the predicate device (Clinitek 200+, 500). The evaluation explicitly states it followed "Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (2002) NCCLS, EP9A," which is a standard for comparing a new method to an existing method (the predicate) using patient samples.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for the training set. For reflectance photometers with "intelligent image analyzer SW," a training set would typically be used during the development phase to optimize the algorithms for color interpretation. However, this 510(k) summary focuses on the validation of the final product.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established. This information is generally part of the device's internal development process and is not typically detailed in a 510(k) summary, which focuses on the validation of the finished device.

Summary

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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: onbix@naver.com

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:

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,

1. 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 (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 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:

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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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.