The ACON™ U120 Urine Analyzer is intended for use in conjunction with the ACON Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite. The ACON Urinalysis Reagent Strips are available in different combinations of the aforementioned analytes. The instrument is intended for professional, in vitro diagnostic use only. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract.

Device Description

The U120 Urine Analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip. Without a urine analyzer, operators must visually compare the reagent areas of the strip to a color chart using the naked eye. Obviously, visual determination for urinalysis is a time consuming task and is prone to inaccuracy due to human misinterpretation and variable light sources. To minimize the variability associated with visual testing, the ACON U120 Urine Analyzer is specifically designed for improved accuracy and efficiency of urinalysis featuring data management and report generation capabilities.

AI/ML Overview

The provided text describes the ACON™ U120 Urine Analyzer and its substantial equivalence to a predicate device. However, it does not include specific acceptance criteria or a detailed study proving the device meets particular numerical performance targets. The document focuses on demonstrating substantial equivalence to a predicate device (Bayer Clinitek Status Urine Chemistry Analyzer) through various tests, rather than establishing and meeting predefined performance metrics.

Therefore, many of the requested sections (Table of acceptance criteria and reported device performance, sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set, training ground truth establishment) cannot be extracted from the given text.

Here's an analysis based on the information available:

Acceptance Criteria and Study Overview for ACON™ U120 Urine Analyzer

The provided document describes the ACON™ U120 Urine Analyzer and its comparison to a predicate device, the Bayer Clinitek Status Urine Chemistry Analyzer (K031947). The primary goal of the studies mentioned was to demonstrate "substantial equivalence" to the predicate device, rather than meeting a specific set of numerical acceptance criteria publicly disclosed in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the document.
The submission focuses on demonstrating substantial equivalence without detailing specific numerical performance acceptance criteria for each analyte. The "Discussion of Non-Clinical Tests Performed" and "Discussion of Clinical Tests Performed" sections indicate that various studies were conducted to show the device's performance is comparable to the predicate.

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

The document states: "Studies were conducted in-house and in clinical setting..." and "Clinical studies were conducted using the ACON U120 Urine Analyzer." However, specific sample sizes for clinical or test sets are not provided. The provenance of the data (country of origin, retrospective/prospective) is also not specified.

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

Not explicitly provided. The document mentions "inexperienced intended users" in the context of obtaining comparable testing results, but does not detail how ground truth for the test set was established or the number/qualifications of any experts involved.

4. Adjudication Method for the Test Set

Not described in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The study compared the ACON U120 Urine Analyzer against the predicate device, with a focus on whether "inexperienced intended users were able to obtain comparable testing results." This suggests a device-to-device comparison rather than an AI-assisted human vs. human-alone study.

6. Standalone Performance Study

The clinical study described compares the ACON U120 Urine Analyzer directly with the Bayer Clinitek Status Urine Chemistry Analyzer. This implies a standalone performance comparison of the device against the predicate. The document states: "Study results indicate that the inexperienced intended users were able to obtain comparable testing results when using the ACON U120 Urine Analyzer and a legally marketed Bayer Clinitek Status Urine Chemistry Analyzer (K031947)."

7. Type of Ground Truth Used

The document implies that the predicate device's results (Bayer Clinitek Status Urine Chemistry Analyzer) served as the de facto "ground truth" or reference for establishing substantial equivalence. The goal was to show "comparable testing results." No mention of pathology, expert consensus (beyond the predicate), or outcomes data as "ground truth" is made.

8. Sample Size for the Training Set

Not applicable/Not provided. This device is a reflectance photometer, which measures the intensity and color of light reflecting from reagent areas on urinalysis strips. It is not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning.

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

Not applicable/Not provided as this is not an AI/ML algorithm that uses a training set.

Summary

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JUL 30 2007

5. 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The Assigned 510(k) number is

Submitter's Identification:

ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121

Tel.: 858-875-8028 Fax: 858-875-8099

Date Prepared: June 27, 2007

Contact Person:

Jinn-nan Lin, Ph.D. V.P., Regulatory Affairs

Proprietary Name of the Device:

ACON™ U120 Urine Analyzer

Common Name:

Urine Chemistry Analyzer

Regulation Section and Classification:

21 CFR § 862.2900 Automated Urinalysis System
21 CFR § 862.1340 Urinary Glucose (Non-Quantitative) Test System
21 CFR § 862.1115 Urinary Bilirubin and its Conjugates (Non-Quantitative) Test System
21 CFR § 862.1435 Ketones (Non-Quantitative) Test System
21 CFR § 864.6550 Occult Blood Test
21 CFR § 862.1550 Urinary pH (Non-Quantitative) Test System
21 CFR § 862.1645 Urinary Protein or Albumin (Non-Quantitative) Test System

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21 CFR § 862.1785 Urinary Urobilinogen (Non-Quantitative) Test System
21 CFR & 862.1510 Nitrite (Non-Quantitative) Test System
21 CFR § 864.7675 Leukocyte Peroxidase Test
Ascorbic Acid Test System 21 CFR § 862.1095
Class I: Automated Urinalysis System; Urinary Leukocytes, Urinary pH, Nitrite, Urinary Protein, Ketones, Urinary Urobilinogen, Urinary Bilirubin, Specific Gravity and Ascorbic Acid

Class II: Urinary Glucose and Occult Blood

Product Code:

KQO Automated Urinalysis System
Urinary Glucose (non-quant.) test system JIL
Blood, Occult, Colorimetric, in urine JIO
Test, Urine Leukocyte LJX
CEN Urinary, pH (non-quant.)
Nitrite (urinary, non-quant.) test system JMT
Protein or Albumin (urinary, non-quant.) test system JIR
Ketones (urinary, non-quant.) test system JIN
Urinary Urobilinogen (non-quant.) test system CDM
Urinary Bilirubin & its conjugates (urinary, non-quant.) test system JJB
Acid, Ascorbic, 2, 4-Dinitrophenylhydrazine (Spectrophotometric) JMA

Medical Specialty:

Clinical Chemistry

Predicate Device:

Bayer Clinitek Status Urine Chemistry Analyzer Bayer Healthcare, LLC, marketed by Bayer Healthcare, LLC, located at Medfield, MA 02052, USA. 510(k) Number: K031947

Description:

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consuming task and is prone to inaccuracy due to human misinterpretation and variable light sources. To minimize the variability associated with visual testing, the ACON U120 Urine Analyzer is specifically designed for improved accuracy and efficiency of urinalysis featuring data management and report generation capabilities.

Intended Use:

Feature	Specifications
Methodology	Reflectance Photometer
Detection	Photosensitive diode
Throughput	Single Test Mode: 40 tests/hourContinuous Test Mode: 120 tests/hour
Memory	Last 500 results
Strip Incubation Time	1 minute
PC Port	Standard RS232C Port (cable not included)
Printing Capabilities	Internal heat-sensitive printer (included)External printer (not included)25 Pin Parallel External Printer Port (included)
Available Languages on Screen	English and Spanish
Ambient Operating Conditions	0-40°C (32-104°F); ≤85% Relative Humidity (non-condensing)
Optimum Operating Conditions	15-30°C (59-86°F); ≤75% Relative Humidity (non-condensing)
Power Source	220 Volts AC (±10%), 50 Hz (±1)110 Volts AC (±10%), 60 Hz (±1) 110-230V AC, 50/60Hz
Line Leakage Current	<0.5 mA
Weight	2.6 kg (5.73 lbs)
Dimensions	27.1 (L) × 26.5 (W) × 14.8 (H) cm
Display Dimensions	10.6 (W) × 2.8 (H) cm

Technological Characteristics:

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Comparison to Predicate Devices:

The ACON U120 Urine Analyzer is substantially equivalent to the Bayer Clinitek Status Urine Chemistry Analyzer, K031947.

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Studies were conducted in-house and in clinical setting to demonstrate the performance of the ACON U120 Urine Analyzer and that the intended user can easily operate the system and obtain urinalysis results as the predicate device.

Laboratory Testing:

The performance characteristics of the ACON U120 Urine Analyzer were verified by many tests including temperature flex study, humidity flex study, voltage flex study, repeatability study, readability study, electric security testing, device comparison study, configuration tests and operation tests.

Discussion of Clinical Tests Performed:

Clinical studies were conducted using the ACON U120 Urine Analyzer. Clinical study data are presented and clinical accuracy between the ACON U120 Urine Analyzer and Bayer Clinitek Status Urine Chemistry Analyzer per ACON clinical study protocol for U120 Urine Analyzer is compared. Study results indicate that the inexperienced intended users were able to obtain comparable testing results when using the ACON U120 Urine Analyzer and a legally marketed Bayer Clinitek Status Urine Chemistry Analyzer (K031947).

Conclusion:

The laboratory testing and clinical study results demonstrated that the ACON U120 Urine Analyzer is safe, accurate and easy-to-use. It is also demonstrated that the ACON U120 Urine Analyzer is substantially equivalent to the Bayer Clinitek Status Urine Chemistry Analyzer (K031947), currently sold on the U.S. market.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 3 0 2007

Acon Laboratories, Inc. c/o Mr. Martin O'Connor Germaine Laboratories, Inc. 4139 Gardendale Center #101 San Antonio TX, 78229

Re: K070929

Trade/Device Name: Acon™ U120 Urine Analyzer Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL, JIO, LJX, JRE, CEN, JMT, JIR, JIN CDM, JJB, JMA, KQO Dated: May 30, 2006 Received: June 4, 2007

Dear Mr. O'Connor:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

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

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Sean M. Cooper, M.S., D.V.M. 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

510(k) Number (if known): K070929

ACONTM U120 Urine Analyzer Device Name:

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 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)

Carol Benam
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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K070929

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.