The CLINITEK Advantus™ Urinalysis analyzer is a semi-automated, benchtop analyzer. It is designed to read Bayer® Reagent Strips for Urinalysis, such as, MULTISTIX® 10 SG and MULTISTIX PRO® Reagent Strips.

This analyzer is intended for the measurement of the following: Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH. Protein, Protein-to-Creatinine Ratio, Specific Gravity, and Urobilinogen. These measurements are used to assist diagnosis in the following areas:

Kidney Function .
Urinary tract infections .
Metabolic disorders (e.g. diabetes mellitus) .
. Liver Function

Tests performed using the CLINITEK Advantus™ are intended for in vitro diagnostic use.

Device Description

The CLINITEK Advantus™ Urinalysis analyzer is a semi-automated, bench top analyzer. It is designed to read Bayer® Reagent Strips for Urinalysis, such as, MULTISTIX® 10 SG and Bayer MULTISTIX PRO® Reagent Strips.

The analyzer is a reflectance spectrophotometer that analyzes the color and intensity of the light reflected from the reagent area and reports the results in clinically meaningful units. The analyzer can determine and report the color of the urine.

All testing takes place on the fixed platform. The fixed platform consists of 3 sections: the strip loading station, the incubation/read station, and the waste bin. Strips are placed on the strip loading station. The push bar moves the strips to the incubation/read station, where they are tested. When testing is complete, the strips drop into the waste bin. When testing is complete, an internal thermal printer prints the test results.

AI/ML Overview

The provided text describes the CLINITEK Advantus™ Urinalysis analyzer and its performance assessment for 510(k) submission. However, it does not explicitly provide a table of acceptance criteria with reported device performance or detailed information about the studies. Here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance:

The document states, "Studies were conducted as internal laboratory setting and in clinical settings to demonstrate the performance of the CLINITEK Advantus™ analyzer and assess its substantial equivalence against the predicate devices and where applicable the referenced laboratory methods." It also highlights the device's ability to "preserve reagent algorithms and performance parameters."

While specific numerical acceptance criteria (e.g., accuracy percentages, sensitivity/specificity thresholds) and a direct performance comparison table are not provided in this summary, the core acceptance criterion is substantial equivalence to the predicate devices (CLINITEK 500 and CLINITEK 200+).

Inferred Table of Acceptance Criteria & Reported Performance:

Feature/Parameter	Acceptance Criteria	Reported Device Performance (Inferred)
Overall Performance	Substantial equivalence to predicate devices (CLINITEK 500, CLINITEK 200+)	Demonstrated through internal lab and clinical studies.
Accuracy/Precision	Performance comparable to predicate devices and referenced laboratory methods for all measured analytes.	Assessed to be similar to predicates.
Reproducibility	Consistent results across multiple tests and conditions.	Implied by assessment of substantial equivalence.
Reagent Strip Compatibility	Accurate reading of Bayer® Reagent Strips (MULTISTIX® 10 SG, MULTISTIX PRO®).	Device designed for and reads these specific strips.
Software Functionality	Meets software requirements specifications, passes hazard analysis, and verification/validation.	Software Development Life Cycle information submitted and reviewed.
Operator Usability	User-friendly interaction via touch screen, automatic calibration, no manual calculations required.	Improved communications, load list input, improved QC, easy strip switching.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Sample Size for Test Set: Not specified.
Data Provenance: The studies were conducted in "internal laboratory setting and in clinical settings." This implies both controlled lab environments and real-world clinical usage. The country of origin is not explicitly stated, but the manufacturer is Bayer HealthCare, LLC, located in Norwood, MA, USA, suggesting the studies likely occurred in the US. The studies appear to be prospective to demonstrate device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document mentions "referenced laboratory methods" for comparison, which would imply the use of validated, possibly expert-performed, gold standard methods.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not specified. The comparison is against predicate devices and "referenced laboratory methods," suggesting a direct comparison rather than a human adjudication process for image interpretation.

5. 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: Not applicable. This device is an automated urinalysis analyzer, not an AI-assisted diagnostic tool for human readers interpreting complex images. Its function is to read reagent strips, and the comparison is largely against other automated or reference methods, not human interpretation improvement.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Yes, the device itself is a standalone automated system. The performance assessment would inherently be of the "algorithm only" (the reflectance spectrophotometer and its interpretation logic) without continuous human intervention during the reading process. Humans load the strips and review results, but the reading itself is automated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: The ground truth would have been established by the performance of the predicate devices (CLINITEK 500 and CLINITEK 200+) and "referenced laboratory methods." For urinalysis, these reference methods typically include established manual chemical tests, microscopy, or other validated laboratory analyzers. It implies a comparison to established, accepted diagnostic methods for each analyte.

8. The sample size for the training set:

Sample Size for Training Set: Not specified. The document states "reagent algorithms and performance parameters" are preserved, suggesting a legacy of development, but details on specific training sets for new algorithms in this device are not provided.

9. How the ground truth for the training set was established:

Ground Truth for Training Set: Not specified. Given the nature of a spectrophotometric reader, the "training" (calibration, algorithm development) would typically involve known concentrations of analytes and corresponding reflectance values to build the correlation between color intensity and analyte concentration. This would be established using highly accurate laboratory standards and methods.

Summary

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Section 5 - 510(k) Summary

K063276

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitter information

Contact person:	Noor MalkiManager, Regulatory Affairs & Compliance
Address:	Bayer HealthCare, LLCDiagnostic Division2 Edgewater DriveNorwood, MA 02062	DEC 2 8 2006
Phone:	781-269-3401
Date summary prepared:	October 26, 2006
Device Information
Proprietary Name:	Bayer CLINITEK Advantus™
Common name:	Urine Chemistry Analyzer
Main classification name:	Automated Urinalysis System
Main classification number:	21 CFR 862.2900, Class I
Main classification panel:	Clinical Chemistry and Clinical Toxicology

Predicate Devices

Element	Predicate I	Predicate II
Device Name	CLINITEK 500	CLINITEK 200+
Common name	Urine Chemistry Analyzer	Urine Chemistry Analyzer
510(k) Number	CLINITEK family internal filing	K926359
Manufacturer	Bayer HealthCare, LLC	Heraeus Kulzer, Inc.

Device Description

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Section 5 - 510(k) Summary

Statement of Intended Use

The CLINITEK Advantus™ Urinalysis analyzer is a semi-automated, bench top analyzer. It is designed to read Bayer® Reagent Strips for Urinalysis, such as, MULTISTIX® 10 SG and MULTISTIX PRO® Reagent Strips.

This analyzer is intended for the measurement of the following: Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Specific Gravitv, and Urobilinogen,

Tests performed using the CLINITEK Advantus™ are intended for in vitro diagnostic use.

Summary of Technological Characteristics

The analyzer utilizes system optics, push bar mechanics, measurement engine, barcode reading system, and is designed to preserve reagent algorithms and performance parameters.

Interaction with the CLINITEK Advantus™ analyzer is via an integrated touch screen. The analyzer features a color touch screen, ability for microscopic data entry, improved communications to LIS/HIS systems, input of load list, improved system QC, easy switching between traditional urine strips and newer strips, such as MULTISTIX PRO. The User is not required to make any calculations. Calibration is performed automatically each time a reagent strip is analyzed.

Assessment of Performance

Studies were conducted as internal laboratory setting and in clinical settings to demonstrate the performance of the CLINITEK Advantus™ analyzer and assess its substantial equivalence against the predicate devices and where applicable the referenced laboratory methods. In addition information on Software Development Life Cycle including software requirements specifications, device hazard analysis, and overall verification and validation activities were included to provide additional assurance of device performance.

Conclusion

In conclusion, these studies demonstrate that the CLINITEK Advantus is similar to both predicates in both Technological Characteristics and Intended Use. The data presented is a summary of external clinical evaluation, internal laboratory evaluation, and software development information. This information provides assurance that the CLINITEK Advantus™ is substantially equivalent to the currently marketed CLINITEK 500 and CLINTIEK 200+.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem featuring a stylized eagle with its wings spread. The eagle is depicted in a simple, graphic style, with bold lines and a sense of motion.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Noor Malki Manager, Regulatory Affairs & Compliance Bayer HealthCare, LLC Diagnostic Division 2 Edgewater Drive Norwood, MA 02062

DEC 2 8 2006

Re: K063276

Trade/Device Name: Bayer CLINITEK AdvantusTM Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: Class II Product Code: JIL, JIO, JFY, JJB, JIN, LJX, JMT, CEN, JIR, JRE, CDM, KQO Dated: October 26, 2006 Received: October 30, 2006

Dear Ms. Malki:

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 vours.

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

Jean 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): K063276

Device Name: CLINITEK Advantus™

Indications For Use:

Kidney Function .
Urinary tract infections .
Metabolic disorders (e.g. diabetes mellitus) .
. Liver Function

Tests performed using the CLINITEK Advantus™ are intended for in vitro diagnostic use.

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 Device Evaluation (OIVD)

Carol C. Benson
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of

K063276

Regulation Number and Section

§ 862.1340 Urinary glucose (nonquantitative) test system.

(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(b)
Classification. Class II.