The Clinitek Status®+ Urine Chemistry Analyzer is a portable easy to use analyzer. It is designed to read only Siemens Reagent Strips for Urinalysis and Clinitest® hCG tests.

This analyzer is intended for the measurement of the following in urine: Albumin, Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).

These measurements are used to assist diagnosis in the following areas:

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

Tests performed using the Clinitek Status®+ Analyzer are intended for in vitro diagnostic use only.

The Clinitek Status®+ Analyzer is intended for near patient (point-of-care) facilities and centralized laboratory locations.

Device Description

The Clinitek Status®+ Analyzer, a device modification to the current Clinitek Status®, is a portable easy to use urine chemistry analyzer. It is designed to read only Siemens Reagent Strips for Urinalysis and Clinitest® hCG tests.

Identical to the Clinitek Status Analyzer, the Clinitek Status+ analyzer is intended for the measurement of the following in urine: Albumin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).

The enhanced Analyzer identifies automatically all instrument-read Siemens strip types and adds a quality check to assess if the strip has been compromised by humidity exposure.

In addition, the enhanced Analyzer provides reporting flexibility by allowing users to select specific test parameters to report from on a given strip and provides enhanced security to allow for user/operator access restrictions.

When the connector is attached to the enhanced analyzer (Clinitek Status+), the model is referred to as Clinitek Status Connect System. Additional functionality is enabled including bar code data entry, quality control management, and connectivity to hospital network.

The optical system consists of six light emitting diodes, a light quide, a mirror, a lens and a detector. Light from the LEDs travels along the light quide and is reflected off the calibration bar, strip or cassette onto the mirror. It is then directed through an aperture on the lens, from where it is focused onto the detector. The light intensity detected is converted into electrical impulses, which are processed by the instrument's microprocessor and converted into clinically meaningful results.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Clinitek Status+ Analyzer and Clinitek Status Connect System, based on the provided 510(k) summary:

Clinitek Status+ Analyzer and Clinitek Status Connect System

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the study as a comparison to a predicate device, focusing on "percent positive agreement (relative sensitivity) and percent negative agreement (relative specificity)." It states that the device "meet prescribed performance requirements." However, specific numerical acceptance criteria or numerical reported performance values for sensitivity and specificity are not provided in the summary. The document only offers a general statement of compliance.

Parameter/Measurement Type	Acceptance Criteria (Not explicitly stated in document, only 'prescribed performance requirements')	Reported Device Performance
Urinalysis Strips (Multistix® 10SG): Percent Positive Agreement (Relative Sensitivity)	"prescribed performance requirements"	"meet prescribed performance requirements for percent positive agreement (relative sensitivity) relative to the predicate device (Clinitek Status)."
Urinalysis Strips (Multistix® 10SG): Percent Negative Agreement (Relative Specificity)	"prescribed performance requirements"	"meet prescribed performance requirements for percent negative agreement (relative specificity) relative to the predicate device (Clinitek Status)."
hCG levels	"prescribed limits"	"performance for both hCG levels tested meet prescribed limits."

2. Sample Size and Data Provenance

Sample Size for Test Set: 150 urine specimens
Data Provenance: The document does not explicitly state the country of origin. It describes the study as "An internal study was conducted to demonstrate the performance." This suggests it was likely conducted in a controlled lab environment by Siemens Healthcare Diagnostics. The study is retrospective in the sense that it evaluates the modified device against an existing predicate device using collected specimens.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

The study compares the modified device's results to the predicate device's results, implying the predicate device's results serve as a form of "ground truth" or reference for performance. The initial ground truth establishment for the predicate device would have likely involved expert consensus, but this is not detailed for this specific study.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not specified. The study directly compares the results of the modified device to the predicate device. It does not describe a process of expert adjudication for discrepancies, but rather a direct comparison of results.

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

MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. This study focuses on the technical performance of the device itself (algorithm only) compared to a predicate device, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Standalone Performance: Yes, a standalone (algorithm only) performance assessment was done. The study specifically investigated "the impact of the proposed software enhancements on performance" and compared the device's readings to the predicate device's readings. This is a standalone evaluation of the device's ability to interpret the strips.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this study was the results obtained from the predicate device (Clinitek Status) when evaluating the same urine specimens. The study aims to show that the modified device's results are substantially equivalent to the predicate device.

8. Sample Size for the Training Set

Sample Size for Training Set: Not specified. The document does not provide details about a separate training set. This study seems to be a verification/validation study for a device with software enhancements, not the initial development of a new algorithm where training data would typically be mentioned.

9. How Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable/not specified, as details about a separate training set or its ground truth establishment are not provided in the summary.

Summary

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510(k) Summary - updated

10 91216

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

Submitter information

Contact person:	Noor MalkiHead, Point of Care Regulatory Affairs
Address:	Siemens Healthcare DiagnosticsPoint of Care Products2 Edgewater DriveNorwood, MA 02062	OCT - 9 2009
Phone:	781-269-3401
Date summary prepared:	September 25, 2009
Device InformationProprietary Name:	Clinitek Status®+ AnalyzerClinitek Status® Connect System
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 Device
Device Name	Clinitek Status
Common name	Urine Chemistry Analyzer
510(k) Number	K031947 and K032563
Manufacturer	Siemens Healthcare Diagnostics Limited

Device Description

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to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).

The enhanced Analyzer identifies automatically all instrument-read Siemens strip types and adds a quality check to assess if the strip has been compromised by humidity exposure.

Statement of Intended Use

The Clinitek Status®+ Analyzer Urine Chemistry Analyzer is a portable easy to use analyzer. It is designed to read only Siemens Reagent Strips for Urinalysis and Clinitest® hCG tests.

This analyzer is intended for the measurement of the following in urine: Albumin, Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocvtes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).

These measurements are used to assist diagnosis in the following areas:

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

Tests performed using the Clinitek Status®+ Analyzer are intended for in vitro diagnostic use only.

The Clinitek Status®+ Analyzer is intended for near patient (point-of-care) facilities and centralized laboratory locations.

Summary of Technological Characteristics

The Clinitek Status+ and Clinitek Status Connect System operating principle, technical platform, instrument and reagent analytical method, and intended use remain the same as the current Clinitek Status analyzer. In addition, it uses the same test strips and cassettes currently used on the Clinitek Status analyzer.

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510(k) Summary - updated

Assessment of Performance

An internal study was conducted to demonstrate the performance of the Clinitek Status+ Analyzer and Clinitek Status Connect System (modified device) and assess its substantial equivalence against the Clinitek Status (predicate device). The scope of the study covered the impact of the proposed software enhancements on performance with both urinalysis strips (Multistix® 10SG) and hCG cassettes (Clinitest® hCG).

Over the study duration, 150 urine specimens were evaluated. The testing was performed to ensure that the software enhancement has not impacted current performance. Based on data analysis, the Urinalysis method comparison results for all 5 of the test conditions meet prescribed performance requirements for percent positive agreement (relative sensitivity) and percent negative agreement (relative specificity) relative to the predicate device (Clinitek Status). Also, performance for both hCG levels tested meet prescribed limits.

In addition information on Software Development Life Cycle including software requirements specifications, risk management report, and overall verification and validation plans were included to provide additional assurance of device performance.

Conclusion

In conclusion, the modified device (Clinitek Status+ and Clinitek Status Connect System) has the same Technological Characteristics and Intended Use as the predicate. The data presented is a summary of risk management activities, internal laboratory performance evaluation and software development information which all provide assurance that the modified device is substantially equivalent to the currently marketed Clinitek Status.

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Image /page/3/Picture/0 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Siemens Healthcare Diagnostics c/o Noor Malki Senior Manager, Regulatory Affairs (POC & Walpole sites) 2 Edgewater Drive, Norwood, MA 02062

OCT - 9 2009

Re: K091216

Trade/Device Name: Clinitek Status+Analyzer And Clinitek Status Connect System, Models 1780, 1797

Regulation Number: 21 CFR 862.1340

Regulation Name: Urinary glucose (nonquantitative) test system.

Regulatory Class: II

Product Code: JIL, JIP, JHI, JFY, JIR, JJB, JIN, LJX, JMT, CEN, JRE, CDM, KOO Dated: September 25, 2009

Received: October 1, 2009

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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) 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 Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Courtney C. 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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Indication for Use

510(k) Number (if known): K091216

Device Name: Clinitek Status®+ Analyzer

Clinitek Status® Connect System (consist of Clinitek Status®+ Analyzer with Connector attached).

Indication For Use:

The Clinitek Status®+ Urine Chemistry Analyzer is a portable easy to use analyzer. It is designed to read only Siemens Reagent Strips for Urinalysis and Clinitest® hCG tests.

These measurements are used to assist diagnosis in the following areas:

Kidney Function
Urinary tract infections

Metabolic disorders (e.g. diabetes mellitus) .

Liver Function

Pregnancy

Tests performed using the Clinitek Status®+ Analyzer are intended for in vitro diagnostic use only.

The Clinitek Status®+ Analyzer is intended for near patient (point-of-care) facilities and centralized laboratory locations.

Prescription Use X (21 CFR Part 801 Subpart D)

Over the
(21 CFR

Over the Counter Use (21 CFR Part 801 Subpart C)

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

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Carol Benson

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

510(k) R 091216

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.