The CLINITEK Status® Urine Chemistry Analyzer is a portable, easy to use instrument which reads Bayer reagent test strips for urinalysis (Multistix brand reagent strips), for testing in the clinical laboratory.

The automated analyzer is intended for the measurement of the following analytes: glucose, bilirubin, ketone, specific gravity, occult blood, pH, protein, urobilinogen, nitrite, leukocytes, albumin and creatinine.

Device Description

The Clinitek Status® Urine Chemistry Analyzer is a portable, easy to use instrument which reads Baver urine reagent test strips (Multistix® brand). for testing in the clinical laboratory.

The Clinitek Status reports semi-quantitatively assays for 12 urine analytes [albumin (protein-low), bilirubin, blood (occult), creatinine, glucose, ketone, leukocyte, nitrite, pH, protein (protein-high), specific gravity, and urobilinogen). Reagent strip results are automatically displayed on the Clinitek Status in one (1) minute. A printed hardcopy can also be created either from the results screen or recalled from memory.

The analyzer features a display, internal printer, a serial computer interface, and either electrical outlet or battery operation. Communication between the operator and the analyzer is made through the display using the user interface touch screen on the front surface of the instrument.

The instrument performs a "self-test" and calibration each time the instrument is turned on. Each time a test is run the analyzer re-calibrates using a white plastic calibration bar located at the back of the test strip table.

AI/ML Overview

Based on the provided text, here's an analysis of the acceptance criteria and the study information for the Clinitek Status Urinalysis Instrument:

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria in a table format with corresponding reported device performance values. Instead, it relies on the concept of substantial equivalence to predicate devices. The core argument for acceptance is that:

"The Clinitek Status instrument is similar in technological characteristics, device performance and intended use therefore is substantially equivalent to the predicate devices, the Clinitek 50 (# K960546), visual Multistix 10SG (# K905396), Clinitek Microalbumin (# K972706) and Multistix PRO 10LS (# K992257)."

This implies that the performance of the Clinitek Status is deemed acceptable if it performs comparably to these already approved predicate devices for the specified analytes. Without a direct table in the provided text, it's not possible to extract specific numerical acceptance thresholds (e.g., minimum sensitivity/specificity) or precise performance metrics for the Clinitek Status itself, as the submission focuses on equivalence.

Therefore, a table of acceptance criteria and reported device performance cannot be generated due to lack of explicit numerical data in the provided K031947 summary. The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence.

Study Information

The document does not contain details of any specific performance study that would fully address many of the requested points below. The submission focuses on demonstrating substantial equivalence primarily through technical characteristics and intended use alignment with predicate devices, rather than presenting a detailed, independent performance study with specific metrics.

Here's an attempt to answer the questions based only on the provided text, acknowledging significant gaps:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document does not describe any specific test set or clinical study.
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):
- Not specified. Since no test set or ground truth establishment process is described, this information is not available.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. No information on a test set or adjudication is provided.
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:
- No MRMC study was mentioned. This device is an automated instrument for reading reagent strips, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable in the context of this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The Clinitek Status is an automated instrument that reads reagent strips; it inherently operates in a "standalone" fashion (algorithm/instrument only) for generating results. However, the document does not describe an independent "standalone performance study" with specific metrics beyond the general claim of substantial equivalence. The mechanism of its operation is standalone, but a dedicated study report is not provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. Given the lack of a detailed performance study, the type of ground truth used (if any controlled testing was done beyond verification against predicate devices) is not mentioned. For urinalysis, typical ground truth might involve quantitative chemical analyses or expert visual interpretation, but the document doesn't confirm this.
The sample size for the training set:
- Not applicable/Not specified. This device is not described as using machine learning or AI models that would require a "training set" in the conventional sense. It's an instrument based on optical detection and established chemistry principles.
How the ground truth for the training set was established:
- Not applicable/Not specified. See point 7.

Summary

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K031947

DEC I 9 2003

Appendix A Summary of Safety and Effectiveness

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

1. Submitters Information

Contact person:	Mary E. Gray, RACNPT Regulatory Affairs Manager
Address:	Bayer Healthcare, LLCA subsidiary of Bayer Corporation63 North StreetMedfield, MA 02052
Phone:	(508) 359-3826
e-mail address:	mary.gray.b@bayer.com
Date Summary Prepared:	June 20, 2003
Device Information
Proprietary Name:	Clinitek Status Urinalysis Instrument
Common Name:	Urine chemistry analyzer
Classification Name:	Automated urinalysis system
Classification Number:	21 CFR 862.2900, Class I
Classification Panel:	Clinical Chemistry and Clinical Toxicology

3. Predicate Device Information

Device Name:	Clinitek 50	Multistix Pro	Multistix 10 SG	ClinitekMicroalbumin
Manufacturer:	BayerHealthcare, LLC	BayerCorporation	BayerCorporation	BayerCorporation
510(k)Number:	# K960546	# K992257	# K905396	# K972706

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Appendix A Summary of Safety and Effectiveness

4. Device Description

The Clinitek Status® Urine Chemistry Analyzer is a portable, easy to use instrument which reads Baver urine reagent test strips (Multistix® brand). for testing in the clinical laboratory.

5. Statement of Intended Use

The Clinitek Status® Urine Chemistry Analyzer is a portable, easy to use instrument which reads Bayer reagent test strips for urinalysis (Multistix® brand reagent strips), for testing in the clinical laboratory.

6. Summary of Technological Characteristics

The Clinitek Status instrument is similar in technological characteristics, device performance and intended use therefore is substantially equivalent to the predicate devices, the Clinitek 50 (# K960546), visual Multistix 10SG (# K905396), Clinitek Microalbumin (# K972706) and Multistix PRO 10LS (# K992257).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 9 2003

Mary E. Gray, RAC NPT Regulatory Affairs Manager Baver HealthCare LLC Diagnostics Division 63 North Street Medfield, MA 02052

Re: K031947

Trade/Device Name: Bayer Clinitek Status® Urine Chemistry Analyzer Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: JFY, JIL, JIP, KQO Dated: October 8, 2003 Received: October 9, 2003

Dear Ms. Gray:

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 º20).

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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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K031947

Bayer Clinitek Status® Urine Chemistry Analyzer Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) RC: 1947

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.