(178 days)
Not Found
No
The summary describes a standard automated urine chemistry analyzer that reads reagent strips and reports results. There is no mention of AI, ML, or any advanced algorithms beyond basic calibration and reading of color changes on the strips.
No.
The device is an analyzer that reads urine test strips to measure analytes, providing diagnostic information rather than directly treating a condition.
Yes
Explanation: The device measures various analytes in urine (glucose, bilirubin, ketone, etc.) which are indicators of health or disease states, and it is intended for use in a clinical laboratory setting to provide information for diagnosis or monitoring.
No
The device description clearly states it is a portable instrument with hardware components like a display, internal printer, serial computer interface, and touch screen. It also performs physical actions like reading test strips and re-calibrating using a physical bar.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it "reads Bayer reagent test strips for urinalysis... for testing in the clinical laboratory." Urinalysis is a type of in vitro diagnostic testing.
- Device Description: The description details how the device analyzes urine samples using reagent strips to measure various analytes. This process is performed outside of the body (in vitro) to provide diagnostic information.
- Analytes Measured: The list of analytes measured (glucose, bilirubin, ketone, etc.) are all substances found in urine that are used for diagnostic purposes.
- Care Setting: The intended user/care setting is the "clinical laboratory," which is a common environment for performing in vitro diagnostic tests.
The device's function is to analyze a biological sample (urine) outside of the body using chemical reactions (on the reagent strips) to provide information about a patient's health status. This directly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
JFY, JIL, JIP, KQO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K960546, # K992257, # K905396, # K972706
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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, RAC
NPT Regulatory Affairs Manager | |
|------------------------|-----------------------------------------------------------------------------------------------------|--|
| Address: | Bayer Healthcare, LLC
A subsidiary of Bayer Corporation
63 North Street
Medfield, 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 | Clinitek
Microalbumin |
|-------------------|--------------------------|----------------------|----------------------|--------------------------|
| Manufacturer: | Bayer
Healthcare, LLC | Bayer
Corporation | Bayer
Corporation | Bayer
Corporation |
| 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.
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.
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.
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.
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):
Bayer Clinitek Status® Urine Chemistry Analyzer Device Name:
Indications for 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.
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.
(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
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