(59 days)
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No
The description focuses on reflectance spectrophotometry and standard laboratory testing procedures, with no mention of AI or ML technologies.
No.
The device is an in vitro diagnostic (IVD) device used to analyze urine and assist in the diagnosis of medical conditions, rather than providing therapy directly.
Yes
The document explicitly states that the measurements provided by the device are "used to assist diagnosis" and that the tests performed are "intended for in vitro diagnostic use."
No
The device description clearly states it is a "semi-automated, benchtop analyzer" and describes physical components like a fixed platform, strip loading station, incubation/read station, waste bin, and internal thermal printer, indicating it is a hardware device with integrated software.
Yes, based on the provided text, the CLINITEK Advantus™ Urinalysis analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "Tests performed using the CLINITEK Advantus™ are intended for in vitro diagnostic use."
- Purpose: The device is designed to analyze urine samples (which are biological specimens) to measure various analytes. These measurements are used to "assist diagnosis" in areas like kidney function, urinary tract infections, metabolic disorders, and liver function. This aligns directly with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for the diagnosis, treatment, or prevention of disease.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JIL, JIO, JFY, JJB, JIN, LJX, JMT, CEN, JIR, JRE, CDM, KQO
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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key results: 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+.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
CLINITEK family internal filing, K926359
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.
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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
§ 862.1340 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.
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Section 5 - 510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter information
| Contact person: | Noor Malki
Manager, Regulatory Affairs & Compliance | |
|-----------------------------|----------------------------------------------------------------------------------------|--------------|
| Address: | Bayer HealthCare, LLC
Diagnostic Division
2 Edgewater Drive
Norwood, 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
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.
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Section 5 - 510(k) Summary
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.
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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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:
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.
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
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