(125 days)
MULTISTIX® 10-SG Reagent Strips for Urinalysis (visual readout), CLINITEK® 200+ Urine Chemistry Analyzer, CLINITEK® ATLAS Urine Chemistry Analyzer
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No
The description focuses on reflectance spectrophotometry and standard data management, with no mention of AI/ML terms or functionalities.
No
The device is an analyzer that determines chemical components in urine for diagnostic purposes, not for treating or preventing disease.
Yes
The device "measures the reflectance off a reacted Bayer Reagent Strip for Urinalysis" to determine various substances in urine, such as glucose, bilirubin, and protein. This information is used for "routine urinalysis," which falls under the scope of diagnostic testing to assess a patient's health status.
No
The device description explicitly states it is a "portable reflectance spectrophotometer," which is a hardware device.
Yes, based on the provided information, the CLINITEK 50 Urine Chemistry Analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for the "determination of glucose, bilirubin, ketone, blood, protein, urobilinogen, nitrite and leukocytes in urine, urine pH, specific gravity and color." This involves testing biological samples (urine) in vitro (outside the body) to provide information about a person's health status.
- Device Description: It describes a "reflectance spectrophotometer that instrumentally measures the reflectance off a reacted Bayer Reagent Strip for Urinalysis." This is a common method used in IVD devices to analyze chemical reactions in biological samples.
- Predicate Devices: The predicate devices listed are other urine chemistry analyzers and reagent strips, which are also IVD devices. This further supports the classification.
The core function of analyzing chemical components in a biological sample (urine) outside the body for diagnostic purposes clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CLINITEK 50 Urine Chemistry Analyzer is for use with Bayer Reagent Strips for Urinalysis such as MULTISTIX 10-SG Reagent Strips for the determination of glucose, bilirubin, ketone, blood, protein, urobilinogen, nitrite and leukocytes in urine, urine pH, specific gravity and color. The tests provided on Bayer Reagent Strips and urine color are considered routine urinalysis.
Product codes
75 KQO
Device Description
The CLINITEK 50 Urine Chemistry Analyzer is a portable reflectance spectrophotometer that instrumentally measures the reflectance off a reacted Bayer Reagent Strip for Urinalysis. The CLINITEK 50 Urine Chemistry Analyzer displays and prints urinalysis results and can be connected to a laboratory computer for data management.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Physician office laboratories
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 in-house and in clinical settings to demonstrate that the performance of the CLINITEK 50 Urine Chemistry Analyzer is equivalent to the predicate devices and that the intended user can easily operate the instrument and obtain urinalysis results.
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.
MULTISTIX® 10-SG Reagent Strips for Urinalysis (visual readout), CLINITEK® 200+ Urine Chemistry Analyzer, CLINITEK® ATLAS Urine Chemistry Analyzer
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
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§ 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.
0
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510(k) SAFETY AND EFFECTIVENESS SUMMARY
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| Prepared: | February 5, 1996 | K960546 | |
|---|---|---|---|
| Submitter: | Bayer Corporation, Business Group Diagnostics | ||
| Address: | 1884 Miles Avenue, P. O. Box 70 | ||
| Elkhart, IN 46515 | |||
| (219) 262-6929 | JUN 12 1996 | ||
| Contact: | Rosanne M. Savol, R.A.C. | ||
| Manager, Regulatory Affairs | |||
| Device: | Trade Name: | CLINITEK 50 Urine Chemistry | |
| Analyzer | |||
| Common Name: | Urine chemistry analyzer | ||
| Document Control Number: | K96 | ||
| Classification | |||
| Information: | Division of Clinical Laboratory Devices | ||
| Panel - Clinical Chemistry and Toxicology | |||
| Classification Code -- 75 KQO (automated urinalysis system) | |||
| Predicate Devices: | MULTISTIX® 10-SG Reagent Strips for Urinalysis | ||
| (visual readout) | |||
| CLINITEK® 200+ Urine Chemistry Analyzer | |||
| CLINITEK® ATLAS Urine Chemistry Analyzer | |||
| Device Description: | The CLINITEK 50 Urine Chemistry Analyzer is a portable | ||
| reflectance spectrophotometer that instrumentally measures the | |||
| reflectance off a reacted Bayer Reagent Strip for Urinalysis. | |||
| The CLINITEK 50 Urine Chemistry Analyzer displays and | |||
| prints urinalysis results and can be connected to a laboratory | |||
| computer for data management. | |||
| Intended Use: | The CLINITEK 50 Urine Chemistry Analyzer is for use with | ||
| Bayer Reagent Strips for Urinalysis such as MULTISTIX 10-SG | |||
| Reagent Strips for the determination of glucose, bilirubin, | |||
| ketone, blood, protein, urobilinogen, nitrite and leukocytes in | |||
| urine, urine pH, specific gravity and color. The tests provided | |||
| on Bayer Reagent Strips and urine color are considered routine | |||
| urinalysis. |
1
Bayer Corporation, Business Group Diagnostics CLINITEK® 50 Urine Chemistry Analyzer
Technological Characteristics:
- 1899
The CLINITEK 50 Urine Chemistry Analyzer is a reflectance spectrophotometer. It has similar technological characteristics to other CLINITEK® Urine Chemistry Analyzers such as the CLINITEK 200+ and CLINITEK ATLAS Analyzers. It is a small, portable instrument which makes it suitable for physician office laboratories. The user manually dips a Bayer Reagent Strip into a urine specimen and places it on the CLINITEK 50 Urine Chemistry Analyzer. The instrument times the reactions on the strip, measures the reflectance off the strip and converts the results to clinically meaningful units that correspond to the color chart on the bottle label of the strip. The urinalysis results are displayed on the instrument and can be printed or transferred to a laboratory computer.
Performance Studies:
Studies were conducted in-house and in clinical settings to demonstrate that the performance of the CLINITEK 50 Urine Chemistry Analyzer is equivalent to the predicate devices and that the intended user can easily operate the instrument and obtain urinalysis results.
Conclusion:
The results of in-house and clinical evaluations of the CLINITEK 50 Urine Chemistry Analyzer demonstrate that the device is equivalent in performance to the predicate devices and suitable for its intended use.