(123 days)
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No
The description details a simple chemical test strip and does not mention any computational analysis, image processing, or AI/ML terms.
No
The device is a diagnostic test kit used to detect urinary tract infections by analyzing urine samples, not to treat them.
Yes
The device is described as a "home use test for nitrite and leukocytes (WBC's) in urine" intended to "detect urinary tract infections," which actively identifies a specific condition, falling under the definition of a diagnostic device.
No
The device description explicitly states it is a "plastic strip to which is affixed two reagent pads," indicating it is a physical hardware device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "Detection of Urinary Tract Infection" by testing for "nitrite and leukocytes (WBC's) in urine." This involves examining a specimen (urine) in vitro (outside the body) to gain information about a person's health status (presence of a UTI).
- Device Description: The device is a "plastic strip to which is affixed two reagent pads to test for nitrite and leukocytes (WBC's) in a urine specimen." This describes a tool used to perform a test on a biological sample.
- Performance Studies: The description of the performance studies mentions testing in "clinical settings" and comparing results obtained by "lay persons" and "health care professionals" using the device on urine samples. This further confirms its use in a diagnostic context.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that description perfectly.
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Intended Use / Indications for Use
CHEK-STIX U.T.I. Test Strips for the Detection of Urinary Tract Infection is an O.T.C. home use test for nitrite and leukocytes (WBC's) in urine. It is intended to be used by lay persons to detect urinary tract infections.
Product codes
CH(75), JMT, LJX
Device Description
CHEK-STIX U.T.I. Test Strips for the Detection of Urinary Tract Infection is a plastic strip to which is affixed two reagent pads to test for nitrite and leukocytes (WBC's) in a urine specimen. The product is provided as a carton containing a bottle of five strips and a package insert.
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
lay persons / O.T.C. home use
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
A study was conducted in clinical settings to demonstrate that lay persons can obtain results with CHEK-STIX U.T.I. comparable to results obtained by health care professionals.
Summary of Performance Studies
Study Type: Lay person use evaluation.
Sample Size: Not specified.
Key Results: Agreement between the two groups was 97% for the nitrite test and 85% for the WBC test.
Key Metrics
Agreement for nitrite test: 97%
Agreement for WBC test: 85%
Predicate Device(s)
MULTISTIX® 2 Reagent Strips for Urinalysis
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1510 Nitrite (nonquantitative) test system.
(a)
Identification. A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.(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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JU - 5 1996 510(k) SAFETY AND EFFECTIVENESS SUMMARY June 19, 1996 Prepared: Bayer Corporation, Business Group Diagnostics Submitter: 1884 Miles Avenue, P. O. Box 70 Address: Elkhart, IN 46515 (219) 262-6929 Rosanne M. Savol, R.A.C. Contact: Manager, Regulatory Affairs Trade/Proprietary Name: CHEK-STIX U.T.I. Test Strips for Device: the Detection of Urinary Tract Infection Test for nitrite in urine Common/Usual Name: Test for leukocytes (WBC's) in urine Document Control Number: K960888 Classification Division of Clinical Laboratory Devices Information: Panel - Clinical Chemistry and Toxicology Classification Codes -- CH(75) JMT [Diazo (Colorimetric), Nitrite (Urinary, Non-Quant.)] CH(75) LJX (Urine Leukocyte Test) Predicate Device: MULTISTIX® 2 Reagent Strips for Urinalysis Manufactured by Bayer Corporation CHEK-STIX U.T.I. Test Strips for the Detection of Device Description: Urinary Tract Infection is a plastic strip to which is affixed two reagent pads to test for nitrite and leukocytes (WBC's) in a urine specimen. The product is provided as a carton containing a bottle of five strips and a package insert. CHEK-STIX U.T.I. Test Strips for the Detection of Intended Use: Urinary Tract Infection is an O.T.C. home use test for nitrite and leukocytes (WBC's) in urine. It is intended to be used by lay persons to detect urinary tract infections.
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Technological Characteristics:
CHEK-STIX U.T.I. Test Strips are dry reagent strips which, when in contact with a urine specimen, reacts with nitrite and leukocyte esterase in the specimen to give a pink and a purple color. The color of the strip is compared to a color chart on the bottle label to obtain the result. CHEK-STIX U.T.I. has the same test pads as are on strips used by doctors and clinical labs.
Assessment of Performance:
A study was conducted in clinical settings to demonstrate that lay persons can obtain results with CHEK-STIX U.T.I. comparable to results obtained by health care professionals.
Agreement between the two groups was 97% for the nitrite test and 85% for the WBC test.
Conclusion:
The results of the patient-use evaluation demonstrate that lay persons can use CHEK-STIX U.T.I. Test Strips and obtain results that are in agreement with results obtained by health care professionals. The instructions are simple to understand and afford the home user a way to detect urinary tract infections.