(285 days)
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No
The device is a simple reagent strip test that relies on a chemical reaction to detect nitrite. There is no mention of AI/ML, image processing, or complex data analysis.
No
The device is a diagnostic test used to identify nitrite in urine for the detection of Urinary Tract Infection, not to treat it.
Yes
The device identifies nitrite in urine, which is used for the detection of Urinary Tract Infection. This is a clear indication that it is used to diagnose a medical condition.
No
The device description explicitly states it is a "reagent strip test," which is a physical, hardware component used to measure the presence of nitrite in urine.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "identify nitrite in urine" for the "detection of Urinary Tract Infection." This involves testing a sample (urine) taken from the human body to provide information about a physiological state (presence of UTI).
- Device Description: The description further clarifies that it's a "reagent strip test used to measure the presence of Nitrite in urine." This confirms it's a test performed in vitro (outside the body) on a biological sample.
- Performance Studies: The document describes clinical trials comparing the device to predicate devices, which is a common requirement for IVDs to demonstrate performance and equivalence.
- Key Metrics: The inclusion of metrics like Sensitivity, Specificity, and Accuracy are standard performance indicators for diagnostic tests.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
UriTest- Nitrite in Urine is a nonquantitative test to identify nitrite in urine. Nitrite identification is used for the detection of Urinary Tract Infection.
Product codes
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Device Description
UriTest - Nitrite in Urine is a reagent strip test used to measure the presence of Nitrite in urine. Nitrite is produced by most organisms commonly associated with urinary tract infection. Nitrite is used to detect urinary tract infection.
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
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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
A clinical trial was done to compare the performance of the UriTest to the Bayer Multistix. To assure a sufficient number of positive specimens. a urine sample was spiked with bacteria. Spiked specimens were tested with both the UriTest - Nitrite in Urine and the Bayer Multistix.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical trial was done to compare the performance of the UriTest to the Bayer Multistix. These data clearly demonstrate that the performance of the Uritest is substantially equivalent to the predicate device; Bayer Multistix.
Bayer vs. UriTest (Professional User)
TCPI + (16 observed Bayer +, 7 observed Bayer -)
TCPI - (0 observed Bayer +, 78 observed Bayer -)
Sensitivity = 100.00%
Specificity = 91.76%
Accuracy = 93.07%
Bayer vs. UriTest (Lay User)
TCPI + (16 observed Bayer +, 9 observed Bayer -)
TCPI - (0 observed Bayer +, 76 observed Bayer -)
Sensitivity = 100.00%
Specificity = 89.41%
Accuracy = 91.09%
Spiked Samples (100% agreement observed)
TCPI + (33 observed Bayer +, 0 observed Bayer -)
TCPI - (0 observed Bayer +, 0 observed Bayer -)
Sensitivity = 100.00%
Specificity = Not Valid
Accuracy = 100.00%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Professional User: Sensitivity = 100.00%, Specificity = 91.76%, Accuracy = 93.07%
Lay User: Sensitivity = 100.00%, Specificity = 89.41%, Accuracy = 91.09%
Spiked Samples: Sensitivity = 100.00%, Specificity = Not Valid, Accuracy = 100.00%
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.
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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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§ 862.1510 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.
0
JUL 22
K95-4685/A5-
510k Summary
Date of Summary: July 2, 1996
DUPLICATE
Product Name: Uri-Test - Nitrite in Urine
Product Brand Name: Health Check - Health Check is a subsidiary of TCPI
Sponsor's Name: TCPI - Technical Chemical and Products, Inc. 2241 SOUTH W. 15th ST. POMPANO BEACH, FL 33069
CORRESPONDENT: MDC ASSOCIATES Fran White Regulatory Consultant 15 Oak Street Beverly Farms, Ma 01915
SUBSTANTIALLY EQUIVALENT DEVICES:
Product: MULTISTIX- Reagent Strip for Urinalysis Manufactured by: Bayer Diagnostics
Product: CHEMSTRIP - Urine Test Strip Manufactured by: Boehringer Mannheim
PRODUCT DESCRIPTION:
UriTest - Nitrite in Urine is a reagent strip test used to measure the presence of Nitrite in urine. Nitrite is produced by most organisms commonly associated with urinary tract infection. Nitrite is used to detect urinary tract infection.
INTENDED USE:
UriTest- Nitrite in Urine is a nonquantitative test to identify nitrite in urine. Nitrite identification is used for the detection of Urinary Tract Infection.
1
SUMMARY OF TECHNOLOGY:
Like the predicate device, UriTest Nitrite in Urine test strips are impregnated with the appropriate chemicals (25% w/w Arsanilic Acid, 10% w/w N-1-Naphthylethylendiamine Dihydrochloride, 65% w/w Tartaric Acid). Nitrite if present in patient urine reacts with amine to give an diazonium salt, which couples sulfanilamide to yield a positive pink - red reaction.
PERFORMANCE DATA:
A clinical trial was done to compare the performance of the UriTest to the Bayer Multistix. These data clearly demonstrate that the performance of the Uritest is substantially equivalent to the predicate device; Bayer Multistix.
Bayer vs. UriTest (Professional User)
| Bayer + | Bayer - | |
|---|---|---|
| TCPI + | 16 | 7 |
| TCPI - | 0 | 78 |
| Sensitivity = | 100.00% |
|---|---|
| Specificity = | 91.76% |
| Accuracy = | 93.07% |
Bayer vs. UriTest (Lay User)
| Bayer + | Bayer - | |
|---|---|---|
| TCPI + | 16 | 9 |
| TCPI - | 0 | 76 |
| Sensitivity = | 100.00% |
|---|---|
| Specificity = | 89.41% |
| Accuracy = | 91.09% |
2
To assure a sufficient number of positive specimens. a urine sample was spiked with bacteria. Spiked specimens were tested with both the UriTest - Nitrite in Urine and the Bayer Multistix. 100% agreement was observed.
Spiked Samples
| Bayer + | Bayer - | |
|---|---|---|
| TCPI + | 33 | 0 |
| TCPI - | 0 | 0 |
| Sensitivity = | 100.00% |
|---|---|
| Specificity = | Not Valid |
| Accuracy = | 100.00% |
STATEMENT OF SAFETY AND EFFICACY:
When compared to a Bayer Multistix and performed by untrained consumers, the product performance was as follows:
Sensitivity - 100% Specificity - 89% Accuracy - 90%
These data clearly demonstrate the safety and efficacy of the Uri-Test-Nitrite in Urine.
Technical Chemical and Products, Inc. confirm that any/all data provided in this submission may be released upon request.