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510(k) Data Aggregation
K Number
K242767Device Name
Safecare Urinary Tract Infection Test
Manufacturer
Safecare Biotech (Hangzhou) Co., Ltd.
Date Cleared
2025-01-10
(119 days)
Product Code
JMT, LJX
Regulation Number
862.1510Why did this record match?
Product Code :
JMT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Safecare Urinary Tract Infection Test is for the qualitative detection of Leukocytes (LEU,white blood cells) and nitrite (NIT) in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use.
Device Description
Urinary Tract Infection Test is in vitro diagnostic test device for qualitative detection of leukocyte and nitrite in urine. The device is composed of two-color pads aligned on a strip. One pad is employed for testing leukocyte and the other for nitrite by visually reading the color change of the pad and comparing with the corresponding blocks on a color chart. The Safecare Urinary Tract Infection Test are for the qualitative detection of Leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use only.
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K Number
K170118Device Name
Scanostics UTI Check Application Test System
Manufacturer
Teco Diagnostics
Date Cleared
2017-09-21
(251 days)
Product Code
JMT, KQO, LJX
Regulation Number
862.1510Why did this record match?
Product Code :
JMT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Scanostics UTI Check Application test system consists of the Scanostics UTI Check Application and the URS-2L (UTI) Urine Test Strips. The test system is intended for the qualitative detection of nitrite and leukocytes in urine as an aid in the screening of urinary tract infections (UTI). It is intended for over-the-counter home use only.
Device Description
The Scanostics UTI Check Application test system consists of the Scanostics UTI Check Application and the URS-2L (UTI) Urine Test Strips. The Scanostics UTI Check Application measures the colour developed in two reaction zones (leukocytes and nitrite pads) on the UTI test strip following application of a urine sample. The developed colors are then compared to calibration colours located on the Scanostics backing material and the result for each pad is determined based on the minimum colour distance between the developed colours and calibration colours.
The URS-2L UTI Test Strip comprises of two reagent pads areas, which are absorbent material saturated with chemically active substances, then dried and affixed to the plastic strip with double-sided adhesive.
The backing card comprises of thirty-two (32) calibration colour blocks and three (3) black and white alignment squares printed onto a rigid card stock and die cut to provide a groove for the strip (preventing strip misalignment). The use of the backing card is primarily to compensate for different lighting environments as it allows the calibration colours and the test strip to be subjected to the same conditions as the reagent pads for comparison - this would not be possible if the calibration colours were stored within the application itself.
The representative platform for the test system is the iPhone 6 with iOS 9. The application has been proven to be compatible on the iPhone 6S (iOS 9) and iPod touch (8th gen with iOS 8 and iOS 9). The application's core technology is based on four (4) patents held by Teco Diagnostics (US 8655009, 8877140, 8911679 and 8506901).
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K Number
K100024Device Name
TECO DIAGNOSTICS UTI DETECTION STRIPS
Manufacturer
TECO DIAGNOSTICS
Date Cleared
2011-02-17
(408 days)
Product Code
JMT, LJX, TES
Regulation Number
862.1510Why did this record match?
Product Code :
JMT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Teco Diagnostics UTI Test Strips are intended for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.
Device Description
Teco Diagnostics UTI Test Strips provides tests for the qualitative determination of leukocytes and nitrite in urine. The product is a firm plastic strip to which is affixed two separate dry reagent pad areas that is used for urinalysis. The reagent pad areas are bibulous material saturated with chemically active substances. All UTI Test Strips are carefully packaged along with a desiccant in a sealed, foil pouch. The color chart for reading the strips is on the outside of the foil pouch. A package insert is packaged along with the foil pouch into a box. The package insert contains all the necessary product information. Results of each test are based on the color produced from the reaction of each reagent pad area once the Urine Reagent Strip comes into contact with a urine sample. Each parameter is color coded accordingly as described in the color chart. Results with Teco Diagnostics UTI Test Strips can be obtained in clinically meaningful units directly by comparison with the color chart. The color blocks represent nominal values will vary around the nominal values.
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K Number
K993850Device Name
URINALYSIS REAGENT STRIPS (10 PARAMETERS)
Manufacturer
INTERNATIONAL NEWTECH DEVELOPMENT, INC.
Date Cleared
2000-01-03
(52 days)
Product Code
JMT, CDM, CEN, CIN, JIL, JIN, JIO, JIR, JJB, JMA, JMZ, JRE, LJX
Regulation Number
862.1510Why did this record match?
Product Code :
JMT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Urinalysis Reagent Strips provide tests for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leucocytes in urine.
Device Description
Not Found
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K Number
K990873Device Name
DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE
Manufacturer
AMERITEK, INC.
Date Cleared
1999-09-01
(169 days)
Product Code
JMT, JIR
Regulation Number
862.1510Why did this record match?
Product Code :
JMT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
dBest Urinary Tract Infection Test Kit for Home-Use is a simple one step urinalysis assay for rapid, semi-quantitative detection of the presence of Nitrite and Protein in human urine to aid in the diagnosis of urinary track infection. The dBest Urinary Tract Infection Kits are for home-use only.
Device Description
dBest Urinary Tract Infection Test Kit for Home-Use is a simple one step urinalysis assay for rapid, semi-quantitative detection of the presence of Nitrite and Protein in human urine.
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K Number
K954685Device Name
URITEST - NITRITE IN URINE TEST
Manufacturer
TCPI, INC.
Date Cleared
1996-07-22
(285 days)
Product Code
JMT
Regulation Number
862.1510Why did this record match?
Product Code :
JMT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
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.
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K Number
K960888Device Name
CHEK-STIX U.T.I. SELF-TEST
Manufacturer
BAYER CORP.
Date Cleared
1996-07-05
(123 days)
Product Code
JMT
Regulation Number
862.1510Why did this record match?
Product Code :
JMT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
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K Number
K953672Device Name
FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS
Manufacturer
POLYMER TECHNOLOGY INTL.
Date Cleared
1996-07-01
(329 days)
Product Code
JMT
Regulation Number
862.1510Why did this record match?
Product Code :
JMT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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