# K993850: Urinalysis Reagent Strips (10 Parameters) - Pathway: 510(k) (Traditional) - Applicant: International Newtech Development, Inc. - Decided: Jan 3, 2000 after 52 days - Product code: JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)) - Device class: 1 - Regulation: 21 CFR 862.1510 - Recalls of this device: 2 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage No predicates in its family tree. 4 later devices descend from it; 1 cites it directly. 0 of 5 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - None. FDA’s file for it is a 510(k) statement, which names no predicate. ## Most influential descendants - K040703: Uristik H Series Reagent Strips for Urinalysis (2004), 3 descendants of its own - K082811: Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine Analyzers (2009), 1 descendant of its own - K232317: UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips (2024), 0 descendants of its own - K111999: Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip for Urinalysis, and Healgen 4 Reagent Strip for Urinal (2012), 0 descendants of its own ## Recalls of this device - May 22, 2023 · Class II · Z-0044-2024: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ke - May 22, 2023 · Class II · Z-0057-2024: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ke ## Indications for use Urinalysis Reagent Strips provide tests for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leucocytes in urine. Source page: https://510kreport.com/device/K993850 Methodology: https://510kreport.com/methodology