Cleared Traditional

Minuteful - kidney test

K210069 · Healthy.Io, Ltd. · Chemistry
Jul 2022
Decision
541d
Days
Class 1
Risk

About This 510(k) Submission

K210069 is an FDA 510(k) clearance for the Minuteful - kidney test, a Indicator Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIR), submitted by Healthy.Io, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on July 6, 2022, 541 days after receiving the submission on January 11, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1645.

Submission Details

510(k) Number K210069 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2021
Decision Date July 06, 2022
Days to Decision 541 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIR — Indicator Method, Protein Or Albumin (urinary, Non-quant.)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1645

Similar Devices — JIR Indicator Method, Protein Or Albumin (urinary, Non-quant.)

All 37
Minuteful-kidney test
K222921 · Healthy.Io, Ltd. · Sep 2023
Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)
K150330 · ACON Laboratories, Inc. · Apr 2015
TECO MICROALBUMIN 2-1 COMBO STRIPS
K061419 · Teco Diagnostics · Jan 2007
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
K022538 · Diagnostic Chemicals, Ltd. (Usa) · Aug 2002
URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING
K001810 · Flexsite Diagnostics, Inc. · Aug 2000
IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15
K994035 · Diagnostic Chemicals , Ltd. · Feb 2000