Cleared Traditional

K222921 - Minuteful-kidney test

K222921 is an FDA 510(k) clearance for Minuteful-kidney test, manufactured by Healthy.Io, Ltd.. The device is a Class 1 Chemistry device with product code JIR cleared through the Traditional 510(k) pathway after a 347-day FDA review.

K222921 · Healthy.Io, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
347d
Days
Class 1
Risk

K222921 is an FDA 510(k) clearance for the Minuteful-kidney test. Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by Healthy.Io, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on September 8, 2023 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1645 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Healthy.Io, Ltd. devices

FDA 510(k) Submission Details - K222921

510(k) Number K222921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2022
Decision Date September 08, 2023
Days to Decision 347 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
259d slower than avg
Panel avg: 88d · This submission: 347d
Pathway characteristics
Predicate-based equivalence.

JIR Device Classification - Class 1, General Controls

Product Code JIR Indicator Method, Protein Or Albumin (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1645
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JIR Indicator Method, Protein Or Albumin (urinary, Non-quant.)

All 28
Devices cleared under the same product code (JIR) and FDA review panel - the closest regulatory comparables to K222921.
Minuteful - kidney test
K210069 · Healthy.Io, Ltd. · Jul 2022
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K061419 · Teco Diagnostics · Jan 2007
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
K022538 · Diagnostic Chemicals, Ltd. (Usa) · Aug 2002
IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15
K994035 · Diagnostic Chemicals , Ltd. · Feb 2000
NEW MULTIPLES REAGENT STRIPS
K992257 · Bayer Corp. · Nov 1999