Cleared Traditional

K210069 - Minuteful - kidney test (FDA 510(k) Clearance)

Class I Chemistry device.

K210069 · Healthy.Io, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
541d
Days
Class 1
Risk

K210069 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 July 6, 2022 after a review of 541 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Healthy.Io, Ltd. devices

Submission Details

510(k) Number K210069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
453d slower than avg
Panel avg: 88d · This submission: 541d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.

Clinical Evidence

ClinicalTrials.gov
NCT04626271 Completed Interventional Industry-sponsored

Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands

250
Patients (actual)
2
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Albuminuria
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Healthy.io Ltd. (industry)
Started 2020-08-31 → Primary completion 2020-10-23 → Completed 2020-10-25
Primary outcome
Accuracy Evaluation: The Degree of Agreement (%) of the ACR | U.S. Urine Analysis Test System as Compared to the Comparator Device
Secondary outcome
Usability Evaluation: User Performance Analysis
View full study on ClinicalTrials.gov