Cleared Traditional

K182384 - ACR LAB Urine Analysis Test System

K182384 is an FDA 510(k) clearance for ACR LAB Urine Analysis Test System, manufactured by Healthy.Io, Ltd.. The device is a Class 2 Chemistry device with product code JFY cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K182384 · Healthy.Io, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
329d
Days
Class 2
Risk

K182384 is an FDA 510(k) clearance for the ACR LAB Urine Analysis Test System. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Healthy.Io, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on July 26, 2019 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 - K182384

510(k) Number K182384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2018
Decision Date July 26, 2019
Days to Decision 329 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
241d slower than avg
Panel avg: 88d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFY Device Classification - Class 2, Special Controls

Product Code JFY Enzymatic Method, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JFY Enzymatic Method, Creatinine

All 33
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