Cleared Traditional

K150330 - Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)

K150330 is an FDA 510(k) clearance for Mission Urinalysis Reagent Strips (Micr..., manufactured by ACON Laboratories, Inc.. The device is a Class 1 Chemistry device with product code JIR cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K150330 · ACON Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
79d
Days
Class 1
Risk

K150330 is an FDA 510(k) clearance for the Mission Urinalysis Reagent Strips (Microalbumin/Creatinine). Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on April 30, 2015 after a review of 79 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all ACON Laboratories, Inc. devices

FDA 510(k) Submission Details - K150330

510(k) Number K150330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2015
Decision Date April 30, 2015
Days to Decision 79 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
9d faster than avg
Panel avg: 88d · This submission: 79d
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 K150330.
Minuteful-kidney test
K222921 · Healthy.Io, Ltd. · Sep 2023
Minuteful - kidney test
K210069 · Healthy.Io, Ltd. · Jul 2022
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
IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15
K994035 · Diagnostic Chemicals , Ltd. · Feb 2000
NEW MULTIPLES REAGENT STRIPS
K992257 · Bayer Corp. · Nov 1999