Cleared Special

FORESIGHT U120 URINE ANALYZER (K120124) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K120124 · ACON Laboratories, Inc. · Chemistry device
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Mar 2012
Decision
49d
Days
Class 2
Risk

K120124 is an FDA 510(k) clearance for the FORESIGHT U120 URINE ANALYZER. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on March 6, 2012 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1340 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all ACON Laboratories, Inc. devices

Submission Details

510(k) Number K120124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2012
Decision Date March 06, 2012
Days to Decision 49 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1340
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 - JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)

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