Cleared Traditional

K112430 - I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE (FDA 510(k) Clearance)

Class I Chemistry device.

K112430 · Abbott Pont of Care, Inc. · Chemistry device
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Dec 2011
Decision
118d
Days
Class 1
Risk

K112430 is an FDA 510(k) clearance for the I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE. Classified as Acid, Lactic, Enzymatic Method (product code KHP), Class I - General Controls.

Submitted by Abbott Pont of Care, Inc. (Princton, US). The FDA issued a Cleared decision on December 20, 2011 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1450 - 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. Standard predicate reliance. 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 Abbott Pont of Care, Inc. devices

Submission Details

510(k) Number K112430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2011
Decision Date December 20, 2011
Days to Decision 118 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 88d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KHP Acid, Lactic, Enzymatic Method
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1450
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.