Cleared Special

K012478 - MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER

K012478 is an FDA 510(k) clearance for MODIFICATION TO: I-STAT PORTABLE CLINIC..., manufactured by I-Stat Corp.. The device is a Class 2 Chemistry device with product code CHL cleared through the Special 510(k) pathway after a 18-day FDA review.

K012478 · I-Stat Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
18d
Days
Class 2
Risk

K012478 is an FDA 510(k) clearance for the MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by I-Stat Corp. (East Windsor, US). The FDA issued a Cleared decision on August 20, 2001 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - 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.

FDA 510(k) Submission Details - K012478

510(k) Number K012478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2001
Decision Date August 20, 2001
Days to Decision 18 days
Submission Type Special
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
71d faster than avg
Panel avg: 89d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

CHL Device Classification - Class 2, Special Controls

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
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 - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 186
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K012478 · MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER
Download PDF FDA Summary I-Stat Corp.