Cleared Special

K001154 - I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER

K001154 is an FDA 510(k) clearance for I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER, manufactured by I-Stat Corp.. The device is a Class 2 Chemistry device with product code JGS cleared through the Special 510(k) pathway after a 8-day FDA review.

K001154 · I-Stat Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
8d
Days
Class 2
Risk

K001154 is an FDA 510(k) clearance for the I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by I-Stat Corp. (East Windsor, US). The FDA issued a Cleared decision on April 18, 2000 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 - K001154

510(k) Number K001154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date April 18, 2000
Days to Decision 8 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
81d faster than avg
Panel avg: 89d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

JGS Device Classification - Class 2, Special Controls

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
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 - JGS Electrode, Ion Specific, Sodium

All 161
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K001154.
EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER
K002407 · Medica Corp. · Feb 2001
BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER
K002855 · Biocare Corp. · Oct 2000
STATLYTE NA/K/CL/LI ANALYZER
K001761 · Nova Biomedical Corp. · Aug 2000
STAT PROFILE PHOX PLUS ANALYZER
K000895 · Nova Biomedical Corp. · Apr 2000
HICHEM ISE ELECTROLYTE REFERENCE
K992842 · Elan Holdings, Inc. · Nov 1999
HICHEM ISE ELECTROLYTE BUFFER
K992844 · Elan Holdings, Inc. · Nov 1999
K001154 · I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER
Download PDF FDA Summary I-Stat Corp.