Cleared Traditional

K001387 - I-STAT PORTABLE CLINICAL ANALYZER

K001387 is the FDA 510(k) clearance for I-STAT PORTABLE CLINICAL ANALYZER by I-Stat Corp.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K001387 · I-Stat Corp. · Chemistry device
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Oct 2000
Decision
156d
Days
Class 2
Risk

K001387 is an FDA 510(k) clearance for the I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by I-Stat Corp. (East Windsor, US). The FDA issued a Cleared decision on October 5, 2000 after a review of 156 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 I-Stat Corp. devices

Submission Details

510(k) Number K001387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2000
Decision Date October 05, 2000
Days to Decision 156 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
68d slower than avg
Panel avg: 88d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CGA Glucose Oxidase, Glucose

All 191
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K001387.
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K990649 · Bayer Corp. · Jul 1999