Cleared Traditional

K921477 - I-STAT(TM) LEVELS 1

K921477 is the FDA 510(k) clearance for I-STAT(TM) LEVELS 1 by I-Stat Corp.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K921477 · I-Stat Corp. · Chemistry device
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Nov 1992
Decision
217d
Days
Class 1
Risk

K921477 is an FDA 510(k) clearance for the I-STAT(TM) LEVELS 1,2,3 CONTROLS. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by I-Stat Corp. (Ontario K2l 1t9, Canada, CA). The FDA issued a Cleared decision on November 2, 1992 after a review of 217 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 K921477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1992
Decision Date November 02, 1992
Days to Decision 217 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 88d · This submission: 217d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

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