Cleared Traditional

K961142 - STRATEC LIA II ANALYZER

K961142 is an FDA 510(k) clearance for STRATEC LIA II ANALYZER, manufactured by Nichols Institute Diagnostics. The device is a Class 1 Hematology device with product code JJE cleared through the Traditional 510(k) pathway after a 334-day FDA review.

K961142 · Nichols Institute Diagnostics · Hematology device
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Feb 1997
Decision
334d
Days
Class 1
Risk

K961142 is an FDA 510(k) clearance for the STRATEC LIA II ANALYZER. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on February 18, 1997 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2160 - the FDA hematology device 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nichols Institute Diagnostics devices

FDA 510(k) Submission Details - K961142

510(k) Number K961142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1996
Decision Date February 18, 1997
Days to Decision 334 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 113d · This submission: 334d
Pathway characteristics
Predicate-based equivalence.

JJE Device Classification - Class 1, General Controls

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 159
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