Cleared Traditional

K925702 - NICHOLS APO B CHEMILUMINESCENCE ASSAY

K925702 is the FDA 510(k) clearance for NICHOLS APO B CHEMILUMINESCENCE ASSAY by Nichols Institute Diagnostics. It is a Class 1 Immunology device (product code MSJ) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K925702 · Nichols Institute Diagnostics · Immunology device
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Dec 1992
Decision
41d
Days
Class 1
Risk

K925702 is an FDA 510(k) clearance for the NICHOLS APO B CHEMILUMINESCENCE ASSAY. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on December 23, 1992 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1475 - the FDA immunology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nichols Institute Diagnostics devices

Submission Details

510(k) Number K925702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1992
Decision Date December 23, 1992
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 104d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MSJ Apolipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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 - MSJ Apolipoproteins

All 30
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K925702.
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K921037 · Baxter Diagnostics, Inc. · May 1992