Cleared Traditional

K931777 - APO A-1 CHEMILUMINESCENCE ASSAY

K931777 is the FDA 510(k) clearance for APO A-1 CHEMILUMINESCENCE ASSAY by Nichols Institute. It is a Class 1 Immunology device (product code MSJ) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K931777 · Nichols Institute · Immunology device
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Aug 1993
Decision
129d
Days
Class 1
Risk

K931777 is an FDA 510(k) clearance for the APO A-1 CHEMILUMINESCENCE ASSAY. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Nichols Institute (San Juan Capistrano, US). The FDA issued a Cleared decision on August 16, 1993 after a review of 129 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nichols Institute devices

Submission Details

510(k) Number K931777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1993
Decision Date August 16, 1993
Days to Decision 129 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 104d · This submission: 129d
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 31
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K931777.
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K964010 · Beckman Instruments, Inc. · Feb 1997
NICHOLS APO B CHEMILUMINESCENCE ASSAY
K925702 · Nichols Institute Diagnostics · Dec 1992
IL TEST APOLIPOROTEIN B (APO B)
K923080 · Instrumentation Laboratory CO · Oct 1992
IL TEST APOLIPOPROTEIN A1
K923087 · Instrumentation Laboratory CO · Oct 1992