Cleared Traditional

K932606 - APOLIPOPROTIEN A-1 (APO A-1)

K932606 is an FDA 510(k) clearance for APOLIPOPROTIEN A-1 (APO A-1), manufactured by Sigma Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JHN cleared through the Traditional 510(k) pathway after a 370-day FDA review.

K932606 · Sigma Diagnostics, Inc. · Chemistry device
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Jun 1994
Decision
370d
Days
Class 1
Risk

K932606 is an FDA 510(k) clearance for the APOLIPOPROTIEN A-1 (APO A-1). Classified as Turbidimetric Method, Lipoproteins (product code JHN), Class I - General Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 2, 1994 after a review of 370 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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. Elevated predicate reliance profile. 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 Sigma Diagnostics, Inc. devices

FDA 510(k) Submission Details - K932606

510(k) Number K932606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1993
Decision Date June 02, 1994
Days to Decision 370 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
282d slower than avg
Panel avg: 88d · This submission: 370d
Pathway characteristics
Predicate-based equivalence.

JHN Device Classification - Class 1, General Controls

Product Code JHN Turbidimetric Method, Lipoproteins
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.