Cleared Traditional

K931366 - TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL

K931366 is the FDA 510(k) clearance for TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL by Medical Analysis Systems, Inc.. It is a Class 1 Immunology device (product code JJY) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K931366 · Medical Analysis Systems, Inc. · Immunology device
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Jul 1993
Decision
133d
Days
Class 1
Risk

K931366 is an FDA 510(k) clearance for the TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL, L-1,2,3. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Medical Analysis Systems, Inc. (Camarillo, US). The FDA issued a Cleared decision on July 28, 1993 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - 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 Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K931366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1993
Decision Date July 28, 1993
Days to Decision 133 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
29d slower than avg
Panel avg: 104d · This submission: 133d
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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