Cleared Traditional

K931366 - TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL, L-1,2,3

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

K931366 · Medical Analysis Systems, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K931366

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
28d slower than avg
Panel avg: 105d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

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)

All 594
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K931366.
BECKMAN VIGIL PLUS CONTROL
K930850 · Beckman Instruments, Inc. · Sep 1993
LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2
K933317 · Bio-Rad · Aug 1993
DADE(R) TUMOR MARKER CONTROL
K924919 · Baxter Diagnostics, Inc. · Aug 1993
LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II
K932076 · Bio-Rad · Jun 1993
DOCUMENT ENZYME
K932458 · Casco Standards · Jun 1993
MULTITROL IMMUNOLOGY CONTROL
K923663 · Behring Diagnostics, Inc. · Jun 1993