Cleared Traditional

K911854 - DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL

K911854 is the FDA 510(k) clearance for DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL by Baxter Healthcare Corp. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K911854 · Baxter Healthcare Corp · Chemistry device
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Jun 1991
Decision
45d
Days
Class 1
Risk

K911854 is an FDA 510(k) clearance for the DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on June 10, 1991 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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: 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K911854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1991
Decision Date June 10, 1991
Days to Decision 45 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
43d faster than avg
Panel avg: 88d · This submission: 45d
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)

All 319
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K911854.
DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL
K912455 · Baxter Healthcare Corp · Aug 1991
LINEARITY TEST KITS
K912441 · Boehringer Mannheim Corp. · Jul 1991
ANEMIA I, II
K911984 · Ciba Corning Diagnostics Corp. · Jun 1991
CHEM-CHEX LIPID
K905389 · Streck Laboratories, Inc. · Dec 1990
QCLYTE PROTEIN BASED ISE CONTROL
K904968 · Baxter Healthcare Corp · Dec 1990
KODATROL I AND II CONTROL AND DILUENT SET
K904768 · Eastman Kodak Company · Nov 1990