Cleared Traditional

DADE LIPID-TROL (K893580) - FDA 510(k) Clearance

Class I Chemistry device.

K893580 · Baxter Healthcare Corp · Chemistry device
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Jul 1989
Decision
72d
Days
Class 1
Risk

K893580 is an FDA 510(k) clearance for the DADE LIPID-TROL. 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 July 20, 1989 after a review of 72 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 K893580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1989
Decision Date July 20, 1989
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 88d · This submission: 72d
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 165
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K893580.
SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS
K894852 · Instrumentation Laboratory CO · Sep 1989
LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II
K894078 · Bio-Rad · Aug 1989
LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM
K894252 · Bio-Rad · Aug 1989
LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II
K891680 · Bio-Rad · Jun 1989
MONI-TROL(R)
K891929 · Baxter Healthcare Corp · May 1989
RIATRAC PLUS
K890470 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1989