Cleared Traditional

DADE(R) TDM CONTROL (K892642) - FDA 510(k) Clearance

Class I Toxicology device.

K892642 · Baxter Healthcare Corp · Toxicology device
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Feb 1990
Decision
296d
Days
Class 1
Risk

K892642 is an FDA 510(k) clearance for the DADE(R) TDM 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 February 2, 1990 after a review of 296 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1660 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K892642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1989
Decision Date February 02, 1990
Days to Decision 296 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 87d · This submission: 296d
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 K892642.
AFFINITY HLH TEST SYSTEM
K903407 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1990
PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM
K902536 · Boehringer Mannheim Corp. · Jul 1990
PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM
K902573 · Boehringer Mannheim Corp. · Jul 1990
LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3
K895905 · Bio-Rad · Jan 1990
SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS
K894852 · Instrumentation Laboratory CO · Sep 1989
LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II
K894078 · Bio-Rad · Aug 1989