Cleared Traditional

K892642 - DADE(R) TDM CONTROL

K892642 is an FDA 510(k) clearance for DADE TDM CONTROL, manufactured by Baxter Healthcare Corp. The device is a Class 1 Toxicology device with product code JJY cleared through the Traditional 510(k) pathway after a 296-day FDA review.

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

FDA 510(k) Submission Details - K892642

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.

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 598
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K892642.
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CHEM-CHEX
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CLP COMPREHENSIVE LIPID CONTROL-LR
K896246 · Creative Laboratory Products, Inc. · Jan 1990