Cleared Traditional

DADE TDM CONTROL (K883190) - FDA 510(k) Clearance

Class I Pathology device.

K883190 · Baxter Healthcare Corp · Pathology device
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Sep 1988
Decision
43d
Days
Class 1
Risk

K883190 is an FDA 510(k) clearance for the DADE TDM CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on September 9, 1988 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 862.3280 - the FDA pathology 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: 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 K883190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1988
Decision Date September 09, 1988
Days to Decision 43 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 77d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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 - DIF Drug Mixture Control Materials

All 77
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K883190.
DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III
K892380 · Baxter Healthcare Corp · Feb 1990
BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG.
K895816 · Bio-Rad · Dec 1989
EMIT (R) HVA NEGATIVE URINE
K883210 · Syva Co. · Sep 1988
EMIT HVA CONTROL KIT
K881944 · Syva Co. · Jul 1988
LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL
K880145 · Bio-Rad · Jun 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL
K881989 · Bio-Rad · Jun 1988