Cleared Traditional

DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III (K903566) - FDA 510(k) Clearance

Class I Immunology device.

K903566 · Baxter Healthcare Corp · Immunology device
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Sep 1990
Decision
48d
Days
Class 1
Risk

K903566 is an FDA 510(k) clearance for the DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Tampa, US). The FDA issued a Cleared decision on September 24, 1990 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology 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 K903566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1990
Decision Date September 24, 1990
Days to Decision 48 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 104d · This submission: 48d
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 K903566.
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
DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2
K903933 · Baxter Healthcare Corp · Oct 1990
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