Cleared Traditional

K812556 - DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C

K812556 is the FDA 510(k) clearance for DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C by American Dade. It is a Class 1 Immunology device (product code JJY) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K812556 · American Dade · Immunology device
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Nov 1981
Decision
55d
Days
Class 1
Risk

K812556 is an FDA 510(k) clearance for the DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on November 2, 1981 after a review of 55 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 American Dade devices

Submission Details

510(k) Number K812556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1981
Decision Date November 02, 1981
Days to Decision 55 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
49d faster than avg
Panel avg: 104d · This submission: 55d
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 463
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K812556.
ORTHO* UNASSAYED CONTROL SERUM LEVEL I
K813321 · Ortho Diagnostic Systems, Inc. · Dec 1981
ORTHO* UNASSAYED CONTROL SERUM LEVEL III
K813322 · Ortho Diagnostic Systems, Inc. · Dec 1981
ORTHO UNASSAYED CONTROL SERUM LEVEL II
K813167 · Ortho Diagnostic Systems, Inc. · Nov 1981
BECKMAN ICS NORMAL CONTROL SERA
K812650 · Beckman Instruments, Inc. · Oct 1981
BOVINE CHEMISTRY CONTROL I.X. & II.X.
K812583 · American Dade · Sep 1981
HELENA FETAL-TEK 200 MARKER
K811695 · Helena Laboratories · Jul 1981