Cleared Traditional

TRI-LEVEL LIGAND CONTROL (K873450) - FDA 510(k) Clearance

Class I Immunology device.

K873450 · Ciba Corning Diagnostics Corp. · Immunology device
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Sep 1987
Decision
25d
Days
Class 1
Risk

K873450 is an FDA 510(k) clearance for the TRI-LEVEL LIGAND CONTROL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on September 21, 1987 after a review of 25 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 Ciba Corning Diagnostics Corp. devices

Submission Details

510(k) Number K873450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1987
Decision Date September 21, 1987
Days to Decision 25 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 104d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 210
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K873450.
LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3
K891475 · Bio-Rad · Aug 1989
AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665
K880039 · Sigma Diagnostics, Inc. · Feb 1988
BILE ACIDS CONTROLS
K873342 · Sigma Diagnostics, Inc. · Oct 1987
TOTAL/IGE THEOPHYLLINE CONTROL SERA
K870151 · 3M Company · Mar 1987
TESTPACK ACUTE HCG SERUM CONTROLS
K863126 · Abbott Laboratories · Sep 1986
EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST
K861221 · Em Diagnostic Systems, Inc. · Apr 1986