Cleared Traditional

GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED (K861000) - FDA 510(k) Clearance

Class I Chemistry device.

K861000 · Ciba Corning Diagnostics Corp. · Chemistry device
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Apr 1986
Decision
16d
Days
Class 1
Risk

K861000 is an FDA 510(k) clearance for the GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on April 3, 1986 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry 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 K861000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1986
Decision Date April 03, 1986
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 88d · This submission: 16d
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 222
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K861000.
GILFORD UNIQUAL NORMAL CONTROL SERUM - ASSAYED
K861068 · Ciba Corning Diagnostics Corp. · Apr 1986
PRECINORM IM AND PRECIPATH IM
K860970 · Boehringer Mannheim Corp. · Apr 1986
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED
K860998 · Ciba Corning Diagnostics Corp. · Apr 1986
BOVINE CHEMISTRY CONTROL I.X AND II.X
K860355 · American Dade · Mar 1986
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO
K850574 · American Dade · Apr 1985
DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H
K850575 · American Dade · Apr 1985