Cleared Traditional

K914619 - CVM

K914619 is an FDA 510(k) clearance for CVM, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K914619 · Ciba Corning Diagnostics Corp. · Chemistry device
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Nov 1991
Decision
37d
Days
Class 1
Risk

K914619 is an FDA 510(k) clearance for the CVM. 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 November 22, 1991 after a review of 37 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

FDA 510(k) Submission Details - K914619

510(k) Number K914619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1991
Decision Date November 22, 1991
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

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 515
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K914619.
N/T PROTEIN CONTROL UY
K914890 · Behring Diagnostics, Inc. · Feb 1992
LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&2
K914255 · Bio-Rad · Jan 1992
RAI-TROL ELEVATED LIPIDS CONTROL
K915191 · Reagents Applications, Inc. · Dec 1991
CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)
K913133 · Bionostics, Inc. · Sep 1991
LIPID LINEARITY CONTROLS
K913224 · Creative Laboratory Products, Inc. · Sep 1991
CHEM-CHEX
K913687 · Streck Laboratories, Inc. · Sep 1991