Cleared Traditional

K963251 - CIBA CORNING ACS

Also marketed or referenced as:
180 DPD ASSAY

K963251 is an FDA 510(k) clearance for CIBA CORNING ACS, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 1 Chemistry device with product code JMM cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K963251 · Ciba Corning Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
57d
Days
Class 1
Risk

K963251 is an FDA 510(k) clearance for the CIBA CORNING ACS. Classified as Column Chromatography & Color Development, Hydroxyproline (product code JMM), Class I - General Controls.

Submitted by Ciba Corning Diagnostics Corp. (Irvine, US). The FDA issued a Cleared decision on October 15, 1996 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1400 - 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 - K963251

510(k) Number K963251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1996
Decision Date October 15, 1996
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

JMM Device Classification - Class 1, General Controls

Product Code JMM Column Chromatography & Color Development, Hydroxyproline
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1400
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 - JMM Column Chromatography & Color Development, Hydroxyproline

All 7
Devices cleared under the same product code (JMM) and FDA review panel - the closest regulatory comparables to K963251.
IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5
K980833 · Diagnostic Products Corp. · May 1998
DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K972580 · Bayer Corp. · Sep 1997
IMMULITE PYRILINKS-D
K971312 · Diagnostic Products Corp. · May 1997
ACTIVE CROSSLAPS ELISA
K960171 · Diagnostic Systems Laboratories, Inc. · Mar 1996
HYPRONOSTICON TM
K770603 · Organon, Inc. · Sep 1977