Cleared Traditional

K915366 - MODEL 560 EXPRESS CLINICAL CHEMISTRY AN...

K915366 is an FDA 510(k) clearance for MODEL 560 EXPRESS CLINICAL CHEMISTRY AN..., manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 1 Chemistry device with product code JJE cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K915366 · Ciba Corning Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
111d
Days
Class 1
Risk

K915366 is an FDA 510(k) clearance for the MODEL 560 EXPRESS CLINICAL CHEMISTRY ANALYZER. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on March 17, 1992 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K915366

510(k) Number K915366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1991
Decision Date March 17, 1992
Days to Decision 111 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
23d slower than avg
Panel avg: 88d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

JJE Device Classification - Class 1, General Controls

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 145
Devices cleared under the same product code (JJE) and FDA review panel - the closest regulatory comparables to K915366.
BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER
K921661 · Boehringer Mannheim Corp. · Jun 1992
OLYMPUS AU5200 CLINICAL CHEMISTRY ANALYZER
K922220 · Olympus Corp. · Jun 1992
ROCHE COBAS MIRA PLUS
K920402 · Roche Diagnostic Systems, Inc. · Apr 1992
DIMENSION AR CLINICAL CHEMISTRY SYSTEM
K915106 · Dupont Medical Products · Jan 1992
KODAK EKTACHEM DTII SYSTEM
K912844 · Eastman Kodak Company · Sep 1991
AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)
K912024 · Wako Chemicals USA, Inc. · Jul 1991