Cleared Traditional

K894576 - CIBA CORNING CERTAIN LYTE

K894576 is an FDA 510(k) clearance for CIBA CORNING CERTAIN LYTE, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 1 Chemistry device with product code JJR cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K894576 · Ciba Corning Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
101d
Days
Class 1
Risk

K894576 is an FDA 510(k) clearance for the CIBA CORNING CERTAIN LYTE. Classified as Electrolyte Controls (assayed And Unassayed) (product code JJR), Class I - General Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on October 30, 1989 after a review of 101 days - within the typical 510(k) review window.

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: 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 - K894576

510(k) Number K894576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1989
Decision Date October 30, 1989
Days to Decision 101 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
13d slower than avg
Panel avg: 88d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

JJR Device Classification - Class 1, General Controls

Product Code JJR Electrolyte 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 - JJR Electrolyte Controls (assayed And Unassayed)

All 9
Devices cleared under the same product code (JJR) and FDA review panel - the closest regulatory comparables to K894576.
RNA MEDICAL HEMAT CONTROL
K955630 · Bionostics, Inc. · Mar 1996
AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL
K951435 · Aalto Scientific, Ltd. · May 1995
SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING
K943925 · Quantimetrix Corp. · Oct 1994
QCLYTE PROTEIN-BASED ISE CONTROL
K895582 · Baxter Healthcare Corp · Oct 1989
DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET
K881773 · Casco Standards · Jun 1988
PROTEIN BASE ISE CONTROL
K880710 · Bionostics, Inc. · Mar 1988