Cleared Traditional

K850209 - QUICK-LYTE

K850209 is the FDA 510(k) clearance for QUICK-LYTE by Seragen Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K850209 · Seragen Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
40d
Days
Class 2
Risk

K850209 is an FDA 510(k) clearance for the QUICK-LYTE. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Seragen Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 27, 1985 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 Seragen Diagnostics, Inc. devices

Submission Details

510(k) Number K850209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1985
Decision Date February 27, 1985
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JGS Electrode, Ion Specific, Sodium

All 116
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K850209.
AVL MODEL 983 ELECTROLYTE ANALYZER
K861087 · Avl Scientific Corp. · Apr 1986
ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA
K852473 · Roche Diagnostic Systems, Inc. · Jul 1985
DC-3 FLUIDS PACK, DC-5 FLUIDS PACK
K852595 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1985
AVL MODEL 982 ELECTROLYTE ANALYZER
K844587 · Avl Scientific Corp. · Jan 1985
CORNING 614 NA/K ANALYZER
K843530 · Corning Medical & Scientific · Dec 1984
STANDARDS & ACCESSORIES FOR NOVA INSTRU
K842873 · Diagnostic Chemicals, Ltd. (Usa) · Oct 1984