Cleared Traditional

K853699 - EASY ANALYZER & EASY-TEST REAGENT

K853699 is the FDA 510(k) clearance for EASY ANALYZER & EASY-TEST REAGENT by Diagnostic Systems. It is a Class 1 Chemistry device (product code JJE) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K853699 · Diagnostic Systems · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
21d
Days
Class 1
Risk

K853699 is an FDA 510(k) clearance for the EASY ANALYZER & EASY-TEST REAGENT. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Diagnostic Systems (Gibbstown, US). The FDA issued a Cleared decision on September 25, 1985 after a review of 21 days - a notably fast clearance cycle.

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: 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 Diagnostic Systems devices

Submission Details

510(k) Number K853699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1985
Decision Date September 25, 1985
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 143
Devices cleared under the same product code (JJE) and FDA review panel - the closest regulatory comparables to K853699.
ES 22
K854243 · Boehringer Mannheim Corp. · Nov 1985
KODAKEKTACHEM DTR MODULE
K854138 · Eastman Kodak Company · Nov 1985
HITACHI 704
K854025 · Boehringer Mannheim Corp. · Oct 1985
REFLOTRON SYSTEM
K852133 · Boehringer Mannheim Corp. · Sep 1985
HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193
K853003 · Hi Chem, Inc. · Aug 1985
CLINALYZER MODEL VX-1000
K851638 · Alpkem Corp. · May 1985