Cleared Traditional

PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER (K870777) - FDA 510(k) Clearance

Class I Chemistry device.

K870777 · Kone Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
15d
Days
Class 1
Risk

K870777 is an FDA 510(k) clearance for the PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Kone Instruments, Inc. (Benseville, US). The FDA issued a Cleared decision on March 13, 1987 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2170 - 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 Kone Instruments, Inc. devices

Submission Details

510(k) Number K870777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1987
Decision Date March 13, 1987
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 88d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJF Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2170
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 - JJF Analyzer, Chemistry, Micro, For Clinical Use

All 12
Devices cleared under the same product code (JJF) and FDA review panel - the closest regulatory comparables to K870777.
SYVA EDMS
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SYVA ETS SYSTEM
K863245 · Syva Co. · Mar 1987
SYNCHRON CX3
K864236 · Beckman Instruments, Inc. · Dec 1986
COBAS MIRA
K851172 · Roche Diagnostic Systems, Inc. · May 1985
IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS
K844586 · Instrumentation Laboratory CO · Dec 1984