Cleared Traditional

RIA SOFTWARE (K832760) - FDA 510(k) Clearance

Class I Chemistry device.

K832760 · Kemble Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1983
Decision
56d
Days
Class 1
Risk

K832760 is an FDA 510(k) clearance for the RIA SOFTWARE. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Kemble Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2100 - 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 Kemble Instruments, Inc. devices

Submission Details

510(k) Number K832760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1983
Decision Date October 14, 1983
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
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 - JQP Calculator/data Processing Module, For Clinical Use

All 30
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K832760.
CLINIFACTS 10 DATA MANAGEMENT SYSTEM
K844907 · Miles Laboratories, Inc. · Jan 1985
ACLAIM-QAP IBM PERSONAL COMPUTER EDT
K833353 · American Dade · Dec 1983
DUPONT LINEARIZATION MODULE
K832746 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1983
QAP MICROCOMPUTER SYSTEM
K823110 · American Dade · Nov 1982
EMIT CLINICAL PROCESSOR #CP-5000
K822932 · Syva Co. · Nov 1982
SYVA LAB PROCESSOR 6000
K822381 · Syva Co. · Aug 1982