Cleared Traditional

LYRIS MODULAR INFO SYSTEM (K831830) - FDA 510(k) Clearance

Class I Chemistry device.

K831830 · Biovation, Inc. · Chemistry device
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Jun 1984
Decision
384d
Days
Class 1
Risk

K831830 is an FDA 510(k) clearance for the LYRIS MODULAR INFO SYSTEM. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Biovation, Inc. (Walker, US). The FDA issued a Cleared decision on June 25, 1984 after a review of 384 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Biovation, Inc. devices

Submission Details

510(k) Number K831830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1983
Decision Date June 25, 1984
Days to Decision 384 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
296d slower than avg
Panel avg: 88d · This submission: 384d
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 77
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K831830.
CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM
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K850659 · Syva Co. · Apr 1985
DUPONT LINEARIZATION MODULE
K832746 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1983
EMIT CLINICAL PROCESSOR #CP-5000
K822932 · Syva Co. · Nov 1982