Cleared Traditional

K831830 - LYRIS MODULAR INFO SYSTEM

K831830 is an FDA 510(k) clearance for LYRIS MODULAR INFO SYSTEM, manufactured by Biovation, Inc.. The device is a Class 1 Chemistry device with product code JQP cleared through the Traditional 510(k) pathway after a 384-day FDA review.

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

FDA 510(k) Submission Details - K831830

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.

JQP Device Classification - Class 1, General Controls

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 56
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K831830.
DIRECT READOUT MODULE ACCESSORY
K861412 · E.I. Dupont DE Nemours & Co., Inc. · May 1986
SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER
K850659 · Syva Co. · Apr 1985
CLINIFACTS 10 DATA MANAGEMENT SYSTEM
K844907 · Miles Laboratories, Inc. · Jan 1985
GELSCAN SOFTWARE 2190
K834490 · Lkb Instruments, Inc. · May 1984
HYBRITECH DATA STATION
K834300 · Hybritech, Inc. · Feb 1984
LABORATORY DATA MGMT SYSTEM SDMS
K831838 · Vickers America Medical Corp. · Jan 1984