Cleared Traditional

K844907 - CLINIFACTS 10 DATA MANAGEMENT SYSTEM

K844907 is an FDA 510(k) clearance for CLINIFACTS 10 DATA MANAGEMENT SYSTEM, manufactured by Miles Laboratories, Inc.. The device is a Class 1 Chemistry device with product code JQP cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K844907 · Miles Laboratories, Inc. · Chemistry device
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Jan 1985
Decision
32d
Days
Class 1
Risk

K844907 is an FDA 510(k) clearance for the CLINIFACTS 10 DATA MANAGEMENT SYSTEM. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on January 18, 1985 after a review of 32 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.

FDA 510(k) Submission Details - K844907

510(k) Number K844907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1984
Decision Date January 18, 1985
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 89d · This submission: 32d
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 74
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K844907.
BIOVATION MAX DATA MANAGEMENT SYSTEM
K853026 · Biovation, Inc. · Aug 1985
ATAC 2000 CHEMISTRY ANALYZER
K851321 · Turpen Laboratory Systems, Inc. · Apr 1985
SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER
K850659 · Syva Co. · Apr 1985
ISO-DATA IMMUNOASSAY NETWORK SYSTEM
K843365 · Iso-Data, Inc. · Sep 1984
CHEMISTRY CONSOLE
K842401 · Biovation, Inc. · Sep 1984
LYRIS MODULAR INFO SYSTEM
K831830 · Biovation, Inc. · Jun 1984
K844907 · CLINIFACTS 10 DATA MANAGEMENT SYSTEM
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