Cleared Traditional

K844907 - CLINIFACTS 10 DATA MANAGEMENT SYSTEM

K844907 is the FDA 510(k) clearance for CLINIFACTS 10 DATA MANAGEMENT SYSTEM by Miles Laboratories, Inc.. It is a Class 1 Chemistry device (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.

View all Miles Laboratories, Inc. devices

Submission Details

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
56d faster than avg
Panel avg: 88d · This submission: 32d
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 48
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K844907.
CLINIFACTS 200 DATA MANAGEMENT SYSTEM
K861778 · Miles Laboratories, Inc. · Jul 1986
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K861412 · E.I. Dupont DE Nemours & Co., Inc. · May 1986
SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER
K850659 · Syva Co. · Apr 1985
GELSCAN SOFTWARE 2190
K834490 · Lkb Instruments, Inc. · May 1984
HYBRITECH DATA STATION
K834300 · Hybritech, Inc. · Feb 1984
ACLAIM-QAP IBM PERSONAL COMPUTER EDT
K833353 · American Dade · Dec 1983