Cleared Traditional

K861844 - GLUCOFACTS DATA MANAGEMENT SYSTEM

K861844 is the FDA 510(k) clearance for GLUCOFACTS 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 91-day FDA review.

K861844 · Miles Laboratories, Inc. · Chemistry device
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Aug 1986
Decision
91d
Days
Class 1
Risk

K861844 is an FDA 510(k) clearance for the GLUCOFACTS 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 August 12, 1986 after a review of 91 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K861844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1986
Decision Date August 12, 1986
Days to Decision 91 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
3d slower than avg
Panel avg: 88d · This submission: 91d
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 K861844.
COBAS MFC
K885292 · Roche Diagnostic Systems, Inc. · Mar 1989
KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM
K871339 · Kallestad Diag, A Div. of Erbamont, Inc. · May 1987
710 PLUS
K864557 · Ciba Corning Diagnostics Corp. · Feb 1987
GLUCOFACTS DATA PRINTER
K861779 · Miles Laboratories, Inc. · Aug 1986
CLINIFACTS 200 DATA MANAGEMENT SYSTEM
K861778 · Miles Laboratories, Inc. · Jul 1986
DIRECT READOUT MODULE ACCESSORY
K861412 · E.I. Dupont DE Nemours & Co., Inc. · May 1986