Cleared Traditional

FERROFAST (K863109) - FDA 510(k) Clearance

Class I Chemistry device.

K863109 · J. D. Assoc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1986
Decision
103d
Days
Class 1
Risk

K863109 is an FDA 510(k) clearance for the FERROFAST. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on November 24, 1986 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1410 - 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 J. D. Assoc. devices

Submission Details

510(k) Number K863109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1986
Decision Date November 24, 1986
Days to Decision 103 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 88d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIY Photometric Method, Iron (non-heme)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1410
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 - JIY Photometric Method, Iron (non-heme)

All 66
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K863109.
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061793 · Dade Behring, Inc. · Aug 2006
DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
K060264 · Dade Behring, Inc. · Mar 2006
IRON
K981241 · Abbott Laboratories · May 1998
IL TEST IRON
K972363 · Instrumentation Laboratory CO · Aug 1997
IRON TEST
K935176 · Em Diagnostic Systems, Inc. · Dec 1993
IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R
K930166 · Em Diagnostic Systems, Inc. · Apr 1993