Cleared Traditional

FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY (K864882) - FDA 510(k) Clearance

Class I Chemistry device.

K864882 · Pointe Scientific, Inc., · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
40d
Days
Class 1
Risk

K864882 is an FDA 510(k) clearance for the FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Pointe Scientific, Inc., (Detroit, US). The FDA issued a Cleared decision on January 21, 1987 after a review of 40 days - a notably fast clearance cycle.

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: 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K864882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1986
Decision Date January 21, 1987
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
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 K864882.
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