Cleared Traditional

PARAMAX IRON REAGENT (K881104) - FDA 510(k) Clearance

Class I Chemistry device.

K881104 · Baxter Healthcare Corp · Chemistry device
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Apr 1988
Decision
44d
Days
Class 1
Risk

K881104 is an FDA 510(k) clearance for the PARAMAX IRON REAGENT. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on April 28, 1988 after a review of 44 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K881104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1988
Decision Date April 28, 1988
Days to Decision 44 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
44d faster than avg
Panel avg: 88d · This submission: 44d
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 15
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K881104.
EASY-TEST IRON (IRON) ITEM NO. 16686
K892863 · Em Diagnostic Systems, Inc. · Jun 1989
IRON REAGENTS ITEM NUMBER: SR1017
K890304 · Em Diagnostic Systems, Inc. · Feb 1989
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE)
K884355 · Eastman Kodak Company · Dec 1988
LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT
K870986 · Beckman Instruments, Inc. · Apr 1987
IRON(IRN) TESTPACK, ITEM NO. 67659/95
K870144 · Em Diagnostic Systems, Inc. · Feb 1987
SYSTE MATE IRON, HEM NO. 67224
K845020 · Em Diagnostic Systems, Inc. · Jan 1985