Cleared Traditional

PARAMAX AMMONIA REAGENT (K880651) - FDA 510(k) Clearance

Class I Chemistry device.

K880651 · Baxter Healthcare Corp · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
36d
Days
Class 1
Risk

K880651 is an FDA 510(k) clearance for the PARAMAX AMMONIA REAGENT. Classified as Enzymatic Method, Ammonia (product code JIF), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on March 24, 1988 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1065 - 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 K880651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1988
Decision Date March 24, 1988
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIF Enzymatic Method, Ammonia
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1065
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 - JIF Enzymatic Method, Ammonia

All 14
Devices cleared under the same product code (JIF) and FDA review panel - the closest regulatory comparables to K880651.
AMM
K981467 · Abbott Laboratories · Jun 1998
BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR
K934925 · Beckman Instruments, Inc. · Apr 1994
ROCHE REAGENT FOR AMMONIA
K913124 · Roche Diagnostic Systems, Inc. · Aug 1991
EASY-TEST AMMONIA (AMON) ITEM NO. 16695
K872110 · Em Diagnostic Systems, Inc. · Jul 1987
ABBOTT SPECTRUM AMMONIA REAGENT
K870787 · Abbott Laboratories · Mar 1987
AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95
K870143 · Em Diagnostic Systems, Inc. · Feb 1987