Cleared Traditional

K913124 - ROCHE REAGENT FOR AMMONIA

K913124 is the FDA 510(k) clearance for ROCHE REAGENT FOR AMMONIA by Roche Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code JIF) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K913124 · Roche Diagnostic Systems, Inc. · Chemistry device
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Aug 1991
Decision
28d
Days
Class 1
Risk

K913124 is an FDA 510(k) clearance for the ROCHE REAGENT FOR AMMONIA. Classified as Enzymatic Method, Ammonia (product code JIF), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on August 12, 1991 after a review of 28 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K913124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1991
Decision Date August 12, 1991
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
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 23
Devices cleared under the same product code (JIF) and FDA review panel - the closest regulatory comparables to K913124.
AMM
K981467 · Abbott Laboratories · Jun 1998
AMMONIA ASSAY CAT. NO. 200-02
K932556 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1994
BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR
K934925 · Beckman Instruments, Inc. · Apr 1994
PARAMAX AMMONIA REAGENT
K880651 · Baxter Healthcare Corp · Mar 1988
EASY-TEST AMMONIA (AMON) ITEM NO. 16695
K872110 · Em Diagnostic Systems, Inc. · Jul 1987
ABBOTT SPECTRUM AMMONIA REAGENT
K870787 · Abbott Laboratories · Mar 1987