Cleared Traditional

K901758 - ROCHE REAGENT FOR MAGNESIUM

K901758 is the FDA 510(k) clearance for ROCHE REAGENT FOR MAGNESIUM by Roche Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code JGJ) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K901758 · Roche Diagnostic Systems, Inc. · Chemistry device
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May 1990
Decision
35d
Days
Class 1
Risk

K901758 is an FDA 510(k) clearance for the ROCHE REAGENT FOR MAGNESIUM. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on May 23, 1990 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1495 - 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 K901758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1990
Decision Date May 23, 1990
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JGJ Photometric Method, Magnesium
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1495
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 - JGJ Photometric Method, Magnesium

All 58
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K901758.
MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK
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TECHNICON CHEM I SYSTEM MAGNESIUM METHOD
K903306 · Technicon Instruments Corp. · Aug 1990
SYNERMED MAGNESIUM REAGENT KIT
K902919 · Synermed, Inc. · Jul 1990
CHEM I CLINICAL ANALYZER URINE MAGNESIUM
K901124 · Technicon Instruments Corp. · May 1990
COULTER MAGNESIUM REAGENT
K901265 · Coulter Corp. · Mar 1990
MAGNESIUM TEST ITEM NUMBER: 65419
K894508 · Em Diagnostic Systems, Inc. · Aug 1989