Cleared Traditional

K991717 - CARESIDE MG

K991717 is an FDA 510(k) clearance for CARESIDE MG, manufactured by Careside, Inc.. The device is a Class 1 Chemistry device with product code JGJ cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K991717 · Careside, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
82d
Days
Class 1
Risk

K991717 is an FDA 510(k) clearance for the CARESIDE MG. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on August 10, 1999 after a review of 82 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 Careside, Inc. devices

FDA 510(k) Submission Details - K991717

510(k) Number K991717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1999
Decision Date August 10, 1999
Days to Decision 82 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 88d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

JGJ Device Classification - Class 1, General Controls

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 85
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K991717.
WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001
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JAS MAGNESIUM REAGENT
K003835 · Jas Diagnostics, Inc. · Mar 2001
MAGNESIUM PRODUCT NO'S, 112-01, 112-02
K991761 · A.P. Total Care, Inc. · Sep 1999
MG
K981791 · Abbott Laboratories · Oct 1998
ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353
K983416 · Boehringer Mannheim Corp. · Oct 1998
MG
K981192 · Abbott Laboratories · May 1998