Cleared Traditional

K040508 - VITALAB MAGNESIUM REAGENT

K040508 is an FDA 510(k) clearance for VITALAB MAGNESIUM REAGENT, manufactured by Clinical Data, Inc.. The device is a Class 1 Chemistry device with product code JGJ cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K040508 · Clinical Data, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
10d
Days
Class 1
Risk

K040508 is an FDA 510(k) clearance for the VITALAB MAGNESIUM REAGENT. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Clinical Data, Inc. (Brea, US). The FDA issued a Cleared decision on March 8, 2004 after a review of 10 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 Clinical Data, Inc. devices

FDA 510(k) Submission Details - K040508

510(k) Number K040508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2004
Decision Date March 08, 2004
Days to Decision 10 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 88d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Entela, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JGJ Photometric Method, Magnesium

All 83
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K040508.
EASYRA MG REAGENT, MODEL 10220
K092737 · Medica Corp. · Nov 2009
PICCOLO MAGNESIUM TEST SYSTEM
K091910 · Abaxis, Inc. · Oct 2009
MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7
K063208 · Diagnostic Chemicals , Ltd. · Jan 2007
PICCOLO MAGNESIUM TEST SYSTEM
K040115 · Abaxis, Inc. · Jan 2004
WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001
K012326 · Wiener Laboratories Saic · Nov 2001
JAS MAGNESIUM REAGENT
K003835 · Jas Diagnostics, Inc. · Mar 2001