Cleared Traditional

MAGLUMI 2000 25-OH Vitamin D (K191499) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191499 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
56d
Days
Class 2
Risk

K191499 is an FDA 510(k) clearance for the MAGLUMI 2000 25-OH Vitamin D. Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Shenzhen New Industries Biomedical Engineering Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 1, 2019 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1825 - 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 Shenzhen New Industries Biomedical Engineering Co., Ltd. devices

Submission Details

510(k) Number K191499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2019
Decision Date August 01, 2019
Days to Decision 56 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
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MRG System, Test, Vitamin D
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1825
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Consultant

LSI International, Inc.
Joe Shia

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 - MRG System, Test, Vitamin D

All 16
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K191499.
Access 25(OH) Vitamin D Total
K223503 · Beckman Coulter, Inc. · Jan 2023
Elecsys Vitamin D total III
K210901 · Roche Diagnostics · Sep 2021
ADVIA Centaur Vitamin D Total (VitD)
K200509 · Siemens Healthcare Diagnostics, Inc. · May 2020
BioPlex 2200 25-OH Vitamin D Kit
K180577 · Bio-Rad Laboratories · Jun 2018
Diazyme EZ Vitamin D Assay
K172992 · Diazyme Laboratories · Jan 2018
LOCI Total Vitamin D Total Assay, LOCI VITD CAL
K162298 · Siemens Healthcare Diagnostics · Mar 2017