Cleared Traditional

K180577 - BioPlex 2200 25-OH Vitamin D Kit

K180577 is the FDA 510(k) clearance for BioPlex 2200 25-OH Vitamin D Kit by Bio-Rad Laboratories. It is a Class 2 Chemistry device (product code MRG) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K180577 · Bio-Rad Laboratories · Chemistry device
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Jun 2018
Decision
109d
Days
Class 2
Risk

K180577 is an FDA 510(k) clearance for the BioPlex 2200 25-OH Vitamin D Kit. Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on June 22, 2018 after a review of 109 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Bio-Rad Laboratories devices

Submission Details

510(k) Number K180577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2018
Decision Date June 22, 2018
Days to Decision 109 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
21d slower than avg
Panel avg: 88d · This submission: 109d
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 Peers - MRG System, Test, Vitamin D

All 24
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K180577.
Elecsys Vitamin D total III
K210901 · Roche Diagnostics · Sep 2021
ADVIA Centaur Vitamin D Total (VitD)
K200509 · Siemens Healthcare Diagnostics, Inc. · May 2020
MAGLUMI 2000 25-OH Vitamin D
K191499 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Aug 2019
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
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5
K162840 · Roche Diagnostics · Feb 2017