Cleared Traditional

K072536 - ESA BIOSCIENCES INC. VITAMIN D HPLC TEST

K072536 is an FDA 510(k) clearance for ESA BIOSCIENCES INC. VITAMIN D HPLC TEST, manufactured by Esa Biosciences, Inc.. The device is a Class 2 Chemistry device with product code MRG cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K072536 · Esa Biosciences, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
243d
Days
Class 2
Risk

K072536 is an FDA 510(k) clearance for the ESA BIOSCIENCES INC. VITAMIN D HPLC TEST. Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Esa Biosciences, Inc. (Chelmsford, US). The FDA issued a Cleared decision on May 7, 2008 after a review of 243 days - an extended review 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: 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 Esa Biosciences, Inc. devices

FDA 510(k) Submission Details - K072536

510(k) Number K072536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2007
Decision Date May 07, 2008
Days to Decision 243 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 88d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRG Device Classification - Class 2, Special Controls

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 40
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K072536.
ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
K110619 · Biokit, S.A. · Nov 2011
ADVIA CENTAUR VITAMIN D TOTAL ASSAY
K110586 · Siemens Healthcare Diagnostics, Inc. · Oct 2011
DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,
K102432 · Diazyme Laboratories · Jan 2011
LIAISON 25 OH VITAMIN D TOTAL
K071480 · DiaSorin, Inc. · Oct 2007
1,25-DIHYDROXY VITAMIN D EIA
K051110 · Immunodiagnostic Systems , Ltd. · Jul 2005
GAMMA-B 1,25-DIHYDROXY VITAMIN D
K042519 · Immunodiagnostic Systems , Ltd. · Dec 2004