Cleared Special

K103716 - ROCHE ELECSYS FOLATE RBC

Also marketed or referenced as:
ROCHE ELECSYS FOLATE RBC CALSET

K103716 is an FDA 510(k) clearance for ROCHE ELECSYS FOLATE RBC, manufactured by Roche Diagnostics. The device is a Class 2 Chemistry device with product code CGN cleared through the Special 510(k) pathway after a 142-day FDA review.

K103716 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
142d
Days
Class 2
Risk

K103716 is an FDA 510(k) clearance for the ROCHE ELECSYS FOLATE RBC. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on May 12, 2011 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1295 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K103716

510(k) Number K103716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2010
Decision Date May 12, 2011
Days to Decision 142 days
Submission Type Special
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
54d slower than avg
Panel avg: 88d · This submission: 142d
Pathway characteristics
Modification to existing cleared device.

CGN Device Classification - Class 2, Special Controls

Product Code CGN Acid, Folic, Radioimmunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1295
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 - CGN Acid, Folic, Radioimmunoassay

All 59
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K103716.
Atellica IM Folate Assay
K172201 · Siemens Healthcare Diagnostics, Inc. · Apr 2018
Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
K161646 · Diazyme Laboratories · Nov 2016
ELECSYS FOLATE III
K141426 · Roche Diagnostics · Oct 2014
ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74
K092740 · Abbott Laboratories · Mar 2010
AIA-PACK RBC FOLATE
K091332 · Tosoh Bioscience, Inc. · Oct 2009
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS
K082340 · Roche Diagnostics Corp. · Jun 2009
K103716 · ROCHE ELECSYS FOLATE RBC
Download PDF FDA Summary Roche Diagnostics