Cleared Special

K031756 - ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY

K031756 is the FDA 510(k) clearance for ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code CGN) cleared through the Special 510(k) pathway after a 19-day FDA review.

K031756 · Roche Diagnostics Corp. · Chemistry device
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Jun 2003
Decision
19d
Days
Class 2
Risk

K031756 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on June 25, 2003 after a review of 19 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K031756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2003
Decision Date June 25, 2003
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 45
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K031756.
FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208
K060774 · Beckman Coulter, Inc. · Apr 2006
ELECSYS RBC FOLATE HEMOLYZED REAGENT
K051292 · Roche Diagnostics Corp. · Jun 2005
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
K043318 · Roche Diagnostics Corp. · Dec 2004
ABBOTT ARCHITECT FOLATE
K023397 · Abbott Laboratories · Dec 2002
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA
K001266 · Ortho-Clinical Diagnostics, Inc. · May 2000
IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06
K993254 · Diagnostic Products Corp. · Nov 1999