Cleared Special

K051292 - ELECSYS RBC FOLATE HEMOLYZED REAGENT

K051292 is an FDA 510(k) clearance for ELECSYS RBC FOLATE HEMOLYZED REAGENT, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with product code CGN cleared through the Special 510(k) pathway after a 30-day FDA review.

K051292 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
30d
Days
Class 2
Risk

K051292 is an FDA 510(k) clearance for the ELECSYS RBC FOLATE HEMOLYZED REAGENT. 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 17, 2005 after a review of 30 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.

FDA 510(k) Submission Details - K051292

510(k) Number K051292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2005
Decision Date June 17, 2005
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
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 K051292.
AIA-PACK RBC FOLATE
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FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208
K060774 · Beckman Coulter, Inc. · Apr 2006
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
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ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
K031756 · Roche Diagnostics Corp. · Jun 2003
ABBOTT ARCHITECT FOLATE
K023397 · Abbott Laboratories · Dec 2002
K051292 · ELECSYS RBC FOLATE HEMOLYZED REAGENT
Download PDF FDA Summary Roche Diagnostics Cor…