Cleared Traditional

K091332 - AIA-PACK RBC FOLATE

K091332 is an FDA 510(k) clearance for AIA-PACK RBC FOLATE, manufactured by Tosoh Bioscience, Inc.. The device is a Class 2 Chemistry device with product code CGN cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K091332 · Tosoh Bioscience, Inc. · Chemistry device
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Oct 2009
Decision
149d
Days
Class 2
Risk

K091332 is an FDA 510(k) clearance for the AIA-PACK RBC FOLATE. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Tosoh Bioscience, Inc. (Grove City, US). The FDA issued a Cleared decision on October 2, 2009 after a review of 149 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. 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 Tosoh Bioscience, Inc. devices

FDA 510(k) Submission Details - K091332

510(k) Number K091332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2009
Decision Date October 02, 2009
Days to Decision 149 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
61d slower than avg
Panel avg: 88d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 55
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K091332.
ELECSYS FOLATE III
K141426 · Roche Diagnostics · Oct 2014
ROCHE ELECSYS FOLATE RBC
K103716 · Roche Diagnostics · May 2011
ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74
K092740 · Abbott Laboratories · Mar 2010
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS
K082340 · Roche Diagnostics Corp. · Jun 2009
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