Cleared Traditional

AIA-PACK RBC FOLATE (K091332) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091332 · Tosoh Bioscience, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 63
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K091332.
Elecsys Folate III
K233060 · Roche Diagnostics · Jun 2024
Access Folate Assay
K223590 · Beckman Coulter, Inc. · Aug 2023
LIAISON® Folate
K192586 · DiaSorin, Inc. · May 2020
Atellica IM Folate Assay
K172201 · Siemens Healthcare Diagnostics, Inc. · Apr 2018
ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74
K092740 · Abbott Laboratories · Mar 2010
ABBOTT ARCHITECT FOLATE
K023397 · Abbott Laboratories · Dec 2002