Cleared Traditional

K023397 - ABBOTT ARCHITECT FOLATE

K023397 is an FDA 510(k) clearance for ABBOTT ARCHITECT FOLATE, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CGN cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K023397 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
68d
Days
Class 2
Risk

K023397 is an FDA 510(k) clearance for the ABBOTT ARCHITECT FOLATE. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 16, 2002 after a review of 68 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K023397

510(k) Number K023397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2002
Decision Date December 16, 2002
Days to Decision 68 days
Submission Type Traditional
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
20d faster than avg
Panel avg: 88d · This submission: 68d
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 54
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K023397.
ELECSYS RBC FOLATE HEMOLYZED REAGENT
K051292 · Roche Diagnostics Corp. · Jun 2005
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
K043318 · Roche Diagnostics Corp. · Dec 2004
ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
K031756 · Roche Diagnostics Corp. · Jun 2003
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY
K010050 · Bayer Diagnostics Corp. · Feb 2001
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