Cleared Traditional

K161646 - Diazyme Folate Assay

K161646 is an FDA 510(k) clearance for Diazyme Folate Assay, manufactured by Diazyme Laboratories. The device is a Class 2 Chemistry device with product code CGN cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K161646 · Diazyme Laboratories · Chemistry device
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Nov 2016
Decision
142d
Days
Class 2
Risk

K161646 is an FDA 510(k) clearance for the Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on November 4, 2016 after a review of 142 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 Diazyme Laboratories devices

FDA 510(k) Submission Details - K161646

510(k) Number K161646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2016
Decision Date November 04, 2016
Days to Decision 142 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 88d · This submission: 142d
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 56
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K161646.
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
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