Cleared Traditional

K984166 - VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE...

K984166 is the FDA 510(k) clearance for VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE... by Ortho-Clinical Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CGN) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K984166 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
77d
Days
Class 2
Risk

K984166 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNO.... Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on February 5, 1999 after a review of 77 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 Ortho-Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K984166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1998
Decision Date February 05, 1999
Days to Decision 77 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
11d faster than avg
Panel avg: 88d · This submission: 77d
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 50
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K984166.
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
AIA-PACK FOLATE ASSAY
K992365 · Tosoh Medics, Inc. · Aug 1999
ABBOTT ARCHITECT FOLATE
K984301 · Abbott Laboratories · Feb 1999
ABBOTT AXSYM FOLATE
K972232 · Abbott Laboratories · Jun 1997
AIA-PACK FOLATE ASSAY
K964349 · Tosoh Medics, Inc. · Nov 1996