Cleared Special

K001266 - VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA

K001266 is an FDA 510(k) clearance for VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE..., manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CGN cleared through the Special 510(k) pathway after a 12-day FDA review.

K001266 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
12d
Days
Class 2
Risk

K001266 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE .... 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 May 2, 2000 after a review of 12 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K001266

510(k) Number K001266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2000
Decision Date May 02, 2000
Days to Decision 12 days
Submission Type Special
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
77d faster than avg
Panel avg: 89d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

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 62
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K001266.
ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
K031756 · Roche Diagnostics Corp. · Jun 2003
ABBOTT ARCHITECT FOLATE
K023397 · Abbott Laboratories · Dec 2002
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY
K010050 · Bayer Diagnostics Corp. · Feb 2001
IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06
K993254 · Diagnostic Products Corp. · Nov 1999
AIA-PACK FOLATE ASSAY
K992365 · Tosoh Medics, Inc. · Aug 1999
CHIRON DIAGNOSTICS ACS: 180 FOLATE
K991582 · Chiron Diagnostics Corp. · Jun 1999
K001266 · VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA
Download PDF FDA Summary Ortho-Clinical Diagno…