Cleared Traditional

K984321 - VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMI...

K984321 is the FDA 510(k) clearance for VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMI... by Ortho-Clinical Diagnostics, Inc.. It is a Class 2 Immunology device (product code CDD) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K984321 · Ortho-Clinical Diagnostics, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Jan 1999
Decision
50d
Days
Class 2
Risk

K984321 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGEN.... Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on January 22, 1999 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1810 - the FDA immunology device 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 K984321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1998
Decision Date January 22, 1999
Days to Decision 50 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 104d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDD Radioassay, Vitamin B12
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1810
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 Immunology devices follow this clearance model.

Regulatory Peers - CDD Radioassay, Vitamin B12

All 55
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K984321.
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
K041133 · Bayer Healthcare, LLC · Jul 2004
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS
K013899 · Ortho-Clinical Diagnostics · Jan 2002
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12
K993571 · Bayer Corp. · Dec 1999
ELECSYS VITAMIN B12 ASSAY
K973702 · Boehringer Mannheim Corp. · Nov 1997
ELECSYS FOLATE
K973674 · Boehringer Mannheim Corp. · Nov 1997
IMMULITE VITAMIN B12 (LKVB1,LKVB5)
K971177 · Diagnostic Products Corp. · May 1997