Cleared Traditional

K991907 - ADDITIONAL IMS ASSAYS FOR THE BAYER ADV...

K991907 is the FDA 510(k) clearance for ADDITIONAL IMS ASSAYS FOR THE BAYER ADV... by Bayer Corp.. It is a Class 2 Immunology device (product code CZW) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K991907 · Bayer Corp. · Immunology device
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Nov 1999
Decision
155d
Days
Class 2
Risk

K991907 is an FDA 510(k) clearance for the ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM. Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on November 9, 1999 after a review of 155 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bayer Corp. devices

Submission Details

510(k) Number K991907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1999
Decision Date November 09, 1999
Days to Decision 155 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
51d slower than avg
Panel avg: 104d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZW Complement C3, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - CZW Complement C3, Antigen, Antiserum, Control

All 32
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K991907.
DIMENSION C3 FLEX REAGENT CARTRIDGE
K994296 · Dade Behring, Inc. · Mar 2000
C3 MININEPH ANTISERUM
K981783 · The Binding Site, Ltd. · Dec 1999
K-ASSAY C3
K993437 · Kamiya Biomedical Co. · Nov 1999
C3
K983441 · Abbott Laboratories · Nov 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
K964842 · Beckman Instruments, Inc. · Jun 1997
OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT
K962409 · Olympus America, Inc. · Oct 1996