Cleared Traditional

K992399 - ADDITIONAL IMS ASSAYS FOR THE BAYER ADV...

K992399 is the FDA 510(k) clearance for ADDITIONAL IMS ASSAYS FOR THE BAYER ADV... by Bayer Corp.. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K992399 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
58d
Days
Class 2
Risk

K992399 is an FDA 510(k) clearance for the ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on September 15, 1999 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - 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 Bayer Corp. devices

Submission Details

510(k) Number K992399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1999
Decision Date September 15, 1999
Days to Decision 58 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
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
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 - CIX Bromcresol Green Dye-binding, Albumin

All 76
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K992399.
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
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VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4
K023875 · Ortho-Clinical Diagnostics, Inc. · Dec 2002
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
K011720 · Olympus America, Inc. · Jun 2001
ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
K991576 · Bayer Corp. · Jun 1999
RANDOX ALBUMIN
K984494 · Randox Laboratories, Ltd. · Mar 1999
ALBG
K981758 · Abbott Laboratories · Jun 1998