Cleared Traditional

K991817 - ADDITIONAL IMS ASSAYS FOR THE BAYER ADV...

K991817 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 CIJ) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K991817 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
56d
Days
Class 2
Risk

K991817 is an FDA 510(k) clearance for the ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM. Classified as Saccharogenic, Amylase (product code CIJ), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on July 22, 1999 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1070 - 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 K991817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1999
Decision Date July 22, 1999
Days to Decision 56 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
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIJ Saccharogenic, Amylase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1070
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 - CIJ Saccharogenic, Amylase

All 28
Devices cleared under the same product code (CIJ) and FDA review panel - the closest regulatory comparables to K991817.
AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
K023396 · Pointe Scientific, Inc., · Dec 2002
AMYLASE (ETHYLIDENE PNGPG7) KIT
K953211 · Randox Laboratories, Ltd. · Jun 1996
AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)
K951494 · Emd Chemicals, Inc. · Dec 1995
LIQUID AMYLASE (CNPG3) REAGENT SET
K940735 · Pointe Scientific, Inc., · Aug 1994
DMA AMYLASE (DEMAND) PROCEDURE
K940010 · Data Medical Associates, Inc. · Mar 1994
OLYMPUS AMYLASE REAGENT
K931301 · Olympus Corp. · Oct 1993