Cleared Traditional

K982328 - BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNO...

K982328 is the FDA 510(k) clearance for BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNO... by Bayer Corp.. It is a Class 2 Chemistry device (product code CJO) cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K982328 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
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Jan 1999
Decision
211d
Days
Class 2
Risk

K982328 is an FDA 510(k) clearance for the BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM). Classified as Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes (product code CJO), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on January 29, 1999 after a review of 211 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Bayer Corp. devices

Submission Details

510(k) Number K982328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1998
Decision Date January 29, 1999
Days to Decision 211 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
123d slower than avg
Panel avg: 88d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJO Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 - CJO Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes

Devices cleared under the same product code (CJO) and FDA review panel - the closest regulatory comparables to K982328.
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