Cleared Traditional

K982328 - BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

K982328 is an FDA 510(k) clearance for BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNO..., manufactured by Bayer Corp.. The device is a Class 2 Chemistry device with 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)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K982328

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.

CJO Device Classification - Class 2, Special Controls

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.
DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI
K122323 · Siemens Healthcare Diagnostics · Aug 2012
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K121907 · Siemens Healthcare Diagnostics · Jul 2012