Cleared Traditional

K882225 - -AMYLASE EPS

K882225 is an FDA 510(k) clearance for -AMYLASE EPS, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code CIJ cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K882225 · Boehringer Mannheim Corp. · Chemistry device
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Jan 1989
Decision
222d
Days
Class 2
Risk

K882225 is an FDA 510(k) clearance for the -AMYLASE EPS. Classified as Saccharogenic, Amylase (product code CIJ), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 3, 1989 after a review of 222 days - an extended review 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: 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K882225

510(k) Number K882225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1988
Decision Date January 03, 1989
Days to Decision 222 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 88d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIJ Device Classification - Class 2, Special Controls

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 K882225.
DMA AMYLASE (DEMAND) PROCEDURE
K940010 · Data Medical Associates, Inc. · Mar 1994
OLYMPUS AMYLASE REAGENT
K931301 · Olympus Corp. · Oct 1993
BIOTROL AMYLASE CNPG3
K931141 · Biotrol, USA, Inc. · May 1993
ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL
K873250 · Roche Diagnostic Systems, Inc. · Oct 1987
IL 35260, IL TEST AMYLASE REAGENT
K873572 · Instrumentation Laboratory CO · Oct 1987
BIOTROL ALPHA AMYLASE
K872831 · Biotrol, USA, Inc. · Sep 1987