Cleared Traditional

-AMYLASE EPS (K882225) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 10
Devices cleared under the same product code (CIJ) and FDA review panel - the closest regulatory comparables to K882225.
OLYMPUS AMYLASE REAGENT
K931301 · Olympus Corp. · Oct 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
D.A.T. (TM) AMYLASE REAGENT
K871943 · Behring Diagnostics, Inc. · Jun 1987
AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1
K863719 · Technicon Instruments Corp. · Nov 1986
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95
K860935 · Em Diagnostic Systems, Inc. · May 1986