Cleared Traditional

PANCREATIC A-AMYLASE PNP (K892848) - FDA 510(k) Clearance

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

K892848 · Boehringer Mannheim Corp. · Chemistry device
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Jul 1989
Decision
93d
Days
Class 2
Risk

K892848 is an FDA 510(k) clearance for the PANCREATIC A-AMYLASE PNP. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 20, 1989 after a review of 93 days - within the typical 510(k) review window.

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 K892848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1989
Decision Date July 20, 1989
Days to Decision 93 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
5d slower than avg
Panel avg: 88d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFJ Catalytic Methods, 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 - JFJ Catalytic Methods, Amylase

All 38
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K892848.
AMYLASE REAGENT
K896650 · Sigma Chemical Co. · Feb 1990
AMYLASE TEST (AML) ITEM NUMBER: 65404
K893751 · Em Diagnostic Systems, Inc. · Aug 1989
ABBOTT SPECTRUM AMYLASE REAGENT
K891241 · Abbott Laboratories · Aug 1989
REFLOTRON (R) AMYLASE
K874704 · Boehringer Mannheim Corp. · Jan 1988
A-GENT LIQUID AMYLASE
K873944 · Abbott Laboratories · Nov 1987
RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)
K871269 · Technicon Instruments Corp. · Apr 1987