Cleared Traditional

K892848 - PANCREATIC A-AMYLASE PNP

K892848 is an FDA 510(k) clearance for PANCREATIC A-AMYLASE PNP, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code JFJ cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K892848 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K892848

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.

JFJ Device Classification - Class 2, Special Controls

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 79
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
AMYLASE SR LIQUID STABLE REAGENT SET
K885176 · Medical Analysis Systems, Inc. · Feb 1989
AMYLASE 405 CATALOG NUMBER 301-34
K880867 · Diagnostic Chemicals, Ltd. (Usa) · Apr 1988
REFLOTRON (R) AMYLASE
K874704 · Boehringer Mannheim Corp. · Jan 1988