Cleared Traditional

K874704 - REFLOTRON AMYLASE

K874704 is an FDA 510(k) clearance for REFLOTRON AMYLASE, 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 47-day FDA review.

K874704 · Boehringer Mannheim Corp. · Chemistry device
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Jan 1988
Decision
47d
Days
Class 2
Risk

K874704 is an FDA 510(k) clearance for the REFLOTRON (R) AMYLASE. 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 January 5, 1988 after a review of 47 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K874704

510(k) Number K874704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1987
Decision Date January 05, 1988
Days to Decision 47 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
41d faster than avg
Panel avg: 88d · This submission: 47d
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 K874704.
PANCREATIC A-AMYLASE PNP
K892848 · Boehringer Mannheim Corp. · Jul 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
A-GENT LIQUID AMYLASE
K873944 · Abbott Laboratories · Nov 1987
BNP-AMYLASE TEST
K873133 · Sclavo, Inc. · Oct 1987
AMYLASE TEST KIT
K872023 · Ciba Corning Diagnostics Corp. · Aug 1987