Cleared Traditional

K931141 - BIOTROL AMYLASE CNPG3

K931141 is the FDA 510(k) clearance for BIOTROL AMYLASE CNPG3 by Biotrol, USA, Inc.. It is a Class 2 Chemistry device (product code CIJ) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K931141 · Biotrol, USA, Inc. · Chemistry device
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May 1993
Decision
82d
Days
Class 2
Risk

K931141 is an FDA 510(k) clearance for the BIOTROL AMYLASE CNPG3. Classified as Saccharogenic, Amylase (product code CIJ), Class II - Special Controls.

Submitted by Biotrol, USA, Inc. (Exton, US). The FDA issued a Cleared decision on May 26, 1993 after a review of 82 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 Biotrol, USA, Inc. devices

Submission Details

510(k) Number K931141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1993
Decision Date May 26, 1993
Days to Decision 82 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 88d · This submission: 82d
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 28
Devices cleared under the same product code (CIJ) and FDA review panel - the closest regulatory comparables to K931141.
LIQUID AMYLASE (CNPG3) REAGENT SET
K940735 · Pointe Scientific, Inc., · Aug 1994
DMA AMYLASE (DEMAND) PROCEDURE
K940010 · Data Medical Associates, Inc. · Mar 1994
OLYMPUS AMYLASE REAGENT
K931301 · Olympus Corp. · Oct 1993
-AMYLASE EPS
K882225 · Boehringer Mannheim Corp. · Jan 1989
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