Cleared Traditional

K910158 - AMYLASE

K910158 is the FDA 510(k) clearance for AMYLASE by Pointe Scientific, Inc.,. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K910158 · Pointe Scientific, Inc., · Chemistry device
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Apr 1991
Decision
105d
Days
Class 2
Risk

K910158 is an FDA 510(k) clearance for the AMYLASE. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on April 30, 1991 after a review of 105 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K910158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1991
Decision Date April 30, 1991
Days to Decision 105 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
17d slower than avg
Panel avg: 88d · This submission: 105d
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 72
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K910158.
ABBOTT QUICKSTART AMYLASE, #5AXX
K920583 · Em Diagnostic Systems, Inc. · Mar 1992
IL TEST(TM) AMLYLASE
K913744 · Instrumentation Laboratory CO · Feb 1992
AMYLASE REAGENT (PROCEDURE 577)
K913858 · Sigma Diagnostics, Inc. · Sep 1991
ROCHE COBAS READY AMYLASE REAGENT
K903309 · Roche Diagnostic Systems, Inc. · Sep 1990
SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404
K903332 · Em Diagnostic Systems, Inc. · Aug 1990
AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS
K902326 · Catachem, Inc. · Jul 1990